INNERDYNE INC
S-1/A, 1996-05-10
SURGICAL & MEDICAL INSTRUMENTS & APPARATUS
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<PAGE>
   
      AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON MAY 10, 1996
    
 
                                                       REGISTRATION NO. 333-3196
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
 
                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549
                         ------------------------------
   
                                AMENDMENT NO. 2
    
                                       TO
                                    FORM S-1
                             REGISTRATION STATEMENT
                                     UNDER
                           THE SECURITIES ACT OF 1933
                            ------------------------
                                INNERDYNE, INC.
             (Exact Name of Registrant as specified in its charter)
 
<TABLE>
<S>                              <C>                            <C>
           DELAWARE                          3841                  87-0431168
 (State or other jurisdiction    (Primary Standard Industrial   (I.R.S. Employer
              of                 Classification Code Number)     Identification
incorporation or organization)                                      Number)
</TABLE>
 
                              1244 REAMWOOD AVENUE
                              SUNNYVALE, CA 94089
                                 (408) 745-6010
              (Address, including zip code, and telephone number,
       including area code, of Registrant's principal executive offices)
 
                               WILLIAM G. MAVITY
                     PRESIDENT AND CHIEF EXECUTIVE OFFICER
                                INNERDYNE, INC.
                              1244 REAMWOOD AVENUE
                              SUNNYVALE, CA 94089
                                 (408) 745-6010
           (Name, address, including zip code, and telephone number,
                   including area code, of agent for service)
                         ------------------------------
 
                                   COPIES TO:
 
<TABLE>
<S>                                       <C>
           Cathryn S. Chinn                           Mark E. Bonham
          Glen R. Van Ligten                        Robert D. Brownell
           Laura A. Gordon                             Warren Chao
          VENTURE LAW GROUP,                WILSON SONSINI GOODRICH & ROSATI,
      A Professional Corporation                 Professional Corporation
         2800 Sand Hill Road                        650 Page Mill Road
         Menlo Park, CA 94025                    Palo Alto, CA 94304-1050
            (415) 854-4488                            (415) 493-9300
</TABLE>
 
                         ------------------------------
 
        APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
AS SOON AS PRACTICABLE AFTER THE EFFECTIVE DATE OF THIS REGISTRATION STATEMENT.
 
    If  any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to  Rule 415 under the Securities Act  of
1933, check the following box. /X/
 
    If  this Form  is filed  to register  additional securities  for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list  the  Securities  Act  registration number  of  the  earlier  effective
registration statement for the same offering. / /
 
    If  this Form  is a post-effective  amendment filed pursuant  to Rule 462(c)
under the Securities Act,  check the following box  and list the Securities  Act
registration number of the earlier effective registration statement for the same
offering. / /
 
    If  delivery of the prospectus is expected  to be made pursuant to Rule 434,
please check the following box. / /
 
                         ------------------------------
 
    REGISTRANT HEREBY AMENDS THIS REGISTRATION  STATEMENT ON SUCH DATE OR  DATES
AS  MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE
A FURTHER AMENDMENT WHICH SPECIFICALLY  STATES THAT THIS REGISTRATION  STATEMENT
SHALL  THEREAFTER  BECOME  EFFECTIVE  IN ACCORDANCE  WITH  SECTION  8(A)  OF THE
SECURITIES ACT  OF  1933  OR  UNTIL THIS  REGISTRATION  STATEMENT  SHALL  BECOME
EFFECTIVE  ON  SUCH  DATE  AS THE  SECURITIES  AND  EXCHANGE  COMMISSION, ACTING
PURSUANT TO SAID SECTION 8(A), MAY DETERMINE.
 
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<PAGE>
                                INNERDYNE, INC.
                             CROSS REFERENCE SHEET
         PURSUANT TO ITEM 501(b) of Regulation S-K Showing Location in
                     Prospectus of Part I Items of Form S-1
 
<TABLE>
<CAPTION>
                  ITEM NUMBER AND HEADING
            IN FORM S-1 REGISTRATION STATEMENT                                LOCATION IN PROSPECTUS
- -----------------------------------------------------------  ---------------------------------------------------------
<C>        <S>                                               <C>
       1.  Forepart of the Registration Statement and
            Outside Front Cover Page of Prospectus.........  Outside Front Cover Page
 
       2.  Inside Front and Outside Back Cover Pages of
            Prospectus.....................................  Inside Front and Outside Back Cover Page
 
       3.  Summary Information, Risk Factors and Ratio of
            Earnings to Fixed Charges......................  Prospectus Summary; Risk Factors
 
       4.  Use of Proceeds.................................  Use of Proceeds
 
       5.  Determination of Offering Price.................  Underwriting
 
       6.  Dilution........................................  Dilution
 
       7.  Selling Security Holders........................  Principal and Selling Stockholders
 
       8.  Plan of Distribution............................  Outside and Inside Front Cover Pages; Underwriting
 
       9.  Description of Securities to be Registered......  Description of Capital Stock; Underwriting
 
      10.  Interests of Named Experts and Counsel..........  Legal Matters; Experts
 
      11.  Information with Respect to the Registrant......  Outside and Inside Front Cover Pages; Prospectus Summary;
                                                              The Company; Risk Factors; Dividend Policy;
                                                              Capitalization; Selected Financial Data; Management's
                                                              Discussion and Analysis of Financial Condition and
                                                              Results of Operations; Business; Management; Certain
                                                              Transactions; Principal and Selling Stockholders;
                                                              Description of Capital Stock; Shares Eligible for Future
                                                              Sale; Financial Statements
 
      12.  Disclosure of Commission Position on
            Indemnification for Securities Act
            Liabilities....................................  Not Applicable
</TABLE>
<PAGE>
INFORMATION   CONTAINED  HEREIN  IS  SUBJECT   TO  COMPLETION  OR  AMENDMENT.  A
REGISTRATION STATEMENT  RELATING TO  THESE SECURITIES  HAS BEEN  FILED WITH  THE
SECURITIES  AND EXCHANGE  COMMISSION. THESE SECURITIES  MAY NOT BE  SOLD NOR MAY
OFFERS TO BUY BE ACCEPTED PRIOR  TO THE TIME THE REGISTRATION STATEMENT  BECOMES
EFFECTIVE.  THIS  PROSPECTUS  SHALL  NOT  CONSTITUTE AN  OFFER  TO  SELL  OR THE
SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE  SECURITIES
IN  ANY STATE IN WHICH SUCH OFFER,  SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR
TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE.
<PAGE>
PROSPECTUS
 
   
                   SUBJECT TO COMPLETION, DATED MAY 10, 1996
                                2,350,000 SHARES
    
 
                                     [LOGO]
                                  COMMON STOCK
 
   
    All of the 2,350,000 shares of Common Stock offered hereby are being sold by
InnerDyne, Inc. ("InnerDyne" or  the "Company"). The  Company's Common Stock  is
traded  on the Nasdaq National  Market under the symbol  "IDYN." On May 8, 1996,
the last sale price of the Common  Stock was $3.875 per share. See "Price  Range
of Common Stock."
    
 
                            ------------------------
 
    PROSPECTIVE  INVESTORS SHOULD CONSIDER CAREFULLY  THE DISCUSSION UNDER "RISK
FACTORS" COMMENCING ON PAGE 5.
                              --------------------
 
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES  AND
   EXCHANGE  COMMISSION  OR ANY  STATE  SECURITIES COMMISSION  NOR  HAS THE
     SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION
       PASSED UPON THE  ACCURACY OR ADEQUACY  OF THIS PROSPECTUS.  ANY
                REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE
 
<TABLE>
<S>                                         <C>                 <C>                 <C>
                                                                   UNDERWRITING
                                                                    DISCOUNTS
                                                 PRICE TO              AND             PROCEEDS TO
                                                  PUBLIC         COMMISSIONS (1)       COMPANY (2)
Per Share.................................          $                   $                   $
Total (3).................................  $                   $                   $
</TABLE>
 
(1)  The  Company  has  agreed to  indemnify  the  Underwriters  against certain
    liabilities, including  liabilities under  the Securities  Act of  1933,  as
    amended  (the  "Securities Act").  The Company  has also  agreed to  sell to
    Cruttenden Roth Incorporated, the  representative (the "Representative")  of
    the  several Underwriters  (the "Underwriters"),  for nominal consideration,
    warrants to purchase up to 235,000  shares of Common Stock exercisable at  a
    per share price equal to 120% of the Price to Public. See "Underwriting."
 
   
(2)  Before deducting expenses  payable by the Company  estimated to be $575,000
    (including  the  Representative's  nonaccountable  expense  allowance).  See
    "Underwriting."
    
 
(3)  The Company and the selling  stockholders (the "Selling Stockholders") have
    granted to the Underwriters a 45-day  option to purchase up to an  aggregate
    of   352,500   additional   shares   of  Common   Stock   solely   to  cover
    over-allotments, if any.  To the extent  that the option  is exercised,  the
    Underwriters  will offer the additional shares  at the Price to Public shown
    above. If the Underwriters exercise the over-allotment option, the Company's
    independent directors will determine whether such shares will be sold by the
    Company or  by  the Selling  Stockholders.  If  all shares  subject  to  the
    over-allotment  option are sold  by the Company, the  total Price to Public,
    Underwriting Discounts  and  Commissions and  Proceeds  to Company  will  be
    $          , $          and $          , respectively. If the over-allotment
    shares are sold by the Selling Stockholders, no additional proceeds will  be
    received  by the Company, and Selling  Stockholders will receive proceeds of
    $        . See "Underwriting."
 
    The shares of Common Stock are offered by the several Underwriters when,  as
and  if delivered to and  accepted by the Underwriters,  subject to the right to
reject any  order in  whole  or in  part and  certain  other conditions.  It  is
expected  that delivery of such shares will be made at the offices of Cruttenden
Roth Incorporated, Irvine,  California or  at the facilities  of the  Depository
Trust Company on or about              , 1996.
 
                            ------------------------
 
                                CRUTTENDEN ROTH
                                  INCORPORATED
 
               THE DATE OF THIS PROSPECTUS IS             , 1996
<PAGE>
                                     [LOGO]
 
    InnerDyne  designs,  develops,  manufactures  and  commercializes  minimally
invasive surgical access products incorporating its proprietary radial  dilation
technologies for laparoscopic procedures. The Company is exploring the potential
use of its radial dilation technology in other applications, such as intra-organ
access,  vascular access, orthopedic procedures  and feeding tube placement. The
Company also has  proprietary technology in  the areas of  thermal ablation  and
biocompatible   coatings,  which  it  intends   to  continue  developing  either
internally or through strategic alliances.
 
A pictorial depiction of a STEP product that has partially penetrated an
abdominal wall.
        RADIALLY EXPANDING STEP-REGISTERED TRADEMARK- WITH BLUNT DILATOR
 
A pictorial depiction of a trocar that is being manipulated by a hand and that
has partially penetrated an abdominal wall.
                    CONVENTIONAL TROCAR WITH SHARP METAL TIP
 
    A COMPANY-SPONSORED STUDY HAS SHOWN THAT  THE WOUND LEFT BY THE Step  DEVICE
AFTER  A LAPAROSCOPIC PROCEDURE IS APPROXIMATELY  ONE-HALF THE SIZE OF THAT MADE
WITH A TROCAR.
                            ------------------------
 
    IN CONNECTION WITH THIS OFFERING, THE UNDERWRITERS MAY OVER-ALLOT OR  EFFECT
TRANSACTIONS WHICH STABILIZE OR MAINTAIN THE MARKET PRICE OF THE COMMON STOCK OF
THE  COMPANY AT  A LEVEL ABOVE  THAT WHICH  MIGHT OTHERWISE PREVAIL  IN THE OPEN
MARKET. SUCH TRANSACTIONS MAY BE EFFECTED ON THE NASDAQ NATIONAL MARKET, IN  THE
OVER-THE-COUNTER  MARKET OR  OTHERWISE. SUCH  STABILIZING, IF  COMMENCED, MAY BE
DISCONTINUED AT ANY TIME.
 
    IN CONNECTION  WITH THE  OFFERING, CERTAIN  UNDERWRITERS AND  SELLING  GROUP
MEMBERS  (IF ANY)  OR THEIR RESPECTIVE  AFFILIATES MAY ENGAGE  IN PASSIVE MARKET
MAKING TRANSACTIONS IN THE COMMON STOCK  OF THE COMPANY ON NASDAQ IN  ACCORDANCE
WITH RULE 10B-6A UNDER THE SECURITIES EXCHANGE ACT OF 1934. SEE "UNDERWRITING."
 
    R.E.D.-Registered  Trademark- and  TRC-Registered Trademark-  are registered
trademarks of  the Company.  ENABL-TM-, INNERDYNE-TM-,  the InnerDyne  logo  and
STEP-TM- are trademarks of the Company. Trademarks of other entities may also be
referred to in this Prospectus.
<PAGE>
                               PROSPECTUS SUMMARY
 
    THE  FOLLOWING SUMMARY  IS QUALIFIED  IN ITS  ENTIRETY BY  THE MORE DETAILED
INFORMATION, INCLUDING  "RISK  FACTORS,"  AND  FINANCIAL  STATEMENTS  AND  NOTES
THERETO,  APPEARING  ELSEWHERE  IN  THIS  PROSPECTUS.  THE  DISCUSSION  IN  THIS
PROSPECTUS  CONTAINS   FORWARD-LOOKING  STATEMENTS   THAT  INVOLVE   RISKS   AND
UNCERTAINTIES.  THE COMPANY'S ACTUAL RESULTS  COULD DIFFER MATERIALLY FROM THOSE
DISCUSSED HERE.  FACTORS THAT  COULD  CAUSE OR  CONTRIBUTE TO  SUCH  DIFFERENCES
INCLUDE,  BUT ARE NOT LIMITED TO, THOSE DISCUSSED IN THE SECTIONS ENTITLED "RISK
FACTORS," "MANAGEMENT'S  DISCUSSION  AND  ANALYSIS OF  FINANCIAL  CONDITION  AND
RESULTS  OF OPERATIONS" AND "BUSINESS," AS  WELL AS THOSE DISCUSSED ELSEWHERE IN
THIS PROSPECTUS.
 
    InnerDyne,  Inc.   ("InnerDyne"  or   the  "Company")   designs,   develops,
manufactures  and commercializes  minimally invasive  surgical ("M.I.S.") access
products incorporating its proprietary  radial dilation technology. The  Company
also   has  proprietary  technology  in  the   areas  of  thermal  ablation  and
biocompatible  coatings,  which  it   intends  to  continue  developing   either
internally or through strategic alliances.
 
    The  Company's STEP  access products enable  a surgeon to  perform an M.I.S.
procedure without  the  use of  a  sharp-bladed trocar  to  gain access  to  the
patient's  abdominal cavity. Access with the  Company's STEP product is provided
by inserting an  expandable sheath into  the body  cavity through the  use of  a
standard  insufflation needle, creating only a  small puncture wound. The needle
is then removed  and the sheath  is expanded to  an appropriately sized  working
channel  by insertion of a blunt dilator  and cannula into the sheath. The blunt
dilator is then removed,  leaving the cannula in  place. The radial dilation  of
the puncture wound into an appropriately sized working channel holds the cannula
in  place and obviates  the need for  an anchoring system  that can increase the
wound size left following surgery and increase trauma to adjacent tissues. After
completion of  the  procedure, the  rigid  cannula  is removed  and  the  sheath
retracts,  permitting the opening  in the abdominal musculature  to recover to a
residual wound size  that is approximately  half the  size of that  made with  a
trocar of similar size.
 
    The  Company believes that the positive attributes of the STEP product could
significantly affect  health care  system costs  and patient  satisfaction  with
M.I.S.  procedures in which trocars have traditionally been used. The results of
a Company-sponsored  retrospective  comparative outcomes  study  examining  this
issue  were released during  the fourth quarter  of 1995. The  study included 98
patients and compared an almost equal number of procedures performed using  STEP
devices  and conventional trocars for  access. Statistically significant results
of that study  indicated that STEP  reduced device-related complications  during
surgery  by over  90% and  resulted in an  approximately 22%  savings in surgery
time. Based upon published operating room costs, this time savings would  equate
to  dollar savings of $345 to $515  per procedure. Management also believes that
post-procedure complications, such as infection and incisional hernias at access
sites, may  be  reduced  with  the  use  of  the  STEP  device  as  compared  to
conventional trocars.
 
    It  is  estimated that  in 1994  over  1.0 million  procedures traditionally
accomplished through  open surgery  were performed  in the  United States  using
M.I.S.  techniques. Domestic M.I.S. procedures  are expected by industry sources
to grow at a  rate of almost 11%  through 1997, to a  level of over 1.4  million
procedures.  Furthermore, it  is estimated that  more than  5.3 million domestic
surgical procedures performed in 1994 were considered to be potential candidates
for minimally invasive approaches.
 
    InnerDyne is exploring the potential use of its proprietary radial  dilation
technology for intra-organ access with its Radially Expanding Dilator ("R.E.D.")
product  and  in  other  applications  such  as  vascular  access,  feeding tube
placement and  orthopedic  procedures. The  Company  has also  made  significant
investments  in research and development of its proprietary thermal ablation and
biocompatible coatings technology. The  Company's ENABL Thermal Ablation  System
is  designed to  treat excessive  menstrual bleeding  by thermally  ablating the
endometrial lining of the uterus. The Company recently announced the signing  of
an  agreement with Boston Scientific  Corporation ("Boston Scientific") covering
the potential  application  and  use of  InnerDyne's  proprietary  biocompatible
coating  technologies with Boston Scientific's stents, grafts, vena cava filters
and other implantable medical devices. The Company intends to continue to pursue
licensing of  its  biocompatible  coatings technologies  to  third  parties  for
various applications.
 
                                       3
<PAGE>
                                  THE OFFERING
 
<TABLE>
<S>                                 <C>
Common Stock offered hereby.......  2,350,000 shares
Common Stock to be outstanding
 after the offering...............  20,939,911 shares (1)(2)
Use of Proceeds...................  To  fund additional development activities and expansion
                                    of marketing, sales and manufacturing activities and for
                                    general corporate purposes, including working capital.
Nasdaq National Market Symbol.....  IDYN
</TABLE>
 
                             SUMMARY FINANCIAL DATA
                     (IN THOUSANDS, EXCEPT PER SHARE DATA)
 
   
<TABLE>
<CAPTION>
                                                                                           THREE MONTHS ENDED
                                                            YEAR ENDED DECEMBER 31,            MARCH 31,
                                                       ---------------------------------  --------------------
                                                          1993        1994       1995       1995       1996
                                                       ----------  ----------  ---------  ---------  ---------
<S>                                                    <C>         <C>         <C>        <C>        <C>
STATEMENT OF OPERATIONS DATA:
  Revenue............................................  $       43  $      879  $   5,275  $   1,235  $   1,582
  Operating loss.....................................     (10,765)    (10,061)    (5,848)    (1,539)    (1,601)
  Net loss...........................................     (10,359)     (9,904)    (5,627)    (1,469)    (1,584)
  Net loss per share (3).............................       (0.69)      (0.61)     (0.32)     (0.09)     (0.09)
  Weighted average shares outstanding (3)............      15,103      16,197     17,561     16,633     18,337
</TABLE>
    
 
   
<TABLE>
<CAPTION>
                                                                                              MARCH 31, 1996
                                                                                       ----------------------------
                                                                                        ACTUAL    AS ADJUSTED(1)(4)
                                                                                       ---------  -----------------
<S>                                                                                    <C>        <C>
BALANCE SHEET DATA:
  Cash, cash equivalents and marketable investment securities........................  $   1,820     $     9,623
  Working capital....................................................................      2,312          10,115
  Total assets.......................................................................      4,725          12,528
  Long-term debt, excluding current installments.....................................        230             230
  Net stockholders' equity...........................................................      3,095          10,898
</TABLE>
    
 
- ------------------------
 
(1) Assumes  the Underwriters'  over-allotment option  from the  Company is  not
    exercised. See "Underwriting."
 
   
(2)  Based on the  number of shares  outstanding as of  March 31, 1996. Includes
    242,952 shares issued  upon exercise  of warrants on  or prior  to April  1,
    1996. Excludes (i) an aggregate of 1,993,784 shares of Common Stock issuable
    upon  exercise of options  outstanding as of March  31, 1996, (ii) 1,881,739
    shares of Common Stock reserved for issuance pursuant to the Company's stock
    option and  stock  purchase plans,  (iii)  235,000 shares  of  Common  Stock
    issuable  upon  exercise of  the Representative's  Warrant and  (iv) 166,667
    shares of Common Stock to be issued to Boston Scientific Corporation in  May
    1996. See "Management -- Stock Plans," "Underwriting" and Note 8 of Notes to
    Financial Statements.
    
 
(3)  For an  explanation of the  determination of  the number of  shares used in
    computing net loss per share, see Note 2 of Notes to Financial Statements.
 
   
(4) As adjusted to give effect to  the sale of 2,350,000 shares of Common  Stock
    offered by the Company at an assumed offering price of $3.875 per share. See
    "Use of Proceeds" and "Capitalization."
    
 
                            ------------------------
 
    EXCEPT  AS OTHERWISE  NOTED, ALL INFORMATION  IN THIS  PROSPECTUS ASSUMES NO
EXERCISE OF THE UNDERWRITER'S OVER-ALLOTMENT OPTION. SEE "UNDERWRITING."
 
                                       4
<PAGE>
                                  RISK FACTORS
 
    IN  ADDITION TO THE OTHER INFORMATION IN THIS PROSPECTUS, THE FOLLOWING RISK
FACTORS SHOULD  BE  CONSIDERED  CAREFULLY  IN EVALUATING  THE  COMPANY  AND  ITS
BUSINESS  BEFORE  PURCHASING SHARES  OF THE  COMMON  STOCK OFFERED  HEREBY. THIS
PROSPECTUS  CONTAINS  FORWARD-LOOKING   STATEMENTS  WHICH   INVOLVE  RISKS   AND
UNCERTAINTIES.  THE COMPANY'S ACTUAL  RESULTS MAY DIFFER  SIGNIFICANTLY FROM THE
RESULTS DISCUSSED IN  THE FORWARD-LOOKING STATEMENTS.  FACTORS THAT MIGHT  CAUSE
SUCH  A DIFFERENCE INCLUDE, BUT  ARE NOT LIMITED TO,  THOSE DISCUSSED BELOW. THE
COMPANY UNDERTAKES NO OBLIGATION TO PUBLICLY RELEASE THE RESULT OF ANY REVISIONS
TO THESE  FORWARD-LOOKING STATEMENTS  WHICH MAY  BE MADE  TO REFLECT  EVENTS  OR
CIRCUMSTANCES   AFTER  THE  DATE   HEREOF  OR  TO   REFLECT  THE  OCCURRENCE  OF
UNANTICIPATED EVENTS.
 
   
    HISTORY OF  LOSSES;  PROFITABILITY  UNCERTAIN.   InnerDyne  has  experienced
operating  losses since its  inception in December  1985. InnerDyne reported net
losses of $1.6 million on revenues of $1.6 million, $5.6 million on revenues  of
$5.3 million, $9.9 million on revenues of $878,909 and $10.4 million on revenues
of  $42,821 for the three months ended March 31, 1996 and the fiscal years ended
December 31, 1995, 1994 and 1993, respectively. As of March 31, 1996,  InnerDyne
had an accumulated deficit of approximately $48.2 million.
    
 
    In the future, the Company expects to incur substantial additional operating
losses and have cash outflow requirements as a result of expenditures related to
expansion   of  sales  and  marketing  capability,  expansion  of  manufacturing
capacity,  research  and  development  activities,  compliance  with  regulatory
requirements,   and  possible   investment  in  or   acquisition  of  additional
complementary products, technologies  or businesses. The  timing and amounts  of
these  expenditures will depend upon  many factors, such as  the progress of the
Company's research and development, and will include factors that may be  beyond
the  Company's control, such as the  results of product trials, the requirements
for and the time  required to obtain regulatory  approval for existing  products
and  any  other products  that  may be  developed  or acquired,  and  the market
acceptance of the Company's products. The Company believes that it is likely  to
incur operating losses at least through 1996. The cash needs of the Company have
changed  significantly as a result  of the merger completed  during 1994 and the
support requirements  of  the  added  business focus  areas.  There  can  be  no
assurance  that the Company will not continue  to incur losses, that the Company
will be able to raise cash as  necessary to fund operations or that the  Company
will  ever achieve profitability.  See "Management's Discussion  and Analysis of
Financial Condition and Results of Operations."
 
    INTENSE COMPETITION.  The  primary industry in  which the Company  competes,
minimally  invasive surgery, is dominated by two large, well-positioned entities
that are intensely competitive and  frequently offer substantial discounts as  a
competitive  tactic. The United States Surgical Corporation ("U.S. Surgical") is
primarily engaged  in developing,  manufacturing  and marketing  surgical  wound
management  products, and  has historically been  the firm  most responsible for
providing products that have  led to the growth  of the industry. U.S.  Surgical
supplies  a broad  line of products  to the M.I.S.  industry, including products
which  facilitate  access,  assessment   and  treatment.  Ethicon   Endo-Surgery
("Ethicon"),  a Johnson &  Johnson company, has  made a major  investment in the
M.I.S. field in recent  years and is  one of the  leading suppliers of  hospital
products  in  the world.  Furthermore, U.S.  Surgical  and Ethicon  each utilize
purchasing contracts  that link  discounts on  the purchase  of one  product  to
purchases  of other products in their  broad product lines. Substantially all of
the hospitals in the United States have purchasing contracts with one or both of
these entities. Accordingly, customers may  be dissuaded from purchasing  access
products  from the Company rather than U.S. Surgical or Ethicon to the extent it
would cause them to lose discounts on products that they regularly purchase from
U.S. Surgical or Ethicon.
 
    The Company  faces a  formidable task  in successfully  gaining  significant
revenues  within  the  M.I.S. access  market.  In order  to  succeed, management
believes that  the  Company will  need  to objectively  demonstrate  substantial
product  benefits, and its sales effort must be able to effectively present such
benefits to both clinicians  and health care  administrators. The M.I.S.  access
market is
 
                                       5
<PAGE>
dominated  by U.S.  Surgical and  Ethicon. Both  entities introduced  new access
devices, trocars with  added features, during  the past two  years. A number  of
other entities participate in various segments of the M.I.S. access market.
 
    There  can be  no assurance  that the Company  will be  able to successfully
compete in the M.I.S. access market, and failure to do so would have a  material
adverse  effect on  the Company's business,  financial condition  and results of
operations.
 
    In  the  thermal  ablation  market,   the  Company  considers  its   primary
competition  to be  current therapies for  the treatment  of excessive menstrual
bleeding, including drug therapy, dilatation and curettage, surgical endometrial
ablation  and  hysterectomy.  The  Company  will  also  compete  against   other
techniques  under development for the treatment of excessive menstrual bleeding,
including endometrial  ablation techniques  that employ  radio frequency  ("RF")
energy  or freezing techniques ("cryoablation")  and the uterine balloon therapy
system being clinically tested by Gynecare, Inc.
 
    There  are  many  large  companies  with  significantly  greater  financial,
manufacturing,  marketing,  distribution  and technical  resources  and clinical
experience than  the  Company that  are  developing and  marketing  devices  for
surgical  removal of the uterus, uterine fibroids, the endometrial lining of the
uterus and  other uterine  tissues or  are developing  non-surgical methods  for
treating  these conditions. Additionally, there are smaller companies developing
alternative methods of uterine  tissue ablation that  compete with the  Company.
There  can be no assurance  that these companies will  not succeed in developing
technologies and products that  are more effective than  any which have been  or
are  being  developed  by  the  Company  or  that  would  render  the  Company's
technologies or products  obsolete or  not competitive.  Such competition  could
have  a  material  and  adverse  effect  on  the  Company's  business, financial
condition and results of operations. As a result of the entry of large and small
companies into  the market,  the  Company expects  competition for  devices  and
systems used to treat excessive menstrual bleeding to increase. See "Business --
Competition."
 
    CONTINUED  DEPENDENCE ON Step  PRODUCTS.  To date,  substantially all of the
Company's revenues  from product  sales are  attributable to  STEP products  and
InnerDyne  currently  anticipates that  sales  of STEP  products  will represent
substantially  all  of   the  Company's  revenues   in  the  immediate   future.
Accordingly,  the success  of the  Company is  largely dependent  upon increased
market acceptance  of  its STEP  product  line by  the  medical community  as  a
reliable,  safe and cost-effective access product for minimally invasive surgery
("M.I.S."). InnerDyne  commenced commercial  sales of  its STEP  product in  the
fourth quarter of 1994, and to date sales have been made to a relatively limited
number   of  physicians  and  hospitals.  Recommendations  and  endorsements  by
influential members of  the medical  community are important  for the  increased
market  acceptance of the Company's STEP products, and there can be no assurance
that existing recommendations  or endorsements  will be maintained  or that  new
ones  will be obtained.  Failure to increase market  acceptance of the Company's
STEP products would have a material adverse effect upon the Company's  business,
financial  condition and  results of operations.  See "Business  -- Products and
Technology."
 
    RELIANCE ON FUTURE PRODUCTS AND NEW APPLICATIONS; UNCERTAINTY OF  TECHNOLOGY
CHANGES.    The  medical  device industry  is  characterized  by  innovation and
technological  change.  The   Company  has  made   significant  investments   in
researching  and  developing  its  proprietary  technologies,  including  radial
dilation, thermal ablation and biocompatible coatings. During 1996, the  Company
expects  to commercially introduce on a limited basis the Reposable STEP and the
MiniSTEP, each of which is a further  enhancement of its STEP product line.  The
future  success of  the Company  will depend  in part  on the  timely commercial
introduction and market acceptance of these products. There can be no  assurance
that  these products will  be timely introduced in  commercial quantities, if at
all, or that  such products  will achieve market  acceptance. A  failure by  the
Company  to timely  introduce such  products or  a failure  of such  products to
achieve market acceptance could have a material adverse effect on the  Company's
business,  financial condition and results of  operations. The future success of
the Company will also depend upon,  among other factors, its ability to  develop
and  gain regulatory clearance  for new and  enhanced versions of  products in a
timely fashion, including, but not limited to, the ENABL
 
                                       6
<PAGE>
Thermal Ablation System. There can be no assurance that the Company will be able
to successfully develop new products  or technologies, manufacture new  products
in  commercial volumes,  obtain regulatory approvals  on a timely  basis or gain
market acceptance  of  such  products.  Delays  in  development,  manufacturing,
regulatory  approval or market acceptance of new or enhanced products could have
a material adverse  impact on  the Company's business,  financial condition  and
results of operations. See "Business -- Research and Development."
 
    LIMITED   MANUFACTURING  EXPERIENCE;  COMPLIANCE   WITH  GOOD  MANUFACTURING
PRACTICES.  The Company  initiated manufacture of  commercial quantities of  its
STEP  access  device in  its Salt  Lake  City, Utah  facility during  late 1994.
Accordingly, the Company has limited  experience in manufacturing M.I.S.  access
products  or other  products in commercial  quantities at  acceptable costs. The
Company's success will depend in part on its ability to manufacture its products
in compliance with the Good  Manufacturing Practices ("GMP") regulations of  the
United  States Food  and Drug  Administration (the  "FDA") and  other regulatory
requirements in sufficient quantities and  on a timely basis, while  maintaining
product   quality  and  acceptable   manufacturing  costs.  Manufacturers  often
encounter difficulties  in  scaling up  production  of new  products,  including
problems  involving production yields, quality  control and assurance, component
supply and  shortages of  qualified personnel.  Failure to  maintain  production
volumes  or increase  production volumes  in a  timely or  cost-effective manner
would have  a  material adverse  effect  on the  Company's  business,  financial
condition  and results of operations. The  Company was recently inspected by the
FDA and cited  for certain  GMP deficiencies.  See "Risk  Factors --  Government
Regulation" and "Business -- Manufacturing" and "-- Government Regulation."
 
    POTENTIAL  FLUCTUATIONS  IN  OPERATING  RESULTS.    The  Company's quarterly
operating results have  in the past  fluctuated and will  continue to  fluctuate
significantly  in the  future depending  on the  timing and  shipment of product
orders, new product introductions and changes in pricing policies by the Company
or its  competitors, the  timing  and market  acceptance  of the  Company's  new
products   and  product   enhancements,  the  continued   market  acceptance  of
InnerDyne's STEP product line  by the medical  community, the Company's  product
mix,  the mix of distribution channels  through which the Company's products are
sold, the extent  to which the  Company recognizes licensing  revenues during  a
quarter,  and the  Company's ability  to obtain  sufficient supplies  of sole or
limited source  components  for its  products.  In particular,  fluctuations  in
production  volumes affect gross  margins from quarter  to quarter. Furthermore,
gross margins can fluctuate  from quarter to quarter  to the extent the  Company
recognizes  license revenue during a quarter  because the Company derives higher
gross margins  from license  revenue than  from product  sales. In  response  to
competitive pressures or new product introductions, the Company may take certain
pricing  or  other  actions  that  could  materially  and  adversely  affect the
Company's operating  results.  In addition,  new  product introductions  by  the
Company  could  contribute to  quarterly  fluctuations in  operating  results as
orders for new products commence and orders for existing products decline.
 
    The Company's expense  levels are  based, in  part, on  its expectations  of
future  revenues. Because a substantial portion of the Company's revenue in each
quarter normally results from  orders booked and shipped  in the final weeks  of
that  quarter, revenue  levels are  extremely difficult  to predict.  If revenue
levels are below  expectations, net income  will be disproportionately  affected
because  only a small portion of the  Company's expenses varies with its revenue
during any  particular quarter.  In  addition, the  Company typically  does  not
operate with any material backlog as of any particular date.
 
    As a result of the foregoing factors and potential fluctuations in operating
results,  results of operations  in any particular quarter  should not be relied
upon as an indicator of future performance. In addition, in some future  quarter
the  Company's operating results may be  below the expectations of public market
analysts and investors. In such event,  the price of the Company's Common  Stock
would  likely be materially and adversely affected. See "Management's Discussion
and Analysis of Financial Condition and Results of Operations."
 
                                       7
<PAGE>
    LIMITED SALES,  MARKETING  AND  DISTRIBUTION EXPERIENCE.    InnerDyne  began
commercial  sales of its  first M.I.S. access  product in the  fourth quarter of
1994 and, therefore, has limited  sales, marketing and distribution  experience.
The  Company is marketing its M.I.S.  access products mainly to general surgeons
and  gynecologists.  In  the  United  States,  InnerDyne  markets  its  products
primarily  through direct representatives who are employed by the Company within
selected geographical areas and a  network of independent sales  representatives
who  typically sell  other complementary  M.I.S. products  to the  same customer
base. If the need  arises, the Company  may expand its  sales force, which  will
require  recruiting and training additional personnel. There can be no assurance
that the Company will be able to recruit and train such additional personnel  in
a  timely fashion.  Loss of  a significant  number of  InnerDyne's current sales
personnel or independent sales representatives, or failure to attract additional
personnel, could  have a  material  adverse effect  on the  Company's  business,
financial condition and results of operations.
 
    The  Company expects  to market  its products  outside of  the United States
through  international  distributors   in  selected   foreign  countries   after
regulatory  approvals, if necessary, are  obtained. Although InnerDyne currently
has relationships with a limited number of international distributors, there can
be  no  assurance  that  the  Company  will  be  able  to  build  a  network  of
international  distributors capable  of effectively marketing  its M.I.S. access
products or  that such  distributors  will generate  significant sales  of  such
products.  The Company  has limited  experience in  marketing its  products, and
faces substantial competition from  well-entrenched and formidable  competitors.
As  a  result, there  can be  no  assurance that  the Company  will successfully
achieve acceptable levels of product sales  at prices which provide an  adequate
return.  Failure to do so would have  a material adverse effect on the Company's
business, financial condition and results of operations. See "Business --  Sales
and Marketing."
 
    PATENTS  AND PROPRIETARY RIGHTS.  The Company's success will depend in large
part on its ability to obtain  patent protection for products and processes,  to
preserve  its trade  secrets and to  operate without  infringing the proprietary
rights of third  parties. Although  InnerDyne has obtained  certain patents  and
applied  for  additional  United  States and  foreign  patents  covering certain
aspects of its technology, no assurance can be given that any additional patents
will be  issued  or  that  the  scope of  any  patent  protection  will  exclude
competitors  or provide  a competitive advantage,  or that any  of the Company's
patents will be held valid if subsequently challenged. The validity and  breadth
of  claims  covered in  medical technology  patents  involves complex  legal and
factual questions and therefore may  be highly uncertain. InnerDyne also  relies
upon  unpatented trade secrets, and  no assurance can be  given that others will
not independently develop  or otherwise acquire  substantially equivalent  trade
secrets.  In addition, whether  or not the Company's  patents are issued, others
may hold  or receive  patents that  contain claims  having a  scope that  covers
products developed by InnerDyne.
 
    There   has  been   substantial  litigation   regarding  patent   and  other
intellectual property rights in the medical device industry and companies in the
medical device  industry have  used litigation  to gain  competitive  advantage.
Litigation  involving the Company would result in substantial cost and diversion
of management attention from the day-to-day operation of the business, but could
be necessary to enforce patents issued to the Company, to protect trade  secrets
and  other  specialized  knowledge unknown  to  outside parties,  to  defend the
Company against claimed infringement of the rights of others or to determine the
scope and validity of the proprietary rights of others. An adverse determination
in litigation  could subject  the Company  to significant  liabilities to  third
parties,  could require  the Company to  seek licenses from  third parties under
less favorable terms  than might  otherwise be  possible and  could prevent  the
Company  from manufacturing, selling  or using its products,  any of which could
have a material adverse  effect on the  Company's business, financial  condition
and results of operations.
 
    The  Company has in the past, and  may in the future, receive correspondence
from third parties claiming that the Company's products or technologies infringe
intellectual property rights of such third  parties. The Company and its  patent
counsel  thoroughly review such claims and  no such outstanding claims currently
exist. However,  there can  be  no assurance  that  InnerDyne will  not  receive
additional claims that
 
                                       8
<PAGE>
its  products or technologies infringe third  party rights or that third parties
will not litigate such claims. Any such occurrence could have a material adverse
effect on the Company's business, financial condition and results of operations.
See "Business -- Patents and Proprietary Rights."
 
    GOVERNMENT REGULATION.    Clinical  testing, manufacture  and  sale  of  the
Company's  products, including the STEP product line, the ENABL Thermal Ablation
System and  the  Company's biocompatible  coatings  technology, are  subject  to
regulation  by the FDA and corresponding  state and foreign regulatory agencies.
Pursuant to  the Federal  Food,  Drug, and  Cosmetic  Act, and  the  regulations
promulgated  thereunder, the FDA regulates the preclinical and clinical testing,
manufacture,  labeling,   distribution  and   promotion  of   medical   devices.
Noncompliance  with applicable requirements  can result in,  among other things,
fines, injunctions, civil  penalties, recall  or seizure of  products, total  or
partial  suspension of production, failure of  the government to grant premarket
clearance or premarket approval for  devices, withdrawal of marketing  approvals
and  criminal prosecution.  The FDA  also has  the authority  to request recall,
repair, replacement  or  refund  of  the cost  of  any  device  manufactured  or
distributed by the Company.
 
    Before  a new device can be introduced  in the market, the manufacturer must
generally obtain FDA clearance of 510(k) notification or approval of a premarket
appoval ("PMA")  application. A  PMA application  must be  filed if  a  proposed
device is not substantially equivalent to a legally marketed Class I or Class II
device,  or if it is a  Class III device for which  the FDA has called for PMAs.
The PMA process can be expensive, uncertain and lengthy, and a number of devices
for which  FDA approval  has been  sought  by other  companies have  never  been
approved for marketing. Management expects that the ENABL System will be subject
to  the PMA approval process prior to  marketing within the United States. There
can be  no assurance  that the  Company will  be able  to obtain  the  necessary
regulatory  approval on a timely basis, or at  all, and a delay in receipt of or
failure to receive  such approval would  have a material  adverse effect on  the
Company's business, financial condition and results of operations.
 
    A  510(k) clearance will be granted if the submitted information establishes
that the proposed  device is  "substantially equivalent" to  a legally  marketed
Class  I or Class II medical device or  a Class III medical device for which the
FDA has not called for  PMAs. For any of  the Company's devices cleared  through
the  510(k)  process,  modifications or  enhancements  that  could significantly
affect the safety  or effectiveness  of the device  or that  constitute a  major
change  to the intended use of the  device will require a new 510(k) submission.
There can  be  no  assurance  that the  Company  will  obtain  510(k)  premarket
clearance  within a reasonable time frame, or at  all, for any of the devices or
modifications for which it may file a 510(k).
 
    The Company has  received clearance from  the FDA for  the marketing of  its
STEP  device for use  in accessing the  abdominal and thoracic  cavities for the
performance of  minimally invasive  surgical procedures.  The Company  has  also
received  FDA  clearance  for  the marketing  of  its  Radial  Expanding Dilator
("R.E.D.")  product  for   use  in   the  areas   of  gastrostomy,   cystostomy,
cholecystotomy, the dilation of biliary and urethral strictures, laparoscopy and
enterostomy.  The  Company has  also received  market clearance  for alternative
versions of its STEP and R.E.D. products, including products designed to  employ
its  radial  dilation  technology  in  vascular  applications  and  for  biliary
indications. Although the Company has been successful in preparing requests  for
510(k)  clearance, there can  be no assurance that  510(k) clearances for future
products or product modifications can be obtained in a timely manner or at  all,
or  that  any existing  clearance  can be  successfully  maintained. A  delay in
receipt of, or  failure to  receive or maintain,  such clearances  would have  a
material  adverse  effect on  the  Company's business,  financial  condition and
results of operations. Although the Company is strictly limited to marketing its
products for the  indications for which  they were cleared,  physicians are  not
prohibited  by the FDA from using the  products for indications other than those
cleared by the FDA. There can be  no assurance that the Company will not  become
subject  to FDA action resulting  from physician use of  its products outside of
their approved indications.
 
                                       9
<PAGE>
    The Company has made modifications to  its cleared devices that the  Company
believes  do not require the  submission of new 510(k)  notices. There can be no
assurance, however,  that  the  FDA  would  agree  with  any  of  the  Company's
determinations  not to submit  a new 510(k)  notice for any  of these changes or
would not require  the Company  to submit  a new 510(k)  notice for  any of  the
changes  made to  the device. If  the FDA requires  the Company to  submit a new
510(k) notice for any  device modification, the Company  may be prohibited  from
marketing the modified device until the 510(k) notice is cleared by the FDA.
 
    Any  devices  manufactured or  distributed by  the  Company pursuant  to FDA
clearance or approval are subject to pervasive and continuing regulation by  the
FDA and certain state agencies and various foreign governments. Manufacturers of
medical  devices for marketing  in the United  States are required  to adhere to
applicable regulations setting  forth detailed GMP  requirements, which  include
testing,  control and documentation requirements. Manufacturers must also comply
with Medical Device Reporting ("MDR") requirements that a firm report to the FDA
any incident in which its product may  have caused or contributed to a death  or
serious  injury,  or  in  which  its  product  malfunctioned  and,  if  the  the
malfunction were to recur, it would be likely to cause or contribute to a  death
or serious injury.
 
   
    The Company is registered as a manufacturer of medical devices with the FDA.
The  Company  is subject  to routine  inspection  by the  FDA and  certain state
agencies for  compliance  with  GMP requirements,  MDR  requirements  and  other
applicable  regulations.  The  Company's  Salt  Lake  City,  Utah  manufacturing
facility was inspected  by the  FDA for  the first  time in  January 1996.  That
inspection resulted in the issuance by the FDA of a Form FDA 483, which detailed
specific  areas where the  FDA inspector observed  that the Company's operations
were not  in full  compliance  with applicable  areas  of the  GMP  regulations.
Corrective  action  addressing  all identified  GMP  deficiencies  was initiated
immediately, and  the Company  responded to  the FDA  District Office.  The  FDA
District  Office  issued  a Warning  Letter  stating  that it  appears  that the
Company's response to the Form FDA 483 is adequate; however, an FDA reinspection
is required to  assure that  the corrections  the Company  has taken  adequately
address the noted GMP deficiencies. The FDA also notified the Company that until
the  agency determines that  corrections are adequate,  federal agencies will be
advised of  the issuance  of  the Warning  Letter so  that  they may  take  this
information  into account when  considering awards of  contracts, and no pending
510(k) notifications  for devices  to which  the observed  GMP deficiencies  are
reasonably  related  will  be  cleared, and  no  requests  for  Certificates For
Products For Export will be approved.  The Company submitted a written  response
to the Warning Letter and requested a meeting with District officials to discuss
the  matter. During  that meeting, District  official acknowledged  that the GMP
deficiencies observed during  the inspection were  "borderline" with respect  to
the  agency's  policies  regarding  the  issuance  of  a  Warning  Letter.  They
explained, however, that the Warning Letter  was based on observations that  the
Company  was not following its  own written procedures and  on the fact that the
Company's internal  audits  had  not found  these  deficiencies.  Following  the
meeting,  the FDA acknowledged the  Company's representation that the corrective
action plan would  be completed by  April 8,  1996, and stated  that the  agency
would  initiate a reinspection within 60 days of that date. The scope of the FDA
reinspection could be  more comprehensive  than the initial  inspection. At  the
current  time, the  Company has no  pending submissions for  either clearance to
market new or modified products, or  to export to new foreign markets.  However,
failure  to adequately address  these GMP deficiencies  within a reasonable time
frame would have  an adverse effect  on future product  sales. Accordingly,  the
Company   has  undertaken  a  review  of   the  GMP  compliance  of  its  entire
manufacturing process. However, there can be no assurance that the FDA will deem
the Company's corrective  action to  be adequate or  that additional  corrective
action,  in  areas not  addressed by  the Form  FDA 483,  will not  be required.
Failure to achieve satisfactory GMP compliance could have a significant  adverse
effect  on the Company's  ability to continue to  manufacture and distribute its
products and, in the most serious cases,  could result in the seizure or  recall
of  products, injunction and/or civil fines. See "Risk Factors -- Manufacturing"
and "Business -- Government Regulation."
    
 
                                       10
<PAGE>
    DEPENDENCE ON SOLE SOURCES.  The materials utilized in the Company's  M.I.S.
products  consist of both standard and custom components that are purchased from
a variety of independent sources. The plastic parts used in the STEP product are
injection molded by outside  vendors. The majority of  these parts are  produced
utilizing  molds that  have been  specially machined  for and  are owned  by the
Company. Although the Company maintains significant inventories of molded parts,
any inability  to utilize  these molds  for  any reason  might have  a  material
adverse  effect upon  the Company's  ability to  meet its  customers' demand for
product. In addition to plastic parts produced from injection molds owned by the
Company, a number of other materials are available only from a limited number of
sources at the  present time, including  the sheath component  of the  Company's
STEP products. Efforts to identify and qualify additional sources of this sheath
component  and  other  key  materials  and  components  are  underway.  Although
InnerDyne believes that alternative sources of these components can be obtained,
internal  testing  and  qualification   of  substitute  vendors  could   require
significant  lead times and  additional regulatory submissions.  There can be no
assurance that such internal testing and qualification or additional  regulatory
approvals  will be obtained in a timely  fashion, if at all. Any interruption of
supply of raw materials  could have a material  adverse effect on the  Company's
ability  to manufacture its  products, and therefore  on its business, financial
condition and results of operations. See "Business -- Manufacturing."
 
    UNCERTAINTY RELATING TO THIRD  PARTY REIMBURSEMENT.   In the United  States,
health  care providers, such as hospitals  and physicians, that purchase medical
devices, such as the Company's  products, generally rely on third-party  payors,
principally federal Medicare, state Medicaid and private health insurance plans,
to  reimburse all  or part  of the cost  of the  procedure in  which the medical
device is being  used. In  addition, certain  health care  providers are  moving
toward  a  managed  care system  in  which  such providers  contract  to provide
comprehensive health care for  a fixed cost per  person. Managed care  providers
are  attempting to control the cost of health care by authorizing fewer elective
surgical procedures. The Company is unable to predict what changes will be  made
in  the  reimbursement  methods  utilized  by  third-party  health  care payors.
Furthermore, the Company could be adversely affected by changes in reimbursement
policies of  governmental or  private health  care payors,  particularly to  the
extent  any  such  changes  affect reimbursement  for  procedures  in  which the
Company's products are used. Failure by physicians, hospitals and other users of
the Company's  products  to obtain  sufficient  reimbursement from  health  care
payors  for  procedures in  which  the Company's  products  are used  or adverse
changes  in  governmental  and  private  third-party  payors'  policies   toward
reimbursement  for such procedures  would have a material  adverse effect on the
Company's business, financial condition and results of operations.
 
    If the Company  obtains the necessary  foreign regulatory approvals,  market
acceptance   of  the  Company's  products  in  international  markets  would  be
dependent, in part,  upon the  availability of  reimbursement within  prevailing
health  care payment systems.  Reimbursement and health  care payment systems in
international  markets  vary   significantly  by  country,   and  include   both
government-sponsored  health care and private  insurance. The Company intends to
seek international reimbursement approvals, although  there can be no  assurance
that  any such  approvals will be  obtained in a  timely manner, if  at all, and
failure to receive international reimbursement  approvals could have an  adverse
effect  on  market acceptance  of the  Company's  products in  the international
markets in which such approvals are sought.
 
    DEPENDENCE ON INTERNATIONAL SALES.   In the future,  the Company expects  to
derive  an increasing  portion of its  revenue from international  sales. To the
extent  the  Company's  international  sales  increase  in  future  periods,   a
significant  portion of  the Company's  revenues could  be subject  to the risks
associated  with   international   sales,  including   economic   or   political
instability,   shipping  delays,  changes  in  applicable  regulatory  policies,
fluctuations in foreign currency exchange rates and various trade  restrictions,
all  of which could have significant impact  on the Company's ability to deliver
products on a competitive and timely basis. Future imposition of, or significant
increases in  the  level  of,  customs duties,  import  quotas  or  other  trade
restrictions  could have an adverse effect  on the Company's business, financial
condition  and  results  of  operations.  The  regulation  of  medical  devices,
 
                                       11
<PAGE>
particularly  in the European Community, continues to expand and there can be no
assurance that new laws or  regulations will not have  an adverse effect on  the
Company.  For example,  the European Union  has promulgated  rules which require
that medical products receive  the right by  mid-1998 to affix  the CE mark,  an
international  symbol of adherence to quality assurance standards and compliance
with applicable European medical device directives. Failure to receive the right
to affix the  CE mark will  prohibit the  Company from selling  its products  in
member  countries  of  the  European  Union.  See  "Management's  Discussion and
Analysis of Financial Condition and Results of Operations."
 
    FUTURE ADDITIONAL CAPITAL REQUIREMENTS; NO ASSURANCE FUTURE CAPITAL WILL  BE
AVAILABLE.   The Company's capital requirements will depend on numerous factors,
including market  acceptance and  demand  for its  products; the  resources  the
Company  devotes to the development, manufacture  and marketing of its products;
the  progress  of  the  Company's  clinical  research  and  product  development
programs; the receipt of, and the time required to obtain, regulatory clearances
and  approvals;  the resources  required to  protect the  Company's intellectual
property; the resources expended, if  any, to acquire complementary  businesses,
products  and technologies;  and other  factors. The  timing and  amount of such
capital requirements cannot be accurately predicted. Funds may also be used  for
the  acquisition of businesses, products and technologies that are complementary
to those of the  Company. Consequently, although the  Company believes that  the
proceeds  of this Offering, together with  revenues, credit facilities and other
sources of liquidity, will provide adequate funding for its capital requirements
through at least  1997, the Company  may be required  to raise additional  funds
through  public  or  private financings,  collaborative  relationships  or other
arrangements. There  can be  no  assurance that  the  Company will  not  require
additional funding or that such additional funding, if needed, will be available
on  terms attractive to the Company, or at all. Any additional equity financings
may be dilutive to stockholders, and  debt financing, if available, may  involve
restrictive  covenants. See "Use  of Proceeds" and  "Management's Discussion and
Analysis of  Financial Condition  and  Results of  Operations --  Liquidity  and
Capital Resources."
 
    DEPENDENCE  ON KEY PERSONNEL.  InnerDyne  is dependent upon a limited number
of key management  and technical  personnel. The Company's  future success  will
depend  in  part  upon  its  ability  to  attract  and  retain  highly qualified
personnel. The Company  will compete  for such personnel  with other  companies,
academic institutions, government entities and other organizations. There can be
no  assurance  that  the  Company  will be  successful  in  hiring  or retaining
qualified personnel.  The loss  of key  personnel or  the inability  to hire  or
retain qualified personnel could have a material adverse effect on the Company's
business,  financial  condition  and  results of  operations.  See  "Business --
Employees" and "Management."
 
    PRODUCT LIABILITY; CLAIMS IN EXCESS OF INSURANCE COVERAGE.  The development,
manufacture and  sale of  the  Company's products  entail  the risk  of  product
liability  claims, involving  both potential  financial exposure  and associated
adverse publicity. The  Company's current product  liability insurance  coverage
limits  are $1,000,000 per occurrence and $2,000,000 in the aggregate, and there
can be  no assurance  that such  coverage  limits are  adequate to  protect  the
Company  from any liabilities it might incur in connection with the development,
manufacture and sale  of its current  and potential products.  In addition,  the
Company  may require  increased product  liability insurance.  Product liability
insurance is expensive  and may  not be available  in the  future on  acceptable
terms,  or at all. In addition, if such  insurance is available, there can be no
assurance that  the limits  of coverage  of such  policies will  be adequate.  A
successful product liability claim in excess of the Company's insurance coverage
could  have  a  material adverse  effect  on the  Company's  business, financial
condition and  results of  operations. See  "Business --  Product Liability  and
Insurance."
 
    STOCK PRICE VOLATILITY.  The stock market, in general, and stocks of medical
device  companies in particular, have from  time to time experienced significant
price and volume fluctuations that are unrelated to the operating performance of
particular companies. These broad market  fluctuations may adversely affect  the
market price of the Company's Common Stock. In addition, the market price of the
Common  Stock has been and is likely  to continue to be highly volatile. Factors
such as  fluctuations  in  the Company's  operating  results,  announcements  of
technological innovations or new products by the Company or its competitors, FDA
and international regulatory actions, actions with
 
                                       12
<PAGE>
respect  to  reimbursement  matters,  developments with  respect  to  patents or
proprietary rights, public concern as to the safety of products developed by the
Company or  others, changes  in health  care  policy in  the United  States  and
internationally,  changes in stock market  analyst recommendations regarding the
Company, other medical device companies or the medical device industry generally
or general market conditions may have  a significant effect on the market  price
of the Common Stock.
 
    ENVIRONMENTAL  REGULATIONS.  The  Company is subject to  a variety of local,
state and  federal  governmental  regulations  relating  to  the  use,  storage,
handling,  manufacture and disposal of toxic and other hazardous substances used
to manufacture the Company's products. The Company believes that it is currently
in  compliance   in  all   material   respects  with   applicable   governmental
environmental  regulations. Nevertheless, the  failure by the  Company to comply
with current or future environmental regulations could result in the  imposition
of substantial fines on the Company, suspension of production, alteration of its
manufacturing  processes  or  cessation  of  operations.  Compliance  with  such
regulations could require the Company to acquire expensive remediation equipment
or to incur substantial expenses. Any failure by the Company to control the use,
disposal, removal or storage of, or to adequately restrict the discharge of,  or
assist  in  the cleanup  of, hazardous  or toxic  substances, could  subject the
Company to significant liabilities, including joint and several liability  under
certain  statutes.  The imposition  of such  liabilities  could have  a material
adverse effect on  the Company's  business, financial condition  and results  of
operations.
 
    CONTROL  BY DIRECTORS AND  PRINCIPAL STOCKHOLDERS.   Following completion of
this Offering, directors and principal stockholders of the Company, and  certain
of  their affiliates, will  beneficially own approximately  29% of the Company's
outstanding Common Stock. Accordingly, these persons, as a group, may be able to
control the  Company and  significantly affect  the direction  of the  Company's
affairs   and  business,  including  any   determination  with  respect  to  the
acquisition or disposition of assets by the Company, future issuances of  Common
Stock  or other securities  by the Company  and the election  of directors. Such
concentration of ownership may  also have the effect  of delaying, deferring  or
preventing  a  change in  control  of the  Company.  See "Principal  and Selling
Stockholders."
 
    ANTI-TAKEOVER   EFFECT   OF   CERTAIN    CHARTER   PROVISIONS   OF    COMMON
STOCK.   Provisions of the Company's Certificate of Incorporation that allow the
Company to  issue Preferred  Stock without  any vote  or further  action by  the
stockholders as well as the fact that the Company's Certificate of Incorporation
does  not permit stockholders to cumulate votes in the election of directors may
have the effect of making it more difficult for a third party to acquire, or  of
discouraging  a third party from attempting  to acquire, control of the Company.
Certain provisions of Delaware law applicable to the Company could also delay or
make more  difficult a  merger,  tender offer  or  proxy contest  involving  the
Company,  including  Section 203,  which prohibits  a Delaware  corporation from
engaging in  any business  combination  with any  interested stockholder  for  a
period  of three years unless certain  conditions are met. The possible issuance
of Preferred  Stock, the  inability of  stockholders to  cumulate votes  in  the
election  of directors and provisions  of Delaware law could  have the effect of
delaying, deferring or preventing a change in control of the Company,  including
without  limitation, discouraging a  proxy contest or  making more difficult the
acquisition of a substantial block of  the Company's Common Stock. The  possible
issuance of Preferred Stock and these provisions could also limit the price that
investors  might be  willing to pay  in the  future for shares  of the Company's
Common Stock. See  "Description of  Capital Stock  -- Preferred  Stock" and  "--
Certain Charter Provisions and Delaware Anti-Takeover Statute."
 
   
    DILUTION.   Assuming a price to public of $3.88, investors purchasing shares
of Common Stock in the offering will incur immediate and substantial dilution in
net tangible book value of  the Common Stock of $3.35  per share. To the  extent
that  currently outstanding options  to purchase the  Company's Common Stock are
exercised, there will be further dilution. See "Dilution."
    
 
    LACK OF DIVIDENDS.   The Company  has not  paid any dividends  and does  not
anticipate  paying  any  dividends  in  the  foreseeable  future.  See "Dividend
Policy."
 
                                       13
<PAGE>
                                  THE COMPANY
 
    The  Company  was  incorporated   in  Utah  in   December  1985  as   Midsix
Cardiovascular/Pulmonary,   Inc.  and   changed  its   name  in   July  1987  to
CardioPulmonics,  Inc.  and  in  April  1994  to  InnerDyne,  Inc.  The  Company
reincorporated  in Delaware in  January 1992. The  Company's principal executive
offices are located at 1244 Reamwood Avenue, Sunnyvale, California 94089 and its
telephone number at that location is (408) 745-6010.
 
                                USE OF PROCEEDS
 
   
    The net proceeds to  the Company from  the sale of  the 2,350,000 shares  of
Common  Stock offered  by the Company  hereby are estimated  to be approximately
$7,803,000 ($9,032,000 if the  Underwriters' over-allotment option is  exercised
in  full and all of the shares subject  to such option are sold by the Company),
at  an  assumed  offering  price  of  $3.875  per  share  and  after   deducting
underwriting  discounts and commissions and  estimated offering expenses payable
by the Company. The principal purposes  of this offering are to fund  additional
development activities and to obtain additional capital to fund the expansion of
marketing,  sales and manufacturing  activities for the  Company's M.I.S. access
products. The Company expects to use the  balance of the net proceeds from  this
offering for general corporate purposes, including working capital. A portion of
the  net proceeds may also  be used for the  acquisition of businesses, products
and technologies that are complementary to those of the Company. The Company has
no current plans, agreements or commitments and is not currently engaged in  any
negotiations with respect to any such transaction. The amounts and timing of the
Company's  actual expenditures  to fund  the expansion  of marketing,  sales and
manufacturing activities for the  Company's M.I.S. access  products and to  fund
additional development activities may vary significantly depending upon numerous
factors,  including  the extent  to which  the  Company's products  gain greater
market acceptance; the  costs and timing  of expansion of  marketing, sales  and
manufacturing  activities; the progress of the Company's development activities,
including clinical  trials; actions  relating  to regulatory  and  reimbursement
matters;  and competition. Pending such uses,  the net proceeds of this offering
will be invested in investment grade, interest-bearing securities.
    
 
                                       14
<PAGE>
                          PRICE RANGE OF COMMON STOCK
 
    The Company's Common  Stock has been  traded on the  Nasdaq National  Market
under  the symbol IDYN  since the merger  in April 1994  with InnerDyne Medical,
Inc. From January 1992 to April 1994,  the Company's Common Stock traded on  the
Nasdaq  National Market under the symbol CRDS. The prices per share reflected in
the table below represent the range of low and high closing sale prices for  the
Company's  Common  Stock  as reported  in  the  Nasdaq National  Market  for the
quarters indicated.  These prices  reflect inter-dealer  prices, without  retail
mark-up, mark-down or commission and may not represent actual transactions.
<TABLE>
<CAPTION>
                                                                                                HIGH          LOW
                                                                                                -----         ---
<S>                                                                                          <C>          <C>
FISCAL 1994
  First Quarter ended March 31, 1994.......................................................       3 3/8        1 3/4
  Second Quarter ended June 30, 1994.......................................................       2 5/8        1 5/8
  Third Quarter ended September 30, 1994...................................................       2 5/8        1 3/8
  Fourth Quarter ended December 31, 1994...................................................       4 1/4        2 1/4
 
<CAPTION>
 
                                                                                                HIGH          LOW
                                                                                                -----         ---
<S>                                                                                          <C>          <C>
FISCAL 1995
  First Quarter ended March 31, 1995.......................................................       5 1/4        3 1/4
  Second Quarter ended June 30, 1995.......................................................       4 5/8        2 1/2
  Third Quarter ended September 30, 1995...................................................       3 7/8        1 7/8
  Fourth Quarter ended December 31, 1995...................................................       3 3/8        2 1/4
<CAPTION>
 
                                                                                                HIGH          LOW
                                                                                                -----         ---
<S>                                                                                          <C>          <C>
FISCAL 1996
  First Quarter ended March 31, 1996.......................................................       4 1/4        2 3/8
</TABLE>
 
   
    The closing sale price of the Company's Common Stock was $3.875 per share on
May  8, 1996. As of March 31, 1996, there were approximately 300 stockholders of
record of the Company.
    
 
                                DIVIDEND POLICY
 
    The Company has not historically paid cash dividends. The Company  currently
intends  to retain all future earnings, if any, for use in its business and does
not anticipate paying any cash dividends in the foreseeable future. The  Company
is  prohibited from paying dividends or making any other distributions under the
terms of its credit agreement with Silicon  Valley Bank. See Note 6 of Notes  to
Financial Statements.
 
                                       15
<PAGE>
                                 CAPITALIZATION
 
   
    The  following table sets  forth the capitalization of  the Company at March
31, 1996 (i)  on an actual  basis and (ii)  as adjusted to  reflect the sale  of
2,350,000  shares of Common  Stock offered by  the Company hereby  at an assumed
offering price of $3.875 per  share (after deducting underwriting discounts  and
commissions  and estimated offering expenses payable by the Company). This table
should be read in conjunction with  the Financial Statements of the Company  and
Notes thereto included elsewhere in this Prospectus.
    
 
   
<TABLE>
<CAPTION>
                                                                                    MARCH 31, 1996
                                                                               ------------------------
                                                                                 ACTUAL     AS ADJUSTED
                                                                               -----------  -----------
                                                                                (IN THOUSANDS, EXCEPT
                                                                                     SHARE DATA)
                                                                               ------------------------
<S>                                                                            <C>          <C>
Long-term debt, excluding current installments...............................  $       230   $     230
Stockholders' equity:
  Preferred Stock, $.01 par value, 1,000,000 shares authorized; no shares
   issued and outstanding actual and as adjusted.............................      --           --
  Common Stock, $.01 par value, 40,000,000 shares authorized; 18,566,111
   shares issued and outstanding actual, 20,916,111 shares issued and
   outstanding as adjusted (1)...............................................          186         209
  Additional paid-in capital.................................................       51,109      58,889
  Accumulated deficit........................................................      (48,200)    (48,200)
                                                                               -----------  -----------
    Net stockholders' equity.................................................  $     3,095   $  10,898
                                                                               -----------  -----------
                                                                               -----------  -----------
    Total capitalization.....................................................  $     3,325   $  11,128
                                                                               -----------  -----------
                                                                               -----------  -----------
</TABLE>
    
 
- ------------------------
   
(1) Common  Stock issued and  outstanding does not  include (i) 1,993,784 shares
    issuable upon exercise  of stock options  outstanding as of  March 31,  1996
    under the Company's 1987 Stock Option Plan (the "1987 Plan"), 1989 Incentive
    Stock  Plan (the  "1989 Plan")  and 1991  Directors' Stock  Option Plan (the
    "Directors' Plan"), (ii) 643,406 shares of Common Stock available for future
    grant pursuant to the Company's 1987 Plan, 1989 Plan and Directors' Plan  or
    (iii)  68,048 shares  issuable upon exercise  of warrants  outstanding as of
    March 31, 1996 (such warrants expired  at 5:00 p.m. (Pacific time) on  April
    1, 1996 to the extent not exercised prior to such time). For the period from
    April  1, 1996  through May  1, 1996,  the Company  issued 12,018  shares of
    Common Stock upon  exercise of  options outstanding  as of  March 31,  1996,
    granted  options under  the 1987 Plan  to purchase 225,000  shares of Common
    Stock and issued  23,800 shares of  Common Stock upon  exercise of  warrants
    outstanding  as of March 31, 1996.  Common Stock issued and outstanding also
    excludes 235,000  shares  issuable  upon exercise  of  the  Representative's
    Warrant.  See "Management -- Stock  Plans" and Note 8  of Notes to Financial
    Statements.
    
 
                                       16
<PAGE>
                                    DILUTION
 
   
    The net  tangible  book value  of  the Company  as  of March  31,  1996  was
approximately  $3,095,000, or  $0.167 per  share. "Net  tangible book  value per
share" represents the amount of the  Company's total tangible assets less  total
liabilities,  divided by 18,566,111, the number  of outstanding shares of Common
Stock. After giving effect to the sale by the Company of the 2,350,000 shares of
Common Stock offered hereby at an assumed offering price of $3.875 per share and
after deduction of underwriting discounts and commissions and estimated offering
expenses payable by the Company, the Company's net tangible book value at  March
31,  1996  would have  been approximately  $10,898,000, or  $0.521 per  share of
Common Stock. This represents an immediate  increase in net tangible book  value
of $0.354 per share to existing stockholders and an immediate dilution of $3.354
per  share to investors purchasing shares of  Common Stock in this offering. The
following table illustrates this per share dilution:
    
 
   
<TABLE>
<CAPTION>
Assumed offering price per share...................................             $   3.875
<S>                                                                  <C>        <C>
  Net tangible book value per share at March 31, 1996..............  $   0.167
  Increase in net tangible book value per share attributable to new
   investors.......................................................      0.354
                                                                     ---------
Net tangible book value per share after this offering..............                 0.521
                                                                                ---------
Dilution per share to new investors................................             $   3.354
                                                                                ---------
                                                                                ---------
</TABLE>
    
 
   
    The foregoing table assumes no exercise of the Underwriters'  over-allotment
option and no exercise of outstanding options or warrants. As of March 31, 1996,
there were options outstanding to purchase 1,993,784 shares of Common Stock at a
weighted  average exercise price of $2.07  per share and warrants outstanding to
purchase 68,048 shares of Common Stock at  an exercise price of $2.90 per  share
(as  amended). To the extent such options  and warrants are exercised, there may
be further dilution to new investors. See "Management -- Stock Plans" and Note 8
of Notes to Financial Statements.
    
 
                                       17
<PAGE>
                            SELECTED FINANCIAL DATA
 
   
    The following  selected  financial  data  of the  Company  is  qualified  by
reference  to and should be read in conjunction with Management's Discussion and
Analysis of Financial Condition and Results of Operations and with the Company's
financial statements and  notes thereto included  elsewhere in this  Prospectus.
The  statements of operations data  for the years ended  December 31, 1993, 1994
and 1995 and the quarters ended March  31, 1995 and 1996 and the balance  sheets
data  as of December  31, 1994 and  1995 and as  of March 31,  1996, are derived
from, and  are  qualified by  reference  to, the  audited  financial  statements
included elsewhere in this Prospectus. The statements of operations data for the
years  ended  December 31,  1991  and 1992  and the  balance  sheets data  as of
December 31,  1991,  1992 and  1993,  are derived  from,  and are  qualified  by
reference to, audited financial statements not included in this Prospectus.
    
 
   
<TABLE>
<CAPTION>
                                                                                              THREE MONTHS ENDED
                                                    YEAR ENDED DECEMBER 31,                       MARCH 31,
                                    -------------------------------------------------------  --------------------
                                      1991       1992        1993        1994       1995       1995       1996
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
                                                        (IN THOUSANDS, EXCEPT PER SHARE DATA)
<S>                                 <C>        <C>        <C>         <C>         <C>        <C>        <C>
STATEMENTS OF OPERATIONS DATA:
Product sales.....................  $     292  $     133  $   --      $      276  $   4,730  $     954  $   1,520
Licensing, contract and grant
 revenue..........................         84     --              43         603        545        281         63
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
  Revenue.........................        376        133          43         879      5,275      1,235      1,582
Costs and Expenses:
  Cost of product sales...........        197         93         490       1,940      3,149        680        896
  Research, development,
   regulatory and clinical........      4,334      6,728       5,793       3,952      2,299        582        580
  Sales and marketing.............     --         --           1,107       2,063      3,895        994      1,182
  General and administrative......      1,188      2,509       3,417       2,985      1,779        518        525
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
    Total costs and expenses......      5,718      9,330      10,808      10,940     11,123      2,774      3,184
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
      Operating loss..............     (5,342)    (9,197)    (10,765)    (10,061)    (5,848)    (1,539)    (1,601)
Other income (expense):
  Interest income.................        133        972         605         460        251         75         25
  Interest expense................        (75)       (90)       (148)        (64)       (29)        (6)        (9)
  Gain (loss) on asset disposal...     --         --             (52)       (240)        (1)         1          1
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
    Total other income............         58        882         406         157        221         70         17
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
      Net loss....................  $  (5,284) $  (8,315) $  (10,359) $   (9,904) $  (5,627) $  (1,469) $  (1,584)
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
Net loss per share (1)............  $    (.57) $    (.64) $     (.69) $     (.61) $    (.32) $   (0.09) $   (0.09)
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
Weighted average shares
 outstanding (1)..................      9,267     12,895      15,103      16,197     17,561     16,633     18,337
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
                                    ---------  ---------  ----------  ----------  ---------  ---------  ---------
</TABLE>
    
 
   
<TABLE>
<CAPTION>
                                                                 DECEMBER 31,                         MARCH 31,
                                            -------------------------------------------------------  -----------
                                              1991       1992        1993        1994       1995        1996
                                            ---------  ---------  ----------  ----------  ---------  -----------
<S>                                         <C>        <C>        <C>         <C>         <C>        <C>
BALANCE SHEETS DATA:
Cash, cash equivalents and marketable
 investment securities....................  $     690  $  23,358  $   15,788  $    5,731  $   2,718   $   1,820
Working capital...........................     (1,331)    22,727      14,519       5,138      3,141       2,312
Total assets..............................      2,695     25,609      17,550       7,847      5,370       4,725
Long-term debt, excluding current
 installments.............................        131        338         199          30        187         230
Net stockholders' equity..................       (220)    23,903      15,667       6,292      4,010       3,095
</TABLE>
    
 
- ------------------------
(1) See  Note  2 of  Notes to  Financial  Statements for  an explanation  of the
    determination of the number of shares used to compute net loss per share.
 
                                       18
<PAGE>
               MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
                      CONDITION AND RESULTS OF OPERATIONS
 
    THIS   PROSPECTUS   CONTAINS,   IN  ADDITION   TO   HISTORICAL  INFORMATION,
FORWARD-LOOKING STATEMENTS WHICH INVOLVE RISKS AND UNCERTAINTIES. THE  COMPANY'S
ACTUAL  RESULTS  MAY  DIFFER SIGNIFICANTLY  FROM  THE RESULTS  DISCUSSED  IN THE
FORWARD-LOOKING STATEMENTS. FACTORS THAT MIGHT  CAUSE SUCH A DIFFERENCE  INCLUDE
THOSE  DISCUSSED BELOW, AS WELL AS THOSE DISCUSSED ELSEWHERE IN THIS PROSPECTUS.
THE COMPANY  UNDERTAKES NO  OBLIGATION TO  PUBLICLY RELEASE  THE RESULT  OF  ANY
REVISIONS  TO  THESE FORWARD-LOOKING  STATEMENTS WHICH  MAY  BE MADE  TO REFLECT
EVENTS OR CIRCUMSTANCES AFTER  THE DATE HEREOF OR  TO REFLECT THE OCCURRENCE  OF
UNANTICIPATED EVENTS.
 
BACKGROUND
 
    InnerDyne,  Inc. (the "Company" or "InnerDyne") is the successor corporation
resulting from  the  merger  of CardioPulmonics,  Inc.  ("CardioPulmonics")  and
InnerDyne  Medical, Inc. ("IMI")  in April 1994.  CardioPulmonics was founded in
1985  to   develop,   manufacture   and   market   proprietary   pulmonary   and
cardiopulmonary  products.  These  efforts  resulted  in  the  development  of a
blood-gas exchange device and  proprietary biocompatible coatings  technologies.
IMI  was founded in  1989 to develop  medical devices used  in M.I.S. procedures
incorporating  IMI's   proprietary   radial  dilation   and   thermal   ablation
technologies.  Subsequent  to  the  merger,  InnerDyne  discontinued  efforts to
develop and commercialize the blood-gas exchange device and focused primarily on
the development, manufacture and commercialization of proprietary M.I.S.  access
products.  InnerDyne  commercially introduced  its  first M.I.S.  access device,
STEP, in the fourth quarter of 1994. The Company intends to continue  developing
its  proprietary radial  dilation, thermal  ablation and  biocompatible coatings
technologies, internally or through strategic alliances.
 
    InnerDyne has experienced operating losses  since its inception in  December
1985.  InnerDyne reported  net losses of  $5,627,115 on  revenues of $5,275,060,
$9,904,142 on revenues of  $878,909 and $10,359,233 on  revenues of $42,821  for
the  fiscal years ended  December 31, 1995,  1994 and 1993,  respectively. As of
December 31, 1995, the Company had an accumulated deficit of $46,615,496.
 
    To date, substantially all of the Company's revenues from product sales  are
attributable  to STEP products and InnerDyne currently anticipates that sales of
STEP products will represent substantially all of the Company's revenues in  the
immediate  future. Accordingly, the success of  the Company is largely dependent
upon increased  market  acceptance of  its  STEP  product line  by  the  medical
community  as  a reliable,  safe and  cost-effective  access product  for M.I.S.
InnerDyne commenced commercial sales of its  STEP product in the fourth  quarter
of  1994, and  to date sales  have been made  to a relatively  limited number of
physicians  and  hospitals.  Recommendations  and  endorsements  by  influential
members  of  the  medical  community  are  important  for  the  increased market
acceptance of the Company's  STEP products, and there  can be no assurance  that
existing  recommendations or  endorsements will be  maintained or  that new ones
will be obtained. Failure  to increase market acceptance  of the Company's  STEP
products  would  have a  material adverse  effect  upon the  Company's business,
financial condition and results  of operations. See  "Risk Factors --  Continued
Dependence on STEP Products" and "Business -- Products and Technology."
 
RESULTS OF OPERATIONS
 
   
    YEARS ENDED DECEMBER 31, 1993, 1994 AND 1995
    
 
    Total  revenues of $5,275,060  were realized during  the year ended December
31, 1995, compared to total  revenues of $878,909 in  1994 and $42,821 in  1993.
Total  revenues  are comprised  of revenues  from  product sales  and licensing,
contract and grant revenues. Product sales increased to $4,729,651 in 1995  from
$275,517  in 1994, reflecting  sales of the STEP  device, which was commercially
introduced in the fourth quarter of 1994. Licensing, contract and grant revenues
were $545,409, $603,392 and $42,281 in 1995, 1994 and 1993, respectively.  These
revenues  related to agreements  with third parties  covering the development of
the Company's  proprietary  thermal ablation  technology  and licensing  of  the
Company's proprietary biocompatible coatings technology. Licensing, contract and
grant revenues
 
                                       19
<PAGE>
   
fluctuate  from year to year, and from quarter to quarter, based upon the number
of agreements in effect and the amount and timing of the payments to be made  to
InnerDyne pursuant to such agreements.
    
 
    Total  costs and expenses were $11,122,791  in 1995, compared to $10,939,559
in 1994 and  $10,807,855 in  1993. Expenses in  1995 and  1994 include  start-up
costs to build the Company's manufacturing capability and increases in sales and
marketing  expenses  for M.I.S.  products, as  the Company  built the  sales and
marketing resources necessary to  support commercialization of M.I.S.  products,
which  began in the  fourth quarter of  1994. Expenses in  1994 and 1993 include
costs related to development programs that have been completed or  discontinued.
Expenses  associated  with  the  Company's  merger  are  also  reflected  in the
Company's 1994 and 1993 results.
 
    Cost of product  sales were $3,148,915  in 1995, compared  to $1,939,974  in
1994  and $489,692  in 1993.  Cost of product  sales are  primarily comprised of
direct material costs  of components  for finished  products, as  well as  labor
costs  and an allocated portion  of overhead expenses. Cost  of product sales in
1995 and  late  1994  include  start-up  manufacturing  and  "pilot"  production
expense,  as  well as  costs of  producing  higher volumes  of the  STEP device.
Although the Company  anticipates that cost  of product sales  will continue  to
increase  in absolute  dollars in  future periods,  cost of  product sales  as a
percentage of revenue is  expected to decrease in  1996 if sales and  production
volume increase.
 
    Research,  development, regulatory and clinical  expenses were $2,299,311 in
1995  compared  to  $3,951,536  in  1994  and  $5,793,455  in  1993.   Research,
development,  regulatory and clinical expenses are primarily comprised of salary
and benefits, costs incurred in  protecting the Company's intellectual  property
and  an allocated portion of  overhead expenses. The decreases  in 1995 and 1994
reflect the  completion or  discontinuation of  development programs,  including
costs  associated with development, clinical trials and regulatory submission of
a device using the  Company's gas exchange and  blood pumping technologies.  The
Company   anticipates  that  research,   development,  regulatory  and  clinical
expenditures will not continue to decline in absolute dollars, and are likely to
increase in future periods.
 
    Sales and marketing expenses were $3,895,338 in 1995 compared to  $2,063,123
in  1994  and $1,107,334  in 1993.  Sales and  marketing expenses  are primarily
comprised of salary, benefits and commissions; an allocated portion of  overhead
expenses;  advertising, promotional  and customer  service expenses  and cost of
product samples.  The increase  reflects the  expansion of  sales and  marketing
functions  for M.I.S.  products as  sales volumes increased  in 1995  and as the
Company assembled its sales force of direct and independent representatives  and
international distributors following the initial commercialization of its M.I.S.
products  in  the  fourth  quarter  of  1994.  The  increase  in  1995  included
compensation  to  sales  representatives,  costs  of  sample  and  demonstration
product,   costs  to  complete  outcomes   studies,  costs  of  promotional  and
advertising  programs   and   costs   associated   with   establishing   foreign
distributors.  InnerDyne expects that sales and marketing expenses will continue
to increase in absolute dollars.
 
    General and administrative  expenses were  $1,779,227 in  1995, compared  to
$2,984,926  in 1994 and $3,417,374 in  1993. General and administrative expenses
are primarily comprised of salary and benefits, an allocated portion of overhead
expenses, as well as  legal, accounting, insurance  and other general  corporate
expenses.  The decrease in expenses  in 1995 compared to  1994 and 1993 reflects
efficiencies resulting from the Company's April 1994 merger, particularly in the
areas of general and administrative  staffing, insurance costs and  professional
services. Also, 1994 expenses included legal, accounting, consulting, filing and
other  expenses related to the  merger, as well as  expenses associated with the
integration of the two companies.  The 1993 expenses included significant  costs
related  to reductions in  force and consulting  expenses for interim management
while the Company conducted a search for a Chief Executive Officer. The  Company
anticipates  that general and administrative  expenses will increase in absolute
dollars to support expanding operations.
 
    Interest income was $250,594 in 1995, $459,830 in 1994 and $605,343 in 1993.
The decreases  in  1995 and  1994  were due  to  lower interest  earned  as  the
Company's  cash, cash equivalents and marketable investment securities declined.
Interest   expense    was   $28,908    in   1995,    $63,511   in    1994    and
 
                                       20
<PAGE>
$147,610  in 1993. This  interest expense was  primarily the result  of debt and
capital leases  incurred  to finance  equipment  to support  operations  of  the
Company,  in addition to interest incurred in  1994 and 1993 related to loans to
IMI from its stockholders.
 
    Primarily for the reasons outlined  above, InnerDyne incurred net losses  of
$5,627,115  or $.32 per share in 1995, $9,904,142  or $.61 per share in 1994 and
$10,359,233 or $.69 per share in  1993. Management believes that the Company  is
likely to incur operating losses at least through 1996.
 
   
    THREE MONTHS ENDED MARCH 31, 1995 AND 1996
    
 
   
    Total  revenues  for  the  three-month  period  ended  March  31,  1996 were
$1,582,400, compared to $1,235,136 for the corresponding period in 1995. Product
sales increased to $1,519,880  for the three month  period ended March 31,  1996
from  $954,466 for the corresponding period  in 1995, reflecting increased sales
of the Company's  STEP device. Licensing,  contract and grant  revenues for  the
three  month period ended March 31, 1996  were $62,520, compared to $280,670 for
the corresponding  period in  1995. These  revenues related  to agreements  with
third  parties  covering the  development of  the Company's  proprietary thermal
ablation technology,  the  development  of non-competing  applications  for  the
Company's  radial  dilation  technology  and  the  licensing  of  the  Company's
proprietary biocompatible coatings technology. The licensing, contract and grant
revenues for the  three-month period ended  March 31, 1995  included a  one-time
payment from a single licensor. Licensing, contract and grant revenues fluctuate
from  quarter to quarter, based upon the  number of agreements in effect and the
amount and timing  of the  payments to  be made  to InnerDyne  pursuant to  such
agreements.
    
 
   
    Cost  of product sales  was $896,305 for the  three-month period ended March
31, 1996, compared to $680,488 for the same period in 1995. The increase in cost
of product sales for the three month period ended March 31, 1996 is attributable
to the increase in production  and sales volume compared  to the same period  in
1995.  In addition, cost of  product sales for the  three months ended March 31,
1995 included  significant start-up  manufacturing costs.  Although the  Company
anticipates  that cost  of product sales  will continue to  increase in absolute
dollars in future periods, cost of product  sales as a percentage of revenue  is
expected to decrease in 1996 if sales and production volumes increase.
    
 
   
    Research,  development, regulatory and clinical expenses for the three-month
period ended  March 31,  1996 were  $579,611, relatively  unchanged compared  to
$582,101  for  the  corresponding  period  in  1995.  The  Company  expects that
research, development,  regulatory and  clinical expenditures  will increase  in
absolute dollars in future periods.
    
 
   
    Sales  and  marketing expenses  were $1,182,453  for the  three-month period
ended March 31,  1996, compared  to $993,519  for the  three-month period  ended
March  31,  1995, reflecting  the growth  of the  Company's sales  and marketing
functions to support commercialization of its M.I.S. products. InnerDyne expects
that sales and marketing expenses will continue to increase in absolute dollars.
    
 
   
    General and administrative expenses were $525,336 for the three months ended
March 31, 1996, relatively  unchanged from $517,766 for  the three months  ended
March 31, 1995. The Company anticipates that general and administrative expenses
will increase in absolute dollars to support expanding operations.
    
 
   
    Interest/other  income, net decreased to  $17,063 for the three-month period
ended March 31, 1996, compared to $69,860 for the same period in 1995, primarily
as a result of lower interest income in the 1996 period due to lower cash,  cash
equivalent and marketable investment securities balances.
    
 
   
    The  Company incurred a net loss of  $1,584,242, or $0.09 per share, for the
three-month period ended March 31, 1996,  compared to a net loss of  $1,468,878,
or  $0.09 per share, for  the same period in  1995. Management believes that the
Company is likely to incur operating losses at least through 1996.
    
 
LIQUIDITY AND CAPITAL RESOURCES
 
   
    For the  period  from its  inception  to March  31,  1996, the  Company  has
incurred  a cumulative net loss of approximately $48.2 million. Since inception,
the Company's cash expenditures have exceeded  its revenues. Prior to 1992,  the
Company was funded primarily through private placements of equity securities. In
1992,  the Company completed  an initial public offering  of 2,875,000 shares of
its Common Stock at $11 per share, which raised approximately $28.8 million (net
of underwriter's
    
 
                                       21
<PAGE>
discounts and offering  expenses). In June  1995, the Company  closed a  private
placement  of 1,435,599  shares of  the Company's  Common Stock  and warrants to
purchase 287,200 additional shares of Common  Stock, with gross proceeds to  the
Company  of  approximately  $3.2  million.  The  1994  acquisition  of  IMI  was
accomplished through issuance of additional Common Stock of the Company.
 
   
    At March 31, 1996, cash and cash equivalents totaled $1,820,049, compared to
a total cash, cash equivalents  and marketable investment securities balance  of
$2,718,418 at December 31, 1995. The Company had $89,153 and $542,658 in capital
expenditures in the quarter ended March 31, 1996 and the year ended December 31,
1995,  respectively. Working capital  totaled $2,311,504 at  March 31, 1996, and
the  Company  had  long-term  debt,  excluding  current  installments,  totaling
$230,249 relating to financing of equipment.
    
 
   
    In  February  1996, the  Company renewed  its  credit facility  with Silicon
Valley Bank. Subject to certain covenants and conditions, the Company may borrow
up to $2,000,000 on a revolving credit  basis at prime plus 1 1/4% and  $750,000
as  a 42-month term loan  at prime plus 1 3/4%.  The revolving credit portion of
the facility  is available  based on  the existence  and magnitude  of  eligible
receivables,  and the term  loan portion of  the facility is  available based on
eligible equipment purchases.  As of March  31, 1996, the  Company had  borrowed
$326,245  under the term loan provision of the credit facility for the financing
of capital expenditures.
    
 
    In March and April of 1996, holders of warrants to purchase an aggregate  of
242,952  shares  of Common  Stock exercised  such  warrants, resulting  in total
proceeds to the Company of $704,561.
 
    In the future, the Company expects to incur substantial additional operating
losses and cash  outflow requirements  as a  result of  expenditures related  to
expansion   of  sales  and  marketing  capability,  expansion  of  manufacturing
capacity,  research  and  development  activities,  compliance  with  regulatory
requirements,   and  possible   investment  in  or   acquisition  of  additional
complementary products, technologies  or businesses. The  timing and amounts  of
these  expenditures will depend  upon many factors, such  as the availability of
capital, progress of the Company's  research and development, and factors  which
may  be beyond the Company's control, such as the results of product trials, the
requirements for  and  the  time  required to  obtain  regulatory  approval  for
existing  products and any other products that may be developed or acquired, and
market acceptance of the Company's products.
 
    The  Company's  capital  requirements  will  depend  on  numerous   factors,
including  market  acceptance and  demand for  its  products; the  resources the
Company devotes to the development,  manufacture and marketing of its  products;
the  progress  of  the  Company's  clinical  research  and  product  development
programs; the receipt of, and the time required to obtain, regulatory clearances
and approvals;  the resources  required to  protect the  Company's  intellectual
property;  and other factors. The timing and amount of such capital requirements
cannot be accurately predicted.  Funds may also be  used for the acquisition  of
businesses,  products and  technologies that are  complementary to  those of the
Company. Consequently, although the Company  believes that the proceeds of  this
Offering,  together  with  revenues,  credit  facilities  and  other  sources of
liquidity, will provide adequate funding for its capital requirements through at
least 1997, the Company may be required to raise additional funds through public
or private financings, collaborative relationships or other arrangements.  There
can be no assurance that the Company will not require additional funding or that
such additional funding, if needed, will be available on terms attractive to the
Company,  or  at  all.  Any  additional equity  financings  may  be  dilutive to
stockholders,  and  debt  financing,  if  available,  may  involve   restrictive
covenants.  See  "Risk Factors  --  Future Additional  Capital  Requirements; No
Assurance Future Capital Will Be Available" and "Use of Proceeds."
 
                                       22
<PAGE>
                                    BUSINESS
 
THE COMPANY
 
    InnerDyne, Inc. (the "Company" or "InnerDyne") is primarily focused upon the
development and commercialization of access  products used to perform  minimally
invasive  surgical ("M.I.S.") procedures.  The Company also  intends to continue
developing its  radial dilation,  thermal  ablation and  biocompatible  coatings
technologies, internally or through strategic alliances.
 
INDUSTRY BACKGROUND
 
    MINIMALLY INVASIVE SURGICAL PROCEDURES
 
    Medical practitioners have, for many years, sought means to improve the care
of their patients and minimize the trauma and recovery time associated with such
care.  In addition, as life expectancy  has increased, overall health care costs
have far outpaced the average inflation rate in recent years. The performance of
surgical procedures utilizing minimally invasive techniques has been a  response
to  both the need  to continuously improve  the quality of  patient care and the
increasing pressures to control the total cost of providing that care. Minimally
invasive surgical procedures typically involve a few small incisions rather than
the large incisions used in  traditional open surgery, thereby reducing  patient
trauma.  M.I.S. procedures require three basic capabilities: (1) a means to gain
access to the treatment site; (2) a means to assess the treatment site; and  (3)
a means to provide therapy.
 
    Although less invasive alternatives to traditional open surgery have existed
for  a number of years, the trend  towards minimally invasive techniques was not
widespread until the late 1980s. At that time, surgeons developed and  perfected
a  technique for  gall bladder  removal through  the use  of specialized access,
diagnostic and treatment devices. By 1994, an estimated 85% of the approximately
625,000 gall  bladder  procedures in  the  United States  were  performed  using
minimally  invasive techniques. A number of  surgical procedures other than gall
bladder surgery  have  also been  converted  to minimally  invasive  approaches,
including  the  treatment  of  gynecological  disorders  and  the  diagnosis and
treatment of vascular disease. In addition, M.I.S. procedures may be useful  for
intra-organ  diagnostic and treatment  procedures. It is  estimated that in 1994
over 1.0 million procedures traditionally accomplished through open surgery were
performed  in  the  United  States  using  M.I.S.  techniques.  Domestic  M.I.S.
procedures  are expected  by industry sources  to grow  at a rate  of almost 11%
through 1997, to  a level  of over 1.4  million procedures.  Furthermore, it  is
estimated  that more than 5.3 million  domestic surgical procedures performed in
1994  were  considered  to  be  potential  candidates  for  minimally   invasive
approaches.
 
    M.I.S. ACCESS DEVICES
 
    The  trocar is the conventional device that  is used by surgeons to access a
possible treatment site  in a M.I.S.  procedure. A trocar  is a sharply  pointed
cutting  instrument surrounded  by a  rigid sheath,  or cannula,  that is forced
through the abdominal wall by the surgeon  and cuts through the muscle and  skin
layers  which make up the abdominal  wall. Trocar insertion is normally preceded
by the insertion of an insufflation (inflation) needle into the abdominal cavity
through which a gas can be pumped to insufflate the abdominal cavity as a  means
of  providing working space  and added clearance such  that internal body organs
are less likely to  be damaged as  the sharp-bladed trocar  is inserted. Once  a
trocar  has  penetrated  the abdominal  wall,  the cutting  surface  is removed,
leaving the cannula through which instruments and diagnostic tools can be placed
into the abdominal cavity of the patient. The proximal end of the trocar,  which
remains  outside the body, is normally equipped  with a valve system designed to
allow  the  passage  of  instruments  while  maintaining  the  insufflation  gas
pressure.  Trocars  are most  commonly provided  in 5mm,  10mm and  12mm working
channel sizes, and leave residual wounds which approximate these nominal  sizes.
From  one to as many  as five trocars are used  for access in M.I.S. procedures,
depending on the extent and complexity of the particular procedure. In addition,
anchors are frequently used with  trocars to assure maintenance of  insufflation
pressure and to
 
                                       23
<PAGE>
prevent  slippage of the trocars as instruments are passed through them during a
procedure. These anchor devices, when used,  can further enlarge the wound  size
and increase trauma to adjacent tissues.
 
    Trocars  consist  of two  types: disposable  and reusable.  Industry sources
estimate that in 1995 sales of  disposable trocars in the United States  totaled
approximately  $230 to $240 million and  that global sales totaled approximately
$300 million. Reusable trocars are used to a greater extent internationally than
in the United States. Reusable trocars must be sharpened from time to time  when
they  become  dull. Between  sharpening  and after  a  number of  sharpenings, a
reusable trocar may not consistently and cleanly cut through the muscle and skin
layers that make  up the  abdominal wall.  As a  result, the  potential risk  of
serious  trauma to  the patient  is increased  because greater  pressure must be
applied to force the trocar through the abdominal wall, causing it to  partially
collapse  and reduce the  space created by  the insufflation. In  addition, as a
trocar is a  sharply-pointed cutting instrument,  medical personnel that  handle
and  clean reusable trocars are subject to the significant risk of cuts and skin
punctures from a device that has been in contact with a patient's blood.
 
    Another device  commonly  used  in M.I.S.  procedures  is  the  percutaneous
catheter.  A number of minimally  invasive percutaneous catheter-based therapies
have been developed to treat vascular disease, including coronary and peripheral
transluminal angioplasty,  artherectomy  and  vascular  stenting.  In  addition,
minimally   invasive   catheter-based  diagnostic   procedures  such   as  x-ray
angiography and ultrasound  imaging are  also used by  physicians in  connection
with   therapeutic   procedures.  Industry   sources   estimate  that   in  1994
approximately 2.2  million minimally  invasive vascular  access procedures  were
performed worldwide.
 
    Surgeons  who  perform  M.I.S.  procedures  to  diagnose  or  treat vascular
diseases undertake a multiple step process to obtain access to the  vasculature.
The  physician first punctures the  femoral artery to create  an access site for
the catheter  devices.  The  physician  then inserts  an  introducer  sheath  (a
flexible  cannula) into the femoral artery and places a guiding catheter through
the introducer sheath to create a path from outside the patient to the  arterial
system.  The  physician advances  a small  guidewire through  the inside  of the
guiding catheter into the  femoral artery and up  into the arterial system.  The
physician  then  delivers  the  therapeutic  or  diagnostic  catheter  over  the
guidewire through the inside of the guiding catheter into the artery and  across
the  treatment  site. The  insertion of  the introducer  sheath and  the guiding
catheter is normally preceded  by the administration  of an anticoagulant  drug,
which is generally continued throughout the procedure.
 
    The  conventional  technique used  to  access the  vasculature  suffers from
certain drawbacks. If  a physician needs  to utilize a  device that exceeds  the
diameter of the introducer sheath, the physician must insert a new sheath with a
wider  diameter.  Depending on  the  width and  number  of devices  used  by the
physician, this process can  increase the likelihood of  trauma to the  arterial
vessel.  Additionally, following  catheter-based procedures,  the physician must
close the arterial access site. In current practice, anticoagulation therapy  is
generally  discontinued for up to four hours prior to closure of the access site
to allow the patient's  clotting function to normalize.  During this period,  an
introducer  sheath  is typically  left  in place,  and  the patient  must remain
immobile to prevent bleeding at the access site.
 
    Advanced access  devices  may also  prove  useful for  intra-organ  surgical
procedures.  The surgical treatment of an organ deep within the abdominal cavity
is typically conducted  through open  surgery, involving  a three  to five  inch
incision  that is made in  the abdominal wall to give  access to the organ. Open
surgery requires a hospital stay and a prolonged recovery period. Alternatively,
the organ can  be treated through  a less invasive  technique that involves  the
insertion  of a long flexible  channel and scope through  a natural body orifice
such as the  mouth or  the rectum  to gain access  to the  organ. However,  this
technique  is limited  in its  effectiveness due to  the restricted  size of the
channel and the torturous path that must be navigated by the scope.
 
                                       24
<PAGE>
    M.I.S. TREATMENT FOR MENORRHAGIA
 
    In recent years, M.I.S.  procedures have been  developed to treat  excessive
menstrual bleeding. Women who perceive their menstrual bleeding to be excessive,
including  women who are clinically  diagnosed with excessive menstrual bleeding
("menorrhagia"), may  seek treatment  if this  condition interferes  with  their
daily  lives. A  World Health Organization  survey of  menstrual perceptions and
patterns among 5,322 women in 10 countries found that approximately 19% of women
consider their menstruation abnormally heavy. The most common surgical procedure
for definitive treatment  of excessive menstrual  bleeding is hysterectomy,  the
surgical  removal  of the  uterus through  the vagina  or abdominal  wall, which
results in permanent infertility.  Industry sources estimate that  approximately
19%  of the estimated 600,000 hysterectomy  procedures in the United States each
year are performed to treat  excessive menstrual bleeding. Currently  available,
less   invasive  treatment   options  include   long-term  drug   therapy  using
estrogen-progesterone  medications  or  other  drugs  such  as  GnRH   agonists,
temporary  treatment by dilatation and curettage,  a procedure generally used in
conjunction with drug therapy in which  the uterine contents are either  scraped
away  by  an  instrument  or removed  through  vacuum  aspiration,  and surgical
endometrial ablation.  Surgical endometrial  ablation  is a  minimally  invasive
procedure  that utilizes  a resectoscope,  a video  monitor, a  fluid distention
medium such as glycine or  sorbitol, and a surgical  ablation device such as  an
electrode loop, rollerball or laser.
 
    Each  of  these treatment  methods bears  certain  risks and  limitations. A
hysterectomy can require up to seven days of hospitalization and eight weeks  of
recovery  time,  depending  on  the  type  of  hysterectomy  performed.  Serious
complications   from   hysterectomy   include   hemorrhaging   requiring   blood
transfusions,   injury  to   the  bowel  or   bladder,  intestinal  obstruction,
life-threatening cardiopulmonary events and  death. Other complications  include
postoperative  fever and infections. Although less invasive than a hysterectomy,
the dilatation and curettage procedure  must be repeated periodically, since  it
is  usually  effective only  during  the first  few  menstrual cycles  after the
procedure, and  consequently  subjects  the  patient to  the  risks  of  uterine
perforation,  infection and the complications of general anesthesia each time it
is performed.  Uterine  perforation  is  a  possible  complication  of  surgical
endometrial  ablation and is potentially fatal when  it results in damage to the
internal iliac  vessels,  ureter,  bowel  or  bladder.  Other  complications  of
surgical  endometrial ablation include major  hemorrhaging from uterine vessels,
air  embolus  from  gas-cooled  lasers,  postoperative  intrauterine  or   tubal
infection,  complications associated with general  anesthesia and fluid overload
due to use  of glycine  and sorbitol.  Surgical endometrial  ablation will  also
result in patient infertility.
 
    In light of the limitations of current therapies for menorrhagia, other less
invasive  procedures are  currently being  developed. Although  these procedures
also result  in  patient infertility,  they  are  designed to  result  in  fewer
complications  and  adverse  side effects  and  a shorter  recovery  time. These
procedures include  endometrial ablation  techniques that  employ RF  energy  or
freezing  techniques  and  techniques  that  are  designed  to  treat  excessive
menstrual bleeding by thermally  ablating the endometrial  lining of the  uterus
through  the introduction  of a  heated balloon  catheter or  a heated solution.
These procedures  are  designed  to  destroy  the  endometrial  lining,  thereby
reducing or eliminating excessive menstrual bleeding.
 
    M.I.S. APPLICATIONS FOR BIOCOMPATIBLE COATINGS TECHNOLOGIES
 
    Cardiovascular  disease is the leading cause  of death in the United States.
Atherosclerosis, the principal cause of cardiovascular disease, results from the
progressive accumulation of plaque as a result of the deposit of cholesterol and
other fatty  materials on  the  walls of  arteries. Atherosclerosis  results  in
reduced  blood  flow  to  the  muscles  of  the  heart  and  peripheral anatomy.
Atherosclerosis in the coronary arteries can ultimately lead to heart attack and
death. Arteries  diseased  with  atherosclerosis may  be  treated  with  medical
procedures  designed to increase blood flow. Established treatments include open
heart  surgery,  a  highly  invasive  surgical  procedure,  and  less   invasive
percutaneous   catheter-based  procedures   such  as   coronary  and  peripheral
transluminal angioplasty.
 
                                       25
<PAGE>
    In recent years, a number of new percutaneous catheter-based therapies  have
been  developed  to  increase  blood flow,  including  atherectomy  and vascular
stenting. Industry  sources  estimate  that during  1994  approximately  900,000
balloon   angioplasty,  atherectomy  and   stenting  procedures  were  performed
worldwide. Industry  sources also  indicate that  cardiovascular stenting  is  a
growing  procedure for treating  cardiovascular disease due  to its demonstrated
ability to reduce  the occurrence  of restenosis,  a re-narrowing  of a  treated
blood   vessel  that  typically  occurs  within   six  months  of  treatment  in
approximately one-third of the patients that undergo percutaneous catheter-based
procedures.  Stents  are  implantable  medical  devices  that  reduce   arterial
obstruction by providing a rigid scaffolding to dilate an occluded blood vessel.
Once  placed, stents exert  radial force against  the walls of  blood vessels to
enable the blood vessels to remain open and functional. Recent studies  indicate
that restenosis of vessels treated with stents may be significantly reduced when
the stents are coated with anticoagulants.
 
    In   light  of  the   growth  of  stenting  as   a  procedure  for  treating
cardiovascular disease  and preliminary  indications that  restenosis  following
stenting can be reduced through the coating of stents, the Company believes that
opportunities exist for companies with technology for effectively coating stents
with anticoagulants or other therapeutic drugs.
 
THE INNERDYNE SOLUTION
 
    RADIAL DILATION TECHNOLOGY
 
    The Company believes that its proprietary radial dilation technology enables
a  physician performing a M.I.S. procedure to  access a patient's body through a
less invasive means than a conventional trocar. The Company's STEP device, which
was introduced  in  the  United States  in  November  1994, is  based  upon  the
Company's  proprietary  radial dilation  technology and  is designed  to provide
access to the  abdominal cavity  in order  to facilitate  the visualization  and
treatment  of target areas within the  cavity while minimizing the tissue trauma
associated with such  access. With the  Company's STEP access  device, a  trocar
does not need to be utilized, eliminating the risk of internal organ damage from
contact with the sharp-bladed trocar. Following insufflation of the body cavity,
if  needed, the expandable  sheath enters the  body cavity through  the use of a
standard  insufflation  needle,  creating  only  a  small  puncture  wound.  The
insufflation   needle  is  then  removed  and  the  sheath  is  expanded  to  an
appropriately sized working channel by insertion of a blunt dilator and  cannula
into the sheath. The blunt dilator is then removed, leaving the cannula in place
with  an integral insufflation valve at the proximal end. The radial dilation of
the tissue into  an appropriately  sized working  channel holds  the cannula  in
place  and obviates  the need  for an  anchoring system.  Therefore, the Company
believes  that  the  use  of  the  STEP  can  in  many  cases  reduce  operative
complications and surgery time, and thereby result in lower operating costs. The
STEP  is  currently utilized  in minimally  invasive general,  gynecological and
pediatric surgical procedures.
 
    The Company believes that its proprietary radial dilation technology may  be
useful  in accessing the vasculature as  part of minimally invasive percutaneous
catheter-based procedures that are used to diagnose and treat vascular  disease.
Utilizing  the Company's  proprietary radial  dilation technology,  the flexible
sheath could potentially be inserted into the patient's vasculature and  dilated
to form a working channel to accommodate devices. When using conventional access
devices,  the physician must retract and replace sheaths in order to accommodate
larger devices  that may  be  used during  the  procedure. Such  retraction  and
replacement   of  sheaths  is   not  necessary  when   using  an  access  device
incorporating the  Company's  radial  dilation technology  and,  therefore,  the
trauma  to the patient's  arterial system may be  reduced. Because the Company's
radial dilation technology enables the flexible  sheath to contract and leave  a
smaller  residual opening, an  access device based  on the Company's proprietary
radial dilution technology could potentially reduce bleeding complications.
 
    The Company has  also used  its radial  dilation technology  to develop  the
Radially Expanding Dilator ("R.E.D."), which is designed as an access device for
intra-organ  surgery.  The  Company  believes  that  the  R.E.D.  overcomes  the
limitations  of  conventional  open  surgery  techniques  and  alternative  less
invasive  methods because the  R.E.D. is designed  to provide minimally invasive
access
 
                                       26
<PAGE>
through the abdominal wall,  across the peritoneal space,  and into an  internal
organ.  The  Company believes  that the  use  of the  R.E.D. can  reduce patient
recovery time as compared to conventional open surgical techniques.
 
    THERMAL ABLATION TECHNOLOGY
 
    The Company has  developed proprietary thermal  ablation technology that  is
intended  to thermally ablate  the lining of  a body organ.  The Company's ENABL
Thermal Ablation  System  (the "ENABL  System")  is based  on  this  proprietary
technology  and  is  designed to  treat  menorrhagia by  thermally  ablating the
endometrial lining of the uterus through the controlled introduction and heating
of a normal saline solution IN SITU. The ENABL System is designed as a minimally
invasive procedure that  can be performed  in a clinic  or a physician's  office
without  the use of  general anesthesia. Although this  procedure is expected to
result in the infertility  of the patient, the  Company believes that the  ENABL
System  has  the potential  to result  in fewer  complications and  adverse side
effects and  reduced recovery  times compared  to current  therapies. For  these
reasons  the Company also believes that the ENABL System has the potential to be
more cost-effective than many current therapies.
 
    BIOCOMPATIBLE COATINGS TECHNOLOGIES
 
    The Company has  developed proprietary  biocompatible coatings  technologies
for  bonding the anticoagulant  drug heparin and other  bioactive molecules to a
siloxane subsurface or a variety of other subsurfaces by means of chemical bonds
that it believes are  stronger than those generally  used for this purpose.  The
Company's  thrombo  resistant coating  ("TRC") utilizes  a "tether"  molecule to
attach heparin or other bioactive  molecules to the previously applied  siloxane
subsurface.  One end of the tether molecule is covalently bonded to the siloxane
coating, and the other end  of the tether molecule  is covalently bonded to  the
bioactive  molecule. Because both  points of attachment  utilize covalent bonds,
the Company believes that its coating  process results in a stronger bonding  of
heparin  or other bioactive  molecules to the  surface of the  device than other
methods presently in use, which it believes generally use a weaker ionic bond in
at least one of the attachment points.
 
    The Company  recently announced  the  signing of  an agreement  with  Boston
Scientific  Corporation ("Boston Scientific") covering the potential application
and use  of  InnerDyne's  proprietary biocompatible  coating  technologies  with
Boston  Scientific's  stents, grafts,  vena cava  filters and  other implantable
medical devices.  Because of  the strength  of the  covalent bonds  used in  the
Company's  TRC  technology and  its other  properties  noted above,  the Company
believes that  this  technology may  have  advantages over  presently  available
bioactive coating technologies in several other potential applications.
 
STRATEGY
 
    The Company's primary objective is to leverage its proprietary technology to
develop,  manufacture and commercialize leading  access products used to perform
M.I.S. procedures. The Company  also intends to  continue developing its  radial
dilation,  thermal ablation and  biocompatible coatings technologies, internally
or through strategic alliances.  The key elements of  the Company's strategy  to
achieve its objectives include:
 
    - INCREASE  MARKET PENETRATION OF Step PRODUCTS.  InnerDyne entered into its
      first buying group agreement, with Surgical Care Affiliates, Inc., in late
      1995 and recently announced  that its Short STEP  was awarded the Seal  of
      Acceptance  by  the Alliance  of  Children's Hospitals,  Inc.  The Company
      intends to  further penetrate  the  market for  M.I.S. access  devices  by
      entering  into additional national buying  group agreements, expanding its
      international distribution network, and leveraging the results of clinical
      outcomes and acceptance studies.
 
    - EXPAND Step PRODUCT LINE.  The Company intends to continue to broaden  its
      STEP  product line, with the objective of providing a comprehensive set of
      access  devices  for  M.I.S.   procedures.  In  particular,  the   Company
      anticipates  commercial introduction  on a limited  basis of  two new STEP
      products, MiniSTEP and Reposable STEP, in late 1996.
 
                                       27
<PAGE>
    - COMMERCIALIZE VASCULAR ACCESS TECHNOLOGY.  The Company intends to leverage
      its proprietary  radial dilation  technology for  use in  vascular  access
      applications  such as angioplasty  and angiography. In  February 1996, the
      Company granted a license with  limited exclusivity provisions to use  its
      radial  dilation technology for access in the treatment of carotid disease
      and aortic aneurysms.
 
    - COMMERCIALIZE EnAbl  THERMAL ABLATION  TECHNOLOGY.   The  Company's  ENABL
      System  utilizes proprietary thermal ablation  technology that the Company
      believes  may  offer  significant   therapeutic  advantages  compared   to
      currently  available  treatments  for  excessive  menstrual  bleeding. The
      Company has recently completed initial human clinical safety trials and is
      preparing to  initiate  efficacy  trials in  two  foreign  countries.  The
      Company  is evaluating  whether to  continue the  internal funding  of the
      ENABL System  or  to  pursue  strategic  alternatives  for  the  continued
      development of this system.
 
    - BROADLY  LICENSE  BIOCOMPATIBLE  COATINGS  TECHNOLOGY.    In  addition  to
      utilizing its biocompatible coatings technology internally, the Company is
      pursuing the licensing  of this  technology to third  parties for  various
      applications.   InnerDyne   believes   that   its   biocompatible  coating
      technologies may  be applicable  in the  manufacture of  coated stents  or
      other  in-dwelling devices. The Company  recently announced the signing of
      an agreement with Boston Scientific pursuant to which the Company  granted
      a  license with limited exclusivity provisions to Boston Scientific to use
      InnerDyne's proprietary  biocompatible  coating technologies  with  Boston
      Scientific's  stents,  grafts,  vena cava  filters  and  other implantable
      medical devices.  In  addition,  in  1994, the  Company  entered  into  an
      agreement  pursuant to which it licensed and transferred its biocompatible
      coatings  technology  to  SENKO  Medical  Instrument  Manufacturing,  Inc.
      ("SENKO")  for the enhancement of  membrane oxygenators used in heart-lung
      machines.
 
                                       28
<PAGE>
PRODUCTS AND TECHNOLOGY
 
    The following table summarizes the Company's products and technologies.  The
following  table contains information concerning products and technologies under
development,  and  there  can  be  no  assurance  that  such  products  will  be
successfully   introduced  or  that  such   products  or  technologies  will  be
successfully commercialized  in  accordance with  the  dates set  forth  in  the
following table, or at all.
 
<TABLE>
<CAPTION>
                                                                              COMMERCIAL
        PRODUCT/TECHNOLOGY             APPLICATION/INDICATIONS           AVAILABILITY/STATUS
<S>                                 <C>                             <C>
RADIAL DILATION TECHNOLOGY
    STEP PRODUCT LINE
      STEP 1.0                      Disposable access devices for   510(k) clearance; First
                                     various general and             commercial sales (U.S. &
                                     gynecological M.I.S.            International) commenced in
                                     procedures                      1994
      STEP 1.5                                                      510(k) clearance; First
                                                                     commercial sales (U.S. &
                                                                     International) commenced in
                                                                     1995
      STEP 2.0                                                      510(k) clearance; Commercial
                                                                     sales anticipated in late
                                                                     1996
      Short STEP                    Disposable access device for    510(k) clearance; First
                                     various general and             commercial sales (U.S. &
                                     gynecological M.I.S.            International) commenced in
                                     procedures on smaller           1995
                                     individuals
      MiniSTEP                      Disposable access device for    510(k) clearance; Commercial
                                     various general and             sales anticipated in late
                                     gynecological M.I.S.            1996
                                     procedures performed with
                                     smaller instruments
      Reposable STEP                Reusable/with certain           510(k) clearance; Commercial
                                     disposable parts access         sales anticipated in late
                                     device for general and          1996
                                     gynecological M.I.S.
                                     procedures
    RADIALLY EXPANDING DILATOR      Disposable intra-organ access   510(k) clearance; Limited
     (R.E.D.)                        device for general M.I.S.       release
                                     procedures
    OTHER APPLICATIONS              Vascular access                 510(k) clearance; Under
                                                                     evaluation
                                    Carotid disease & aortic        Licensed to EndoTex in 1996
                                     aneurysm access
                                    Orthopedic access               Under evaluation
                                    Feeding tube placement          Under evaluation
THERMAL ABLATION TECHNOLOGY
    ENABL THERMAL ABLATION SYSTEM   Treatment of excessive uterine  Completed initial human
                                     bleeding                        clinical safety trials;
                                                                     Preparing to initiate
                                                                     efficacy studies
BIOCOMPATIBLE COATINGS
                                    Stent, graft, vena cava filter  Licensed to Boston Scientific
                                     and other implantable medical   in 1996
                                     device coatings
                                    Blood oxygenation enhancement   Licensed to SENKO in 1994
</TABLE>
 
                                       29
<PAGE>
    RADIAL DILATION TECHNOLOGY
 
    The  primary  focus  of  the  Company  is  the  development  and  commercial
application of its proprietary  radial dilation technology.  The key feature  of
this  proprietary technology is the capability to enter the body of a patient by
creating a small puncture wound, which can subsequently be dilated, or increased
in size,  to create  a larger  working channel.  Employment of  radial  dilation
within  an expandable sheath permits the dilation to be accomplished in a manner
that tends  to minimize  tissue  trauma. Upon  completion  of a  procedure,  the
dilation  sequence is reversed, and the result  is a smaller residual wound than
would be  experienced through  the employment  of similarly  sized  conventional
access devices. Potential benefits of radial dilation technology include reduced
risk, less patient trauma and reduced procedure time.
 
    Step  PRODUCT LINE.   The  Company has developed  a family  of STEP products
utilizing InnerDyne's proprietary radial  dilation technology. The initial  STEP
products were introduced commercially in late 1994.
 
    Step.    The  STEP  device  incorporates  the  Company's  proprietary radial
dilation technology  and  is InnerDyne's  first  product  to be  launched  on  a
commercial  basis. The  Company has received  510(k) clearances from  the FDA to
market this  device  for  laparoscopic and  thorascopic  M.I.S.  procedures.  In
contrast   to  conventional  trocars,  the   STEP  device  utilizes  a  standard
insufflation needle for the penetration through the abdominal wall at each  site
where it is utilized. Following removal of the needle, an expandable sheath that
surrounds  the needle is then dilated up to  a 5mm, 10mm or 12mm working channel
through the insertion of a dilator and cannula. Following dilation, the  dilator
is  removed, leaving  a rigid sheath  that serves  as a working  channel with an
integral  insufflation  valve  at  the  proximal  end.  After  completion  of  a
procedure, the rigid cannula is removed, and the sheath retracts, permitting the
opening in each of the muscular layers of the abdominal wall to recover, leaving
a  residual  wound that  is approximately  half the  size of  that made  using a
conventional trocar of similar size.
 
    Management believes  that  positive attributes  of  the STEP  product  could
significantly  affect  health care  system costs  and patient  satisfaction with
M.I.S. procedures in which trocars have traditionally been used. The results  of
a  Company-sponsored  retrospective  comparative outcomes  study  examining this
issue were released  during the fourth  quarter of 1995.  The study included  98
patients, and compared an almost equal number of procedures performed using STEP
devices  and conventional trocars for  access. Statistically significant results
of that study  indicated that STEP  reduced device-related complications  during
surgery  by over 90% and resulted in an approximate 22% savings in surgery time.
Based upon published  operating room costs,  this time savings  would equate  to
dollar  savings  of $345  to $515  per  procedure, a  substantial outcome  for a
product that is believed to  be competitively priced with conventional  trocars.
Management  also believes  that post-procedure complications,  such as infection
and incisional hernias at access sites, may be reduced with the use of the  STEP
device  as compared  to conventional  trocars. A  prospective study  intended to
corroborate and expand the findings of the published outcomes study is underway,
and is expected to be completed during 1996.
 
    SHORT Step.   The Short STEP  is a  conventional STEP device  that has  been
reduced  in length and is particularly  suitable for M.I.S. procedures involving
smaller individuals, particularly children and thin females. The Short STEP  was
commercially introduced in 1995.
 
    REPOSABLE  Step.    The  Reposable  STEP  incorporates  the  radial dilation
features of disposable  STEP devices in  a partially reusable  access device.  A
substantial  market for  reusable trocars  exists, primarily  outside the United
States, where  the pressures  on cost  and the  recognition of  the total  costs
involved  in surgical  procedures are  perceived somewhat  differently. Although
there is  substantial  usage  of  reusable  access  devices  in  the  U.S.,  and
management  expects a  trend toward a  somewhat more frequent  usage of reusable
devices, there are significant offsetting concerns relating to total health care
system costs  and safety  involved  with reusable  devices. The  Reposable  STEP
includes  a number of reusable components, currently consisting of a combination
of metal  and  plastic  parts  that  may  be  cleaned  and  sterilized  by  most
conventional  methods. The dilator,  cannula and needle  are reusable, while the
sleeve and valve are single-use components, designed to be disposed of following
surgery.
 
    MINIStep.  The MiniSTEP is a small-diameter radially dilating access  device
designed   for  use   in  office  micro-laparoscopic   surgery  utilizing  small
instruments. The working diameter of the MiniSTEP
 
                                       30
<PAGE>
ranges  from  2mm  to  8mm.  The  product  will  be  targeted  at  general   and
gynecological  surgeons performing  M.I.S. procedures.  Procedures would include
diagnostic  laparascopy,  as  well  as  therapeutic  procedures  such  as  tubal
sterilization.  Like the  STEP device,  MiniSTEP is  expected to  reduce device-
related surgical complications and surgery time.
 
    R.E.D.  The Radially Expanding Dilator ("R.E.D.") is the second product type
based upon the Company's proprietary  radial dilation technology. The R.E.D.  is
designed  to enable access to organs deep  within the abdominal cavity. The only
current alternative for  this type of  access involves the  insertion of a  long
flexible  channel and scope through a natural  body orifice such as the mouth or
the rectum, and only limited procedures are possible due to the restricted  size
of  the channel and the  tortuous path that must be  navigated by the scope. The
R.E.D. is designed  to provide  access through  the abdominal  wall, across  the
peritoneal  space, and into an internal  organ. InnerDyne believes that with use
of the R.E.D. product, substantial reductions  in patient recovery times may  be
possible.  The Company expects that the  enhanced capabilities of the R.E.D. may
enable additional surgical procedures to be performed through minimally invasive
techniques. This product  has been released  only on a  very limited basis,  and
feedback   indicates   it  enables   additional   procedures  to   be  performed
endoscopically. However, initial experience indicates a relatively high  surgeon
skill  level and  advanced training  is necessary  to perform  these intra-organ
procedures successfully. Accordingly, widespread commercialization of the R.E.D.
will require significant market development efforts. InnerDyne intends to use  a
portion  of the proceeds from this offering to conduct seminars teaching the use
of the R.E.D. product at advanced training centers across the United States.
 
    OTHER APPLICATIONS.    InnerDyne  is  exploring the  potential  use  of  its
proprietary  radial dilation  technology in  other applications  such as feeding
tube placement, vascular access, carotid disease and aortic aneurysm access  and
access for orthopedic procedures.
 
THERMAL ABLATION TECHNOLOGY
 
    EnAbl SYSTEM
 
    The Company's proprietary ENABL Thermal Ablation System (the "ENABL System")
has  been designed to  treat excessive menstrual  bleeding by thermally ablating
the endometrial  lining of  the uterus.  The ENABL  System relies  on  precisely
controlled  introduction and  heating of  a sterile  saline solution  IN SITU to
thermally injure the lining of the uterus.
 
    The Company recently announced the results of an initial safety trial with a
newly redesigned  system. The  results of  this limited  trial give  preliminary
indications  that  the ENABL  System might  represent a  safe means  of ablating
uterine tissue. However, there can be no assurance that the feasibility of  this
technology  will be satisfactorily demonstrated in  efficacy trials, or that the
system will  be  successfully  commercialized,  either  by  the  Company  or  in
collaboration with another entity.
 
    Historically,  the development  of the  Company's ENABL  System had received
financial support from CooperSurgical, Inc. ("CooperSurgical") during late  1994
and  the  first half  of 1995.  In May  1995, the  Company received  notice from
CooperSurgical advising the  Company of  its desire to  discontinue funding  and
forfeit  its future commercialization option  related to InnerDyne's proprietary
endometrial ablation  technology under  the previously  agreed upon  terms.  The
notification  from CooperSurgical did include an alternative proposal that would
have preserved a future  commercialization option under significantly  different
economic  terms.  These terms  were deemed  unacceptable  by InnerDyne,  and the
thermal ablation program has been internally funded since that time.
 
    BIOCOMPATIBLE COATINGS TECHNOLOGIES
 
    The Company  possesses  certain  proprietary technologies  in  the  area  of
biocompatible  coatings.  The  technologies  that  comprise  the  Company's  TRC
capability are  believed to  have  application when  foreign objects  remain  in
contact  with various areas  of the body, particularly  within the blood stream,
for sustained periods of time. These technologies include the ability to deposit
an extremely thin layer (approximately one micron) of siloxane on a surface  and
the  ability to graft a  bioactive substance, such as  the drug heparin, to that
siloxane layer.  TRC Coatings,  employed with  the siloxane  layer alone  or  in
combination with bioactive substances, can extend the life of blood-gas exchange
devices  or provide the capability to extend the duration of contact of a coated
device with  blood  or other  body  fluids while  minimizing  the  physiological
impacts of such contact.
 
                                       31
<PAGE>
    The  Company  recently announced  the signing  of  an agreement  with Boston
Scientific covering the potential application and use of InnerDyne's proprietary
biocompatible coating technologies with Boston Scientific's stents, grafts, vena
cava filters and other  implantable medical devices.  The agreement involves  an
equity  investment by Boston  Scientific in InnerDyne,  initial research support
and future license  fees and royalty  payments if Boston  Scientific decides  to
proceed with a technology transfer.
 
   
    In  addition, in 1994, the Company signed  a license agreement with SENKO, a
Japan-based manufacturer and marketer of membrane oxygenators used in open heart
surgery, pursuant to which the Company  licensed one of its TRC technologies  to
SENKO.  In connection with this agreement,  the Company transferred its siloxane
coating technology to SENKO for the coating of microporous hollow fibers used in
production of  oxygenators. The  technology transfer  was completed  during  the
first  quarter of 1995,  at which time  the Company received  the balance of the
initial payment from SENKO, and the royalty payment period commenced.  InnerDyne
recently  announced it has received an order  from SENKO to build a second fiber
coating system.
    
 
    The Company  has undertaken  a number  of discussions  with other  potential
licensees  of the Company's  biocompatible coating technologies,  and samples of
coated products have been provided to several companies. These discussions  have
been  with parties  interested in  the use  of the  technologies to  enhance gas
exchange, as well as third parties interested in the possible coating of devices
for  various  applications.  To  date,  the  Company  has  not  entered  into  a
contractual arrangement with any such parties.
 
RESEARCH AND DEVELOPMENT
 
    The Company has made significant investments in the research and development
of its proprietary technologies, including radial dilation, thermal ablation and
biocompatible  coatings. Research, development, clinical and regulatory expenses
for the years  ended December 31,  1995, 1994 and  1993 were approximately  $2.3
million,  $4.0 million and $5.8 million respectively. The decrease was primarily
the result of expenses  included in the  1993 and 1994  periods that related  to
completed  or discontinued development programs, including costs associated with
development, clinical trials  and regulatory  submission of a  device using  the
Company's  gas exchange and blood pumping technologies. As of December 31, 1995,
the Company  had  17  full-time  employees  engaged  in  research,  development,
clinical  and  regulatory  activities.  Currently,  the  Company's  research and
development efforts are primarily focused on providing enhanced versions of  the
STEP  device including the Reposable STEP and the MiniSTEP. In addition, limited
usage of the Company's R.E.D. product by  a select group of physicians is  being
routinely  monitored  to determine  both the  effectiveness  and utility  of the
product in intra-organ procedures.
 
    InnerDyne also devotes research and development efforts to pursue  potential
partnerships  that might  lead to utilization  of the  Company's radial dilation
technology in  areas outside  its primary  business focus.  The Company's  first
agreement involving licensing and development of its proprietary radial dilation
technology was announced in February 1996. The agreement with EndoTex covers the
development of access products expected to be used in conjunction with EndoTex's
technologies to treat carotid disease and aortic aneurysms.
 
    The  Company  is  also  continuing development  of  its  proprietary thermal
ablation technology and its ENABL System. The Company recently completed initial
human clinical safety trials  and is preparing to  initiate efficacy studies  in
two foreign countries.
 
    The  Company's  proprietary  biocompatible  coating  technologies  have been
evaluated by  a number  of potential  licensees. These  evaluations are  focused
primarily  on coating gas  exchange fibers and coating  devices (such as stents)
intended for implantation within the human vascular system.
 
    The future success of  the Company will depend  upon its ability to  develop
and  gain regulatory clearance  for new and  enhanced versions of  products in a
timely fashion. In addition, it is likely that the Company will seek to identify
opportunities to obtain products or  technologies from third parties. There  can
be no assurance that the Company will be able to successfully develop or acquire
new
 
                                       32
<PAGE>
products or technologies, license its proprietary technologies to third parties,
obtain  regulatory clearance for its products,  or gain market acceptance of new
and enhanced products. Delays  in development, clearance,  or acceptance of  new
products could have a material adverse effect on the Company's business, results
of operations and financial condition.
 
SALES AND MARKETING
 
    The  Company  is  marketing its  M.I.S.  access products  mainly  to general
surgeons  and   gynecologists.  A   domestic   network  of   independent   sales
representatives,  who typically  sell other  complementary products  to the same
customer base, was  selected and  trained during late  1994 and  early 1995.  In
spite of these efforts, some domestic geographic areas were still not covered by
what  management believed to be adequate representation. As a result, a decision
was made  during the  last half  of  1995 to  hire a  limited number  of  direct
representatives,  who are  InnerDyne employees compensated  on a commission-only
basis. As of the end of  1995, approximately 15 direct representatives had  been
hired  to complement the Company's network of independent sales representatives.
Although it is too early to evaluate the success of this organizational  change,
management  believes  that it  may improve  the  effectiveness of  its marketing
efforts. This United  States network of  sales representatives is  managed on  a
regional  basis  by  Company  employees who  possess  substantial  expertise and
industry experience. Their  efforts are  supported by a  marketing and  customer
service  organization, that also coordinates the Company's advertising and sales
material support, as well as the Company's participation in major industry trade
meetings.
 
    The Company's sales  activities have been  aided since October  1995 by  the
completion  of  a retrospective  outcomes study  comparing the  use of  the STEP
device and  conventional trocars  in a  number of  laparoscopic procedures.  The
study  summary has proven to be valuable, based upon limited experience to date,
in conveying the  benefits of the  STEP device  to health care  providers in  an
effective  manner. The  outcomes comparison  is believed  to have  represented a
positive  contribution  to  discussions  with  Surgical  Care  Affiliates,  Inc.
("SCA"),  one of the largest operators of  surgery centers in the United States;
the Company announced the signing of  its first buying group agreement with  SCA
in October 1995. In order to facilitate distribution to SCA and other customers,
the  Company  also  executed  a  domestic  distribution  agreement  with General
Medical, Inc. in  October 1995. Additional  agreements of a  similar nature  are
being  pursued with other provider and  distribution organizations, in an effort
to acquire greater market share for the Company's M.I.S. access products.
 
    In January 1996, the Company announced that its Short STEP device, a smaller
version of the standard STEP product, had been awarded the Seal of Acceptance by
the Alliance  of Children's  Hospitals,  Inc. ("Alliance").  The Alliance  is  a
wholly-owned  subsidiary  of  Child  Health  Corporation  of  America,  which is
comprised of 35 free-standing children's hospitals across the United States. The
Alliance selected the STEP  system, after extensive  research and review,  based
upon  its  ability  to  reduce  both  the  trauma  and  operative  complications
associated with pediatric laparoscopic surgical  procedures. In exchange for  an
ongoing  royalty payment, the Company is entitled to use this seal in connection
with the marketing and sale of its STEP  line of products. It is hoped that  the
Seal  of Acceptance can help the Company  expand awareness and sales of its STEP
product line for use in the pediatric environment.
 
    Internationally, the Company  expects to  utilize a  network of  independent
distributors to market its products in selected foreign countries. The effort to
identify  and  reach  agreements with  appropriate  foreign  distributors gained
substantial momentum during  the latter portion  of 1995. At  year end,  initial
orders had been received from distributors in 11 countries, primarily in Europe.
Management  expects to make additional progress  in this regard during 1996, and
expects foreign sales to positively impact future revenue growth.
 
    The Company  has limited  experience in  marketing its  products, and  faces
substantial  competition from  well-entrenched and formidable  competitors. As a
result, there can  be no assurance  that the Company  will successfully  achieve
acceptable  levels of product sales at prices that provide an adequate return or
that the Company will be able  to build a network of international  distributors
capable  of  effectively  marketing  its M.I.S.  access  products  or  that such
distributors will generate significant sales of such products. Failure to do  so
would  have  a material  adverse impact  on the  Company's business,  results of
operations and financial condition.
 
                                       33
<PAGE>
MANUFACTURING
 
    The  Company  initiated manufacture  of  commercial quantities  of  its STEP
device  in  its  Salt  Lake  City,  Utah  facility  during  late  1994.  Current
manufacturing  operations  consist  primarily  of the  assembly  and  testing of
purchased components to produce finished  products, which are then packaged  for
sterilization in an outside facility. During 1995, the Company implemented steps
to  automate  various aspects  of  the STEP  assembly  operation to  help reduce
product costs and  to achieve a  more uniform standard  of product  consistency.
During  the assembly process  and following sterilization,  the Company conducts
appropriate tests and  inspection of its  products in an  effort to assure  that
products  meet established specifications,  and to verify  appropriate levels of
product sterility.
 
    The Company has limited experience  in manufacturing M.I.S. access  products
or  other products in commercial quantities  at acceptable costs. The Company is
registered as  a manufacturer  of  medical devices  with appropriate  state  and
federal  authorities,  including  the  FDA,  and  is  pursuing  registration  to
standards which  would  confirm compliance  with  a number  of  foreign  quality
systems.  See "-- Government  Regulation." The Company's  success will depend in
part on its ability to manufacture its products in compliance with the FDA's GMP
regulations and other regulatory requirements in sufficient quantities and on  a
timely  basis, while  maintaining product  quality and  acceptable manufacturing
costs. Manufacturers often  encounter difficulties in  scaling up production  of
new  products, including  problems involving production  yields, quality control
and assurance, component supply and shortages of qualified personnel. Failure to
maintain production  volumes  or increase  production  volumes in  a  timely  or
cost-effective  manner would  have a  material adverse  effect on  the Company's
business, financial condition and results of operations.
 
    The Company was  recently inspected  by the FDA  and cited  for certain  GMP
deficiencies.  See "Risk Factors -- Limited Manufacturing Experience; Compliance
with Good Manufacturing Practices," "-- Government Regulation" and "Business  --
Government Regulation."
 
    The  materials utilized  in the  Company's M.I.S.  products consist  of both
standard and custom components that are purchased from a variety of  independent
sources.  The plastic  parts used  in the STEP  product are  injection molded by
outside vendors. The majority of these  parts are produced utilizing molds  that
have  been specially  machined for  and are owned  by the  Company. Although the
Company maintains  significant inventories  of molded  parts, any  inability  to
utilize these molds for any reason might have a material adverse effect upon the
Company's  ability to  meet its  customers' demand  for product.  In addition to
plastic parts produced from  injection molds owned by  the Company, a number  of
other  materials are  available only  from a  limited number  of sources  at the
present time, including  the sheath  component of the  Company's STEP  products.
Efforts  to identify and qualify additional sources of this sheath component and
other key materials  and components  are underway.  Although InnerDyne  believes
that  alternative sources of these components  can be obtained, internal testing
and qualification of substitute vendors could require significant lead times and
additional regulatory submissions. There can be no assurance that such  internal
testing and qualification or additional regulatory approvals will be obtained in
a  timely fashion, if at all. Any  interruption of supply of raw materials could
have a  material adverse  effect on  the Company's  ability to  manufacture  its
products,  and therefore  on its  business, financial  condition and  results of
operations. See "Risk Factors -- Dependence on Sole Sources."
 
    The  Company  believes  that  future  regulatory  changes  currently   being
considered  by  the  FDA are  likely  to result  in  a system  of  United States
regulatory requirements for manufacturers of medical devices which more  closely
resembles  the system that has been  adopted by most European countries, namely,
the International Standards  Organization 9000  ("ISO 9000")  series of  quality
systems  standards.  Accordingly,  the  Company has  taken  steps  to  bring its
operations into compliance  with these  additional requirements. An  audit by  a
recognized  "notified body," which  is charged with  assessing compliance to the
ISO 9000  standards on  behalf of  a specific  European regulatory  agency,  was
initiated  during  the latter  portion of  1995 and  concluded in  January 1996.
Company operations and
 
                                       34
<PAGE>
documentation were  found to  be  in satisfactory  compliance  to the  ISO  9000
standards and recommendation for certification has been given by the auditors to
the registration body. Such certification should facilitate the introduction and
sale  of the Company's access  products to the member  countries of the European
Economic Community.  This  certification,  if successfully  obtained,  may  also
positively  impact the Company's compliance  with the regulatory requirements of
other countries, which have adopted or may adopt a similar regulatory  structure
or  recognize  such  compliance as  adequate  assurance of  product  quality and
conformance in the future.
 
PATENTS AND PROPRIETARY RIGHTS
 
    It is the Company's policy to aggressively protect its technology by,  among
other things, filing patent applications for the patentable technologies that it
considers  important to the  development of its business.  The Company holds six
issued United  States patents,  and has  several additional  U. S.  and  foreign
patent  applications pending,  covering various  aspects of  its radial dilation
technology. The Company also has a license agreement giving it exclusive rights,
assuming  certain  defined  minimum  payments  are  met,  to  a  related  access
technology  that is covered by  two issued and one  pending patent. In addition,
during 1995 the Company obtained a non-exclusive license to a patent covering  a
specialized  access device  which facilitates the  placement of  a vision device
into the abdominal cavity.
 
   
    The Company holds five issued United States patents and one granted European
patent and has several additional foreign and U. S. patent applications  pending
relating  to its thermal ablation system technology. The Company also holds five
issued United States patents and several issued foreign patents relating to  its
biocompatible  coating technologies, and has additional related U.S. and foreign
applications that are pending. The Company has continued to pursue the expansion
of its  coating-related intellectual  property,  as opportunities  for  business
partnerships in this area have been pursued. See " -- Products and Technology --
Biocompatible Coating Technologies." In addition to patent rights related to its
radial  dilation, thermal  ablation and biocompatible  coating technologies, the
Company also has a number  of issued and pending  patents relating to its  blood
gas  exchange  and pumping  technologies. There  can be  no assurances  that any
pending patent applications will be issued in their present scope, or at all.
    
 
    The Company's success  will depend in  large part on  its ability to  obtain
patent  protection for products and processes, to preserve its trade secrets and
to operate without infringing the proprietary rights of third parties.  Although
InnerDyne  has obtained certain patents and applied for additional United States
and foreign patents covering certain aspects of its technology, no assurance can
be given that any  additional patents will  be issued or that  the scope of  any
patent  protection will exclude competitors  or provide a competitive advantage,
or that  any  of  the Company's  patents  will  be held  valid  if  subsequently
challenged.  The validity  and breadth of  claims covered  in medical technology
patents involves complex legal and factual questions and therefore may be highly
uncertain. InnerDyne also relies upon unpatented trade secrets, and no assurance
can be given  that others will  not independently develop  or otherwise  acquire
substantially  equivalent  trade  secrets.  In  addition,  whether  or  not  the
Company's patents are issued,  others may hold or  receive patents that  contain
claims having a scope that covers products developed by InnerDyne.
 
    There   has  been   substantial  litigation   regarding  patent   and  other
intellectual property rights in the medical device industry and companies in the
medical device  industry have  used litigation  to gain  competitive  advantage.
Litigation  involving the Company would result in substantial cost and diversion
of management attention from the day-to-day operation of the business, but could
be necessary to enforce patents issued to the Company, to protect trade  secrets
and  other  specialized  knowledge unknown  to  outside parties,  to  defend the
Company against claimed infringement of the rights of others or to determine the
scope and validity of the proprietary rights of others. An adverse determination
in litigation  could subject  the Company  to significant  liabilities to  third
parties,  could require  the Company to  seek licenses from  third parties under
less favorable terms than might otherwise be
 
                                       35
<PAGE>
possible and could prevent the Company from manufacturing, selling or using  its
products,  any of which  could have a  material adverse effect  on the Company's
business, financial condition and results of operations.
 
    The Company has in the past,  and may in the future, receive  correspondence
from third parties claiming that the Company's products or technologies infringe
intellectual  property rights of such third  parties. The Company and its patent
counsel thoroughly review such claims  and no such outstanding claims  currently
exist.  However,  there can  be  no assurance  that  InnerDyne will  not receive
additional claims that its products or technologies infringe third party  rights
or  that third parties will not litigate  such claims. Any such occurrence could
have a material adverse  effect on the  Company's business, financial  condition
and results of operations. See "Risk Factors -- Patents and Proprietary Rights."
 
COMPETITION
 
    The  primary  industry in  which  the Company  competes,  minimally invasive
surgery, is dominated by two large, well-positioned entities that are  intensely
competitive  and frequently offer substantial discounts as a competitive tactic.
U.S. Surgical is  primarily engaged in  developing, manufacturing and  marketing
surgical  wound management  products, and  has historically  been the  firm most
responsible for providing products that have led to the growth of the  industry.
U.S.  Surgical  supplies  a  broad  line of  products  to  the  M.I.S. industry,
including products which  facilitate access, assessment  and treatment.  Ethicon
has  made a major investment in  the M.I.S. field in recent  years and is one of
the leading  suppliers of  hospital  products in  the world.  Furthermore,  U.S.
Surgical  and Ethicon each  utilize purchasing contracts  that link discounts on
the purchase  of one  product to  purchasers of  other products  in their  broad
product  lines. Substantially  all of  the hospitals  in the  United States have
purchasing contracts with one or both of these entities. Accordingly,  customers
may  be dissuaded from  purchasing access products from  the Company rather than
U.S. Surgical or Ethicon to the extent it would cause them to lose discounts  on
products that they regularly purchase from U.S. Surgical or Ethicon.
 
    Notwithstanding  the challenges faced by the  Company in selling in a market
dominated by two large competitors, substantially all of the Company's  revenues
since  the fourth quarter of  1994 have come from  product sales in this market.
U.S. Surgical and  Ethicon purchasing  contracts typically  include a  provision
allowing  a certain percentage of purchases  from other vendors, and the Company
has taken and intends to continue to take advantage of such provisions.
 
    The Company  faces a  formidable task  in successfully  gaining  significant
revenues  within  the  M.I.S. access  market.  In order  to  succeed, management
believes that  the  Company will  need  to objectively  demonstrate  substantial
product  benefits, and its sales effort must be able to effectively present such
benefits to both clinicians  and health care  administrators. The M.I.S.  access
market  segment  is  dominated  by  U.S.  Surgical  and  Ethicon.  Both entities
introduced new access devices, trocars with added features, during the past  two
years.  A number of other entities participate in various segments of the M.I.S.
access market.
 
    There can be  no assurance  that the Company  will be  able to  successfully
compete  in the M.I.S. access market and failure  to do so would have a material
adverse effect on  the Company's  business, financial condition  and results  of
operations.
 
    In   the  thermal  ablation  market,   the  Company  considers  its  primary
competition to be  current therapies  for the treatment  of excessive  menstrual
bleeding, including drug therapy, dilatation and curettage, surgical endometrial
ablation   and  hysterectomy.  The  Company  will  also  compete  against  other
techniques under development for the treatment of excessive menstrual  bleeding,
including  endometrial  ablation techniques  that employ  RF energy  or freezing
techniques  ("cryoablation")  and  the  uterine  balloon  therapy  system  being
clinically tested by Gynecare, Inc.
 
    There  are  many  large  companies  with  significantly  greater  financial,
manufacturing, marketing,  distribution  and technical  resources  and  clinical
experience than the Company that are developing
 
                                       36
<PAGE>
and  marketing devices for surgical removal of the uterus, uterine fibroids, the
endometrial lining of  the uterus and  other uterine tissues  or are  developing
non-surgical  methods  for treating  these  conditions. Additionally,  there are
smaller companies developing alternative methods of uterine tissue ablation that
compete with the Company.  There can be no  assurance that these companies  will
not succeed in developing technologies and products that are more effective than
any  which have been or are being developed  by the Company or that would render
the Company's  technologies  or  products  obsolete  or  not  competitive.  Such
competition  could have a material and adverse effect on the Company's business,
financial condition and results of operations. As a result of the entry of large
and small companies into the market, the Company expects competition for devices
and systems used to  treat excessive menstrual bleeding  to increase. See  "Risk
Factors -- Intense Competition."
 
GOVERNMENT REGULATION
 
    Clinical  testing, manufacture and sale of the Company's products, including
the STEP  product line,  the ENABL  Thermal Ablation  System and  the  Company's
biocompatible  coatings technology,  are subject  to regulation  by the  FDA and
corresponding state and  foreign regulatory  agencies. Pursuant  to the  Federal
Food,  Drug, and Cosmetic  Act, and the  regulations promulgated thereunder, the
FDA regulates  the  preclinical  and clinical  testing,  manufacture,  labeling,
distribution  and promotion  of medical  devices. Noncompliance  with applicable
requirements can  result  in,  among other  things,  fines,  injunctions,  civil
penalties,  recall  or  seizure  of products,  total  or  partial  suspension of
production, failure of the government to grant premarket clearance or  premarket
approval   for  devices,   withdrawal  of   marketing  approvals   and  criminal
prosecution.  The  FDA  also  has  the  authority  to  request  recall,  repair,
replacement  or refund of the cost of  any device manufactured or distributed by
the Company.
 
    In the  United States,  medical devices  are classified  into one  of  three
classes (I.E., Class I, II or III) on the basis of the controls deemed necessary
by  the FDA to reasonably ensure their safety and effectiveness. Class I devices
are subject  to general  controls (E.G.,  labeling, premarket  notification  and
adherence  to GMPs)  and Class  II devices  are subject  to general  and special
controls  (E.G.,   performance  standards,   postmarket  surveillance,   patient
registries  and FDA  guidelines). Generally, Class  III devices  are those which
must  receive  premarket  approval  by  the  FDA  to  ensure  their  safety  and
effectiveness  (E.G., life-sustaining, life-supporting  and implantable devices,
or new  devices which  have been  found not  to be  substantially equivalent  to
legally marketed devices).
 
    Before  a new device can be introduced  in the market, the manufacturer must
generally obtain FDA clearance of a 510(k) notification or approval of a PMA.  A
PMA  application  must  be  filed  if a  proposed  device  is  not substantially
equivalent to a legally marketed Class I or Class II device, or if it is a Class
III device for  which the  FDA has  called for  PMAs. The  PMA application  must
contain the results of clinical trials, the results of all relevant bench tests,
laboratory  and animal  studies, a  complete description  of the  device and its
components, and a detailed description  of the methods, facilities and  controls
used  to manufacture the device. The FDA's review of a PMA application generally
takes one to two years from the date the PMA is accepted for filing, but it  may
take  significantly longer. The  review time is  often significantly extended by
the FDA  asking for  more information  or clarification  of information  already
provided  in the submission. Modifications to a device that is the subject of an
approved PMA, its labeling or manufacturing process may require approval by  the
FDA  of PMA supplements or new PMAs. The PMA process can be expensive, uncertain
and lengthy, and a number of devices  for which FDA approval has been sought  by
other companies have never been approved for marketing.
 
    If human clinical trials of a device are required, and the device presents a
"significant  risk," the sponsor  of the trial (usually  the manufacturer or the
distributor of the device) will have to file an Investigational Device Exemption
("IDE")  application  prior  to  commencing  human  clinical  trials.  The   IDE
application must be supported by data, typically including the results of animal
and laboratory testing. If the IDE application is approved by the FDA and one or
more appropriate Institutional Review Boards ("IRBs"), human clinical trials may
begin at a specific number of investigational sites
 
                                       37
<PAGE>
with  a  specific number  of patients,  as approved  by the  FDA. If  the device
presents a  "nonsignificant  risk" to  the  patient,  a sponsor  may  begin  the
clinical trial after obtaining approval for the study by one or more appropriate
IRBs  without  the  need  for  FDA approval.  Sponsors  of  clinical  trials are
permitted to sell investigational devices distributed in the course of the study
provided such compensation does not exceed recovery of the costs of manufacture,
research, development and handling. An IDE  supplement must be submitted to  and
approved  by the FDA before  a sponsor or investigator may  make a change to the
investigational plan that  may affect  its scientific soundness  or the  rights,
safety or welfare of human subjects.
 
    Management expects that the ENABL System will be subject to the PMA approval
process  prior to marketing within the United  States. There can be no assurance
that the Company will be able to  obtain the necessary regulatory approval on  a
timely  basis, or at all, and  a delay in receipt of  or failure to receive such
approval would  have  a  material  adverse effect  on  the  Company's  business,
financial condition and results of operations.
 
    A  510(k) clearance will be granted if the submitted information establishes
that the proposed  device is  "substantially equivalent" to  a legally  marketed
Class  I or Class II medical device or  a Class III medical device for which the
FDA has not called for PMAs. The  FDA recently has been requiring more  rigorous
demonstration  of substantial  equivalence than in  the past,  including in some
cases requiring submission of  clinical trial data. The  FDA may determine  that
the  proposed device is  not substantially equivalent to  a predicate device, or
that  additional  information  is   needed  before  a  substantial   equivalence
determination  can  be made.  It generally  takes  from four  to 12  months from
submission to obtain 510(k)  premarket clearance, but may  take longer. The  FDA
may  determine  that a  proposed  device is  not  substantially equivalent  to a
legally marketed  device, or  that  additional information  is needed  before  a
substantial   equivalence  determination  can  be  made.  A  "not  substantially
equivalent" determination,  or  a  request  for  additional  information,  could
prevent  or delay the  market introduction of  new products that  fall into this
category and could  have a material  adverse effect on  the Company's  business,
financial  condition and results of operations. For any of the Company's devices
cleared through the  510(k) process,  modifications or  enhancements that  could
significantly  affect  the  safety  or  effectiveness  of  the  device  or  that
constitute a major change to the intended  use of the device will require a  new
510(k) submission. There can be no assurance that the Company will obtain 510(k)
premarket  clearance within  the above time  frames, or  at all, for  any of the
devices or modifications for which it may file a 510(k).
 
    The Company has  received clearance from  the FDA for  the marketing of  its
STEP  device for use  in accessing the  abdominal and thoracic  cavities for the
performance of  minimally invasive  surgical procedures.  The Company  has  also
received  FDA clearance for the  marketing of its R.E.D.  product for use in the
areas of gastrostomy,  cystostomy, cholecystotomy, the  dilation of biliary  and
urethral  strictures, laparoscopy and enterostomy. The Company has also received
market clearance  for alternative  versions  of its  STEP and  R.E.D.  products,
including products designed to employ its radial dilation technology in vascular
applications  and  for  biliary  indications.  Although  the  Company  has  been
successful in preparing requests for 510(k) clearance, there can be no assurance
that 510(k)  clearances for  future  products or  product modifications  can  be
obtained  in a timely  manner or at all,  or that any  existing clearance can be
successfully maintained.  A  delay in  receipt  of,  or failure  to  receive  or
maintain,  such clearances would have a material adverse effect on the Company's
business, financial condition and results of operations. Although the Company is
strictly limited to marketing  its products for the  indications for which  they
were  cleared, physicians are not prohibited by  the FDA from using the products
for indications other than those cleared by  the FDA. There can be no  assurance
that  the Company will not become subject to FDA action resulting from physician
use of its products outside of their approved indications.
 
    The Company has made modifications to  its cleared devices that the  Company
believes  do not require the  submission of new 510(k)  notices. There can be no
assurance, however,  that  the  FDA  would  agree  with  any  of  the  Company's
determinations  not to submit  a new 510(k)  notice for any  of these changes or
would not require  the Company  to submit  a new 510(k)  notice for  any of  the
changes
 
                                       38
<PAGE>
made  to the  device. If  the FDA requires  the Company  to submit  a new 510(k)
notice for any device modification, the Company may be prohibited from marketing
the modified device until the 510(k) notice is cleared by the FDA.
 
    Any devices  manufactured or  distributed  by the  Company pursuant  to  FDA
clearance  or approval are subject to pervasive and continuing regulation by the
FDA and certain state agencies and various foreign governments. Manufacturers of
medical devices for  marketing in the  United States are  required to adhere  to
applicable  regulations setting  forth detailed GMP  requirements, which include
testing, control and documentation requirements. Manufacturers must also  comply
with Medical Device Reporting ("MDR") requirements that a firm report to the FDA
any  incident in which its product may have  caused or contributed to a death or
serious injury, or in  which its product malfunctioned  and, if the  malfunction
were  to recur, it would be likely to  cause or contribute to a death or serious
injury. Labeling and promotional activities are  subject to scrutiny by the  FDA
and,  in certain  circumstances, by  the Federal  Trade Commission.  Current FDA
enforcement policy  prohibits  the marketing  of  approved medical  devices  for
unapproved uses.
 
   
    The Company is registered as a manufacturer of medical devices with the FDA.
The  Company  is subject  to routine  inspection  by the  FDA and  certain state
agencies for  compliance  with  GMP requirements,  MDR  requirements  and  other
applicable  regulations.  The  Company's  Salt  Lake  City,  Utah  manufacturing
facility was inspected  by the  FDA for  the first  time in  January 1996.  That
inspection resulted in the issuance by the FDA of a Form FDA 483, which detailed
specific  areas where the  FDA inspector observed  that the Company's operations
were not  in full  compliance  with applicable  areas  of the  GMP  regulations.
Corrective  action  addressing  all identified  GMP  deficiencies  was initiated
immediately, and  the Company  responded to  the FDA  District Office.  The  FDA
District  Office  issued  a Warning  Letter  stating  that it  appears  that the
Company's response to the Form FDA 483 is adequate; however, an FDA reinspection
is required to  assure that  the corrections  the Company  has taken  adequately
address the noted GMP deficiencies. The FDA also notified the Company that until
the  agency determines that  corrections are adequate,  federal agencies will be
advised of  the issuance  of  the Warning  Letter so  that  they may  take  this
information  into account when  considering awards of  contracts, and no pending
510(k) notifications  for devices  to which  the observed  GMP deficiencies  are
reasonably  related  will  be  cleared, and  no  requests  for  Certificates For
Products For Export will be approved.  The Company submitted a written  response
to the Warning Letter and requested a meeting with District officials to discuss
the  matter. During the requested  meeting, District officials acknowledged that
the GMP  deficiencies  observed during  the  inspection were  "borderline"  with
respect  to the  agency's policies regarding  the issuance of  a Warning Letter.
They explained, however, that the Warning Letter was based on observations  that
the  Company was not following  its own written procedures  and on the fact that
the Company's internal audits  had not found  these deficiencies. Following  the
meeting,  the FDA acknowledged the  Company's representation that the corrective
action plan would  be completed by  April 8,  1996, and stated  that the  agency
would  initiate a reinspection within 60 days of that date. The scope of the FDA
reinspection could be  more comprehensive  than the initial  inspection. At  the
current  time, the  Company has no  pending submissions for  either clearance to
market new or modified products, or  to export to new foreign markets.  However,
failure  to adequately address  these GMP deficiencies  within a reasonable time
frame would have  an adverse effect  on future product  sales. Accordingly,  the
Company   has  undertaken  a  review  of   the  GMP  compliance  of  its  entire
manufacturing process. However, there can be no assurance that the FDA will deem
the Company's corrective  action to  be adequate or  that additional  corrective
action,  in  areas not  addressed by  the Form  FDA 483,  will not  be required.
Failure to achieve satisfactory GMP compliance could have a significant  adverse
effect  on the Company's  ability to continue to  manufacture and distribute its
produts and, in  the most  serious cases,  result in  the seizure  or recall  of
products, injunction and/or civil fines. See "Business -- Manufacturing."
    
 
    The  FDA  has  proposed changes  to  the  GMP regulations  that  will likely
increase the  cost of  compliance  with GMP  requirements. Changes  in  existing
requirements  or  adoption of  new requirements  could  have a  material adverse
effect  on   the   Company's   business,   financial   condition   and   results
 
                                       39
<PAGE>
of  operations.  There can  be  no assurance  that  the Company  will  not incur
significant costs to comply with laws and regulations in the future or that laws
and regulations  will not  have a  material adverse  effect upon  the  Company's
business, financial condition or results of operations.
 
    In addition, the Company is subject to medical device regulations in foreign
countries  where the Company's products are sold. Such regulations, particularly
in the European  Community, continue to  expand, and there  can be no  assurance
that new laws or regulations will not have an adverse effect on the Company. For
example,  the European  Union has promulgated  rules which  require that medical
products receive the right  by mid-1998 to affix  the CE mark, an  international
symbol   of  adherence  to  quality  assurance  standards  and  compliance  with
applicable European medical device directives.  Failure to receive the right  to
affix  the CE mark will prohibit the Company from selling its products in member
countries of the European Union.
 
PRODUCT LIABILITY AND INSURANCE
 
    The development, manufacture and sale  of the Company's products entail  the
risk  of product liability  claims, involving both  potential financial exposure
and associated adverse  publicity. To  date, InnerDyne has  not experienced  any
product  liability  claims. The  Company's  current product  liability insurance
coverage limits are $1,000,000 per  occurrence and $2,000,000 in the  aggregate,
and  there can be no assurance that such coverage limits are adequate to protect
the Company  from  any  liabilities  it  might  incur  in  connection  with  the
development,  manufacture and  sale of  its current  and potential  products. In
addition, the Company may require increased product liability insurance. Product
liability insurance  is expensive  and may  not be  available in  the future  on
acceptable  terms, or at all. In addition, if such insurance is available, there
can be  no assurance  that  the limits  of coverage  of  such policies  will  be
adequate.  A  successful  product liability  claim  in excess  of  the Company's
insurance coverage  could  have  a  material adverse  effect  on  the  Company's
business,  financial condition and  results of operations.  See "Risk Factors --
Product Liability and Insurance."
 
EMPLOYEES
 
   
    At March  31,  1996, the  Company  had 91  full-time  and 15  temporary  and
part-time  employees.  The majority  of  the temporary  and  part-time employees
worked at the Company's Salt Lake City facility, and were primarily involved  in
manufacturing  and  support activities  related to  the Company's  M.I.S. access
products. Of the 91 full-time employees on  March 31, 1996, 36 were involved  in
manufacturing operations, 14 in research and development and regulatory/clinical
affairs,  4 in biocompatible coatings development,  10 in administration, and 27
in sales, marketing and customer service.
    
 
    None of  the  Company's employees  is  covered by  a  collective  bargaining
agreement,  and management believes that its  relationship with its employees is
good.
 
FACILITIES
 
    InnerDyne leases approximately 20,500  square feet in Sunnyvale,  California
to  house  the  Company's administrative  personnel,  research  and development,
marketing and sales support activities, of which approximately 6,000 square feet
are subleased  to  another entity.  The  Sunnyvale facility  is  leased  through
December 1998.
 
    Additional space is leased in two separate buildings, totaling approximately
27,000   square  feet,  in   Salt  Lake  City,   Utah.  These  facilities  house
administrative  personnel,  manufacturing   operations,  biocompatible   coating
research  activities and the Company's primary distribution function. The leases
for the Salt Lake City buildings expire in August 1997 and August 1999.
 
    Management believes that currently leased facilities will be sufficient  for
the immediate future, and that adequate additional space is available within the
same  geographical areas. If additional space was  required, and it could not be
obtained in near proximity to current facilities at an acceptable cost, it could
have a material adverse effect on the Company's operations.
 
                                       40
<PAGE>
                                   MANAGEMENT
 
EXECUTIVE OFFICERS AND DIRECTORS
 
   
    The current directors and executive officers  of the Company and their  ages
as of March 31, 1996 are as follows:
    
 
   
<TABLE>
<CAPTION>
              NAME                    AGE                               POSITION
- ---------------------------------  ---------  ------------------------------------------------------------
<S>                                <C>        <C>
William G. Mavity                     46      President, Chief Executive Officer and Director
Robert A. Stern                       39      Vice President and Chief Financial Officer
Daniel Genter                         59      Senior Vice President of Sales and Marketing
Edward W. Benecke                     53      Director
Robert M. Curtis                      50      Director
Eugene J. Fischer (1)(2)              49      Director
Guy P. Nohra (2)                      35      Director
Steven N. Weiss (1)(2)                49      Director
</TABLE>
    
 
- ------------------------
(1) Member of the Audit Committee.
 
(2) Member of the Compensation Committee.
 
    WILLIAM  G. MAVITY joined the Company  as President, Chief Executive Officer
and a director in  October 1993, after  having spent more  than twenty years  in
various  capacities with  the 3M Company  ("3M"), including more  than ten years
within a number of the operating units of 3M's health care business. From August
1992 until  October 1993,  Mr. Mavity  served as  Operations Director  for  3M's
Medical Device Division. From April 1989 until August 1992, Mr. Mavity served as
General  Manager of 3M's  Sarns cardiovascular surgery  business unit. From July
1988 until April 1989, Mr. Mavity served as Manufacturing Manager for the  Sarns
subsidiary. Mr. Mavity holds a B.E.A. degree from the University of Delaware.
 
    ROBERT  A. STERN joined the Company in January of 1996 as Vice President and
Chief Financial Officer. From October 1991  to January 1996, Mr. Stern held  the
position  of Chief  Financial Officer, Vice  President of  Corporate Finance and
member of the  Board of  Directors of  RhoMed Incorporated,  a New  Mexico-based
biopharmaceutical  company. Mr. Stern has had ten years experience in investment
banking and  cash management,  and was  the principal  stockholder and  Managing
Director  of R. A. Stern and Associates from  December 1986 to April of 1990. R.
A. Stern Associates was sold to PaineWebber  in 1989. Mr. Stern received a  B.S.
from  the  University  of  New  Hampshire,  Whittemore  School  of  Business and
Economics.
 
   
    DANIEL J.  GENTER  joined  the Company  in  April  of 1996  as  Senior  Vice
President  of Sales and Marketing. From May  1993 to April 1996, Mr. Genter held
the position of Divisional Vice President  of the Kanetta Pharmacal Division  of
Sanofi   Winthrop  Pharmaceuticals,   a  business   unit  established   for  the
development,  manufacture  and  marketing  of  sterile  parenteral   multisource
pharmaceutical  products. From December  1990 to May 1993,  Mr. Genter served as
Vice President of Marketing for Schein Pharmaceutical, Inc., a manufacturer  and
distributor  of pharmaceutical products. Mr. Genter spent over twenty years with
Johnson & Johnson  in its  McNeil Laboratories,  Critikon and  Home Health  Care
companies,  holding positions in general management, sales management, marketing
and clinical  development.  Mr. Genter  also  served as  President  of  Sharplan
Lasers,  Inc.,  a  medical  laser manufacturer.  Mr.  Genter  studied Mechanical
Engineering at Tulane University and holds a B.S. in Mathematics from the  State
University of New York and an MBA from Pepperdine University.
    
 
    EDWARD  W. BENECKE has served  as a director of  the Company since 1995. Mr.
Benecke serves as the President of Medical Contracts Associates, an organization
that provides  consulting services  to health  care companies  in the  areas  of
marketing  and  distribution. Prior  to forming  the above  entity in  1994, Mr.
Benecke spent 25 years  within various units  of Johnson &  Johnson, one of  the
world's leading
 
                                       41
<PAGE>
suppliers  of health care products. From 1987  to 1993, he was Vice President of
Corporate  National  Accounts  and   headed  an  organization  responsible   for
implementing  and  managing  Johnson &  Johnson's  multi-company  agreements and
overall  business  relationships  with  the  major  multi-hospital  systems  and
alliances  in the  United States.  Mr. Benecke holds  a B.S.  degree in business
administration from Southeast Missouri State University.
 
    ROBERT M. CURTIS became a  director of the Company  in January 1993 and  has
also served as a consultant to the Company since that time. Since December 1991,
Mr.  Curtis  has  been  Principal of  Robert  Curtis  Associates  ("RCA"), which
provides business development and management consulting services to the  medical
device  industry. Prior  to his activities  with RCA, Mr.  Curtis was President,
Chief Executive  Officer  and Chairman  of  the  Board of  Urosystems,  Inc.,  a
clinical  trial-stage device startup  which was acquired  by Medtronic Inc. From
1976 to 1990, he held a number  of positions at Shiley, Inc., a manufacturer  of
medical  devices, and its parent corporation, Pfizer, Inc., a diversified health
care products company.  He has  served, at  various times,  as President,  Chief
Executive  Officer and Chairman of the Board  of Shiley, Inc. and as Senior Vice
President and  member of  the Board  of Directors  of Pfizer  Hospital  Products
Group,  the medical device  division of Pfizer,  Inc. Mr. Curtis  holds B.S. and
M.S. degrees from the University of California, Berkeley.
 
    EUGENE J. FISCHER has served as a director of the Company since 1989.  Since
1989, he has been a general partner of Pathfinder Venture Capital Funds, a group
of  venture  capital funds.  From  1983 to  1988, he  was  a general  partner of
Technology Funding, Ltd.,  a venture  capital management company,  where he  was
responsible for investments in computer and software technology, medical systems
and pharmaceuticals. Mr. Fischer holds B.S. and M.S. degrees from the University
of  Minnesota and the  University of California,  respectively. Mr. Fischer also
serves as a director of a number of privately held companies.
 
    GUY P. NOHRA has served as a  director of InnerDyne since 1994. He has  been
with  Burr,  Egan,  Deleage  &  Co.  since  1989.  His  investment  activity  is
specialized to  the  health  care  marketplace,  which  includes  biotechnology,
medical  devices  and  medical  instrumentation. Prior  to  joining  Burr, Egan,
Deleage & Co., Mr. Nohra was  Product Manager of Medical Products with  Security
Pacific  Trading Corporation.  He holds a  B.A. from Stanford  University and an
M.B.A. from the University of Chicago's  Graduate School of Business. Mr.  Nohra
also serves as a director of Interpore International, an orthopedics company.
 
    STEVEN  N. WEISS has served  as a director of  the Company since 1987. Since
1987, he has been a general partner of Montgomery Medical Ventures II, a venture
capital firm. Mr. Weiss has held a number of senior management positions in  the
medical device industry and holds B.S. and M.S. degrees from City College of New
York  and an M.B.A. from Fordham University. Mr. Weiss also serves as a director
of KeraVision, Inc. and a number of privately held companies.
 
BOARD MEETINGS AND COMMITTEES
 
    The Board of Directors of the Company held a total of eight meetings  during
the  fiscal year ended  December 31, 1995.  The Board of  Directors has an Audit
Committee and a  Compensation Committee.  There is no  committee performing  the
functions of a nominating committee.
 
    The  Audit Committee of the Board of Directors reviews the results and scope
of the audit and other services provided by the Company's independent  auditors,
approves fee arrangements with auditors and reports the results of its review to
the full Board of Directors and to management. This Committee, which consists of
directors Fischer and Weiss, held one meeting during fiscal 1995.
 
    The  Compensation Committee of the  Board of Directors makes recommendations
regarding salaries  and incentive  compensation for  employees of  the  Company,
makes  recommendations  with respect  to  purchase and  option  arrangements for
individuals subject to  Section 16 of  the Securities Exchange  Act of 1934,  as
amended   (the  "Exchange  Act"),  and  makes  recommendations  regarding  other
compensation matters  to the  full  Board of  Directors. This  Committee,  which
consists  of directors Fischer, Nohra and Weiss, held two meetings during fiscal
1995.
 
                                       42
<PAGE>
COMPENSATION OF DIRECTORS
 
    Directors of the Company  are reimbursed for  expenses actually incurred  in
attending  meetings of the  Board of Directors and  its committees. In addition,
nonemployee members of the Board of Directors receive a quarterly fee of  $1,500
(pro  rated in the event that the director  serves for only part of the quarter)
and are reimbursed for expenses actually  incurred in attending meetings of  the
Board  of  Directors and  its committees.  Nonemployee members  of the  Board of
Directors are also eligible  to receive options under  the Directors' Plan.  See
"--  Stock Plans."  Mr. Curtis  and an entity  affiliated with  Mr. Benecke have
entered into consulting agreements with the Company. See "Certain Transactions."
 
EXECUTIVE COMPENSATION
 
    The following  table sets  forth the  compensation awarded  or paid  by  the
Company  for each of the years in  the three-year period ended December 31, 1995
to the Company's Chief Executive Officer.  No other executive officer earned  in
excess of $100,000 during the fiscal year ended December 31, 1995.
 
                           SUMMARY COMPENSATION TABLE
 
   
<TABLE>
<CAPTION>
                                                                                         LONG-TERM
                                                                                       COMPENSATION
                                               ANNUAL COMPENSATION                     -------------
                             --------------------------------------------------------   SECURITIES
                                                                       OTHER ANNUAL     UNDERLYING          ALL OTHER
NAME AND PRINCIPAL POSITION    YEAR     SALARY ($)(3)   BONUS ($)    COMPENSATION ($)   OPTIONS (#)    COMPENSATION ($)(1)
- ---------------------------  ---------  ------------  -------------  ----------------  -------------  ---------------------
<S>                          <C>        <C>           <C>            <C>               <C>            <C>
William G. Mavity (2)             1995   $  193,846   $   20,000(4)    $    100,775               0         $      34
 President and Chief              1994      161,578       40,000             47,660         350,000                62
 Executive Officer                1993       38,256            0             13,356         200,000                 5
</TABLE>
    
 
- ------------------------
(1)  Reflects the cost of  insurance premiums paid by  the Company for term life
    insurance under the Company's group life insurance employee benefit.
 
(2) Mr. Mavity has a severance arrangement with the Company pursuant to which he
    is entitled  to  the  equivalent of  one  year's  salary in  the  event  his
    employment  is terminated without cause. Other Annual Compensation for 1993,
    1994 and 1995 consists of amounts  paid by the Company related to  temporary
    housing  and relocation for  Mr. Mavity, in  addition to lease  costs for an
    automobile provided for Mr. Mavity's use. Mr. Mavity's 1993 salary  reflects
    compensation  paid from October 6, 1993  (when Mr. Mavity joined the Company
    as President and Chief Executive Officer).
 
   
(3) Does not include $9,117, $7,327 and  $2,511 deferred by Mr. Mavity in  1995,
    1994 and 1993, respectively, pursuant to the Company's 401(k) Plan.
    
 
   
(4) Includes amounts earned in 1995 but paid in 1996.
    
 
STOCK OPTION GRANTS IN FISCAL 1995
 
    There were no grants of options to purchase Common Stock of the Company made
during the fiscal year ended December 31, 1995 to the named executive officer.
 
OPTION EXERCISE AND HOLDINGS
 
    The  following table sets forth information  for the named executive officer
with respect to exercises of options to purchase Common Stock of the Company  in
the fiscal year ended December 31, 1995.
 
                                       43
<PAGE>
                AGGREGATED OPTION EXERCISES IN LAST FISCAL YEAR
                       AND FISCAL YEAR-END OPTION VALUES
 
<TABLE>
<CAPTION>
                                                                      NUMBER OF SECURITIES
                                                                     UNDERLYING UNEXERCISED         VALUE OF UNEXERCISED
                                                                       OPTIONS AT FISCAL            IN-THE-MONEY OPTIONS
                           SHARES ACQUIRED          VALUE                 YEAR-END (#)             AT FISCAL YEAR-END ($)
NAME                       ON EXERCISE (#)     REALIZED ($)(1)    (EXERCISABLE/UNEXERCISABLE)   (EXERCISABLE/UNEXERCISABLE) (1)
- ------------------------  -----------------  -------------------  ----------------------------  ----------------------------
<S>                       <C>                <C>                  <C>                           <C>
William G. Mavity                     0                   0             166,666/383,334              $167,708/$444,792
</TABLE>
 
- ------------------------
(1) Value calculated by determining the difference between the fair market value
    of  underlying securities at exercise date  (for value realized) or year-end
    (for value at year-end), and the exercise price.
 
COMPENSATION COMMITTEE INTERLOCKS AND INSIDER PARTICIPATION
 
    The members of  the Compensation  Committee of  the Board  of Directors  are
Eugene  J.  Fischer,  Guy  P.  Nohra  and Steven  N.  Weiss.  No  member  of the
Compensation Committee or executive  officer of the  Company has a  relationship
that  would constitute an  interlocking relationship with  executive officers or
directors of another entity.
 
STOCK PLANS
 
   
    1987 STOCK  OPTION PLAN.   InnerDyne's  1987 Stock  Option Plan  (the  "1987
Plan") was adopted by the Board of Directors and approved by the stockholders in
July  1987.  The 1987  Plan has  been amended  by  action of  the Board  and the
stockholders from time to time since that date to reserve additional shares  for
issuance  under  the 1987  Plan  and make  certain  other amendments.  There are
currently 2,650,000 shares  reserved for  issuance under  the 1987  Plan. As  of
March  31, 1996, 630,798 shares  had been issued upon  exercise of stock options
granted under  the  1987 Plan,  1,607,796  shares were  subject  to  outstanding
options  and  411,406 shares  were  available for  future  grant. The  1987 Plan
provides for  the grant  to employees  of the  Company (including  officers  and
employee directors) of incentive stock options within the meaning of Section 422
of  the Internal Revenue Code of 1986, as amended (the "Code") and for the grant
of nonstatutory stock options to employees  and consultants of the Company.  The
1987  Plan is administered by the Board of Directors or a committee appointed by
the Board. Members  of the Board  receive no additional  compensation for  their
services  in connection with  the administration of the  1987 Plan. Most options
granted under the  1987 Plan  become exercisable cumulatively  over a  four-year
period  beginning on  the optionee's  commencement of  employment with InnerDyne
(for  new  employees)  or  the  date  of  grant  (for  existing  employees),  as
applicable.  The  exercise  price of  options  granted  under the  1987  Plan is
determined by the Board, but may not in any event be less than 100% of the  fair
market  value of InnerDyne's Common Stock on the date of grant, as determined by
the Board or a committee of the Board.  In the case of stock options granted  to
an  optionee who owns more than 10% of  the voting power or value of all classes
of stock of InnerDyne, the exercise price must not be less than 110% of the fair
market value  on the  date of  grant. The  fair market  value per  share is  the
closing  sales price on the  Nasdaq National Market reported  in THE WALL STREET
JOURNAL or by such  other source as  the Board shall deem  reliable on the  last
trading  day  immediately preceding  the date  of grant  of the  option. Options
granted under the 1987 Plan generally expire five years from the date of  grant,
unless otherwise provided in the option agreement.
    
 
    In  the event of  certain changes in  control of the  Company, the 1987 Plan
requires that each outstanding option accelerate and become exercisable in  full
at  least ten days prior  to the consummation of such  change in control on such
conditions as the Board shall determine unless the successor corporation assumes
the  outstanding  options,  substitutes  substantially  equivalent  options   or
provides other consideration in payment of such options in an amount and payment
form  which  the Board,  in its  judgment,  deems reasonable.  Unless terminated
sooner, the 1987  Plan will  terminate ten years  from its  effective date.  The
Board has authority to amend or terminate the 1987 Plan, provided no such action
would  impair the rights  of the holder  of any outstanding  options without the
written consent of such holder.
 
                                       44
<PAGE>
   
    INNERDYNE MEDICAL, INC. 1989 INCENTIVE STOCK  PLAN.  In connection with  the
merger  in  1994  of  CardioPulmonics, Inc.  and  InnerDyne  Medical,  Inc., all
outstanding options under the InnerDyne Medical, Inc. 1989 Incentive Stock  Plan
(the "1989 Plan") were assumed by the Company and became exercisable to purchase
shares  of Common  Stock of  the Company.  An aggregate  of 1,453,536  shares of
Common Stock were reserved  for issuance under  the 1989 Plan.  As of March  31,
1996,  1,051,422 shares had  been issued upon exercise  of stock options granted
under the 1989 Plan and 319,988  shares were subject to outstanding options.  No
options  have been granted under  the 1989 Plan since  the merger. The 1989 Plan
has been terminated and no shares are available for future grant under the  1989
Plan.
    
 
   
    1996  STOCK OPTION PLAN.   The Company's  1996 Stock Option  Plan (the "1996
Plan") was adopted by the Board of Directors in March 1996 and will be submitted
to the stockholders for  approval in May  1996. A total  of 1,000,000 shares  of
Common  Stock have been reserved for future  issuance under the 1996 Plan. As of
March 31, 1996, no stock options had been granted under the 1996 Plan. The  1996
Plan  provides for the grant to employees of the Company (including officers and
employee directors) of incentive stock options within the meaning of Section 422
of the Code and  for the grant  of nonstatutory stock  options to employees  and
consultants  of  the Company.  The 1996  Plan  is administered  by the  Board of
Directors or a committee of the Board of Directors (the "Administrator"),  which
selects  the optionees, determines  the number of  shares to be  subject to each
option and determines the exercise price  of each option. In no event,  however,
may  an individual  employee receive option  grants of more  than 800,000 shares
under the 1996  Plan in any  fiscal year.  The exercise price  of all  incentive
stock  options granted under  the 1996 Plan must  be at least  equal to the fair
market value of the Common Stock on the date of grant. The exercise price of all
nonstatutory stock options granted under the 1996 Plan must be at least equal to
the fair market value of the Common Stock  on the date of grant for grants  made
to  certain of  the Company's executive  officers and  at least 85%  of the fair
market value of the  Common Stock on  the date of grant  for all other  persons.
With  respect to any participant who owns  stock possessing more than 10% of the
voting power of all classes of stock  of the Company, the exercise price of  any
incentive stock option granted must equal at least 110% of the fair market value
on  the grant  date, and  the maximum term  of the  option must  not exceed five
years. The term of all other options granted under the 1996 Plan may not  exceed
ten years.
    
 
    In  the event of  certain changes in  control of the  Company, the 1996 Plan
requires that  each  outstanding  option  be assumed  or  an  equivalent  option
substituted   by  the   successor  corporation;  provided,   however,  that  the
Administrator may, in lieu of such  assumption or substitution, provide for  the
optionee  to have the right to exercise the option as to all or a portion of the
stock  subject  thereto,   including  shares  which   would  not  otherwise   be
exercisable,  in which case each option will be exercisable for 15 days from the
date of notice of  such determination. Unless terminated  sooner, the 1996  Plan
will  terminate ten years  from its effective  date. The Board  has authority to
amend or  terminate the  1996 Plan,  provided no  such action  would impair  the
rights  of the holder of any outstanding  options without the written consent of
such holder.
 
   
    1991 EMPLOYEE STOCK PURCHASE PLAN.  InnerDyne's 1991 Employee Stock Purchase
Plan (the "Purchase Plan") was adopted by the Board of Directors in October 1991
and was approved by stockholders in January 1992. The Purchase Plan was  amended
in  1995  by  action of  the  Board  of Directors  and  stockholders  to reserve
additional shares  for issuance  thereunder. The  Purchase Plan  is intended  to
qualify  under Section 423 of the Code. InnerDyne has reserved 300,000 shares of
Common Stock for issuance under the Purchase Plan. As of March 31, 1996,  61,667
shares had been issued under the Purchase Plan and 238,333 shares were available
for  future issuance. Under the Purchase Plan, an eligible employee may purchase
shares of Common Stock from InnerDyne through payroll deductions of up to 10% of
the employee's base compensation, bonuses,  overtime and sale commissions, at  a
price per share equal to 85% of the lesser of the fair market value of InnerDyne
Common  Stock as of the first day or  the last day of each offering period under
the Purchase  Plan. The  offering  periods are  generally  six months  long  and
commence on or about May 1 and November 1 of each year.
    
 
                                       45
<PAGE>
   
    1991 DIRECTORS' STOCK OPTION PLAN.  InnerDyne's 1991 Directors' Stock Option
Plan  (the "Directors' Plan") was  adopted by the Board  of Directors in October
1991 and was approved by the  stockholders in January 1992. The Directors'  Plan
was  amended in  1995 by action  of the  Board of Directors  and stockholders to
reserve additional  shares  for  issuance  thereunder  and  make  certain  other
amendments.  InnerDyne has reserved 300,000 shares  of Common Stock for issuance
under the Directors' Plan. As  of March 31, 1996,  2,000 shares had been  issued
upon  exercise of stock options granted under the Directors' Plan, 66,000 shares
were subject to outstanding options and 232,000 shares were available for future
grant. The  Directors' Plan  is designed  to operate  automatically and  not  to
require  administration; however, to the  extent administration is necessary, it
will be  provided by  the Board  of Directors.  Only nonemployee  directors  are
eligible  to participate  in the  Directors' Plan.  On the  date of  each annual
meeting of  stockholders,  each  nonemployee director  elected  at  such  annual
meeting receives an option grant for 10,000 shares. If a nonemployee director is
appointed to the Board to fill a vacancy after the date of the annual meeting of
stockholders  (the "Prior  Meeting"), that  director will  receive an  option to
purchase the  number of  shares  of the  Company's  Common Stock  determined  by
multiplying  10,000 times a  fraction, the numerator of  which is the difference
between the number twelve and the number of full months since the Prior  Meeting
and  the denominator of which is twelve. The options granted on the date of each
annual meeting  of  stockholders  become  exercisable  in  whole  on  the  first
anniversary of the date of grant. Options granted after the date of such meeting
(the Prior Meeting) to a director appointed to fill a vacancy become exercisable
in  whole on the  later of one  year from the  date of the  Prior Meeting or six
months from the date of grant. The exercise price of an option granted under the
Directors' Plan is  the fair market  value (based  on the closing  price on  the
Nasdaq  National Market)  of InnerDyne  Common Stock on  the date  the option is
granted. In  the event  of a  merger in  which InnerDyne  is not  the  surviving
corporation, a transfer of all of InnerDyne's stock, a sale of substantially all
of  InnerDyne's  assets  or  a  dissolution  or  liquidation  of  InnerDyne, all
outstanding options will become exercisable in  full at least ten days prior  to
such event on such conditions as the Board shall determine, unless the successor
corporation   assumes  the  outstanding  options  or  substitutes  substantially
equivalent options.
    
 
    During fiscal year 1995, options to  purchase 10,000 shares of Common  Stock
at  an exercise price of $3.875 per share were granted under the Directors' Plan
to each of Edward  W. Benecke, Robert  M. Curtis, Eugene J.  Fischer and Guy  P.
Nohra.  Pursuant to the  policies of the  venture capital firm  with which he is
associated, Mr. Weiss declined his option.
 
    401(k) Plan.   In January  1988, the Board  of Directors  adopted a  Defined
Contribution  Plan that is intended to qualify  under Section 401(k) of the Code
(the "401(k) Plan"). All  employees who are  at least 21 years  of age and  have
completed  at  least three  months  of service  with  InnerDyne are  eligible to
participate in the 401(k) Plan. Pursuant to the 401(k) Plan, eligible  employees
may  elect  to  reduce  their  current compensation  by  up  to  the statutorily
prescribed annual limit ($9,500 in 1996)  and have the amount of such  reduction
contributed  to the 401(k) Plan. The 401(k)  Plan permits, but does not require,
additional matching  and  discretionary  contributions to  the  401(k)  Plan  by
InnerDyne  on behalf of certain participants in the 401(k) Plan. The 401(k) Plan
is intended to qualify under  Section 401 of the  Code so that contributions  by
employees  or  by  InnerDyne to  the  401(k)  Plan, and  income  earned  on plan
contributions, are  not taxable  to employees  until withdrawn  from the  401(k)
Plan,  and so  that contributions  by InnerDyne, if  any, will  be deductible by
InnerDyne when made. To date, InnerDyne has made no contributions to the  401(k)
Plan.
 
LIMITATION OF DIRECTORS' AND OFFICERS' LIABILITY AND INDEMNIFICATION
 
    The  Company has adopted provisions in  its Certificate of Incorporation and
Bylaws providing that InnerDyne  shall indemnify its  directors and officers  to
the  fullest extent  permitted by  the General Corporation  Law of  the State of
Delaware ("Delaware Law"), including  circumstances in which indemnification  is
otherwise  discretionary  under  Delaware  Law.  The  Company  has  entered into
indemnification agreements with its officers and directors containing provisions
that are in some respects  broader than the specific indemnification  provisions
contained in the Delaware Law. The
 
                                       46
<PAGE>
indemnification  agreements  may require  the  Company, among  other  things, to
indemnify such officers and directors against certain liabilities that may arise
by reason  of their  status or  service  as directors  or officers  (other  than
liabilities  arising from willful  misconduct of a  culpable nature), to advance
their expenses incurred as a result of  any proceeding against them as to  which
they  could be indemnified  and to obtain directors'  and officers' insurance if
available on reasonable terms.
 
    At present,  there  is  no  pending litigation  or  proceeding  involving  a
director,  officer, employee  or agent of  the Company  in which indemnification
will be  required or  permitted. The  Company  is not  aware of  any  threatened
litigation or proceeding that may result in a claim for such indemnification.
 
                                       47
<PAGE>
                              CERTAIN TRANSACTIONS
 
    On  June 2, 1995, the Company issued an aggregate of 1,435,999 shares of its
Common Stock and warrants to  purchase 287,200 shares of  its Common Stock in  a
private placement. The warrants, as amended, have an exercise price of $2.90 per
share  and  terminated at  5:00 p.m.  (Pacific  time) on  April 1,  1996, unless
exercised prior  to  such  time. Entities  affiliated  with  Pathfinder  Venture
Capital  Funds (of  which Eugene  J. Fischer,  a director  of the  Company, is a
general partner) purchased an  aggregate of 221,240 shares  of Common Stock  and
warrants  to  purchase 44,248  shares of  Common Stock  in the  financing. These
warrants expired on April 1, 1996. Entities affiliated with Burr, Egan,  Deleage
&  Co. (of which Guy P.  Nohra, a director of the  Company, is a Vice President)
purchased an  aggregate  of 110,620  shares  of  Common Stock  and  warrants  to
purchase  22,124 shares  of Common Stock  in the financing.  These warrants were
exercised prior to April 1, 1996.
 
    William G.  Mavity  and Robert  A.  Stern,  officers of  the  Company,  have
severance  arrangements with the Company pursuant  to which they are entitled to
the equivalent of one year's and six month's salary, respectively, in the  event
of termination of employment without cause.
 
    The  Company has entered  into a consulting agreement  with Mr. Curtis. Such
agreement has  a  one-year  term  beginning February  1,  1995  (with  automatic
renewals  unless modified or  terminated by either party)  and provides that Mr.
Curtis will provide consulting services on an "as-needed" basis, subject to  Mr.
Curtis'  availability. Mr. Curtis is paid at a rate of $1,250 per day or $156.25
per hour. Such consulting agreement  supersedes a previous consulting  agreement
entered  into between the Company  and Mr. Curtis pursuant  to which the Company
made payments  amounting to  $67,437.50  to Mr.  Curtis  during the  year  ended
December  31, 1994. The Company made no  payments to Mr. Curtis pursuant to such
consulting agreement during the year ended December 31, 1995. In connection with
his consulting relationship, Mr. Curtis also received nonstatutory stock options
to purchase 12,000 and 30,000 shares  of the Company's Common Stock at  exercise
prices  of $6.50  and $2.00 per  share on January  8, 1993 and  August 12, 1993,
respectively, which represented the  fair market value  of the Company's  Common
Stock  on the date of the respective grants. The options become exercisable over
a four-year period.
 
    Certain of the Company's stockholders have rights to require the Company  to
register  shares of the Company's Common Stock from time to time pursuant to the
Securities Act of 1933, as amended  (the "Securities Act"). See "Description  of
Capital Stock -- Registration Rights of Certain Holders."
 
    The  Company believes that all of the transactions set forth above were made
on terms no less  favorable to the  Company than could  have been obtained  from
unaffiliated third parties.
 
                                       48
<PAGE>
                       PRINCIPAL AND SELLING STOCKHOLDERS
 
   
    The   following  table  sets  forth  certain  information  with  respect  to
beneficial ownership of the Company's Common Stock  as of March 31, 1996 and  as
adjusted to reflect the sale by the Company of the shares offered hereby, (i) by
each  person known to the Company to  own beneficially more than five percent of
the outstanding shares of Common Stock, (ii) by each director of the Company who
beneficially owns shares of Common Stock,  (iii) by the executive officer  named
in  the  Summary Compensation  Table  and (iv)  by  all directors  and executive
officers of the Company as a group.
    
 
   
<TABLE>
<CAPTION>
                                                                                 SHARES        PERCENT BENEFICIALLY
                                                                               BENEFICIALLY            OWNED
                                                                                OWNED (1)   ---------------------------
                                                                               -----------     BEFORE         AFTER
NAME AND ADDRESS OF BENEFICIAL OWNER                                             NUMBER       OFFERING    OFFERING (2)
- -----------------------------------------------------------------------------  -----------  ------------  -------------
<S>                                                                            <C>          <C>           <C>
Entities affiliated with Burr, Egan, Deleage & Co. (3) ......................    2,351,067        12.7%         11.2%
 One Embarcadero Center, Suite 4050
 San Francisco, CA 94111
Entities affiliated with Pathfinder Venture Capital Funds (4) ...............    2,174,705        11.7%         10.4%
 3000 Sand Hill Road
 Building 3, Suite 255
 Menlo Park, CA 94025
Montgomery Medical Ventures II ..............................................    1,303,918         7.0%          6.2%
 600 Montgomery Street
 San Francisco, CA 94111
Perkins Capital Management, Inc. (5) ........................................    1,426,700         7.7%          6.8%
 730 East Lake Street
 Wayzata, MN 55391-1769
William G. Mavity (6) .......................................................      208,388         1.1%          1.0%
 InnerDyne, Inc.
 1244 Reamwood Avenue
 Sunnyvale, CA 94089
Edward W. Benecke (7) .......................................................       10,000       *              *
 MedAlliance
 18 Country Place
 Lebanon, NJ 08833
Robert M. Curtis (8) ........................................................       46,625       *              *
 P.O. Box 1494
 Healdsburg, CA 95448
Eugene J. Fischer (9) .......................................................    2,184,705        11.8%         10.4%
 Pathfinder Ventures
 3000 Sand Hill Road
 Building 3, Suite 255
 Menlo Park, CA 94025
Guy P. Nohra (10) ...........................................................    2,365,067        12.7%         11.3%
 Burr, Egan, Deleage & Co.
 One Embarcadero Center, Suite 4050
 San Francisco, CA 94111
Steven N. Weiss (11) ........................................................    1,303,918         7.0%          6.2%
 Montgomery Medical Ventures
 600 Montgomery Street
 San Francisco, CA 94111
</TABLE>
    
 
                                       49
<PAGE>
 
   
<TABLE>
<CAPTION>
                                                                                    SHARES        PERCENT BENEFICIALLY
                                                                                  BENEFICIALLY           OWNED
                                                                                   OWNED (1)   --------------------------
                                                                                  -----------     BEFORE        AFTER
NAME AND ADDRESS OF BENEFICIAL OWNER                                                NUMBER       OFFERING      OFFERING
- --------------------------------------------------------------------------------  -----------  ------------  ------------
<S>                                                                               <C>          <C>           <C>
All directors and executive officers as a group                                     6,118,653        32.4%         28.8%
 (7 persons) (12)...............................................................
</TABLE>
    
 
- ------------------------
* Less than 1%
 
 (1) Beneficial ownership  is determined  in accordance  with the  rules of  the
     Securities  and  Exchange  Commission  and  generally  includes  voting  or
     investment power with respect to securities. Shares of Common Stock subject
     to options and  warrants currently  exercisable, or  exercisable within  60
     days,  are deemed  outstanding for computing  the percentage  of the person
     holding such option but are not outstanding for computing the percentage of
     any other person. Except as indicated by footnote, and subject to community
     property laws where applicable, the persons  named in the table above  have
     sole voting and investment power with respect to all shares of Common Stock
     shown as beneficially owned by them.
 
 (2) Assumes  no  exercise  of  the  Underwriters'  over-allotment  option.  See
     "Underwriting." If the Underwriters' over-allotment option is exercised  in
     full,  certain stockholders will sell up  to an aggregate of 352,500 shares
     of Common Stock to the Underwriters. Specifically, entities affiliated with
     Burr, Egan,  Deleage &  Co., entities  affiliated with  Pathfinder  Venture
     Capital Funds and Montgomery Medical Ventures II have indicated an interest
     in  selling  the  shares  subject  to  the  over-allotment  option.  If the
     over-allotment  option  is  exercised  and  if  the  Company's  independent
     directors  determine that  all or  a portion of  the shares  subject to the
     over-allotment option will  be sold  by Selling  Stockholders, such  shares
     will  be allocated,  on a  pro rata  basis, among  the Selling Stockholders
     interested,  at  such  time,  in  selling  shares  upon  exercise  of   the
     over-allotment  option. If the  over-allotment option is  exercised in full
     and each of these entities sells their pro rata share of the 352,500 shares
     subject to the  over-allotment option, (i)  entities affiliated with  Burr,
     Egan, Deleage & Co. will sell an aggregate of up to 142,163 shares and will
     beneficially  own 2,208,904 shares,  or 10.5% of  the Company's outstanding
     Common Stock, after completion of  this Offering, (ii) entities  affiliated
     with  Pathfinder  Venture Capital  Funds will  sell an  aggregate of  up to
     131,483 shares and will beneficially own  2,043,222 shares, or 9.7% of  the
     Company's  outstanding Common Stock, after  completion of this Offering and
     (iii) Montgomery Medical Ventures II will sell an aggregate of up to 78,854
     shares and will beneficially own 1,225,064 shares, or 5.8% of the Company's
     outstanding Common Stock, after completion of this Offering.
 
 (3) Includes 1,988,337 shares held by  ALTA IV Limited Partnership and  362,730
     shares held by C.V. Sofinnova Partners Five.
 
 (4) Includes  798,880  shares held  by Pathfinder  Venture  Capital Fund  II, A
     Limited  Partnership  ("Pathfinder  II"),  and  1,375,825  shares  held  by
     Pathfinder  Venture Capital  Fund III,  A Limited  Partnership ("Pathfinder
     III"). Excludes 44,248 shares subject to warrants that expired  unexercised
     on April 1, 1996.
 
 (5) Consists of 429,600 shares with sole voting power and 1,426,700 shares with
     sole  dispositive  power.  Based  solely on  information  contained  in the
     Schedule 13G  dated January  31, 1996  filed by  the stockholder  with  the
     Commission.
 
   
 (6) Includes  205,729 shares subject  to options exercisable  within 60 days of
     March 31, 1996.
    
 
   
 (7) Includes 10,000 shares  subject to  options exercisable within  60 days  of
     March 31, 1996.
    
 
   
 (8) Includes  46,625 shares  subject to options  exercisable within  60 days of
     March 31, 1996.
    
 
 (9) Includes 798,880 shares held  by Pathfinder II, of  which Mr. Fischer is  a
     general  partner, and 1,375,825 shares held by Pathfinder III, of which Mr.
     Fischer is a general partner. He may be
 
                                       50
<PAGE>
   
     deemed to be a beneficial owner of such shares because of his position as a
     general partner of  such partnerships.  Includes 10,000  shares subject  to
     options exercisable within 60 days of March 31, 1996.
    
 
   
(10) Includes  1,988,337 shares held by ALTA  IV Limited Partnership and 362,730
     shares held by  C.V. Sofinnova  Partners Five. These  funds are  affiliated
     with  Burr, Egan, Deleage & Co., of which Mr. Nohra is a Vice President. He
     disclaims beneficial  ownership  of  such shares.  Includes  14,000  shares
     subject to options exercisable within 60 days of March 31, 1996.
    
 
(11) Includes  1,303,918 shares held by Montgomery Medical Ventures II, of which
     Mr. Weiss is a general  partner of the general  partner of such entity.  He
     may  be  deemed to  be a  beneficial owner  of such  shares because  of his
     position as a general partner of such partnership.
 
   
(12) Includes 286,355 shares subject to options and warrants exercisable  within
     60  days of March 31, 1996 held  by executive officers and directors of the
     Company.
    
 
                                       51
<PAGE>
                          DESCRIPTION OF CAPITAL STOCK
 
    The authorized capital stock of the Company consists of 40,000,000 shares of
Common  Stock, $0.01 par  value, and 1,000,000 shares  of Preferred Stock, $0.01
par value.
 
COMMON STOCK
 
    The holders  of Common  Stock are  entitled to  one vote  per share  on  all
matters  to be  voted upon  by the  stockholders, except  that, upon  giving the
legally required notice, stockholders may  cumulate their votes in the  election
of  directors. Subject to preferences that  may be applicable to any outstanding
Preferred Stock, the  holders of Common  Stock are entitled  to receive  ratably
such  dividends, if any,  as may be declared  from time to time  by the Board of
Directors  out  of  funds  legally  available  therefor.  In  the  event  of   a
liquidation, dissolution or winding up of InnerDyne, the holders of Common Stock
are  entitled  to  share  ratably  in  all  assets  remaining  after  payment of
liabilities,  subject  to  prior  rights  of  Preferred  Stock,  if  any,   then
outstanding.  The Common Stock  has no preemptive or  conversion rights or other
subscription  rights.  There  are  no  redemption  or  sinking  fund  provisions
available  to the Common Stock. All outstanding shares of Common Stock are fully
paid and non-assessable.
 
   
    At March 31, 1996, 18,566,111 shares  of Common Stock were outstanding,  and
options  and warrants  to purchase  an aggregate  of 2,061,832  shares of Common
Stock were also outstanding.
    
 
    The Company has agreed to issue to Cruttenden Roth Incorporated a warrant to
purchase up to 235,000 shares of  Common Stock in connection with the  offering.
See "Certain Transactions."
 
PREFERRED STOCK
 
    The  Company  is  authorized  to  issue  1,000,000  shares  of  undesignated
Preferred Stock.  The  Board  of  Directors  has  the  authority  to  issue  the
undesignated  Preferred Stock in one or more series and to determine the powers,
preferences and  rights  and  the qualifications,  limitations  or  restrictions
granted  to or imposed upon any wholly unissued shares of undesignated Preferred
Stock and  to  fix  the  number  of  shares  constituting  any  series  and  the
designation   of  such  series  without  any  further  vote  or  action  by  the
stockholders. The issuance of Preferred Stock  may have the effect of  delaying,
deferring  or  preventing a  change in  control of  the Company  without further
action by the stockholders and may adversely affect the voting and other  rights
of  the holders of Common  Stock. At present, the Company  has no plans to issue
any shares of Preferred Stock.
 
REGISTRATION RIGHTS OF CERTAIN HOLDERS
 
    The holders of approximately 5,475,706  shares of Common Stock, and  certain
of  their  transferees,  are entitled  to  certain  rights with  respect  to the
registration of such  shares under the  Securities Act. Under  the terms of  the
agreements  between the Company and the  holders of securities with registration
rights, if the  Company proposes  to register any  of its  securities under  the
Securities  Act, either  for its  own account  or the  account of  any holder of
securities in  the  Company,  such  holders  are  entitled  to  notice  of  such
registration  and are entitled to  include shares of their  Common Stock in such
registration, provided, among  other conditions,  that the  underwriters of  any
such  offering shall have the right to  limit the number of such shares included
in such registration.
 
    In addition, the holders, and certain of their transferees, of approximately
5,475,706 of the shares of Common Stock described in the previous paragraph  may
require the Company at any time prior to the earlier of (i) February 15, 1999 or
(ii)  such date as the holder  can sell all of his  or her shares under Rule 144
under the  Securities  Act  during any  90-day  period,  on not  more  than  two
occasions,  to file  a registration  statement under  the Securities  Act at its
expense with respect to their shares of Common Stock. The Company is required to
use its best efforts to effect such registration, subject to certain  conditions
and  limitations. Further, holders of Common  Stock with registration rights may
require the Company to register all or a portion of their shares of Common Stock
on Form S-3, subject to certain conditions and limitations.
 
                                       52
<PAGE>
CERTAIN CHARTER PROVISIONS AND DELAWARE ANTI-TAKOVER STATUTE
 
    Provisions of  the Company's  Certificate of  Incorporation that  allow  the
Company  to issue  Preferred Stock  without any  vote or  further action  by the
stockholders as well as the fact that the Company's Certificate of Incorporation
does not permit stockholders to cumulate votes in the election of directors  may
have  the effect of making it more difficult for a third party to acquire, or of
discouraging a third party from attempting  to acquire, control of the  Company.
The  Company is  subject to the  provisions of  Section 203 of  the Delaware Law
("Section 203")  regulating corporate  takeovers. Section  203 prevents  certain
Delaware corporations, including those whose securities are listed on the Nasdaq
National  Market,  from engaging,  under certain  circumstances, in  a "business
combination" (which  includes  a  merger  or  sale  of  more  than  10%  of  the
corporation's  assets)  with  any "interested  stockholder"  (a  stockholder who
acquired 15% or more of the  corporation's outstanding voting stock without  the
prior  approval  of  the  corporation's  Board  of  Directors)  for  three years
following the date that such  stockholder became an "interested stockholder."  A
Delaware  corporation may "opt out" of Section  203 with an express provision in
its original  certificate  of  incorporation  or an  express  provision  in  its
certificate  of incorporation or bylaws resulting  from an amendment approved by
at least a majority of the outstanding voting shares. The Company has not "opted
out" of the provisions of Section 203. The possible issuance of Preferred Stock,
the inability of stockholders to cumulate votes in the election of directors and
provisions of  Delaware law  could have  the effect  of delaying,  deferring  or
preventing  a change  in control of  the Company,  including without limitation,
discouraging a  proxy contest  or making  more difficult  the acquisition  of  a
substantial  block  of  the Company's  Common  Stock. The  possible  issuance of
Preferred Stock and these provisions could  also limit the price that  investors
might be willing to pay in the future for shares of the Company's Common Stock.
 
TRANSFER AGENT AND REGISTRAR
 
    The  Transfer Agent  and Registrar  for the  Common Stock  is American Stock
Transfer & Trust Company. Its telephone number is (212) 936-5100.
 
LISTING
 
    The Company's Common Stock is listed on the Nasdaq National Market under the
trading symbol "IDYN."
 
                        SHARES ELIGIBLE FOR FUTURE SALE
 
   
    At March 31, 1996, the Company  had 18,566,111 outstanding shares of  Common
Stock.  All  but  6,000 of  such  shares  (the "Restricted  Shares")  are freely
tradeable without restriction  under the  Securities Act,  except for  5,832,299
shares  held by  "affiliates" of  the Company,  as that  term is  defined in the
Securities Act ("Affiliates"), which shares are subject to the resale provisions
of Rule 144  promulgated under  the Securities  Act. The  Restricted Shares  are
subject  to  the  resale  provisions  of  Rule  144,  including  holding  period
requirements. Certain directors of the Company and their Affiliates have  agreed
with the Representative of the Underwriters not to sell, directly or indirectly,
(a)  any of the 5,829,690 shares owned by them for a period of 90 days after the
date of this Prospectus or (b) any shares in excess of (x) the number of  shares
that could be sold under Rule 144 less (y) the number of shares, if any, sold by
such  entities upon exercise  of the Underwriters'  over-allotment option during
the period  beginning  91 days  and  ending 180  days  after the  date  of  this
Prospectus, in each case without the prior written consent of the Representative
of  the Underwriters. The officers, other directors and certain key employees of
the Company and  their Affiliates  have agreed  with the  Representative of  the
Underwriters  not  to sell,  directly  or indirectly,  the  approximately 91,640
shares owned by them for a period of 180 days after the date of this  Prospectus
without the prior written consent of the Representative of the Underwriters.
    
 
    In  general, under Rule 144  as currently in effect,  any person (or persons
whose shares are aggregated) who has beneficially owned "restricted securities,"
as that term is defined in the Securities Act, for at least two years or who  is
an   Affiliate,  is  entitled   to  sell,  within   any  three-month  period,  a
 
                                       53
<PAGE>
number of shares that does not exceed the greater of 1% of the then  outstanding
shares  of the Company's Common  Stock (approximately 209,400 shares immediately
after this  offering) or  the  average weekly  trading  volume during  the  four
calendar  weeks preceding  such sale,  provided that  certain public information
about the Company  as required  by Rule  144 is  then available  and the  seller
complies  with certain other requirements. A person who is not an Affiliate, has
not been an  Affiliate within three  months prior to  sale and has  beneficially
owned  the restricted shares for  at least three years  is entitled to sell such
shares under Rule  144(k) without  regard to  any of  the limitations  described
above.
 
   
    As  of March 31,  1996, there were outstanding  options to acquire 1,993,784
shares under the Company's 1987 Plan, the InnerDyne Medical, Inc. 1989 Incentive
Stock Plan and the 1991 Directors' Stock Option Plan, 1,255,553 of which  shares
are subject to the lock-up agreements described above.
    
 
    The  Company  has  also agreed  not  to  offer, sell,  contract  to  sell or
otherwise dispose of any  shares of Common Stock  or any securities  convertible
into  or exercisable or exchangeable  for Common Stock for  a period of 180 days
after the date  of this  Prospectus, without the  prior written  consent of  the
Representative of the Underwriters, subject to certain limited exceptions.
 
                                       54
<PAGE>
                                  UNDERWRITING
 
    Subject  to  the terms  and conditions  of  the Underwriting  Agreement, the
underwriters  named  below  (the  "Underwriters"),  for  whom  Cruttenden   Roth
Incorporated  is acting as representative (the "Representative"), have agreed to
purchase from the Company  the following respective number  of shares of  Common
Stock:
 
<TABLE>
<CAPTION>
                                                                                              NUMBER OF
UNDERWRITERS                                                                                   SHARES
- -------------------------------------------------------------------------------------------  -----------
<S>                                                                                          <C>
Cruttenden Roth Incorporated...............................................................
 
                                                                                             -----------
    Total..................................................................................    2,350,000
                                                                                             -----------
                                                                                             -----------
</TABLE>
 
    The Underwriting Agreement provides that the obligations of the Underwriters
are  subject to  certain conditions precedent.  The nature  of the Underwriters'
obligation is such  that they  are committed to  purchase all  shares of  Common
Stock  offered  hereby if  any of  such shares  are purchased.  The Underwriting
Agreement contains certain provisions whereby if any Underwriter defaults in its
obligation to purchase shares, and the aggregate obligations of the Underwriters
so defaulting do  not exceed  10% of the  shares offered  hereby, the  remaining
Underwriters, or some of them, must assume such obligations.
 
    The  Representative has advised the Company that the Underwriters propose to
offer the shares of Common  Stock directly to the  public at the offering  price
set  forth on the cover of this Prospectus, and to certain dealers at such price
less a concession not in excess of $       per share. The Underwriters may allow
and such dealers may reallow a concession not in excess of $       per share  to
certain  other dealers. After the public offering of the shares of Common Stock,
the offering price and other selling terms may be changed by the Underwriters.
 
    The Company and the Selling Stockholders have granted to the Underwriters an
option, exercisable no later than 45 days after the date of this Prospectus,  to
purchase  up to an aggregate of 352,500 additional shares of Common Stock solely
to cover over-allotments, if any, at the public offering price set forth on  the
cover  page of this Prospectus, less the underwriting discounts and commissions.
To  the  extent  that  the  Underwriters  exercise  this  option,  each  of  the
Underwriters  will have  a firm  commitment to  purchase approximately  the same
percentage thereof which the number of shares of Common Stock to be purchased by
it shown in the above table bears to the total number of shares of Common  Stock
offered  hereby.  If  the  Underwriters exercise  the  over-allotment  option, a
majority of the  Company's directors that  are not affiliated  with the  Selling
Stockholders  will determine whether such shares will  be sold by the Company or
by the Selling Stockholders. The  number of shares sold  by the Company and  the
Selling  Stockholders, in the aggregate, will not exceed 352,500. The Company or
the Selling Stockholders, as the case may be, will be obligated, pursuant to the
option, to sell such shares to the Underwriters.
 
    The Company  has  agreed  to  indemnify  the  Underwriters  against  certain
liabilities, including liabilities under the Securities Act.
 
    The  Company has agreed  to pay the  Representative a nonaccountable expense
allowance equal to two percent of the aggregate Price to Public (including  with
respect  to shares of Common Stock  underlying the over-allotment option, if and
to the extent it is exercised) set  forth on the front cover of this  Prospectus
for  expenses in connection with this offering,  of which the sum of $30,000 has
been
 
                                       55
<PAGE>
paid. The Representative's expenses in excess of such allowance will be borne by
the Representative. To the  extent that the expenses  of the Representative  are
less  than such allowance,  the excess may  be deemed to  be compensation to the
Representative.
 
    The Company has agreed to sell to Cruttenden Roth Incorporated, for $235,  a
warrant  (the "Representative's  Warrant") to purchase  up to  235,000 shares of
Common Stock at an exercise price per share equal to 120% of the public offering
price  per  share  set  forth  on  the  cover  page  of  this  Prospectus.   The
Representative's Warrant is exercisable for a period of five years beginning one
year  from the date of  this Prospectus and is not  transferable for a period of
one year from the date of this Prospectus except to officers of Cruttenden  Roth
Incorporated   or   any   successor  to   Cruttenden   Roth   Incorporated.  The
Representative's Warrant  includes  a  net  exercise  provision  permitting  the
holder(s)  to pay the exercise price by  cancellation of the exercisability of a
number of shares with a fair market value equal to the aggregate exercise  price
of  the Representative's Warrant.  In addition, the  Company has granted certain
rights  to  the  holders  of  the  Representative's  Warrant  to  register   the
Representative's  Warrant and  the Common Stock  underlying the Representative's
Warrant under the Securities Act.
 
    The Company has  granted to Cruttenden  Roth Incorporated a  right of  first
refusal  for a  period ending three  years from  the date of  this Prospectus to
serve as co-manager with respect to  future public or private financings of  the
Company's  securities, whether such securities are offered by the Company or its
principal stockholders, with the principal objective of raising capital.
 
    Certain directors of the Company and  their Affiliates have agreed with  the
Representative  of the Underwriters not to sell, directly or indirectly, (a) any
of the 5,829,690 shares owned by them for a period of 90 days after the date  of
this  Prospectus or (b)  any shares in excess  of (x) the  number of shares that
could be sold under Rule 144 less (y) the number of shares, if any, sold by such
entities upon exercise  of the  Underwriters' over-allotment  option during  the
period  beginning 91 days and ending 180 days after the date of this Prospectus,
in each case  without the  prior written consent  of the  Representative of  the
Underwriters.  The officers,  other directors and  certain key  employees of the
Company and  their  Affiliates  have  agreed  with  the  Representative  of  the
Underwriters  not  to sell,  directly  or indirectly,  the  approximately 91,640
shares owned by them for a period of 180 days after the date of this  Prospectus
without the prior written consent of the Representative of the Underwriters. The
Company  has  agreed that  it will  not,  without the  prior written  consent of
Cruttenden Roth Incorporated, offer, sell or otherwise dispose of any shares  of
Common Stock, options or warrants to acquire shares of Common Stock for a period
of  six months after  the date of  this Prospectus, except  that the Company may
issue  shares  in   connection  with  acquisitions   and  strategic   commercial
transactions,  grant  additional options  under  its stock  option  plans, issue
shares upon the exercise of outstanding stock options and issue shares  pursuant
to the Purchase Plan.
 
    The  Representative has  advised the  Company that  the Underwriters  do not
intend to confirm sales to any  accounts over which they exercise  discretionary
authority in excess of five percent of the Common Stock offered hereby.
 
                                 LEGAL MATTERS
 
    The  validity of the Common Stock offered hereby will be passed upon for the
Company by Venture Law Group, A  Professional Corporation, 2800 Sand Hill  Road,
Menlo  Park, California  94025. Certain  legal matters  in connection  with this
offering will be passed upon for  the Underwriters by Wilson Sonsini Goodrich  &
Rosati,  Professional  Corporation, 650  Page Mill  Road, Palo  Alto, California
94304.
 
                                    EXPERTS
 
    The audited  financial statements  and  schedule of  InnerDyne, Inc.  as  of
December  31, 1995 and 1994 and  for each of the years  in the three year period
ended December 31, 1995 included  in this Prospectus and Registration  Statement
have    been    included   herein    and    in   the    Registration   Statement
 
                                       56
<PAGE>
in reliance upon  the reports of  KPMG Peat Marwick  LLP, independent  certified
public  accountants appearing elsewhere herein and in the Registration Statement
and upon the authority of said firm as experts in accounting and auditing.
 
                             ADDITIONAL INFORMATION
 
    The Company  has filed  with  the Securities  and Exchange  Commission  (the
"Commission")  a Registration Statement, of  which this Prospectus constitutes a
part, under  the Securities  Act with  respect  to the  shares of  Common  Stock
offered  hereby.  This Prospectus  omits  certain information  contained  in the
Registration Statement, and reference is made to the Registration Statement  and
the  exhibits and schedules thereto for  further information with respect to the
Company and  the  Common  Stock  offered  hereby.  Statements  contained  herein
concerning  the provisions of any documents are not necessarily complete, and in
each instance reference is made to the copy of such document filed as an exhibit
to the Registration Statement. Each such statement is qualified in its  entirety
by such reference.
 
    The  Company is  subject to the  information requirements  of the Securities
Exchange Act  of  1934,  as  amended (the  "Exchange  Act")  and  in  accordance
therewith  files  reports,  proxy  statements  and  other  information  with the
Commission. Reports, proxy statements and other information filed by the Company
with the Commission pursuant to the Exchange Act and the Registration Statement,
including exhibits  and  schedules filed  therewith,  may be  inspected  without
charge  at the public reference facilities  maintained by the Commission at Room
1024, Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549 and at the
regional offices of the Commission located at 7 World Trade Center, Suite  1300,
New  York, New York  10048 and Citicorp  Center, 500 West  Madison Street, Suite
1400, Chicago, Illinois 60661. Copies of such materials may be obtained from the
Public Reference  Section of  the Commission,  Room 1024,  Judiciary Plaza,  450
Fifth  Street, N.W., Washington, D.C. 20549, and its public reference facilities
in New York, New York and Chicago, Illinois, at prescribed rates.
 
                                       57
<PAGE>
                                INNERDYNE, INC.
                         INDEX TO FINANCIAL STATEMENTS
 
   
<TABLE>
<CAPTION>
                                                                                                               PAGE
                                                                                                             ---------
<S>                                                                                                          <C>
FINANCIAL STATEMENTS, INNERDYNE, INC.
 
  Report of KPMG Peat Marwick LLP, Independent Auditors....................................................        F-2
 
  Balance Sheets as of December 31, 1995 and 1994..........................................................        F-3
 
  Statements of Operations for the three years ended December 31, 1995.....................................        F-4
 
  Statements of Stockholders' Equity for the three years ended December 31, 1995...........................        F-5
 
  Statements of Cash Flows for the three years ended December 31, 1995.....................................        F-6
 
Notes to Financial Statements..............................................................................        F-7
 
CONDENSED FINANCIAL STATEMENTS, INNERDYNE, INC. (UNAUDITED)
 
  Condensed Balance Sheets as of March 31, 1996 and December 31, 1995......................................       F-15
 
  Condensed Statements of Operations for the three month periods ended March 31, 1996 and 1995.............       F-16
 
  Condensed Statements of Cash Flows for the three month periods ended March 31, 1996 and 1995.............       F-17
 
  Notes to Condensed Financial Statements..................................................................       F-18
</TABLE>
    
 
                                      F-1
<PAGE>
                          INDEPENDENT AUDITORS' REPORT
 
The Board of Directors and Stockholders
InnerDyne, Inc.:
 
    We  have audited  the accompanying balance  sheets of InnerDyne,  Inc. as of
December  31,  1995  and  1994,  and  the  related  statements  of   operations,
stockholders'  equity, and cash  flows for each  of the years  in the three-year
period  ended   December  31,   1995.  These   financial  statements   are   the
responsibility  of the Company's management. Our responsibility is to express an
opinion on these financial statements based on our audits.
 
    We conducted  our  audits in  accordance  with generally  accepted  auditing
standards.  Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence  supporting
the  amounts and disclosures in the financial statements. An audit also includes
assessing the  accounting  principles used  and  significant estimates  made  by
management,  as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
 
    In our opinion, the financial  statements referred to above present  fairly,
in  all  material respects,  the  financial position  of  InnerDyne, Inc.  as of
December 31, 1995 and 1994, and the results of its operations and its cash flows
for each of  the years  in the  three-year period  ended December  31, 1995,  in
conformity with generally accepted accounting principles.
 
                                          KPMG Peat Marwick LLP
 
San Francisco, California
March 15, 1996
 
                                      F-2
<PAGE>
                                INNERDYNE, INC.
                                 BALANCE SHEETS
                           DECEMBER 31, 1995 AND 1994
 
                                     ASSETS
 
<TABLE>
<CAPTION>
                                                                                        1995            1994
                                                                                   --------------  --------------
<S>                                                                                <C>             <C>
Current assets:
  Cash and cash equivalents......................................................  $    1,720,814  $    3,981,060
  Marketable investment securities (note 4)......................................         997,604       1,750,000
  Accounts receivables, less allowance for doubtful accounts of $73,290 in 1995
   and $-0- in 1994..............................................................         735,911         229,603
  Interest and other receivables.................................................         195,646         171,393
  Inventories (note 5)...........................................................         585,123         393,911
  Prepaid expenses...............................................................          78,959         101,305
                                                                                   --------------  --------------
    Total current assets.........................................................       4,314,057       6,627,272
                                                                                   --------------  --------------
Equipment and leasehold improvements:
  Equipment......................................................................       2,473,578       1,998,608
  Leasehold improvements.........................................................         135,333         375,833
                                                                                   --------------  --------------
                                                                                        2,608,911       2,374,441
Less accumulated depreciation and amortization...................................       1,660,616       1,389,533
                                                                                   --------------  --------------
    Net equipment and leasehold improvements.....................................         948,295         984,908
Deposits.........................................................................         107,251         234,418
                                                                                   --------------  --------------
                                                                                   $    5,369,603  $    7,846,598
                                                                                   --------------  --------------
                                                                                   --------------  --------------
                                      LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
  Current installments of long-term debt (note 6)................................  $       85,058  $      168,902
  Current installments under capital leases (note 7).............................          29,683          41,294
  Accounts payable...............................................................         206,320         387,530
  Accrued expenses...............................................................         852,035         891,814
                                                                                   --------------  --------------
    Total current liabilities....................................................       1,173,096       1,489,540
Long-term debt, excluding current installments (note 6)..........................         186,689          30,035
Obligations under capital leases, excluding current installments (note 7)........        --                35,264
Commitments (note 7)
Stockholders' equity (note 8):
  Preferred stock, $.01 par value. Authorized 1,000,000 shares; no shares issued
   and outstanding in 1995 and 1994..............................................        --              --
  Common stock, $.01 par value. Authorized 40,000,000 shares; issued and
   outstanding 18,315,501 shares in 1995 and 16,616,302 shares in 1994...........         183,155         166,163
  Additional paid-in capital.....................................................      50,442,159      47,113,977
  Accumulated deficit............................................................     (46,615,496)    (40,988,381)
                                                                                   --------------  --------------
    Net stockholders' equity.....................................................       4,009,818       6,291,759
                                                                                   --------------  --------------
                                                                                   $    5,369,603  $    7,846,598
                                                                                   --------------  --------------
                                                                                   --------------  --------------
</TABLE>
 
                See accompanying notes to financial statements.
 
                                      F-3
<PAGE>
                                INNERDYNE, INC.
                            STATEMENTS OF OPERATIONS
                 YEARS ENDED DECEMBER 31, 1995, 1994, AND 1993
 
<TABLE>
<CAPTION>
                                                                        1995            1994            1993
                                                                   --------------  --------------  --------------
<S>                                                                <C>             <C>             <C>
Product sales....................................................  $    4,729,651  $      275,517  $     --
Licensing, contract and grant revenue (note 10)..................         545,409         603,392          42,821
                                                                   --------------  --------------  --------------
    Revenue......................................................       5,275,060         878,909          42,821
Costs and expenses:
  Cost of product sales..........................................       3,148,915       1,939,974         489,692
  Research, development, regulatory and clinical.................       2,299,311       3,951,536       5,793,455
  Sales and marketing............................................       3,895,338       2,063,123       1,107,334
  General and administrative.....................................       1,779,227       2,984,926       3,417,374
                                                                   --------------  --------------  --------------
    Total costs and expenses.....................................      11,122,791      10,939,559      10,807,855
                                                                   --------------  --------------  --------------
    Operating loss...............................................      (5,847,731)    (10,060,650)    (10,765,034)
Other income (expense):
  Interest income................................................         250,594         459,830         605,343
  Interest expense...............................................         (28,908)        (63,511)       (147,610)
  Loss on asset disposal.........................................          (1,070)       (239,811)        (51,932)
                                                                   --------------  --------------  --------------
    Total other income...........................................         220,616         156,508         405,801
                                                                   --------------  --------------  --------------
    Net loss.....................................................  $   (5,627,115) $   (9,904,142) $  (10,359,233)
                                                                   --------------  --------------  --------------
                                                                   --------------  --------------  --------------
Net loss per share...............................................  $         (.32) $         (.61) $         (.69)
                                                                   --------------  --------------  --------------
                                                                   --------------  --------------  --------------
Weighted average shares outstanding..............................      17,561,480      16,196,903      15,102,710
                                                                   --------------  --------------  --------------
                                                                   --------------  --------------  --------------
</TABLE>
 
                See accompanying notes to financial statements.
 
                                      F-4
<PAGE>
                                INNERDYNE, INC.
                       STATEMENTS OF STOCKHOLDERS' EQUITY
                  YEARS ENDED DECEMBER 31, 1995, 1994 AND 1993
 
<TABLE>
<CAPTION>
                                                                                         NOTES
                                                           ADDITIONAL                 RECEIVABLE       NET
                                                 COMMON      PAID-IN    ACCUMULATED      FROM      STOCKHOLDERS'
                                                  STOCK      CAPITAL      DEFICIT     STOCKHOLDERS    EQUITY
                                                ---------  -----------  ------------  -----------  ------------
<S>                                             <C>        <C>          <C>           <C>          <C>
Balances at December 31, 1992.................  $ 145,436  $44,498,354  $(20,725,006)  $ (16,250)  $ 23,902,534
  Issuance of shares upon exercise of stock
   options, under employee stock purchase
   plan, and for services rendered............      2,202      185,022       --           --            187,224
  Issuance of shares for conversation of notes
   and accrued interest.......................      9,728    1,926,570       --           --          1,936,298
  Net loss....................................     --          --        (10,359,233)     --        (10,359,233)
                                                ---------  -----------  ------------  -----------  ------------
Balances at December 31, 1993.................    157,366   46,609,946   (31,084,239)    (16,250)    15,666,823
  Issuance of shares upon exercise of stock
   options and under employee stock purchase
   plan.......................................      6,641      133,321       --           --            139,962
  Issuance of shares for services.............        572      113,866       --           --            114,438
  Issuance of shares for conversion of notes
   and accrued interest.......................      1,103      228,869       --           --            229,972
  Issuance of shares upon exercise of warrants
   for cash and on a net exercise basis.......        481       27,975       --           --             28,456
  Repayment of notes receivable from
   stockholders...............................     --          --            --           16,250         16,250
  Net loss....................................     --          --         (9,904,142)     --         (9,904,142)
                                                ---------  -----------  ------------  -----------  ------------
Balances at December 31, 1994.................    166,163   47,113,977   (40,988,381)     --          6,291,759
  Issuance of shares upon exercise of stock
   options and under employee stock purchase
   plan.......................................      2,632      155,475       --           --            158,107
  Issuance of shares for private placement
   (note 8)...................................     14,360    3,230,998       --           --          3,245,358
  Private placement expenses (note 8).........     --          (58,291)      --           --            (58,291)
  Net loss....................................     --          --         (5,627,115)     --         (5,627,115)
                                                ---------  -----------  ------------  -----------  ------------
Balances at December 31, 1995.................  $ 183,155  $50,442,159  $(46,615,496)  $  --       $  4,009,818
                                                ---------  -----------  ------------  -----------  ------------
                                                ---------  -----------  ------------  -----------  ------------
</TABLE>
 
                See accompanying notes to financial statements.
 
                                      F-5
<PAGE>
                                INNERDYNE, INC.
                            STATEMENTS OF CASH FLOWS
                  YEARS ENDED DECEMBER 31, 1995, 1994 AND 1993
 
<TABLE>
<CAPTION>
                                                                             1995         1994          1993
                                                                          -----------  -----------  ------------
<S>                                                                       <C>          <C>          <C>
Cash flows from operating activities:
  Net loss..............................................................  $(5,627,115) $(9,904,142) $(10,359,233)
  Adjustments to reconcile net loss to net cash used in operating
   activities:
    Depreciation and amortization of equipment and leasehold
     improvements.......................................................      578,201      674,668       553,576
    Amortization of intangible assets...................................      --            77,808        47,405
    Amortization of discount on marketable investment securities........      (51,540)     --            --
    Provision for allowance on doubtful accounts........................       73,290      --            --
    Provision for obsolete inventory....................................       43,881      --            --
    Loss on asset disposal..............................................        1,070      239,811        51,932
    Expense for stock options and shares granted for services...........      --           114,438        51,750
    Interest accrued on convertible note payable........................      --             9,972        61,235
    Decrease (increase) in accounts receivable, interest, and other
     receivables........................................................     (603,851)    (325,246)      314,079
    Decrease (increase) in inventories..................................     (235,093)    (254,334)       77,834
    Decrease (increase) in prepaid expenses and deposits................      149,513     (115,079)     (134,839)
    Increase (decrease) in accounts payable.............................     (181,210)     118,459       224,401
    Increase (decrease) in accrued expenses.............................      (39,779)    (214,698)       76,499
                                                                          -----------  -----------  ------------
      Net cash used in operating activities.............................   (5,892,633)  (9,578,343)   (9,035,361)
                                                                          -----------  -----------  ------------
Cash flows from investing activities:
  Purchase of marketable investment securities..........................   (1,935,064)  (2,788,934)     (539,784)
  Maturity of marketable investment securities..........................    2,739,000    3,578,718     4,204,480
  Proceeds from notes receivable from stockholders......................      --            16,250       --
  Capital expenditures..................................................     (542,658)    (652,430)     (356,353)
  Proceeds from disposal of equipment and leasehold improvements........      --             1,321       --
                                                                          -----------  -----------  ------------
      Net cash provided by investing activities.........................      261,278      154,925     3,308,343
                                                                          -----------  -----------  ------------
Cash flows from financing activities:
  Proceeds from issuance of convertible notes payable...................      --           220,000     1,875,063
  Proceeds from issuance of long-term debt..............................      241,712      --             47,327
  Proceeds from issuance of common stock, net...........................    3,345,174      168,418       135,474
  Principal payments under capital leases...............................      (46,875)     (54,760)      (43,372)
  Principal payments on long-term debt..................................     (168,902)    (176,917)     (194,075)
                                                                          -----------  -----------  ------------
      Net cash provided by financing activities.........................    3,371,109      156,741     1,820,417
                                                                          -----------  -----------  ------------
Net decrease in cash and cash equivalents...............................   (2,260,246)  (9,266,677)   (3,906,601)
Cash and cash equivalents at beginning of year..........................    3,981,060   13,247,737    17,154,338
                                                                          -----------  -----------  ------------
Cash and cash equivalents at end of year................................  $ 1,720,814  $ 3,981,060  $ 13,247,737
                                                                          -----------  -----------  ------------
                                                                          -----------  -----------  ------------
Supplemental Disclosure of Cash Flow Information
Cash paid for interest..................................................  $    28,908  $    52,060  $     85,447
Supplemental Schedule of Noncash Investing and Financing Activities
  Capital lease obligations incurred for purchase of property and
   equipment............................................................  $   --       $   --       $     64,580
  Issuance of common stock in exchange for convertible promissory notes
   and/or accrued interest..............................................  $   --       $   229,972  $  1,936,298
</TABLE>
 
                See accompanying notes to financial statements.
 
                                      F-6
<PAGE>
                                INNERDYNE, INC.
                         NOTES TO FINANCIAL STATEMENTS
                        DECEMBER 31, 1995, 1994 AND 1993
 
(1) DESCRIPTION OF THE COMPANY
    InnerDyne,  Inc. (the Company)  is engaged primarily  in the development and
commercialization of access products used to perform minimally invasive  surgery
(MIS)  procedures.  The Company  markets  its MIS  access  products domestically
through a network of direct  and independent representatives, mainly to  general
surgeons  and  gynecologists,  who  represent  the  primary  medical disciplines
performing MIS procedures in the  U.S. Internationally, the Company markets  its
MIS  products through independent distributors for resale to foreign health care
institutions. The Company  intends to continue  developing its radial  dilation,
thermal  ablation and biocompatible coatings technologies, internally or through
strategic alliances.
 
(2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
    (a)  CASH EQUIVALENTS
 
        The Company  considers  all  highly  liquid  investments  with  original
    maturities  of three months or less to be cash equivalents. Cash equivalents
    consist  of  money  market  funds   and  commercial  paper  of   $1,137,013,
    $3,851,990,   and  $13,076,518  at  December   31,  1995,  1994,  and  1993,
    respectively.
 
    (b)  INVENTORIES
 
        Raw materials and supplies inventories are  stated at the lower of  cost
    or   market.  Finished  goods  are  stated   on  the  basis  of  accumulated
    manufacturing costs, but  not in  excess of market  (net realizable  value).
    Cost is determined using the first-in, first-out (FIFO) method.
 
    (c)  EQUIPMENT AND LEASEHOLD IMPROVEMENTS
 
        Equipment  and leasehold  improvements are stated  at cost. Depreciation
    and amortization of equipment and  leasehold improvements is provided  using
    the straight-line method over the estimated useful lives of the assets which
    range from 3 to 8 years.
 
    (d)  INTANGIBLE ASSETS
 
        Patent   costs  related  to  products  and  technologies  still  in  the
    development stage are expensed as incurred.
 
    (e)  REVENUE RECOGNITION
 
        Revenues are recognized upon shipment of products.
 
    (f)  RESEARCH AND DEVELOPMENT COSTS
 
        Research and development costs are expensed as incurred.
 
    (g)  NET LOSS PER SHARE
 
        The Company's loss per share is based on the weighted average number  of
    common  shares  outstanding  during the  periods.  Common  stock equivalents
    (stock options and warrants)  have not been included  in the computation  as
    they would not have a dilutive effect.
 
    (h)  INCOME TAXES
 
        The  Company accounts  for income  taxes using  the asset  and liability
    method. Under  the  asset and  liability  method, deferred  tax  assets  and
    liabilities  are recognized for the  future tax consequences attributable to
    differences between  the financial  statement carrying  amounts of  existing
    assets  and liabilities and their respective  tax bases. Deferred tax assets
    and liabilities are measured  using enacted tax rates  expected to apply  to
    taxable income in the years in which those
 
                                      F-7
<PAGE>
                                INNERDYNE, INC.
                   NOTES TO FINANCIAL STATEMENTS (CONTINUED)
 
(2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
    temporary differences are expected to be recovered or settled. The effect on
    deferred  tax assets and liabilities of a  change in tax rates is recognized
    in income in the period that includes the enactment date.
 
    (i)  USE OF ESTIMATES
 
        The preparation  of financial  statements in  conformity with  generally
    accepted  accounting principles  requires management  to make  estimates and
    assumptions that affect the reported  amounts of assets and liabilities  and
    disclosure of contingent assets and liabilities at the date of the financial
    statements  and the  reported amounts  of revenues  and expenses  during the
    reporting period. Actual results could differ from those estimates.
 
    (j)  RECLASSIFICATION
 
        Certain amounts in 1994 and 1993 have been reclassified to conform  with
    the 1995 presentation.
 
    (k)  FAIR VALUE DISCLOSURE
 
        At December 31, 1995 and 1994, the book value of the Company's financial
    instruments approximates fair value.
 
(3) MERGER
    On   April  28,  1994,  InnerDyne,  Inc.  (formerly  CardioPulmonics,  Inc.)
completed a merger, whereby  it issued 7,465,237 shares  of its common stock  in
exchange  for all  of the outstanding  common and preferred  stock, warrants and
retirement of  certain notes  payable from  stockholders of  InnerDyne  Medical,
Inc.,  a privately held  California corporation that was  founded to develop and
manufacture proprietary  medical devices  used  in minimally  invasive  surgical
procedures.  In addition,  CardioPulmonics, Inc. assumed  outstanding options to
purchase shares of  common stock of  InnerDyne Medical, Inc.  Subsequent to  the
merger, CardioPulmonics, Inc. changed its name to InnerDyne, Inc. The merger has
been  accounted for as a  pooling-of-interests combination and, accordingly, the
Company's financial statements have been restated  for all periods prior to  the
merger  to include the results of operations, financial positions and cash flows
of InnerDyne Medical, Inc.
 
    Net revenue and net loss for the individual entities prior to the merger are
as follows:
 
<TABLE>
<CAPTION>
                                                              CARDIO-
                                                            PULMONICS,      INNERDYNE
                                                               INC.       MEDICAL, INC.     COMBINED
                                                           -------------  -------------  --------------
<S>                                                        <C>            <C>            <C>
Three months ended March 31, 1994:
  Net revenue............................................  $    --        $      28,957  $       28,957
  Net loss...............................................      1,271,409      1,350,271       2,621,680
Year ended December 31, 1993:
  Net revenue............................................  $      26,600  $      16,221  $       42,821
  Net loss...............................................      6,471,279      3,887,954      10,359,233
</TABLE>
 
    Merger expenses totaling $687,807  and $150,000 related  to the merger  with
InnerDyne   Medical,  Inc.  were  charged  to  expense  during  1994  and  1993,
respectively.
 
                                      F-8
<PAGE>
                                INNERDYNE, INC.
                   NOTES TO FINANCIAL STATEMENTS (CONTINUED)
 
(4) MARKETABLE INVESTMENT SECURITIES
    Marketable debt  and  equity  securities  are  grouped  into  one  of  three
categories:  held-to-maturity, trading,  or available-for-sale. Held-to-maturity
securities are those securities that the Company has the ability and the  intent
to  hold until maturity. Trading securities  are bought and held principally for
the purposes of selling them in the near term. All other securities not included
in held-to-maturity or trading are classified as available-for-sale. At December
31, 1995  and  1994, all  the  Company's marketable  investment  securities  are
classified as held-to-maturity.
 
    Held-to-maturity   securities  are  recorded  at   cost,  adjusted  for  the
amortization or  accretion  of  premiums  or  discounts.  Gains  and  losses  on
investment  security  transactions are  reported on  the specific-identification
method. Dividend and interest  income are recognized when  earned. A decline  in
the  market value of  any available-for-sale or  held-to-maturity security below
cost that is deemed other than temporary results in a charge to earnings and the
establishment of a new cost basis for the security.
 
    The amortized cost, gross unrealized holding gains, gross unrealized holding
losses and fair value for securities by major security type at December 31, 1995
and 1994, were as follows:
 
<TABLE>
<CAPTION>
                                                                                  GROSS
                                                                    GROSS      UNREALIZED
                                                    AMORTI-      UNREALIZED      HOLDING
                                                   ZED COST     HOLDING GAINS    LOSSES      FAIR VALUE
                                                 -------------  -------------  -----------  -------------
<S>                                              <C>            <C>            <C>          <C>
At December 31, 1995:
  Corporate commercial paper
   (due within one year).......................  $     997,604  $    --         $     104   $     997,500
                                                 -------------  -------------  -----------  -------------
                                                 $     997,604  $    --         $     104   $     997,500
                                                 -------------  -------------  -----------  -------------
                                                 -------------  -------------  -----------  -------------
At December 31, 1994:
  U.S. government obligations..................  $    --        $    --         $  --       $    --
  Corporate bonds..............................      1,750,000       --            11,684       1,738,316
                                                 -------------  -------------  -----------  -------------
                                                 $   1,750,000  $    --         $  11,684   $   1,738,316
                                                 -------------  -------------  -----------  -------------
                                                 -------------  -------------  -----------  -------------
</TABLE>
 
    There were no realized gains  or losses on marketable investment  securities
for the years ending December 31, 1995, 1994 and 1993.
 
(5) INVENTORIES
    Inventories consist of the following:
 
<TABLE>
<CAPTION>
                                                                                   1995         1994
                                                                                -----------  -----------
<S>                                                                             <C>          <C>
Raw materials and supplies....................................................  $   445,936  $   344,289
Finished goods................................................................      198,647       65,201
Reserve for obsolescence......................................................      (59,460)     (15,579)
                                                                                -----------  -----------
                                                                                $   585,123  $   393,911
                                                                                -----------  -----------
                                                                                -----------  -----------
</TABLE>
 
                                      F-9
<PAGE>
                                INNERDYNE, INC.
                   NOTES TO FINANCIAL STATEMENTS (CONTINUED)
 
(6) LONG-TERM DEBT
    Long-term debt consists of the following:
 
<TABLE>
<CAPTION>
                                                                                   1995         1994
                                                                                -----------  -----------
<S>                                                                             <C>          <C>
11.5%-16.6% installment financing agreements secured by equipment, payable in
 monthly installments of $13,181 including interest through 1996..............  $    30,035  $   198,937
Prime plus 1.75% (10.25% at December 31, 1995) loan payable to bank, secured
 by equipment, payable in monthly installments of $6,931 including interest
 through 1999.................................................................      241,712      --
                                                                                -----------  -----------
  Total long-term debt........................................................      271,747      198,937
Less current installments.....................................................       85,058      168,902
                                                                                -----------  -----------
  Long-term debt, excluding current installments..............................  $   186,689  $    30,035
                                                                                -----------  -----------
                                                                                -----------  -----------
</TABLE>
 
    The  maturities of long-term  debt for the  years ended December  31, are as
follows: 1996, $85,058, 1997, $66,355, 1998, $73,667, and 1999, $46,667.
 
    In February  1996, the  Company  renewed its  credit facility  with  Silicon
Valley Bank. Subject to certain covenants and conditions, the Company may borrow
up  to $2,000,000 on a revolving credit basis  at prime plus 1 1/4 percent based
on eligible receivables and $750,000 as a 42-month term loan at prime plus 1 3/4
percent based on  eligible equipment  purchases. As  of December  31, 1995,  the
Company  had not drawn on the revolving line of credit and had drawn $241,712 on
the term loan as indicated above.
 
(7) LEASES
    The Company leases certain of  its furniture, machinery and equipment  under
long-term capital leases. Obligations under capital leases represent the present
value  of future noncancelable  rental payments under  various lease agreements.
Capitalized costs  of  $213,713 and  accumulated  amortization of  $191,150  are
included  in property and equipment at December 31, 1995 ($213,713 and $151,299,
respectively, in  1994). Amortization  of assets  held under  capital leases  is
included with depreciation expense.
 
    The  Company also has several  noncancelable operating leases, primarily for
its facilities, that expire over the  next four years. It is generally  expected
that,  in the normal  course of business,  operating leases that  expire will be
renewed or replaced by other leases  with similar terms. Rental expense for  all
operating leases was $347,294 in 1995, $263,070 in 1994 and $193,426 in 1993.
 
    Future  minimum lease  payments under  noncancelable operating  leases (with
initial or  remaining lease  terms in  excess of  one year)  and future  minimum
capital lease payments as of December 31, 1995 are:
 
<TABLE>
<CAPTION>
                                                                                CAPITAL     OPERATING
                                                                                LEASES       LEASES
                                                                               ---------  -------------
<S>                                                                            <C>        <C>
Year ending December 31:
  1996.......................................................................  $  31,445  $     346,160
  1997.......................................................................     --            320,458
  1998.......................................................................     --            286,240
  1999.......................................................................     --             70,560
                                                                               ---------  -------------
    Total minimum lease payments.............................................     31,445  $   1,023,418
                                                                                          -------------
                                                                                          -------------
Less amount representing interest............................................      1,762
                                                                               ---------
    Present value of net minimum lease payments..............................  $  29,683
                                                                               ---------
                                                                               ---------
</TABLE>
 
                                      F-10
<PAGE>
                                INNERDYNE, INC.
                   NOTES TO FINANCIAL STATEMENTS (CONTINUED)
 
(8) CAPITAL STOCK
    The  Company completed  a private  placement of  securities on  June 2, 1995
wherein it  sold  1,435,999 shares  of  common  stock and  287,200  warrants  to
purchase  common stock for cash proceeds of $3,245,358. The Company has reserved
287,200 shares of its  common stock for exercise  of the warrants. The  warrants
(as  amended) are exercisable at an exercise price of $2.90 per share and expire
on April 1, 1996.
 
    The Company  has a  1987 Stock  Option Plan  (the "1987  Plan") and  a  1989
Incentive  Stock  Plan (the  "1989 Plan")  under  which 2,650,000  and 1,453,536
shares have been reserved for issuance, respectively. The exercise price of  all
granted  options under the 1987 Plan and the 1989 Plan must be at least equal to
fair market value on the date of  grant. The number of shares, option price  and
dates  the options become exercisable and expire  are determined by the Board of
Directors on an option-by-option basis. As of December 31, 1995, 707,751  shares
remained  available for  future grant  under the  1987 Plan  and no  shares were
available for future grant under the 1989 Plan.
 
    The Company's  Board of  Directors and  stockholders have  adopted the  1991
Directors'  Stock Option Plan (the  "Directors Plan") for non-employee directors
under which a total of 300,000 shares of common stock are reserved for issuance.
Directors are granted  options annually  to acquire 10,000  shares which  become
exercisable on the first anniversary of the date of grant. The exercise price of
options  granted is the fair  market value on the date  of grant. As of December
31, 1995, 232,000 shares remain available for future grant.
 
    A summary of activity under the 1987  Plan, the 1989 Plan and the  Directors
Plan follows:
 
<TABLE>
<CAPTION>
                                                          YEARS ENDED DECEMBER 31,
                               -------------------------------------------------------------------------------
                                         1995                       1994                       1993
                               -------------------------  -------------------------  -------------------------
                                NUMBER OF     EXERCISE     NUMBER OF     EXERCISE     NUMBER OF     EXERCISE
                                 SHARES        PRICE        SHARES        PRICE        SHARES        PRICE
                               -----------  ------------  -----------  ------------  -----------  ------------
<S>                            <C>          <C>           <C>          <C>           <C>          <C>
Options outstanding at
 beginning of year...........    1,815,898  $   .09-6.50    1,941,660  $   .04-9.25    1,526,731  $   .02-9.25
Options granted..............      455,439     2.50-4.50      894,009      .15-4.00    1,061,621      .15-6.50
                               -----------                -----------                -----------
                                 2,271,337                  2,835,669                  2,588,352
                               -----------                -----------                -----------
Options exercised............      214,093      .13-1.88      657,559      .04-1.88      214,673       .13-.62
Options canceled.............      318,199      .13-4.50      362,212      .13-9.25      432,019      .02-6.50
                               -----------                -----------                -----------
                                   532,292                  1,019,771                    646,692
                               -----------                -----------                -----------
Options outstanding at end of
 year........................    1,739,045  $   .09-6.50    1,815,898  $   .09-6.50    1,941,660  $   .04-9.25
                               -----------                -----------                -----------
                               -----------                -----------                -----------
</TABLE>
 
    At December 31, 1995, outstanding options for 582,632 shares of common stock
are  exercisable. The  Company charged to  compensation expense  $51,750 in 1993
related to issuance of stock options in 1991.
 
    The Board of Directors adopted the  Company's 1996 Stock Option Plan  ("1996
Plan")  in March of 1996  and plans to submit the  1996 Plan to the stockholders
for approval in May 1996. A total of 1,000,000 shares of common stock have  been
reserved  for issuance under the 1996 Plan.  The exercise price of all incentive
stock options granted under  the 1996 Plan  must be at least  equal to the  fair
market value of the common stock on the date of grant. The exercise price of all
nonstatutory stock options granted under the 1996 Plan must be at least equal to
the  fair market value of the common stock  on the date of grant for grants made
to   certain   of    the   Company's   executive    officers   and   at    least
 
                                      F-11
<PAGE>
                                INNERDYNE, INC.
                   NOTES TO FINANCIAL STATEMENTS (CONTINUED)
 
(8) CAPITAL STOCK (CONTINUED)
85%  of the fair market value  of the common stock on  the date of grant for all
other persons. The optionees, number of shares subject to each option,  exercise
price and expiration are determined by the Board of Directors.
 
    The  Company has an employee stock purchase plan, under which 300,000 shares
of common  stock  are  reserved,  whereby qualified  employees  are  allowed  to
purchase  limited amounts  of the  Company's common  stock at  the lesser  of 85
percent of the market value of the stock at the beginning or end of the offering
period. As  of  December 31,  1995,  61,667 shares  had  been issued  under  the
employee  stock  purchase  plan and  238,333  shares were  available  for future
issuance.
 
(9) INCOME TAXES
    The Company has  reported no  income tax expense  or benefit  for the  years
ended  December  31, 1995,  1994, and  1993,  due to  net operating  losses. The
difference between the expected tax benefit and actual tax benefit is  primarily
attributable  to the  effect of  these net operating  losses being  offset by an
increase in the Company's valuation allowance.
 
    The tax  effects of  temporary  differences that  give rise  to  significant
portions  of the deferred  tax assets and  liabilities at December  31, 1995 and
1994, are presented below:
 
<TABLE>
<CAPTION>
                                                                              1995            1994
                                                                         --------------  --------------
<S>                                                                      <C>             <C>
Deferred tax assets:
  Allowance for doubtful accounts......................................  $       27,337  $     --
  Inventories, principally due to additional costs inventoried for tax
   purposes pursuant to the Tax Reform Act of 1986, and reserves for
   obsolescence........................................................         134,078         109,120
  Equipment, principally due to differences in depreciation............         132,046          68,451
  Accrued expenses.....................................................         106,955         147,305
  Startup and package design costs.....................................           5,830         100,261
  Research and development credit carryforwards........................         338,723         338,000
  Net operating loss carryforwards.....................................      13,425,908      11,040,000
  Other................................................................          21,342         213,916
                                                                         --------------  --------------
    Total gross deferred tax assets....................................      14,192,219      12,017,053
    Less valuation allowance...........................................      14,192,219      12,017,053
                                                                         --------------  --------------
Net deferred tax assets................................................  $     --        $     --
                                                                         --------------  --------------
                                                                         --------------  --------------
</TABLE>
 
    The valuation allowance for  deferred tax assets as  of January 1, 1994  was
$12,865,118.  The  net change  in the  valuation allowance  for the  years ended
December 31,  1995  and  1994,  is an  increase  (decrease)  of  $2,175,166  and
($848,065),  respectively. The  increase in the  valuation allowance  in 1995 is
primarily attributable to the increase  in the net operating loss  carryforwards
and credits incurred in 1995.
 
    Subsequently recognized tax benefits relating to the valuation allowance for
deferred  tax assets as of December 31, 1995, will be allocated as an income tax
benefit to be reported in the statement of operations.
 
                                      F-12
<PAGE>
                                INNERDYNE, INC.
                   NOTES TO FINANCIAL STATEMENTS (CONTINUED)
 
(9) INCOME TAXES (CONTINUED)
    At December  31, 1995,  the  Company has  net  operating loss  and  research
activities  credit carryforwards to offset future  income for federal income tax
purposes approximately as follows:
 
<TABLE>
<CAPTION>
                                                               NET OPERATING
                                                             LOSS CARRYFORWARD     RESEARCH
                                                                FOR REGULAR       ACTIVITIES
                                                                INCOME TAX          CREDIT
EXPIRING                                                         PURPOSES        CARRYFORWARD
- -----------------------------------------------------------  -----------------  --------------
<S>                                                          <C>                <C>
2001.......................................................   $        56,000    $    --
2002.......................................................           170,000         --
2003.......................................................           797,000         --
2004.......................................................         1,879,000         182,000
2005.......................................................         3,675,000         267,000
2006.......................................................         6,139,000         354,000
2007.......................................................        11,309,000         294,000
2008.......................................................         8,185,000          33,000
2009.......................................................         7,885,000         127,000
2010.......................................................         5,955,000          77,000
Estimated NOLs and credits which will expire unutilized due
 to the change in ownership described below................       (10,000,000)       (995,000)
                                                             -----------------  --------------
                                                              $    36,050,000    $    339,000
                                                             -----------------  --------------
                                                             -----------------  --------------
</TABLE>
 
    As a result of  the merger discussed  in note 3,  the Company has  undergone
greater  than 50 percent changes of ownership  under the rules of the Tax Reform
Act  of  1986.  Consequently,  certain  of  the  Company's  net  operating  loss
carryforwards  and research  credit carryforwards  will expire  unutilized. Such
estimated amounts have been disclosed in the table above. The maximum amount  of
the remaining net operating loss carryforwards available to offset future income
in  a given year is limited to the product of the Company's value on the date of
ownership change and  the federal  long-term tax-exempt rate,  plus any  limited
carryforward  not utilized in prior years. Net operating losses of approximately
$12,000,000 incurred after the merger are not subject to the change in ownership
limitation.
 
(10) COLLABORATIVE AND LICENSING AGREEMENTS
    During  1995,  the  Company  had  collaborative  development  and  licensing
agreements  with SENKO  Medical Instrument  Manufacturing Co.,  Ltd. (SENKO) and
with  CooperSurgical,  Inc.,  (CooperSurgical)   a  subsidiary  of  The   Cooper
Companies, Inc.
 
    (a)  SENKO
 
        Effective  April 5, 1994,  the Company entered  into a license agreement
    covering  its  proprietary  coating  technology.  Under  the  terms  of  the
    agreement,  the Company licensed its  siloxane coating of microporous hollow
    fibers  to  SENKO,  in  exchange  for  an  initial  payment  and  continuing
    royalties.  The  Company assisted  in the  construction  and startup  of the
    coating system in SENKO's manufacturing facility in Japan. The fibers coated
    by means of this process will  be used in SENKO's membrane oxygenator  line.
    The  agreement covers a period of up to ten years. Revenue totaling $156,693
    was recognized in 1995, $225,700 in 1994 and $0 in 1993.
 
    (b)  COOPERSURGICAL
 
        Effective August  25,  1994,  the  Company  entered  into  an  agreement
    covering  the  development  and future  commercialization  of  the Company's
    proprietary thermal ablation technology for gynecological applications, such
    as the  control  of excessive  uterine  bleeding.  Under the  terms  of  the
    agreement,  CooperSurgical  funded the  continuing development  and clinical
    trials of the
 
                                      F-13
<PAGE>
                                INNERDYNE, INC.
                   NOTES TO FINANCIAL STATEMENTS (CONTINUED)
 
(10) COLLABORATIVE AND LICENSING AGREEMENTS (CONTINUED)
    proprietary technology and application  system. In May 1995,  CooperSurgical
    discontinued  funding and thus forfeited its future commercialization option
    related  to  this  technology.  Revenues  related  to  this  agreement   and
    development  effort totaling $258,683  were recognized in  1995, $335,983 in
    1994 and $0 in 1993.
 
    As a part of earlier development programs focused upon a lung assist device,
the Company also  developed advanced proprietary  technologies related to  blood
gas  exchange  and blood  pumping. These  technologies had  been licensed  to an
entity, formed  by  former  employees  of  the  Company,  Oxygenator  Technology
Development,  Inc. (OTD), which intended to  pursue research in these areas. The
Company had a 45 percent  interest in OTD and has  regained all rights to  these
technologies  due  to  a  failure  by OTD  to  meet  certain  minimum milestones
incorporated within the agreement between  the parties. The financial impact  of
OTD   is  insignificant  and  accordingly  disclosure  of  summarized  financial
information is not included.
 
(11) 401(k) Plan
    The Board of Directors has adopted  a defined contribution plan (the  401(k)
Plan) intended to qualify under Section 401(k) of the internal revenue code. All
employees  who are at  least 21 years of  age and have  completed at least three
months of  service  with  the  Company are  eligible  to  participate.  Eligible
employees  may elect to contribute  to the plan an  amount up to the statutorily
prescribed annual limit ($9,240 in 1995). The 401(k) Plan permits, but does  not
require,  additional matching and discretionary contributions to the 401(k) Plan
by the Company.  To date the  Company has  made no contributions  to the  401(k)
Plan.
 
(12) ACCOUNTING STANDARDS ISSUED NOT YET ADOPTED
    In  October  of  1995,  the  Financial  Accounting  Standards  Board  issued
Statement of Financial Accounting Standards No. 123, Accounting for Stock  Based
Compensation (FASB 123). The Company is required to adopt the provisions of this
statement for years beginning after December 15, 1995. This statement encourages
all entities to adopt a fair value based method of accounting for employee stock
options  or similar  equity instruments.  However, it  also allows  an entity to
continue to measure compensation cost for those plans using the  intrinsic-value
method  of accounting  prescribed by  APB opinion  No. 25,  Accounting for Stock
Issued to Employees (APB 25). Entities electing to remain with the accounting in
APB 25 must make pro forma disclosures  of net income and earnings per share  as
if  the fair value based method of accounting defined in this statement had been
applied. It is currently anticipated that  the Company will continue to  measure
compensation  costs  in  accordance  with APB  25  and  provide  the disclosures
required by FASB 123.
 
                                      F-14
<PAGE>
   
                                INNERDYNE, INC.
                            CONDENSED BALANCE SHEETS
                                     ASSETS
    
 
   
<TABLE>
<CAPTION>
                                                                                 MARCH 31, 1996    DECEMBER 31,
                                                                                 ---------------       1995
                                                                                   (UNAUDITED)    ---------------
                                                                                                    (*SEE NOTE)
<S>                                                                              <C>              <C>
Current assets:
  Cash and cash equivalents....................................................  $     1,820,049  $     1,720,814
  Marketable investment securities.............................................               --          997,604
  Accounts receivable..........................................................          891,635          735,911
  Interest and other receivables...............................................           40,893          195,646
  Inventory....................................................................          714,064          585,123
  Prepaid expenses and other...................................................          245,024           78,959
                                                                                 ---------------  ---------------
    Total current assets.......................................................        3,711,665        4,314,057
Equipment and leasehold improvements, net......................................          905,450          948,295
Other assets...................................................................          107,986          107,251
                                                                                 ---------------  ---------------
                                                                                 $     4,725,101  $     5,369,603
                                                                                 ---------------  ---------------
                                                                                 ---------------  ---------------
 
                                      LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
  Current installments of long-term debt.......................................  $       102,286  $        85,058
  Current obligations under capital leases.....................................           18,040           29,683
  Notes payable................................................................           71,007               --
  Accounts payable.............................................................          311,917          206,320
  Accrued liabilities..........................................................          896,911          852,035
                                                                                 ---------------  ---------------
    Total current liabilities..................................................        1,400,161        1,173,096
Long-term debt, excluding current installments.................................          230,249          186,689
Obligations under capital leases, excluding current installments...............               --               --
Stockholders' equity
  Common stock.................................................................          185,661          183,155
  Additional paid-in-capital...................................................       51,108,768       50,442,159
  Accumulated deficit..........................................................      (48,199,738)     (46,615,496)
                                                                                 ---------------  ---------------
    Net stockholders' equity...................................................        3,094,691        4,009,818
                                                                                 ---------------  ---------------
                                                                                 $     4,725,101  $     5,369,603
                                                                                 ---------------  ---------------
                                                                                 ---------------  ---------------
</TABLE>
    
 
- ------------------------
   
*Condensed from audited financial statements.
    
 
   
            See accompanying notes to condensed financial statements
    
 
                                      F-15
<PAGE>
   
                                INNERDYNE, INC.
                       CONDENSED STATEMENTS OF OPERATIONS
                                  (UNAUDITED)
    
 
   
<TABLE>
<CAPTION>
                                                                                     THREE-MONTH PERIODS ENDED
                                                                                   ------------------------------
                                                                                   MARCH 31, 1996  MARCH 31, 1995
                                                                                   --------------  --------------
<S>                                                                                <C>             <C>
Product, contract and licensing revenue..........................................  $    1,582,400  $    1,235,136
  Cost of product sales..........................................................         896,305         680,488
  Research, development, regulatory and clinical.................................         579,611         582,101
  Sales and marketing............................................................       1,182,453         993,519
  General and administrative.....................................................         525,336         517,766
                                                                                   --------------  --------------
    Total costs and expenses.....................................................       3,183,705       2,773,874
                                                                                   --------------  --------------
    Operating loss...............................................................      (1,601,305)     (1,538,738)
Interest/other income, net.......................................................          17,063          69,860
                                                                                   --------------  --------------
    Net loss.....................................................................  $   (1,584,242) $   (1,468,878)
                                                                                   --------------  --------------
                                                                                   --------------  --------------
Net loss per share...............................................................  $        (0.09) $        (0.09)
                                                                                   --------------  --------------
                                                                                   --------------  --------------
Weighted average shares outstanding..............................................      18,336,852      16,632,708
                                                                                   --------------  --------------
                                                                                   --------------  --------------
</TABLE>
    
 
   
            See accompanying notes to condensed financial statements
    
 
                                      F-16
<PAGE>
   
                                INNERDYNE, INC.
                       CONDENSED STATEMENTS OF CASH FLOWS
                                  (UNAUDITED)
    
 
   
<TABLE>
<CAPTION>
                                                                                      THREE-MONTH PERIODS ENDED
                                                                                    ------------------------------
                                                                                    MARCH 31, 1996  MARCH 31, 1995
                                                                                    --------------  --------------
<S>                                                                                 <C>             <C>
Cash flows from operating activities:
  Net loss........................................................................  $   (1,584,242) $   (1,468,878)
  Adjustments to reconcile net loss to net cash used in operating activities:
    Depreciation and amortization of equipment and leasehold improvements.........         131,999         166,070
    Amortization of intangible assets.............................................              --              --
    Decrease (increase) in receivables............................................            (971)       (458,057)
    Decrease (increase) in inventories............................................        (128,941)       (199,893)
    Decrease (increase) in prepaid expenses, and other assets.....................        (166,800)       (212,812)
    Increase (decrease) in accounts payable.......................................         105,597         (63,360)
    Increase (decrease) in accrued expenses.......................................          44,876          80,633
                                                                                    --------------  --------------
      Net cash used in operating activities.......................................      (1,598,482)     (2,156,297)
                                                                                    --------------  --------------
Cash flows from investing activities:
  Maturity of (investment in) cash investments....................................         997,604       1,250,000
  Capital expenditures............................................................         (89,153)       (120,936)
                                                                                    --------------  --------------
      Net cash provided by (used in) investing activities.........................         908,451       1,129,064
                                                                                    --------------  --------------
Cash flows from financing activities:
  Proceeds from issuance of common stock, net.....................................         669,115           9,553
  Proceeds from issuance of long-term debt........................................          85,533              --
  Proceeds from short-term borrowings.............................................          89,603         108,680
  Principal payments on long-term debt............................................         (24,745)        (35,571)
  Principal payments under capital leases.........................................         (11,643)        (13,063)
  Principal payments on short-term debt...........................................         (18,597)        (10,660)
                                                                                    --------------  --------------
      Net cash provided by financing activities...................................         789,266          58,939
                                                                                    --------------  --------------
Net increase (decrease) in cash and cash equivalents..............................          99,235        (968,294)
Cash and cash equivalents at beginning of period..................................       1,720,814       3,981,060
                                                                                    --------------  --------------
Cash and cash equivalents at end of period........................................  $    1,820,049  $    3,012,766
                                                                                    --------------  --------------
                                                                                    --------------  --------------
Supplemental disclosure of cash flow information:
  Cash paid for interest..........................................................  $        8,744  $        5,839
</TABLE>
    
 
   
            See accompanying notes to condensed financial statements
    
 
                                      F-17
<PAGE>
   
                                INNERDYNE, INC.
                    NOTES TO CONDENSED FINANCIAL STATEMENTS
    
 
   
(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
    
   
    The accompanying  interim  condensed  financial  statements  and  notes  are
unaudited,  but in the opinion of management reflect all adjustments (consisting
of normal recurring accruals) necessary for  a fair presentation of the  results
of  such  periods. The  results of  operations  for any  interim period  are not
necessarily indicative of results for the respective full year. These  condensed
financial  statements  and  Management's Discussion  and  Analysis  of Financial
Condition and Results  of Operations  (MD&A) for  the three  month period  ended
March  31,  1996  should  be  read in  conjunction  with  the  audited financial
statements and notes thereto and MD&A included elsewhere in this Prospectus.
    
 
   
(2) INVENTORIES
    
   
    Inventories consist of the following:
    
 
   
<TABLE>
<CAPTION>
                                                                     MARCH 31,   DECEMBER 31,
                                                                       1996          1995
                                                                    -----------  ------------
<S>                                                                 <C>          <C>
Raw materials and supplies........................................  $   527,863   $  404,800
Finished goods....................................................      186,201      180,323
                                                                    -----------  ------------
                                                                    $   714,064   $  585,123
</TABLE>
    
 
                                      F-18
<PAGE>
   
A picture of four of InnerDyne's STEP products.
    
 
InnerDyne's broad STEP product line utilizes its proprietary radial dilation
technology.
 
   
A pictorial depiction of InnerDyne's Radially Expanding Dilator, which has
accessed an organ within the abdominal cavity.
    
 
InnerDyne's Radially Expanding Dilator is designed to enable access to organs
deep within the abdominal cavity.
<PAGE>
- ------------------------------------------------
                                ------------------------------------------------
- ------------------------------------------------
                                ------------------------------------------------
 
NO  PERSON HAS BEEN  AUTHORIZED IN CONNECTION  WITH THE OFFERING  MADE HEREBY TO
GIVE ANY  INFORMATION OR  TO  MAKE ANY  REPRESENTATIONS  NOT CONTAINED  IN  THIS
PROSPECTUS  AND, IF GIVEN OR MADE,  SUCH INFORMATION OR REPRESENTATIONS MUST NOT
BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY OR ANY UNDERWRITER. THIS
PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO  SELL OR A SOLICITATION OF ANY  OFFER
TO  BUY ANY OF THE SECURITIES  OFFERED HEREBY TO ANY PERSON  OR BY ANYONE IN ANY
JURISDICTION IN WHICH IT IS UNLAWFUL TO MAKE SUCH OFFER OR SOLICITATION. NEITHER
THE DELIVERY OF  THIS PROSPECTUS NOR  ANY SALE MADE  HEREUNDER SHALL, UNDER  ANY
CIRCUMSTANCES,  CREATE ANY IMPLICATION THAT  THE INFORMATION CONTAINED HEREIN IS
CORRECT AS OF ANY DATE SUBSEQUENT TO THE DATE HEREOF.
 
                            ------------------------
 
                               TABLE OF CONTENTS
 
   
<TABLE>
<CAPTION>
                                                   PAGE
<S>                                             <C>
Prospectus Summary............................           3
Risk Factors..................................           5
The Company...................................          14
Use of Proceeds...............................          14
Price Range of Common Stock...................          15
Dividend Policy...............................          15
Capitalization................................          16
Dilution......................................          17
Selected Financial Data.......................          18
Management's Discussion and Analysis of
 Financial Condition and Results of
 Operations...................................          19
Business......................................          23
Management....................................          41
Certain Transactions..........................          48
Principal and Selling Stockholders............          49
Description of Capital Stock..................          52
Shares Eligible for Future Sale...............          53
Underwriting..................................          55
Legal Matters.................................          56
Experts.......................................          56
Additional Information........................          57
Index to Financial Statements.................         F-1
</TABLE>
    
 
                            ------------------------
 
                                2,350,000 SHARES
 
                                     [LOGO]
                                  COMMON STOCK
 
                             ----------------------
 
                                   PROSPECTUS
 
                             ----------------------
 
                                CRUTTENDEN ROTH
                                  INCORPORATED
 
                                           , 1996
 
- ------------------------------------------------
                                ------------------------------------------------
- ------------------------------------------------
                                ------------------------------------------------
<PAGE>
                                    PART II
                     INFORMATION NOT REQUIRED IN PROSPECTUS
 
ITEM 13.  OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
 
    The  following  table  sets  forth  all  expenses,  other  than underwriting
discounts and commissions, payable by the Company in connection with the sale of
Common Stock being registered. All amounts are estimates except the registration
fee and the NASD filing fee.
 
   
<TABLE>
<CAPTION>
                                                                                     AMOUNT
                                                                                   TO BE PAID
                                                                                   -----------
<S>                                                                                <C>
Registration Fee.................................................................  $     3,293
NASD Filing Fee..................................................................        1,455
Nasdaq Listing Fee...............................................................       17,500
Printing.........................................................................      100,000
Legal Fees and Expenses..........................................................      150,000
Accounting Fees and Expenses.....................................................       75,000
Blue Sky Fees and Expenses.......................................................       10,000
Transfer Agent and Registrar Fees................................................        5,000
Representative's nonaccountable expense allowance................................      182,125
Miscellaneous....................................................................       30,627
                                                                                   -----------
    Total........................................................................  $   575,000
                                                                                   -----------
                                                                                   -----------
</TABLE>
    
 
ITEM 14.  INDEMNIFICATION OF OFFICERS AND DIRECTORS
 
    Section 145 of  the General Corporation  Law of the  State of Delaware  (the
"Delaware  Law")  authorizes  a court  to  award,  or a  corporation's  Board of
Directors  to  grant,  indemnification  to  directors  and  officers  in   terms
sufficiently  broad to  permit such indemnification  under certain circumstances
for liabilities (including  reimbursement for expenses  incurred) arising  under
the  Securities  Act. Article  Tenth of  the  Registrant's Amended  and Restated
Certificate of  Incorporation  (Exhibit  3.1  hereto)  and  Article  VI  of  the
Registrant's  Bylaws  (Exhibit 3.2  hereto) provide  for indemnification  of its
directors, officers, employees and other agents to the maximum extent  permitted
by   the  Delaware   Law.  In   addition,  the   Registrant  has   entered  into
Indemnification  Agreements  (Exhibit  10.6   hereto)  with  its  officers   and
directors.  Reference is  also made to  Section 8 of  the Underwriting Agreement
contained in  Exhibit 1.1  hereto, indemnifying  officers and  directors of  the
Registrant against certain liabilities.
 
ITEM 15.  RECENT SALES OF UNREGISTERED SECURITIES
 
    (a)  Since January 1, 1993, the  Registrant issued and sold (without payment
of any selling commission to any person) the following unregistered securities:
 
        (1) In June 1995, the Registrant  issued 1,435,999 shares of its  Common
    Stock  and warrants  to purchase  287,200 shares of  its Common  Stock to 24
    purchasers for aggregate gross proceeds of $3,245,358.
 
        (2) In January 1996,  the Registrant issued 6,000  shares of its  Common
    Stock  to a single entity  in connection with a  license agreement with such
    entity. The Registrant did not receive any cash proceeds from such issuance.
 
        (3) In  March and  April of  1996, holders  of warrants  to purchase  an
    aggregate  of  242,952  shares  of  Common  Stock  exercised  such warrants,
    resulting in total proceeds to the Registrant of $704,568.
 
   
        (4) In May  1996, the  Registrant issued  166,667 shares  of its  Common
    Stock  to a single entity  in connection with a  license agreement with such
    entity, for an aggregate purchase price of $500,001
    
 
                                      II-1
<PAGE>
    (b) There were no underwritten offerings employed in connection with any  of
the transactions set forth in Item 15(a).
 
    The  issuances of the securities  set forth in Item  15(a) were deemed to be
exempt from registration under the Securities Act in reliance on Section 4(2) of
such Act as  transactions by an  issuer not involving  any public offering.  The
recipients  of securities in each  such transaction represented their intentions
to acquire the securities for investment only and not with a view to or for sale
in connection  with  any  distribution thereof  and  appropriate  legends  where
affixed  to  the  securities issued  in  such transactions.  All  recipients had
adequate access, through  their relationships with  the Company, to  information
about the Registrant.
 
ITEM 16.  EXHIBITS AND FINANCIAL STATEMENT SCHEDULE
 
    (a) Exhibits
 
<TABLE>
<C>               <S>
  1.1+            Form of Underwriting Agreement.
  3.1 (7)         Restated Certificate of Incorporation of Registrant.
  3.2 (2)         Bylaws of Registrant.
  5.1+            Opinion of Venture Law Group.
 10.1 *(4)        1987 Stock Option Plan, as amended.
 10.2 *(8)        1991 Directors' Stock Option Plan, as amended.
 10.3 *(8)        1991 Employee Stock Purchase Plan, as amended.
 10.4 (1)         Purchase Agreement (Series C) dated as of June 26, 1990, as amended.
 10.6 (1)         Form of Indemnification Agreement between the Registrant and its officers and directors.
 10.7 *(1)        Defined Contribution "401(k)" Plan as amended January 1, 1990.
 10.8 (1)         Equipment Financing Agreement dated as of June 1, 1990 between Lease Management Services,
                   Inc. and the Registrant.
 10.9 (2)         Lease dated June 1989 between the Registrant and William J. Lowenberg.
 10.12*(2)        Form of Nondisclosure and Consulting Agreement with Herbert G. Taus.
 10.13*(3)        Letter Agreement with William G. Mavity.
 10.14*(4)        Consulting Agreement with Robert M. Curtis dated January 12, 1994.
 10.16(5)         Lease Extension with BSL Associates.
 10.17(5)         Lease Agreements with QAD Associates.
 10.18(5)(10)     Licensing Agreement with SENKO Medical Instrument Mfg. Co., Ltd.
 10.19*(5)        InnerDyne Medical, Inc. 1989 Incentive Stock Plan.
 10.20*(5)        Interventional Thermodynamics Inc. 401(k) Plan.
 10.22(6)(10)     License and Development Agreement dated as of August 25, 1994 by and among InnerDyne,
                   Inc., InnerDyne Medical, Inc. and CooperSurgical, Inc.
 10.23(7)         Loan and Security Agreement and Collateral Assignment, Patent Mortgage and Security
                   Agreement dated as of February 23, 1995 between the Registrant and Silicon Valley Bank.
 10.24(8)         Common Stock and Warrant Purchase Agreement dated as of June 2, 1995 by and among the
                   Registrant and the purchasers named therein, including form of Common Stock Warrant.
 10.25(9)         Amendment to Loan and Security Agreement dated as of February 29, 1996 between the
                   Registrant and Silicon Valley Bank.
 10.26*(9)        1996 Stock Option Plan.
</TABLE>
 
                                      II-2
<PAGE>
<TABLE>
<C>               <S>
 10.27(9)(11)     Licensing, Development and Manufacturing Agreement dated as of February 2, 1996 between
                   the Registrant and EndoTex Interventional Systems, Inc.
 10.28(9)(11)     National Contract dated October 1995 between the Registrant and Surgical Care Affiliates,
                   Inc.
 10.29(9)(11)     License Agreement dated as of January 1, 1996 between the Registrant and Alliance of
                   Children's Hospitals, Inc.
 10.30*(9)        Consulting Agreement dated as of September 1, 1995 between the Registrant and Don Murray &
                   Associates, Inc. and Medical Contracts Associates.
 10.31*(9)        Letter Agreement with Robert A. Stern dated as of January 10, 1996.
 10.32+           Letter Agreement with Daniel J. Genter dated as of March 13, 1996.
 10.33+           Waiver and Amendment to Series B Preferred Stock Purchase Agreement, dated as of March 27,
                   1996, by and among the Company and certain investors.
 10.34+           Form of Representative's Warrant Agreement to be entered into by the Registrant and
                   Cruttenden Roth Incorporated in connection with the offering.
 10.35(11)(12)    Technology Development, Transfer and Licensing Agreement dated as of April 17, 1996
                   between the Registrant and Boston Scientific Corporation.
 10.36(12)        Common Stock Purchase Agreement dated as of April 17, 1996 between the Registrant and
                   Boston Scientific Corporation.
 23.1             Consent of Independent Certified Public Accountants (see page II-6).
 23.2+            Consent of Counsel (included in Exhibit 5.1).
 24.1+            Power of Attorney.
</TABLE>
 
- ------------------------
*Management compensatory plan or arrangement.
 
+Previously filed.
 
 (1) Incorporated  by reference  to exhibits  filed in  response to  Item 16(a),
     "Exhibits," of  the Registrant's  Registration Statement  on Form  S-1,  as
     amended (File No. 33-44361), filed December 4, 1991.
 
 (2) Incorporated  by reference to exhibits filed  in response to Item 14(a)(3),
     "Exhibits," of the  Registrant's Annual Report  on Form 10-K  for the  year
     ended December 31, 1992.
 
 (3) Incorporated  by  reference  to  exhibits  filed  in  response  to  Item 6,
     "Exhibits and Reports on Form 8-K," of the Registrant's Quarterly Report on
     Form 10-Q for quarterly period ended September 30, 1993.
 
 (4) Incorporated by  reference  to  exhibits  filed in  response  to  Item  21,
     "Exhibits   and  Financial   Statement  Schedules,"   of  the  Registrant's
     Registration Statement on Form S-4,  as amended (File No. 33-74624),  filed
     January 31, 1994.
 
 (5) Incorporated  by  reference  to  exhibits  filed  in  response  to  Item 6,
     "Exhibits and Reports on Form 8-K," of the Registrant's Quarterly Report on
     Form 10-QSB for the quarterly period ended June 30, 1994.
 
 (6) Incorporated by reference to exhibits filed in response to Item 6 "Exhibits
     and Reports on  Form 8-K,"  of the  Registrant's Quarterly  Report on  Form
     10-QSB for the quarterly period ended September 30, 1994.
 
                                      II-3
<PAGE>
 (7) Incorporated  by  reference  to  exhibits filed  in  response  to  Item 13,
     "Exhibit List and Reports on Form  8-K," of the Registrant's Annual  Report
     on Form 10-KSB for the year ended December 31, 1994.
 
 (8) Incorporated  by  reference  to  exhibits  filed  in  response  to  Item 6,
     "Exhibits and Reports on Form 8-K" of the Registrant's Quarterly Report  on
     Form 10-QSB for the Quarterly period ended June 30, 1995.
 
 (9) Incorporated  by  reference  to  exhibits filed  in  response  to  Item 13,
     "Exhibit List and Reports on Form  8-K," of the Registrant's Annual  Report
     on Form 10-KSB for the year ended December 31, 1995.
 
 (10) Confidential  treatment granted for  portions of this  exhibit by order of
      the Securities and Exchange Commission.
 
 (11) Confidential treatment requested.
 
 (12) Incorporated by  reference  to  exhibits  filed in  response  to  Item  7,
      "Financial Statements and Exhibits," of the Registrant's Current Report on
      Form 8-K dated April 17, 1996.
 
    (b) Financial Statement Schedule
 
    SCHEDULE II -- VALUATION AND QUALIFYING ACCOUNTS
 
    Schedules  not  listed  above  have  been  omitted  because  the information
required to be set forth therein is not applicable or is shown in the  financial
statements or notes thereto.
 
ITEM 17.  UNDERTAKINGS
 
    The  undersigned Registrant hereby undertakes to provide to the Underwriters
at the closing  specified in  the Underwriting Agreement,  certificates in  such
denominations  and registered in  such names as required  by the Underwriters to
permit prompt delivery to each purchaser.
 
    Insofar as indemnification for liabilities arising under the Securities  Act
of  1933 (the  "Act") may  be permitted  to directors,  officers and controlling
persons of the Registrant  pursuant to the provisions  referenced in Item 14  of
this  Registration Statement or otherwise, the  Registrant has been advised that
in the opinion of the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Act, and is, therefore, unenforceable.
In the event that  a claim for indemnification  against such liabilities  (other
than  the payment by the Registrant of  expenses incurred or paid by a director,
officer, or controlling person  of the Registrant in  the successful defense  of
any  action,  suit  or proceeding)  is  asserted  by such  director,  officer or
controlling person in connection with the securities being registered hereunder,
the Registrant will, unless in  the opinion of its  counsel the matter has  been
settled  by controlling precedent, submit to a court of appropriate jurisdiction
the question whether  such indemnification  by it  is against  public policy  as
expressed  in the  Act and will  be governed  by the final  adjudication of such
issue.
 
    The undersigned registrant hereby undertakes that:
 
        (1) For  purposes  of  determining  any liability  under  the  Act,  the
    information  omitted  from the  form  of prospectus  filed  as part  of this
    Registration Statement in reliance upon Rule 430A and contained in a form of
    prospectus filed by  the Registrant  pursuant to  Rule 424(b)(1)  or (4)  or
    497(h)  under  the Act  shall  be deemed  to  be part  of  this Registration
    Statement as of the time it was declared effective.
 
        (2) For the  purpose of determining  any liability under  the Act,  each
    post-effective  amendment that contains a form of prospectus shall be deemed
    to be  a  new registration  statement  relating to  the  securities  offered
    therein, and the offering of such securities at that time shall be deemed to
    be the initial bona fide offering thereof.
 
                                      II-4
<PAGE>
                                   SIGNATURES
 
   
    Pursuant  to the requirements of the  Securities Act of 1933, the Registrant
has duly caused this Registration  Statement to be signed  on its behalf by  the
undersigned,  thereunto  duly authorized,  in the  City  of Sunnyvale,  State of
California, on May 9, 1996.
    
 
                                          INNERDYNE, INC.
 
                                          By:         /s/ ROBERT A. STERN
                                             -----------------------------------
                                                       Robert A. Stern
                                             VICE PRESIDENT AND CHIEF FINANCIAL
                                                           OFFICER
 
    PURSUANT  TO  THE  REQUIREMENTS  OF   THE  SECURITIES  ACT  OF  1933,   THIS
REGISTRATION  STATEMENT  HAS  BEEN  SIGNED  BY  THE  FOLLOWING  PERSONS  IN  THE
CAPACITIES AND ON THE DATES INDICATED:
 
   
<TABLE>
<CAPTION>
                      SIGNATURE                                           TITLE                          DATE
- ------------------------------------------------------  -----------------------------------------  ----------------
 
<C>                                                     <S>                                        <C>
                        WILLIAM G. MAVITY*
     -------------------------------------------        President, Chief Executive Officer and       May   , 1996
                  William G. Mavity                      Director (Principal Executive Officer)
 
                       /s/ ROBERT A. STERN              Vice President and Chief Financial
     -------------------------------------------         Officer (Principal Financial and            May   , 1996
                   Robert A. Stern                       Accounting Officer)
 
                       EDWARD W. BENECKE*
     -------------------------------------------        Director                                     May   , 1996
                  Edward W. Benecke
 
                        ROBERT M. CURTIS*
     -------------------------------------------        Director                                     May   , 1996
                   Robert M. Curtis
 
                        EUGENE J. FISCHER*
     -------------------------------------------        Director                                     May   , 1996
                  Eugene J. Fischer
 
                           GUY P. NOHRA*
     -------------------------------------------        Director                                     May   , 1996
                     Guy P. Nohra
 
                         STEVEN N. WEISS*
     -------------------------------------------        Director                                     May   , 1996
                   Steven N. Weiss
 
           *By:         /s/ ROBERT A. STERN
       ---------------------------------------
                   Robert A. Stern
                   ATTORNEY-IN-FACT
</TABLE>
    
 
                                      II-5
<PAGE>
                                                                    EXHIBIT 23.1
 
              CONSENT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS
 
    We consent to the use of our report dated March 15, 1996 included herein and
to the reference to our firm under the heading "Experts" in the prospectus.
 
                                          KPMG Peat Marwick LLP
 
   
San Francisco, California
May 9, 1996
    
 
                                      II-6
<PAGE>
                                                                     SCHEDULE II
 
                                INNERDYNE, INC.
 
                       VALUATION AND QUALIFYING ACCOUNTS
 
<TABLE>
<CAPTION>
                                                                                        DEDUCTIONS
                                                                           ADDITIONS   -------------
                                                                          -----------    ACCOUNTS
                                                             BALANCE AT   CHARGED TO    RECEIVABLE    BALANCE AT
                                                              BEGINNING    COSTS AND   AND INVENTORY    END OF
                                                              OF PERIOD    EXPENSES     CHARGED OFF     PERIOD
                                                             -----------  -----------  -------------  -----------
<S>                                                          <C>          <C>          <C>            <C>
Year ended December 31, 1995:
  Allowance for doubtful accounts..........................  $         0  $    73,290   $   --        $    73,290
  Inventory reserves.......................................       15,579       43,881       --             59,460
Year ended December 31, 1994:
  Allowance for doubtful accounts..........................       14,770      --             14,770       --
  Inventory reserves.......................................      187,556       28,236       200,213        15,579
Year ended December 31, 1993:
  Allowance for doubtful accounts..........................       39,330      --             24,560        14,770
  Inventory reserves.......................................      103,000      185,442       100,886       187,556
</TABLE>
 
- ------------------------
 
    Schedules  not  included  above  have  been  omitted  because  the financial
information required to be set  forth therein is not  applicable or is shown  in
the financial statements or notes thereto.
 
                                      S-1
<PAGE>
                                 EXHIBIT INDEX
 
<TABLE>
<C>               <S>
  1.1+            Form of Underwriting Agreement.
  3.1 (7)         Restated Certificate of Incorporation of Registrant.
  3.2 (2)         Bylaws of Registrant.
  5.1+            Opinion of Venture Law Group.
 10.1 *(4)        1987 Stock Option Plan, as amended.
 10.2 *(8)        1991 Directors' Stock Option Plan, as amended.
 10.3 *(8)        1991 Employee Stock Purchase Plan, as amended.
 10.4 (1)         Purchase Agreement (Series C) dated as of June 26, 1990, as amended.
 10.6 (1)         Form of Indemnification Agreement between the Registrant and its officers and directors.
 10.7 *(1)        Defined Contribution "401(k)" Plan as amended January 1, 1990.
 10.8 (1)         Equipment Financing Agreement dated as of June 1, 1990 between Lease Management Services,
                   Inc. and the Registrant.
 10.9 (2)         Lease dated June 1989 between the Registrant and William J. Lowenberg.
 10.12*(2)        Form of Nondisclosure and Consulting Agreement with Herbert G. Taus.
 10.13*(3)        Letter Agreement with William G. Mavity.
 10.14*(4)        Consulting Agreement with Robert M. Curtis dated January 12, 1994.
 10.16(5)         Lease Extension with BSL Associates.
 10.17(5)         Lease Agreements with QAD Associates.
 10.18(5)(10)     Licensing Agreement with SENKO Medical Instrument Mfg. Co., Ltd.
 10.19*(5)        InnerDyne Medical, Inc. 1989 Incentive Stock Plan.
 10.20*(5)        Interventional Thermodynamics Inc. 401(k) Plan.
 10.22(6)(10)     License and Development Agreement dated as of August 25, 1994 by and among InnerDyne,
                   Inc., InnerDyne Medical, Inc. and CooperSurgical, Inc.
 10.23(7)         Loan and Security Agreement and Collateral Assignment, Patent Mortgage and Security
                   Agreement dated as of February 23, 1995 between the Registrant and Silicon Valley Bank.
 10.24(8)         Common Stock and Warrant Purchase Agreement dated as of June 2, 1995 by and among the
                   Registrant and the purchasers named therein, including form of Common Stock Warrant.
 10.25(9)         Amendment to Loan and Security Agreement dated as of February 29, 1996 between the
                   Registrant and Silicon Valley Bank.
 10.26*(9)        1996 Stock Option Plan.
 10.27(9)(11)     Licensing, Development and Manufacturing Agreement dated as of February 2, 1996 between
                   the Registrant and EndoTex Interventional Systems, Inc.
 10.28(9)(11)     National Contract dated October 1995 between the Registrant and Surgical Care Affiliates,
                   Inc.
 10.29(9)(11)     License Agreement dated as of January 1, 1996 between the Registrant and Alliance of
                   Children's Hospitals, Inc.
 10.30*(9)        Consulting Agreement dated as of September 1, 1995 between the Registrant and Don Murray &
                   Associates, Inc. and Medical Contracts Associates.
</TABLE>
<PAGE>
<TABLE>
<C>               <S>
 10.31*(9)        Letter Agreement with Robert A. Stern dated as of January 10, 1996.
 10.32+           Letter Agreement with Daniel J. Genter dated as of March 13, 1996.
 10.33+           Waiver and Amendment to Series B Preferred Stock Purchase Agreement, dated as of March 27,
                   1996, by and among the Company and certain investors.
 10.34+           Form of Representative's Warrant Agreement to be entered into by the Registrant and
                   Cruttenden Roth Incorporated in connection with the offering.
 10.35(11)(12)    Technology Development, Transfer and Licensing Agreement dated as of April 17, 1996
                   between the Registrant and Boston Scientific Corporation.
 10.36(12)        Common Stock Purchase Agreement dated as of April 17, 1996 between the Registrant and
                   Boston Scientific Corporation.
 23.1             Consent of Independent Certified Public Accountants (see page II-6).
 23.2+            Consent of Counsel (included in Exhibit 5.1).
 24.1+            Power of Attorney.
</TABLE>
 
- ------------------------
*Management compensatory plan or arrangement.
 
+Previously filed.
 
 (1) Incorporated  by reference  to exhibits  filed in  response to  Item 16(a),
     "Exhibits," of  the Registrant's  Registration Statement  on Form  S-1,  as
     amended (File No. 33-44361), filed December 4, 1991.
 
 (2) Incorporated  by reference to exhibits filed  in response to Item 14(a)(3),
     "Exhibits," of the  Registrant's Annual Report  on Form 10-K  for the  year
     ended December 31, 1992.
 
 (3) Incorporated  by  reference  to  exhibits  filed  in  response  to  Item 6,
     "Exhibits and Reports on Form 8-K," of the Registrant's Quarterly Report on
     Form 10-Q for quarterly period ended September 30, 1993.
 
 (4) Incorporated by  reference  to  exhibits  filed in  response  to  Item  21,
     "Exhibits   and  Financial   Statement  Schedules,"   of  the  Registrant's
     Registration Statement on Form S-4,  as amended (File No. 33-74624),  filed
     January 31, 1994.
 
 (5) Incorporated  by  reference  to  exhibits  filed  in  response  to  Item 6,
     "Exhibits and Reports on Form 8-K," of the Registrant's Quarterly Report on
     Form 10-QSB for the quarterly period ended June 30, 1994.
 
 (6) Incorporated by reference to exhibits filed in response to Item 6 "Exhibits
     and Reports on  Form 8-K,"  of the  Registrant's Quarterly  Report on  Form
     10-QSB for the quarterly period ended September 30, 1994.
 
 (7) Incorporated  by  reference  to  exhibits filed  in  response  to  Item 13,
     "Exhibit List and Reports on Form  8-K," of the Registrant's Annual  Report
     on Form 10-KSB for the year ended December 31, 1994.
 
 (8) Incorporated  by  reference  to  exhibits  filed  in  response  to  Item 6,
     "Exhibits and Reports on Form 8-K" of the Registrant's Quarterly Report  on
     Form 10-QSB for the Quarterly period ended June 30, 1995.
 
 (9) Incorporated  by  reference  to  exhibits filed  in  response  to  Item 13,
     "Exhibit List and Reports on Form  8-K," of the Registrant's Annual  Report
     on Form 10-KSB for the year ended December 31, 1995.
 
 (10) Confidential  treatment granted for  portions of this  exhibit by order of
      the Securities and Exchange Commission.
 
 (11) Confidential treatment requested.
 
 (12) Incorporated by  reference  to  exhibits  filed in  response  to  Item  7,
      "Financial Statements and Exhibits," of the Registrant's Current Report on
      Form 8-K dated April 17, 1996.


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