EXOGEN INC
10-Q, 1997-08-11
ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS
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                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549
                                  ____________

                                    FORM 10-Q

(Mark One)
[ X ]    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
         SECURITIES EXCHANGE ACT OF 1934

                 For the quarterly period ended June 30, 1997

                                       OR
[   ]    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
         SECURITIES EXCHANGE ACT OF 1934

      For the transition period from ____________ to ____________

                         Commission file number 0-26154

                                  EXOGEN, INC.
             (Exact name of registrant as specified in its charter)

           Delaware                                      22-3208468
(State or other jurisdiction of                      (I.R.S. Employer 
 incorporation or organization)                      Identification No.)

                             10 Constitution Avenue
                       P.O. Box 6860, Piscataway, NJ 08855
              (Address of principal executive offices) (Zip Code)

Registrant's telephone number, including area code     (908) 981-0990

                                       N/A
               Former name, former address and former fiscal year,
                          if changed since last report.


Indicate by check [X] whether the registrant (1) has filed all reports  required
to be filed by  Sections  13 or 15(d)  of the  Securities  Exchange  Act of 1934
during the preceding 12 months (or for such shorter  period that the  registrant
was  required  to file such  reports),  and (2) has been  subject to such filing
requirements for the past 90 days.   Yes [ X ]    No  [   ]

         Indicate  the  number of  shares  outstanding  of each of the  issuer's
classes of common stock,  as of the latest  practicable  date Common Stock,  par
value $0.0001 per share: 9,984,252 shares outstanding at July 31, 1997.
<PAGE>
                                  EXOGEN, INC.
                          Quarterly Report on Form 10-Q
                                  June 30, 1997



                                Table of Contents


                                                                                

PART I--Financial Information  . . . . . . . . . . . . . . . . . . . . . . . . .

         Item 1--Financial Statements:
                  Consolidated Balance Sheets . . . . . . . . . . . . . . . . . 
                  Consolidated Statements of Operations . . . . . . . . . . . . 
                  Consolidated Statements of Cash Flows  . . . . . . . . . . . .
                  Notes to Consolidated Financial Statements  . . . . . . . . . 

         Item 2--Management's Discussion and Analysis of
           Financial Condition and Results of Operations . . . . . . . . . . . .

PART II--Other Information . . . . . . . . . . . . . . . . . . . . . . . . . . .

         Item 1. Legal Proceedings . . . . . . . . . . . . . . . . . . . . . . .

         Item 2. Changes in Securities . . . . . . . . . . . . . . . . . . . . .

         Item 3. Defaults Upon Senior Securities . . . . . . . . . . . . . . . .

         Item 4. Submission of Matters to a Vote of Security Holders . . . . . .

         Item 5. Other Information . . . . . . . . . . . . . . . . . . . . . . .

         Item 6. Exhibits and Reports on Form 8-K . . . . . . . . . . . . . . . 

Signatures  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
<PAGE>
<TABLE>
<CAPTION>
                                                   EXOGEN, INC.

                                           CONSOLIDATED BALANCE SHEETS
                                        (in thousands, except share data)

                                                                                      June 30,     September 30,
                                                                                        1997           1996
                                                                                      --------       --------
                                                                                    (Unaudited)
                    ASSETS
<S>                                                                                   <C>            <C>
Current assets:
    Cash and cash equivalents ..................................................      $  4,338       $  8,115
    Short-term investments .....................................................         4,532          6,824
    Accounts receivable, net ...................................................         3,576          2,943
    Inventories ................................................................         1,465          1,239
    Interest receivable ........................................................           128            202
    Other current assets .......................................................           362            344
                                                                                      --------       --------
                 Total current assets ..........................................        14,401         19,667
Furniture, fixtures and equipment, net .........................................           788            979
Long-term investments ..........................................................         1,010          4,595
Other assets ...................................................................           263            270
                                                                                      --------       --------
                 Total assets ..................................................      $ 16,462       $ 25,511
                                                                                      ========       ========

                    LIABILITIES AND STOCKHOLDERS' EQUITY


Current liabilities:
    Accounts payable ...........................................................      $    394       $    685
    Accrued liabilities ........................................................         2,188          1,625
    Capital lease obligations ..................................................             4             15
    Other current liabilities ..................................................             7            107
                                                                                      --------       --------
                 Total current liabilities .....................................         2,593          2,432
Capital lease obligations ......................................................          --                2
                                                                                      --------       --------
                 Total liabilities .............................................         2,593          2,434

Commitments and contingencies (Note 2)
</TABLE>
<PAGE>
<TABLE>
<CAPTION>
                                                 EXOGEN, INC.

                                          CONSOLIDATED BALANCE SHEETS
                                       (in thousands, except share data)
                                                  (continued)

                                                                                      June 30,     September 30,
                                                                                        1997           1996
                                                                                      --------       --------
                                                                                    (Unaudited)
                     
<S>                                                                                   <C>            <C>
Stockholders' equity:
    Preferred Stock, $0.0001 par value;  3,000,000 shares authorized at June 30,
         1997 and September 30,1996;
         no shares issued or outstanding .......................................          --             --
    Common Stock,  $0.0001 par value; 27,000,000 shares authorized at June 30,
         1997 and September 30, 1996; 9,954,768 shares issued and outstanding at
         June 30, 1997 and 9,909,192 shares issued and outstanding at
         September 30, 1996 ....................................................             1              1
    Additional paid-in capital .................................................        46,492         46,272
    Cumulative translation adjustment ..........................................          (248)           (22)
    Accumulated deficit ........................................................       (32,376)       (23,174)
                                                                                      --------       --------
                 Total stockholders' equity ....................................        13,869         23,077
                                                                                      --------       --------
                 Total liabilities and stockholders' equity ....................      $ 16,462       $ 25,511
                                                                                      ========       ========



           The accompanying notes are an integral part of these consolidated financial statements.
</TABLE>
<PAGE>
<TABLE>
<CAPTION>
                                               EXOGEN, INC.

                                  CONSOLIDATED STATEMENTS OF OPERATIONS
                                  (in thousands, except per share data)


                                                       Three Months Ended           Nine Months Ended
                                                            June 30,                     June 30,
                                                   -----------------------       -----------------------
                                                      1997           1996           1997           1996
                                                   --------       --------       --------       --------
                                                          (Unaudited)                  (Unaudited)
<S>                                                <C>            <C>            <C>            <C>
Revenues:
     Product sales ..........................      $  1,764       $  1,816       $  5,240       $  4,164
     Revenues from development agreements ...          --             --             --              800
                                                   --------       --------       --------       --------
           Total revenues ...................         1,764          1,816          5,240          4,964
                                                   --------       --------       --------       --------

Operating costs and expenses:
     Cost of product sales ..................           961          1,071          3,049          2,443
     Research and development ...............           806            998          2,490          2,999
     Selling, general, and administrative ...         3,053          2,859          9,454          7,714
                                                   --------       --------       --------       --------
           Total operating costs and expenses         4,820          4,928         14,993         13,156
                                                   --------       --------       --------       --------

     Operating loss .........................        (3,056)        (3,112)        (9,753)        (8,192)

Other income (expense):
     Interest income, net ...................           160            334            599          1,146
     Other expense, net .....................            (8)           (19)           (48)          (175)
                                                   --------       --------       --------       --------
           Total other income, net ..........           152            315            551            971
                                                   --------       --------       --------       --------

     Net loss ...............................      $ (2,904)      $ (2,797)      $ (9,202)      $ (7,221)
                                                   ========       ========       ========       ========


Net loss per share ..........................      $  (0.29)      $  (0.28)      $  (0.93)      $  (0.73)
                                                   ========       ========       ========       ========

Weighted average shares outstanding .........         9,955          9,881          9,934          9,866




         The accompanying notes are an integral part of these consolidated financial statements.
</TABLE>
<PAGE>
<TABLE>
<CAPTION>
                                             EXOGEN, INC.

                                 CONSOLIDATED STATEMENTS OF CASH FLOWS
                                            (in thousands)

                                                                                   Nine Months Ended
                                                                                       June 30,
                                                                                ---------------------
                                                                                  1997           1996
                                                                              --------       --------
                                                                                     (Unaudited)
<S>                                                                           <C>            <C>
Cash flows from operating activities:
     Net loss ..........................................................      $ (9,202)      $ (7,221)
     Adjustments to reconcile net loss to net cash used in
        operating activities:
          Depreciation and amortization ................................           364            271
          Amortization of net premium (discount) on short- and long-term
            investments ................................................            56           (219)
          Amortization of nonemployee stock
            option compensation ........................................            90           --
          Provision for losses on accounts receivable ..................           100           --
          Other adjustments ............................................             2             15
     Decrease (increase) in assets:
          Accounts receivable, net .....................................          (929)        (1,724)
          Interest receivable ..........................................            74           (223)
          Inventories ..................................................          (265)            35
          Other current assets .........................................           (21)            22
          Other assets .................................................          --               28
     Increase (decrease) in liabilities:
          Accounts payable .............................................          (277)           263
          Accrued liabilities ..........................................           585            255
          Other current liabilities ....................................           (99)          --
                                                                              --------       --------
               Net cash used in operating activities ...................        (9,522)        (8,498)
                                                                              --------       --------

Cash flows from investing activities:
     Purchase of short- and long-term investments ......................        (1,392)       (19,673)
     Proceeds from sale of short- and long-term
       investments .....................................................         7,212         14,976
     Purchase of furniture, fixtures and equipment .....................          (168)          (381)
                                                                              --------       --------
               Net cash provided by (used in) investing activities .....         5,652         (5,078)
                                                                              --------       --------
</TABLE>
<PAGE>
<TABLE>
<CAPTION>
                                             EXOGEN, INC.

                                 CONSOLIDATED STATEMENTS OF CASH FLOWS
                                            (in thousands)
                                             (continued)

                                                                                   Nine Months Ended
                                                                                       June 30,
                                                                                ---------------------
                                                                                  1997           1996
                                                                              --------       --------
                                                                                     (Unaudited)
<S>                                                                           <C>            <C>
Cash flows from financing activities:
     Proceeds from exercise of stock options ...........................             5             37
     Proceeds from sale of Common Stock ................................           125            104
     Principal payments under capital leases ...........................           (13)           (11)
                                                                              --------       --------
               Net cash provided by financing activities ...............           117            130
                                                                              --------       --------

Effect of exchange rate changes on cash and cash
  equivalents ..........................................................           (24)             3
                                                                              --------       --------

Net decrease in cash and cash equivalents ..............................        (3,777)       (13,443)
Cash and cash equivalents, beginning of period .........................         8,115         22,176
                                                                              --------       --------
Cash and cash equivalents, end of period ...............................      $  4,338       $  8,733
                                                                              ========       ========



       The accompanying notes are an integral part of these consolidated financial statements.
</TABLE>
<PAGE>
                                  EXOGEN, INC.

                   NOTES TO CONSOLIDATED FINANCIAL STATEMENTS


1.       BASIS OF PRESENTATION

         The accompanying  unaudited condensed consolidated financial statements
         reflect all adjustments  (including normal recurring  adjustments) that
         management considers necessary to present fairly the financial position
         of Exogen,  Inc.  ("the  Company") as of June 30, 1997;  the results of
         operations  for the three and nine months ended June 30, 1997 and 1996;
         and the cash  flows for the nine  months  then  ended.  The  results of
         operations  for the  respective  interim  periods  are not  necessarily
         indicative  of the  results  to be  expected  for the  full  year.  The
         unaudited condensed  consolidated  financial statements,  which include
         the  financial  position,  results  of  operations,  and cash flows for
         Exogen,  Inc. and its wholly owned  subsidiary,  Exogen  (Europe) GmbH,
         should be read in conjunction with the audited  consolidated  financial
         statements  for the year ended  September  30,  1996,  included  in the
         Company's Annual Report on Form 10-K.


2.       COMMITMENTS AND CONTINGENCIES

         The Company is subject to claims and litigation in the ordinary  course
         of business.  In management's  opinion, such claims are not material to
         the Company's  financial  position,  its results of operations,  or its
         cash flows.


3.       NET LOSS PER COMMON SHARE

         Net loss per share for the three and nine  months  ended June 30,  1997
         and 1996,  is  calculated  according  to  Accounting  Principles  Board
         Opinion No. 15,  "Earnings  per  Share,"  and is based on the  weighted
         average number of shares of Common Stock outstanding during the periods
         presented. Options have been excluded because they are antidilutive.

         In February  1997,  the  Financial  Accounting  Standards  Board issued
         Statement  of  Financial  Accounting  Standards  No. 128 ("SFAS  128"),
         "Earnings  Per  Share."  This  statement   establishes   standards  for
         computing  and  presenting  earnings per share  ("EPS"),  replacing the
         presentation of currently  required  primary EPS with a presentation of
         Basic EPS.  For  entities  with complex  capital  structures,  SFAS 128
         requires the dual presentation of both Basic EPS and Diluted EPS on the
         face of the statement of operations. Under this new standard, Basic EPS
         is computed based on weighted  average shares  outstanding and excludes
         any potential  dilution;  Diluted EPS reflects  potential dilution from
         the  exercise or  conversion  of  securities  into common stock or from
         other contracts to issue common stock,  and is similar to the currently
         required  fully  diluted  EPS.  SFAS  128 is  effective  for  financial
         statements issued for periods ending after December 15, 1997, including
         interim  periods,  and  earlier  application  is  not  permitted.  When
         adopted,  the Company will be required to restate its EPS for all prior
         periods  presented.  The  Company  does not  expect  the  impact of the
         adoption of SFAS 128 to be material to previously reported EPS.
<PAGE>
4.       NONRECURRING CHARGE

         The operating  loss for the three months and nine months ended June 30,
         1997, includes a nonrecurring charge of approximately $150,000, related
         to a workforce reduction in the quarter ended June 30, 1997.

5.       INVENTORIES

         Inventories consist of the following:
<TABLE>
<CAPTION>

                                                      June 30,     September 30,
                                                       1997            1996
                                                      ------          ------
                                                            (in thousands)
<S>                                                   <C>             <C>

Finished goods .........................              $1,069          $  768
Parts and components ...................                 396             471
                                                      ------          ------
                                                      $1,465          $1,239
                                                      ======          ======
</TABLE>

6.       SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION

<TABLE>
<CAPTION>
                                                     Nine Months Ended June 30,
                                                       1997            1996
                                                       ----            ----
                                                           (in thousands)
<S>                                                   <C>              <C>

         Interest paid...........................     $   10           $  6
</TABLE>
<PAGE>
                                  EXOGEN, INC.


                MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
                       CONDITION AND RESULTS OF OPERATIONS


The following is  management's  discussion of significant  factors that affected
the Company's interim financial condition and results of operations. This should
be read in conjunction  with  Management's  Discussion and Analysis of Financial
Condition and Results of Operations  included in the Company's  Annual Report on
Form 10-K for the fiscal year ended September 30, 1996.

This Report on Form 10-Q contains certain statements of a forward-looking nature
relating to future events or the future  financial  performance  of the Company.
Such  statements  are only  predictions,  and the actual  events or results  may
differ materially from the results discussed in the forward-looking  statements.
Factors  that  could  cause or  contribute  to such  differences  include  those
discussed  below under "Business  Considerations"  as well as those discussed in
other filings made by the Company with the Securities and Exchange Commission.

Results of Operations

Nine Months Ended June 30, 1997, and June 30, 1996

Through June 30, 1997,  essentially all of the Company's  product  revenues were
generated from sales of the Company's Sonic Accelerated  Fracture Healing System
("SAFHS")  Model 2A  device  and the  second-generation  SAFHS  2000(R).  (For a
further   discussion   of   the   second-generation   SAFHS,   see   "Additional
Information--SAFHS  2000(R)"  below.) For the nine months  ended June 30,  1997,
product  sales were $5.2 million  compared with $4.2 million for the nine months
ended June 30, 1996, an increase of $1.1 million (or 26%). International product
sales were 27% of total  product  sales for the nine months ended June 30, 1997,
compared with 8% for the nine months ended June 30, 1996.

For the nine  months  ended June 30,  1997,  the  Company  recorded  no revenues
related to development  agreements with Teijin Limited, a Japanese  corporation,
compared with $800,000 of such revenues  reported for the nine months ended June
30, 1996. These development agreements cover two of the Company's  technologies:
(1) the SAFHS device and (2) the mechanical-stress device under development. The
SAFHS  agreement  provides  for  milestone  payments to the Company for Teijin's
development of the product for launch in Japan. The Company will manufacture and
supply  SAFHS  devices to Teijin for  clinical  trials and  subsequent  sales in
Japan. Teijin is responsible for complying with regulatory  requirements and for
marketing  and  distributing  the SAFHS device in Japan.  The  mechanical-stress
agreement provides for milestone  payments to the Company that will support,  in
part, the Company's clinical trials in the United States in exchange for a first
option in favor of Teijin to negotiate a development and distribution  agreement
for this device for the Japanese market.

Cost of product  sales was $3.0 million for the nine months ended June 30, 1997,
compared  with $2.4 million for the nine months  ended June 30, 1996.  Excluding
revenues  related to  development  agreements,  gross profit for the nine months
ended June 30,  1997,  was $2.2  million  (or 41.8% as a  percentage  of product
sales), compared with $1.7 million (or 41.3%) for the nine months ended June 30,
1996. The $470,000  increase (or 27%) in gross profit was principally due to the
<PAGE>
increase in product volume and reduced per-unit product costs,  partially offset
by a  decrease  in the  average  realized  selling  price of a SAFHS,  which was
approximately  $2,005 for the nine months  ended June 30,  1997,  compared  with
approximately  $2,350 for the nine months ended June 30,  1996.  The decrease in
average  realized  selling  price  was  primarily  due  to an  increase  in  the
allowances  for  returns  and  for  amounts  that  might  not be  reimbursed  by
third-party payors.

Research  and  development  expenses  for the nine months  ended June 30,  1997,
decreased  to $2.5  million from $3.0 million for the nine months ended June 30,
1996.  The  decrease  of  $509,000  (or 17%) was  primarily  due to (1)  reduced
expenditures  for  designing  and  building  the  mechanical-stress  device  for
clinical  studies,  (2) the  discontinuation  of shipments  of SAFHS  devices in
connection  with  certain  clinical  prescriptions  for which  reimbursement  is
currently  not  available,  and (3) reduced  costs  associated  with analyses of
clinical data for the SAFHS therapy.  These  decreases were partially  offset by
increased expenses associated with additional research projects.

Selling, general, and administrative expenses for the nine months ended June 30,
1997, increased to $9.5 million from $7.7 million for the nine months ended June
30, 1996. The $1.7 million (or 23%) increase  resulted from (1) expanded selling
and marketing  efforts  related to the SAFHS Model 2A, both in the United States
and in Europe,  and the second- generation SAFHS 2000, in the United States, (2)
increased  activities relating to reimbursement  efforts, and (3) a nonrecurring
charge of  approximately  $150,000,  related  to a  workforce  reduction  in the
quarter ended June 30, 1997.

Net  interest  income for the nine  months  ended June 30,  1997,  decreased  to
$599,000  from $1.1 million for the nine months ended June 30, 1996,  consistent
with the level of funds available for investment.

The Company  incurred a net loss of $9.2  million,  or $0.93 per share,  for the
nine months ended June 30, 1997,  compared with a net loss of $7.2  million,  or
$0.73 per share,  for the nine months ended June 30, 1996.  The increase of $2.0
million (or 27%) in net loss was caused  principally  by the  factors  discussed
above.

Three Months Ended June 30, 1997, and June 30, 1996

For the three months ended June 30, 1997,  product  sales  remained  constant at
$1.8 million  compared  with  product  sales for the three months ended June 30,
1996.  International product sales were 22% of total product sales for the three
months  ended June 30, 1997,  compared  with 17% for the three months ended June
30, 1996.

The Company recorded no revenues  related to development  agreements with Teijin
Limited,  a Japanese  corporation,  for either the three  months  ended June 30,
1997, or the three months ended June 30, 1996.  (See the  nine-month  discussion
above for a description of the development agreements.)

Cost of product  sales was  $961,000  for the three  months ended June 30, 1997,
compared  with $1.1  million for the three  months  ended June 30,  1996.  Gross
profit for the three  months  ended June 30,  1997,  was $803,000 (or 45.5% as a
percentage  of product  sales),  compared with $745,000 (or 41.0%) for the three
months  ended June 30,  1996.  The $58,000  increase (or 8%) in gross profit was
principally due to the increase in product volume and reduced  per-unit  product
<PAGE>
costs, partially offset by a decrease in the average realized selling price of a
SAFHS, which was approximately  $1,970 for the three months ended June 30, 1997,
compared with approximately $2,285 for the three months ended June 30, 1996. The
decrease in average  realized  selling price was primarily due to an increase in
the  allowances  for  returns and for amounts  that might not be  reimbursed  by
third-party payors.

Research  and  development  expenses  for the three  months ended June 30, 1997,
decreased  to $806,000  from  $998,000 for the three months ended June 30, 1996.
The decrease of $192,000 (or 19%) was  primarily  due to (1) the  completion  of
expenditures  associated  with  several  studies,  (2)  the  discontinuation  of
shipments of SAFHS devices in connection with certain clinical prescriptions for
which reimbursement is currently not available, and (3) reduced expenditures for
designing and building the mechanical-stress device for clinical studies.

Selling,  general,  and administrative  expenses for the three months ended June
30, 1997, increased to $3.1 million from $2.9 million for the three months ended
June 30, 1996.  The $194,000 (or 7%) increase  resulted from (1) a  nonrecurring
charge of  approximately  $150,000,  related  to a  workforce  reduction  in the
quarter  ended  June  30,  1997,  and  (2)  increased   activities  relating  to
reimbursement efforts.

Net  interest  income for the three  months  ended June 30,  1997,  decreased to
$160,000 from $334,000 for the three months ended June 30, 1996, consistent with
the level of funds available for investment.

The Company  incurred a net loss of $2.9  million,  or $0.29 per share,  for the
three months ended June 30, 1997,  compared with a net loss of $2.8 million,  or
$0.28 per share,  for the three  months  ended June 30,  1996.  The  increase of
$107,000  (or 4%) in net loss was caused  principally  by the factors  discussed
above.

Liquidity and Capital Resources

Since  inception,   the  Company's  expenses  have  significantly  exceeded  its
revenues, resulting in an accumulated deficit of $32.4 million at June 30, 1997.
The Company has funded its operations primarily through the private placement of
equity  securities  (aggregating  $17.6 million) and a public offering of Common
Stock in mid-1995 (aggregating $28.5 million).

For the nine  months  ended June 30,  1997,  the  Company  used net cash of $9.5
million for operating activities, primarily to fund (1) selling and marketing of
the SAFHS Model 2A and, in the third quarter of fiscal 1997,  the SAFHS 2000 and
(2) an increase in the international  accounts  receivable days outstanding from
240 days at  September  30,  1996,  to 340 days at June 30,  1997.  The increase
reflects  a  protracted  reimbursement  process  at the  local  level due to the
absence of  nationwide  approval  of the SAFHS  technology  in  Germany.  (For a
further discussion of international  accounts receivable,  see below,  "Business
Considerations--Risks  Associated With International Operations.") The Company's
capital expenditures for the nine months ended June 30, 1997, were $168,000. The
Company   estimates   that  equipment  and   furnishings   to  expand   in-house
manufacturing and administrative  support activities will require essentially no
further  capital  expenditures  during  fiscal 1997 and  approximately  $400,000
during fiscal 1998.

To help conserve its capital resources, the Company reduced its workforce in the
quarter  ended June 30,  1997.  Through the  reduction,  the Company  expects to
realize approximately $750,000 of annual pretax savings;  approximately $221,000
will be saved in fiscal 1997.
<PAGE>
The Company plans to finance its capital needs principally from existing capital
resources,  which the Company believes will be sufficient to fund its operations
through  fiscal  1998,  at  which  time  additional  funding  may  be  required.
Additional  funding may not be available  when needed or on terms  acceptable to
the  Company,  which  would  have a  material  adverse  effect on the  Company's
business, financial condition, results of operations, and cash flows.

Additional Information

SAFHS 2000(R)

In December 1995, the Company filed with the U. S. Food and Drug  Administration
("FDA")  for  a  Pre-Market   Approval  ("PMA")  Supplement  for  the  Company's
second-generation  SAFHS,  SAFHS 2000(R).  In March 1997,  the Company  received
approval of this PMA Supplement, and in May 1997 the Company began marketing the
SAFHS 2000 in the United States.  The SAFHS 2000 is smaller and lighter than the
first-generation SAFHS Model 2A, and is entirely battery operated. Additionally,
the SAFHS 2000 is easier for the patient to use, is less costly to  manufacture,
and provides physicians with the capability to monitor patient compliance.

Business Considerations

Limited Operating History

The Company has a limited  history of operations  that,  to date,  has consisted
primarily of research and development,  product engineering,  obtaining approval
from the FDA for the Company's SAFHS device,  developing the Company's sales and
marketing  organization,  supervising  the  manufacture of the SAFHS device by a
contract manufacturer, developing in-house manufacturing capability, and selling
its SAFHS device  domestically and  internationally.  The Company was formed for
the purpose of acquiring the SAFHS technology and related clinical data, as well
as the  mechanical-stress  technology.  The Company has limited direct  clinical
trial  experience.  The Company received approval of its PMA Application for the
SAFHS  Model 2A device and began  marketing  it in  October  1994,  and  further
received approval of the SAFHS 2000 device and began marketing the SAFHS 2000 in
May 1997,  and  therefore  has limited  experience  in marketing and selling its
products  in  commercial   quantities.   The  Company  had  no  previous  direct
manufacturing  experience prior to commencing in-house refurbishing of its SAFHS
device  in  fiscal  1996.  Whether  the  Company  can  successfully  manage  the
transition to a larger-scale  commercial  enterprise will depend,  in part, upon
further  developing  its  distribution  network;   successfully  developing  its
manufacturing  capability;   and  strengthening  its  financial  and  management
systems,   procedures,   and  controls.   Failure  to  make  such  a  transition
successfully  would have a material  adverse  effect on the Company's  business,
financial condition, results of operations, and cash flows.

Uncertainty of Market Potential and Market Acceptance

The  Company's  SAFHS  device  has been  approved  by the FDA to  treat  closed,
cast-immobilized, fresh fractures of the tibia and distal radius within approved
indications.  The market  potential of the Company's SAFHS device depends on the
acceptance  by the medical  community of the use of  ultrasound  technology as a
safe  and  effective  method  of  treating  fresh  fractures  and the use of the
Company's SAFHS device by physicians for treatment of these fractures. The SAFHS
device is based upon new technology  that had not been used  previously to treat
bone fractures.  In addition, the proper placement of the device at the fracture
site is important for the proper delivery of the therapy,  and acceptance of the
<PAGE>
therapy  will depend,  in part,  on whether the Company can continue to instruct
physicians  and  patients  in the  proper  use of the  device.  There  can be no
assurance that  physicians will prescribe  treatment using the SAFHS device.  In
addition,  use of the SAFHS device depends significantly on the availability and
extent of third-party reimbursement, increased awareness of the effectiveness of
the SAFHS  technology,  and focused  sales  efforts by the  Company.  Electrical
stimulation devices, the only other non-invasive devices commercially  available
for  the  treatment  of bone  fractures,  have  gained  only  limited  physician
acceptance  to date.  Failure of the  Company's  SAFHS device to achieve  market
acceptance  would  have a material  adverse  effect on the  Company's  business,
financial condition, results of operations, and cash flows.

Dependence on Third-Party Reimbursement

The Company has not secured general reimbursement  approval for its SAFHS device
from  any  large  third-party  payor,  and to date  has  received  reimbursement
approval from third-party payors only on a case-by-case basis.  Successful sales
of SAFHS devices in the United States,  Germany, and other markets depend on the
availability of adequate  reimbursement  from third-party payors such as managed
care organizations, workers' compensation insurers, private insurance plans, and
government entities.  There is significant  uncertainty  concerning  third-party
reimbursement  for the use of any medical device  incorporating  new technology,
such as the SAFHS device.  Reimbursement by a third-party  payor may depend on a
number of factors, including the payor's determination that the use of the SAFHS
device is safe and effective,  not  experimental or  investigational,  medically
necessary,  appropriate  for  the  specific  patient,  and  cost-effective.   In
addition,  devices  incorporating  a new  technology  are  often  prescribed  by
physicians for  indications  other than those  approved by the FDA  (off-label).
Reimbursement  for such  off-label  uses may not be  available  or  permitted by
government regulations. Since reimbursement approval is required from each payor
individually, seeking such approvals is a time-consuming and costly process that
requires the Company to provide  scientific and clinical  support for the use of
the SAFHS  device to each  payor  separately.  There  can be no  assurance  that
third-party reimbursement will be consistently available for the SAFHS device or
any  of the  Company's  other  products  that  may be  developed  or  that  such
third-party  reimbursement  will be  adequate.  The United  States  Congress  is
currently  considering  various  proposals to significantly  reduce Medicare and
Medicaid expenditures. Such proposals, if enacted, could have a material adverse
effect on the Company's business,  financial  condition,  results of operations,
and cash flows.  Currently,  the SAFHS device is not covered  under the Medicare
program. In addition, third-party payors are increasingly limiting reimbursement
coverage for medical devices, and in many instances have put pressure on medical
suppliers to lower their prices. The Company currently has limited experience in
obtaining  reimbursement  for its  products in  countries  other than the United
States.   Lack  of  or  inadequate   reimbursement  by  governmental  and  other
third-party  payors for the  Company's  products  would have a material  adverse
effect on the Company's business,  financial  condition,  results of operations,
and cash flows.

History of Losses; Profitability Uncertain; Fluctuations in Operating Results

The Company has incurred  substantial losses since inception and, as of June 30,
1997, has an accumulated  deficit of  approximately  $32.4 million.  Such losses
have resulted  principally from expenses  associated with obtaining FDA approval
for the  Company's  SAFHS  device,  engineering  and  developing  the  SAFHS and
mechanical-stress   devices,  and  establishing  and  expanding  the  sales  and
marketing  organization in the United States and in Europe.  The Company expects
<PAGE>
to generate substantial  additional losses in the future primarily  attributable
to  development  of, and  clinical  trials for,  the  mechanical-stress  device,
clinical trials for expanded indications of the SAFHS technology,  the continued
expansion of domestic and international sales and marketing activities,  and the
expansion  of  in-house  manufacturing  capability.  Results of  operations  may
fluctuate  significantly from quarter to quarter based on such factors, and will
also depend upon reimbursement by third-party payors, new product  introductions
by the Company or its competitors,  timing of regulatory  actions,  expenditures
incurred in the research and development of new products, and the mix of product
sales between the United States and abroad.  The Company's  future  revenues and
profitability are critically dependent on whether it can successfully market and
sell its SAFHS device.  There can be no assurance that  significant  revenues or
profitability will ever be achieved.

Dependence on Principal Product

Essentially all of the Company's product revenues to date have been derived from
sales of its SAFHS  device.  The SAFHS device is expected to continue to account
for substantially all of the Company's revenues for the foreseeable  future. The
Company's   long-term   success   will   depend   in  part  on  the   successful
commercialization  of  the  SAFHS  device  for  its  approved  indications,  the
development  and  regulatory  approval  of SAFHS  devices  to  treat  additional
indications,  and the acceptance of the SAFHS treatment by the medical community
and third-party  payors.  Failure to gain market acceptance for the SAFHS device
or to obtain adequate reimbursement coverage,  among other factors, would have a
material adverse effect on the Company's business,  financial condition, results
of operations, and cash flows.

Limited Sales and Marketing Experience

The Company  began  marketing  the SAFHS device in the United  States in October
1994. Because of limited market awareness of SAFHS therapy,  the sales effort is
a lengthy process,  requiring the Company to educate  physicians and third-party
payors  regarding  the  clinical  benefits and  cost-effectiveness  of the SAFHS
technology,  to assist  patients in the  reimbursement  process,  and to provide
product  support to  patients.  The Company uses a  combination  of direct sales
representatives and a network of independent sales representatives to market and
distribute its products.  Independent  sales  representatives  typically  market
orthopaedic   and  other   devices  for  a  variety  of   manufacturers.   These
representatives  do not have prior  experience  in the sale or use of devices to
accelerate  fresh-fracture  healing.  There  can  be  no  assurance  that  these
independent sales  representatives will commit the necessary resources to market
the SAFHS  device  effectively  or that the  Company's  direct  sales staff will
succeed  in its  efforts to  promote  the SAFHS  technology  to  physicians  and
third-party payors.

The  Company  markets the SAFHS  device in several  European  countries  through
independent  distributors  and sales agents,  and has recorded sales in Germany,
Austria, the Netherlands, Denmark, Switzerland, Belgium, and Israel. The Company
also will collaborate with marketing  partners in the Pacific Rim to assist with
regulatory requirements and to market and distribute the Company's products. The
Company has entered into one such agreement  covering Japan with Teijin Limited,
a Japanese corporation.  Each of the foreign markets in which the Company sells,
or  plans  to  sell,  its  products  has its  own  regulatory  requirements  and
approvals,  and the distribution,  price, and market structure to be established
by the Company  might vary from country to country.  No  assurance  can be given
that the Company can  successfully  market the SAFHS device in Europe or that it
can secure additional  marketing partners in the Pacific Rim on terms acceptable
to the Company, or at all.
<PAGE>
The Company's  marketing  success in the United States and abroad will depend on
whether it can gain further regulatory approvals,  successfully  demonstrate the
cost-effectiveness  of its products,  further develop direct sales capability to
augment its existing  distribution  network,  and  establish  arrangements  with
distributors  and  marketing  partners.  Failure by the Company to  successfully
market  its  products  domestically  and  internationally  would have a material
adverse  effect on the  Company's  business,  financial  condition,  results  of
operations, and cash flows.

Risks Associated with International Operations

The Company  established a subsidiary  in Germany  during fiscal 1995 as part of
its strategy to introduce the SAFHS device in Europe,  and commenced  commercial
distribution  of the device in certain  European  countries  during fiscal 1996.
International  product sales,  which were  principally  in Germany,  were 14% of
total  product  sales in fiscal 1996 and 27% for the nine months  ended June 30,
1997,  and such  revenues are  expected to continue to  represent a  significant
percentage of total revenues.  The Company believes that its  profitability  and
continued growth will require  expansion of sales in foreign markets,  and so it
intends to continue to expand its operations outside the United States and enter
additional  international  markets,  which will require  significant  management
attention and financial  resources.  There can be no assurance  that the Company
will be able to achieve  market  acceptance  of its  products  in  international
markets or maintain or increase international market demand for its products.

As of June 30, 1997, the balance in international  accounts  receivable,  net of
allowances for returns and bad debt, was $1.8 million,  with a days  outstanding
of approximately  340 days. The international  accounts  receivable is primarily
derived  from sales in Germany,  where the Company has  received  limited  local
reimbursement  on a case-by-case  basis. To assist the collection of outstanding
claims and to expedite the reimbursement  process on future claims,  the Company
is  seeking  nationwide  approval  by  the  National  Krankenkasse,  the  German
governing   organization  that  establishes  medical  reimbursement  policy  for
health-care  providers.  To  this  end,  the  Company  has  submitted  a  formal
application to the National  Krankenkasse.  The application  process  includes a
scientific assessment and a reimbursement  assessment;  the Company is currently
in the  scientific-assessment  phase. There can be no assurance that the Company
will obtain a  favorable  ruling on its  request  for  nationwide  approval on a
timely basis, if at all. Lack of approval by the National  Krankenkasse  for the
Company's  products  could  have a  material  adverse  effect  on the  Company's
business, financial condition, results of operations, and cash flows.

The Company's international product sales are denominated in foreign currencies.
Management  can give no assurances  that changes in currency and exchange  rates
will not  materially  affect the  Company's  revenues,  costs,  cash flows,  and
business  practices  and  plans.  Additional  risks  inherent  in the  Company's
international  business  activities  generally  include  unexpected  changes  in
regulatory  requirements,  tariffs and other trade barriers,  extended  accounts
receivable  payment  cycles,   reimbursement   approvals  (both  government  and
private), difficulties in managing international operations, potentially adverse
tax consequences,  restrictions on repatriation of earnings,  and the burdens of
complying with a wide variety of foreign laws.  There can be no assurances  that
such factors will not have a material  adverse  effect on the  Company's  future
international revenues and, consequently,  on the Company's business,  financial
condition, results of operations, and cash flows.
<PAGE>
Manufacturing and Related Risks

The Company has developed in-house  refurbishing  capability for the SAFHS Model
2A device,  and has also  developed  in-house  manufacturing  capability for the
SAFHS 2000 device.  In addition,  the Company  uses a contract  manufacturer  to
manufacture a portion of the Company's SAFHS 2000 production. Both the Company's
and the contract manufacturer's respective facilities have been inspected by the
FDA, and have been approved for the production of the SAFHS 2000 under the FDA's
Good  Manufacturing  Practices ("GMP")  requirements.  Any failure by either the
Company or the  contract  manufacturer  to maintain its  respective  facility in
accordance  with GMP  requirements  could result in the inability to manufacture
the SAFHS device on a commercial scale, and could limit the Company's ability to
deliver the SAFHS device to physicians or patients,  which would have a material
adverse  effect on the  Company's  business,  financial  condition,  results  of
operations, and cash flows.

The Company's arrangement with the contract manufacturer requires the Company to
purchase a minimum  number of SAFHS devices from the contract  manufacturer  for
the term of the  agreement,  effective  to 1998.  Although  the  Company and the
contract  manufacturer are discussing  amending these terms related to the SAFHS
2000,  there  can be no  assurance  that  agreement  on such  amendment  will be
reached.

Several  components  incorporated  in the SAFHS device  currently  are, and will
continue to be,  manufactured  by single- source  vendors.  For certain of these
components,  there  are  relatively  few  alternative  sources  of  supply,  and
establishing  additional or replacement  suppliers for such components cannot be
accomplished  quickly. Any supply interruption from single-source  vendors would
have a material adverse effect on the Company's business,  financial  condition,
results of operations, and cash flows.

Intense Competition and Risks Associated with Rapid Technological Change

The medical device industry is characterized by intense competition. Many of the
Company's  existing  and  potential   competitors  have  substantially   greater
financial,  marketing,  sales,  distribution,  and technical  resources than the
Company  and more  experience  in research  and  development,  clinical  trials,
regulatory matters,  manufacturing,  and marketing.  In addition,  most of these
companies  have  established  third-party   reimbursement  for  their  products.
Furthermore,  the medical  device  industry is  characterized  by rapid  product
development and technological  change.  The Company's products could be rendered
obsolete  or  uneconomical  by  technological  advances  by one or  more  of the
Company's  competitors or by other  therapies such as drugs to treat  conditions
addressed  by  the  Company's  products.   The  Company's  business,   financial
condition,  results of  operations,  and cash flows will depend upon whether the
Company can compete  effectively  with other  developers of such medical devices
and therapies.

The SAFHS device competes with non-invasive  bone-growth  electrical-stimulation
devices and with various surgical  treatments.  The Company's  mechanical-stress
device to prevent bone loss related to osteoporosis,  if developed and marketed,
will  compete  with  drug  therapies  and  exercise  regimens.  There  can be no
assurance  that such  device  will ever be  developed,  approved  by the FDA, or
become  commercially  available.  Four companies  currently  market  electrical-
stimulation  devices for the treatment of non-union  fractures  (fractures  that
remain  unhealed after nine months).  The Company  believes that at least one of
<PAGE>
these  companies  is  conducting  clinical  trials  for  the  use of  electrical
stimulation for the treatment of fresh fractures.  In addition,  other companies
are  developing  a  variety  of  products  and  technologies  to be  used in the
treatment of fractures and  osteoporosis,  including growth factors,  bone-graft
substitutes,  and exercise/physical therapy equipment. There can be no assurance
that  competitors  will not develop  products that are superior to the Company's
products,  achieve greater market acceptance, or render the Company's technology
and products obsolete or noncompetitive.  As a result,  the Company's  long-term
viability may depend on whether it can continue to develop new  products.  There
can be no  assurance  that  the  Company  will be able to  compete  successfully
against  current  or  future  competitors  or that  competition  will not have a
material adverse effect on the Company's business,  financial condition, results
of operations, or cash flows.

Extensive Government Regulation

The manufacture and sale of medical devices are subject to extensive  government
regulation in the United States and in other countries. The process of obtaining
FDA and other required  regulatory  approvals can be time-consuming,  expensive,
and  uncertain,  frequently  requiring  several years from  commencing  clinical
trials to receiving regulatory approval.  For example, the process of conducting
clinical  trials and  obtaining  the PMA for the SAFHS Model 2A took nine years.
The Company is required to file PMA supplements for new or expanded  indications
for its SAFHS  technology.  In addition,  modifications to its SAFHS devices may
require PMA  supplements.  If a  supplement  were not  accepted by the FDA,  the
Company  would be required to  undertake  and complete the entire PMA process in
order to use future  SAFHS  devices to treat  those  additional  indications  or
commercialize a modified device. There can be no assurance that the Company will
obtain any such  approvals  on a timely  basis,  or at all,  which  could have a
material adverse effect on the Company's business,  financial condition, results
of operations, and cash flows.

The Company filed a PMA Supplement for its second-generation  SAFHS, SAFHS 2000,
in December 1995, and in March 1997, the FDA approved this PMA Supplement, which
allows the  Company to  commercially  distribute  the SAFHS  2000.  The  Company
recently filed a PMA Supplement  seeking approval of an expanded  indication for
the SAFHS  2000,  but  withdrew  that  application  in July  1997 to revise  and
resubmit it for both  expanded  and new  applications.  The  Company  expects to
refile this  Supplement  during the fourth  quarter of fiscal 1997.  The Company
will  also be  required  to  file a PMA  application  for its  mechanical-stress
device,  if and when  development  is completed.  No assurance can be given that
such  application  will be made,  and if made,  that a PMA or a supplement to an
existing  PMA will be granted  on a timely  basis,  or at all.  In order for the
Company  to  market  the  SAFHS  device  or  any  future   products  in  foreign
jurisdictions,  it will  be  required  to seek  regulatory  approvals  in  those
jurisdictions.  No assurance  can be given that the Company can obtain  required
regulatory approvals in foreign countries on a timely basis, or at all.

Regulatory  approvals,  if granted,  may include significant  limitations on the
indicated  uses for which a product  may be  marketed.  FDA  enforcement  policy
strictly  prohibits the promotion by the Company and any of its  distributors of
approved  medical devices for off-label uses. There can be no assurance that the
Company  will not  become  subject  to FDA  actions  as a result of  physicians'
prescribing the SAFHS device for off-label uses. In addition,  product approvals
may be  withdrawn  for  failure  to  comply  with  regulatory  standards  or the
occurrence of unforeseen  problems following initial  marketing.  The Company is
required to adhere to FDA regulations setting forth GMP requirements relating to
<PAGE>
tests,  control,  and  documentation.  Ongoing  compliance  with  GMP and  other
applicable regulatory  requirements is monitored through periodic inspections by
state and federal  agencies,  including the FDA, and by  comparable  agencies in
other   countries.   Failure  to  comply  with  applicable   United  States  and
international  regulatory  requirements  can result in  failure of the  relevant
government  agency to grant  pre-market  approval  for  devices,  withdrawal  of
approval, total or partial suspension of production,  fines, injunctions,  civil
penalties, recall or seizure of products, and criminal prosecution. Furthermore,
changes in existing regulations or adoption of new regulations or policies could
prevent the Company from obtaining,  or affect the timing of, future  regulatory
approvals or clearances.

During 1996, the Company received  regulatory  approval of the SAFHS Model 2A in
Germany.  Under German law, medical devices must have a "GS" mark affixed to the
product  labeling.  The GS mark,  which the Company  received in December  1995,
denotes that the product meets certain  safety  standards.  In 1996, the Company
also received the "CE" (Medical  Device  Directive) mark for the SAFHS Model 2A.
The CE mark is  recognized by countries  that are members of the European  Union
and the  European  Free Trade  Association,  and  effective  June 1998,  will be
required to be affixed to all medical devices sold in the European Union.

There can be no  assurance  that the  Company  will be able to obtain  necessary
regulatory  approvals or clearances in the United  States,  Europe,  the Pacific
Rim, or elsewhere on a timely basis,  or at all. Delays in receipt of or failure
to  receive  such  approvals  or  clearances,  the loss of  previously  received
approvals or clearances, or failure to comply with existing or future regulatory
requirements  would have a material  adverse  effect on the Company's  business,
financial condition, results of operations, and cash flows.

Limited Protection of Patents, Copyrights and Proprietary Rights; Risk of Patent
Infringement

The Company relies on a combination of patents, trade secrets,  copyrights,  and
confidentiality  agreements to protect its proprietary  technology,  rights, and
know-how.  No assurance can be given that the Company's patent applications will
issue as patents or that any issued  patents  owned by the Company  will provide
competitive  advantages for the Company's  products or will not be  successfully
challenged  or   circumvented   by   competitors.   Under  current  law,  patent
applications  in the United  States are  maintained in secrecy until patents are
issued,  and patent  applications in foreign countries are maintained in secrecy
for a period after filing.  The right to a device patent in the United States is
attributable  to the first to invent the device,  not the first to file a patent
application.  Accordingly,  the  Company  cannot  be sure that its  products  or
technologies do not infringe  patents that may be granted in the future pursuant
to pending patent  applications or that its products do not infringe any patents
or proprietary rights of third parties. In the event that any relevant claims of
third-party  patents are upheld as valid and  enforceable,  the Company could be
prevented from selling its products or could be required to obtain licenses from
the owners of such  patents or be  required to  redesign  its  products to avoid
infringement.  There can be no assurance  that such licenses  would be available
or, if  available,  would be on terms  acceptable  to the  Company,  or that the
Company would be successful in any attempt to redesign its products or processes
to avoid  infringement.  The  Company's  failure to obtain these  licenses or to
redesign  its products  would have a material  adverse  effect on the  Company's
business,  financial  condition,  results of  operations,  and cash  flows.  The
Company also relies on trade  secrets and  proprietary  information,  and enters
into confidentiality agreements with its employees,  consultants,  and advisors.
There can be no assurance that the  obligations to maintain the  confidentiality
<PAGE>
of such trade  secrets and  proprietary  information  will  effectively  prevent
disclosure  of the  Company's  confidential  information  or provide  meaningful
protection for the Company's  confidential  information if there is unauthorized
use  or  disclosure,   or  that  the  Company's  trade  secrets  or  proprietary
information  will not be independently  developed by the Company's  competitors.
The Company also holds rights to copyrights on text and on software developed by
or for itself for use in its SAFHS  device.  There can be no assurance  that any
copyrights  owned by the Company will  provide  competitive  advantages  for the
Company's products or will not be challenged or circumvented by its competitors.
Litigation may be necessary to defend against claims of infringement, to enforce
patents and  copyrights  issued or licensed to the Company,  or to protect trade
secrets,  and could result in  substantial  cost to, and diversion of effort by,
the Company.  There can be no assurance  that the Company  would  prevail in any
such litigation.

Uncertainty of New Product Development

The Company plans to seek FDA approval to commence  clinical  trials in the near
future to expand the approved  indications  for the SAFHS  technology to include
other fractures,  spine fusion,  and cartilage repair. In addition,  the Company
has  developed  a  mechanical-stress  device to  prevent  bone loss  related  to
osteoporosis.  The Company has  commenced a pilot  clinical  trial in the United
States,  and  anticipates  that it  will be  required  to  undertake  additional
development  activities  and human  clinical  trials before  seeking  regulatory
approval for this device.  There can be no assurance that the  mechanical-stress
device will prove to be safe and efficacious, that product development will ever
be  successfully  completed,  that a PMA, if applied for, will be granted by the
FDA  on a  timely  basis,  or  at  all,  that  adequate  levels  of  third-party
reimbursement will be available, or that the mechanical-stress  device will ever
achieve  commercial  acceptance.  The  Company's  inability to show  efficacy in
additional  applications of its SAFHS  technology,  to successfully  develop the
mechanical-stress   device,   or  to  achieve  market  acceptance  of  such  new
applications  and products would have a material adverse effect on the Company's
business, financial condition, results of operations, and cash flows.

Royalty Payment Obligations; Potential Loss of Exclusive License

The Company is required to pay a royalty on any net  revenues  from sales of the
mechanical-stress device, if such device is successfully developed. In the event
that the Company does not  commercially  exploit the  underlying  technology  as
required by the license agreement for such technology,  the Company will forfeit
its exclusive  license to the  mechanical-  stress  technology.  There can be no
assurance that the Company will commercially  exploit such technology within the
meaning of such license,  and forfeiture of such exclusive  license could have a
material adverse effect on the Company's business,  financial condition, results
of operations, and cash flows.

Product Liability and Insurance

The Company  faces an inherent  business  risk of exposure to product  liability
claims in the event that the use of its products is alleged to have  resulted in
adverse effects. There can be no assurance that liability claims will not exceed
the coverage limits of the Company's  insurance  policies or that such insurance
will  continue to be  available on  commercially  reasonable  terms,  or at all.
Consequently,  product  liability claims could have a material adverse effect on
the Company's business,  financial  condition,  results of operations,  and cash
flows.
<PAGE>
Reliance on Key Personnel

The  Company's  success  depends to a  significant  extent  upon a number of key
management and technical personnel.  The loss of the services of one or more key
employees  could  have a  material  adverse  effect on the  Company's  business,
financial  condition,  results of operations,  and cash flows.  The Company also
believes  that its future  success  will  depend in large part on whether it can
attract and retain highly skilled  technical,  management,  sales and marketing,
and  reimbursement  personnel.  Competition  for such personnel is intense,  and
there can be no assurance  that the Company will be successful in attracting and
retaining such  personnel.  The Company's  failure to attract,  hire, and retain
these personnel would have a material adverse effect on the Company's  business,
financial condition, results of operations, and cash flows.

Possible Volatility of Stock Price

The trading price of the Company's  Common Stock could be subject to significant
fluctuations  in  response  to  variations  in  quarterly   operating   results,
announcements of technological innovations or new products by the Company or its
competitors, changes in earning estimates by analysts, general conditions in the
medical device  industry,  and other events or factors.  In addition,  the stock
market in general has  experienced  extreme price and volume  fluctuations  that
have  affected the market  price for many  companies  in  industries  similar or
related to that of the Company  and that have been  unrelated  to the  operating
performance of these companies.  These market  fluctuations may adversely affect
the market price of the Company's Common Stock.

Certain Anti-Takeover Provisions

The Company's Second Amended and Restated  Certificate of  Incorporation  grants
the  Board  of  Directors  the  authority  to issue up to  3,000,000  shares  of
preferred  stock of the  Company,  $0.0001  par value per share (the  "Preferred
Stock"), in one or more series and to fix the rights,  preferences,  privileges,
and restrictions thereof,  including dividend rights, dividend rates, conversion
rights,  voting rights,  terms of  redemption,  redemption  prices,  liquidation
preferences, and the number of shares constituting any series or the designation
of such series,  without further vote or action by the  stockholders.  Effective
December  6, 1996,  pursuant to the Rights  Agreement,  the  Company's  Board of
Directors  declared  a  dividend  of  one  Right  to  purchase,   under  certain
circumstances, one one-hundredth share of the Company's Series A Preferred Stock
for each outstanding share of Common Stock of the Company.  Although the Company
has no present plans to issue any additional  shares of Preferred  Stock, it may
do so in the future. See Part II, Item 5, "Market for Registrant's Common Equity
and Related Stockholder  Matters--The Stockholder Rights Plan," of the Company's
Form  10-K for the year  ended  September  30,  1996 and the copy of the  Rights
Agreement  attached  as  Exhibit  99.1 to that  Form  10-K for more  information
relating to the Stockholder Rights Plan.
<PAGE>
The Company's Bylaws specify procedures for director nominations by stockholders
and the submission of other proposals for consideration at stockholder meetings.
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  (including  pursuant to the Rights  Plan),  the  procedures
required for director  nominations and stockholder  proposals,  and 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,
making more difficult the  acquisition  of a substantial  block of the Company's
Common Stock,  or limiting the price that  investors  might be willing to pay in
the future for shares of the Company's Common Stock.
<PAGE>
                                     PART II
                                OTHER INFORMATION



ITEM 1.           Legal Proceedings

                  On  April  4,  1995,   a  former   consultant   to   Interpore
                  Orthopaedics,  Inc.  ("Interpore"),  the  company  from  which
                  Exogen  purchased  certain SAFHS  ultrasound  assets,  filed a
                  complaint  against  Interpore  and Exogen in the United States
                  District Court for the Southern District of New York, claiming
                  the right,  pursuant  to the terms of a  consulting  agreement
                  between  such  consultant  and  the  predecessor   company  to
                  Interpore,  to certain  royalties,  not exceeding 1.25% of the
                  net revenues generated from the sale of SAFHS devices. On June
                  5, 1995, Exogen answered the complaint, denied that it has any
                  liability to the consultant, and asserted a number of specific
                  defenses.  On the same day,  Interpore did the same,  and also
                  asserted  cross-claims  against  Exogen,   claiming  that  any
                  royalties found to be due to the consultant  should be paid by
                  Exogen  and that  Exogen  should  be  liable  for  Interpore's
                  attorneys' fees and other costs incurred in the litigation. On
                  July 7, 1995, Exogen answered Interpore's cross-claims, denied
                  that it has any  liability to the  consultant or to Interpore,
                  asserted a number of specific defenses to Interpore's  claims,
                  and asserted cross-claims against Interpore that any royalties
                  found to be due to the consultant  should be paid by Interpore
                  and that Interpore be liable for Exogen's  attorneys' fees and
                  other costs incurred in the  litigation.  Exogen and Interpore
                  since have agreed that (1)  Exogen's  counsel  will assume the
                  status of lead  defense  counsel  in the  litigation;  (2) any
                  adverse  judgment  entered in the  litigation  will be entered
                  against Exogen and Interpore  jointly and  severally;  and (3)
                  Exogen will  indemnify  Interpore  for any  payments  that are
                  required  to be  made to the  consultant  as a  result  of the
                  litigation,  and Exogen and Interpore  thereafter will resolve
                  separately  their respective  liabilities.  As a result of the
                  foregoing,  in March 1996 Exogen and Interpore dismissed their
                  claims  against  each  other  in  this   litigation,   without
                  prejudice to their right to resolve  them,  if  necessary,  as
                  described  above.  The  Company  does  not  believe  that  the
                  consultant's  claims have merit,  and together with Interpore,
                  is vigorously defending this action. All parties are currently
                  engaged in the discovery  process.  There can be no assurance,
                  however, that the consultant's claims will not be upheld.

                  In early March 1997, the Company  received a demand from Pilla
                  Consulting,  Inc. and Arthur A. Pilla (collectively,  "Pilla")
                  for royalties allegedly due pursuant to a consulting agreement
                  between  Pilla  Consulting  and  the  predecessor  company  to
                  Interpore.  Pilla claims  entitlement to royalties of 1.25% of
                  the net revenues generated from the sale of SAFHS devices. The
                  Company does not believe that Pilla's claim has any merit. For
                  that reason,  on April 2, 1997,  the Company filed a complaint
<PAGE>
                  against  Pilla in the Supreme  Court for the State of New York
                  seeking a judicial  declaration that the Company is not liable
                  to Pilla for any  royalties.  Pilla  asserted  a  counterclaim
                  against  the  Company,  seeking  to be  awarded  the  demanded
                  royalties,  that the Company asked the Court to dismiss on the
                  grounds  that Pilla  failed to state a claim  against  Exogen.
                  Pilla  subsequently  asked the Court for permission to replead
                  the  counterclaim,  and Exogen has opposed  this motion on the
                  grounds  that the  amended  claim  also fails to state a claim
                  against Exogen. These motions are pending. The Company intends
                  to  aggressively  pursue  the  action  against  Pilla  and  to
                  vigorously defend against any counterclaim(s) by Pilla seeking
                  said royalties or equivalent  payments under any legal theory.
                  There can be no  assurance,  however,  that Pilla's claim will
                  not be upheld.


ITEM 2.           Changes in Securities

                  None.


ITEM 3.           Defaults Upon Senior Securities

                  None.


ITEM 4.           Submission of Matters to a Vote of Security Holders


                  None.


ITEM 5.           Other Information

                  None.

<PAGE>

ITEM 6.           Exhibits and Reports on Form 8-K

                  (a)      Exhibits

                              3.1     Second Amended and Restated Certificate of
                                      Incorporation of the Company. Incorporated
                                      by   reference   to  Exhibit  3.1  to  the
                                      Company's  Form 10-Q for the third quarter
                                      ended June 30, 1995.
                              3.2     Amended   and   Restated   Bylaws  of  the
                                      Company.   Incorporated  by  reference  to
                                      Exhibit  3.3 to  the  Company's  Form  S-1
                                      Registration  Statement  (Registration No.
                                      33-92740).
                              4.1     See Exhibits 3.1 and 3.2 for provisions of
                                      the  Certificate  of   Incorporation   and
                                      Bylaws of the Company  defining  rights of
                                      holders of Common Stock of the Company.
                              10.1    Amended  and  Restated  Investors'  Rights
                                      Agreement  dated as of  November  14, 1994
                                      among the Company, the investors listed on
                                      Schedule  A thereto,  and the  individuals
                                      listed on Schedule B thereto. Incorporated
                                      by   reference  to  Exhibit  10.1  to  the
                                      Company's Form S-1 Registration  Statement
                                      (Registration No. 33-92740).
                              10.2    Asset Purchase Agreement dated as of March
                                      1, 1993 among  Applied  Epigenetics,  Inc.
                                      ("AEI"),  Interpore  International,  Inc.,
                                      and    Interpore    Orthopaedics,     Inc.
                                      Incorporated  by reference to Exhibit 10.2
                                      to the  Company's  Form  S-1  Registration
                                      Statement   (Registration  No.  33-92740).
                              10.3    [RESERVED]
                              10.4    Employment  Agreement  dated  February  3,
                                      1994  between  the Company and John Bohan.
                                      Incorporated  by reference to Exhibit 10.4
                                      to the  Company's  Form  S-1  Registration
                                      Statement (Registration No. 33-92740).
                              10.5    Form of Consulting  Agreements between the
                                      Company and each of Drs. McLeod and Rubin,
                                      as amended.  Incorporated  by reference to
                                      Exhibit  10.5 to the  Company's  Form  S-1
                                      Registration  Statement  (Registration No.
                                      33-92740).
                              10.6    Form  of   Stock   Restriction   Agreement
                                      between  the  Company  and  each  of  Drs.
                                      McLeod  and  Rubin  and  Messrs.  Reisner,
                                      Ryaby,   Talish,   McBrayer,   and  Bohan.
                                      Incorporated  by reference to Exhibit 10.6
                                      to the  Company's  Form  S-1  Registration
                                      Statement (Registration No. 33-92740).
                              10.7    Form of Stock Purchase  Agreement  between
                                      the Company  and each of Messrs.  Reisner,
                                      Ryaby,   and   Talish.   Incorporated   by
                                      reference to Exhibit 10.7 to the Company's
                                      Form    S-1     Registration     Statement
                                      (Registration No. 33-92740).
<PAGE>
                              10.8+   Manufacturing  Agreement dated January 20,
                                      1994  between  the Company and Hi- Tronics
                                      Designs, Inc. Incorporated by reference to
                                      Exhibit  10.8 to the  Company's  Form  S-1
                                      Registration  Statement  (Registration No.
                                      33-92740).
                              10.9    Form  of 1993  Stock  Option  Plan  Option
                                      Agreement.  Incorporated  by  reference to
                                      Exhibit  10.9 to the  Company's  Form  S-1
                                      Registration  Statement  (Registration No.
                                      33-92740).
                              10.10   1995 Stock Option / Stock  Issuance  Plan.
                                      Incorporated by reference to Exhibit 10.10
                                      to the  Company's  Form  S-1  Registration
                                      Statement (Registration No. 33- 92740).
                              10.11   Employee Stock Purchase Plan. Incorporated
                                      by  reference  to  Exhibit  10.12  to  the
                                      Company's Form S-1 Registration  Statement
                                      (Registration No. 33-92740).
                              10.12   Lease Agreement dated December 13, 1994 by
                                      and   between   the  Company  and  Siemens
                                      Medical  Systems,   Inc.  Incorporated  by
                                      reference   to   Exhibit   10.13   to  the
                                      Company's Form S-1 Registration  Statement
                                      (Registration No. 33-92740).
                              10.13   License  Agreement  dated  March 26,  1992
                                      between  AEI and Drs.  McLeod  and  Rubin.
                                      Incorporated by reference to Exhibit 10.14
                                      to the  Company's  Form  S-1  Registration
                                      Statement (Registration No. 33-92740).
                              10.14   SAFHS  Agreement  dated  November 30, 1995
                                      between the  Company  and Teijin  Limited.
                                      Incorporated by reference to Exhibit 10.14
                                      to the  Company's  Form  10-K for the year
                                      ended September 30, 1995.
                              10.15+  Mechanical-Stress Agreement dated November
                                      30,  1995  between  the Company and Teijin
                                      Limited.   Incorporated  by  reference  to
                                      Exhibit 10.15 to the  Company's  Form 10-K
                                      for the year ended September 30, 1995.
                              10.16   Employment  Agreement  dated March 1, 1997
                                      between   the   Company   and  Patrick  A.
                                      McBrayer.  Incorporated  by  reference  to
                                      Exhibit 10.16 to the  Company's  Form 10-Q
                                      for the  second  quarter  ended  March 31,
                                      1997.
                              21.1    List  of   Subsidiary.   Incorporated   by
                                      reference to Exhibit 21.1 to the Company's
                                      Form 10-K for the year ended September 30,
                                      1995.
                              27*     Financial Data Schedule.
<PAGE>

                              99.1    Preferred Shares Rights  Agreement,  dated
                                      December 6, 1996,  between the Company and
                                      Registrar and Transfer Company,  including
                                      the Certificate of Determination, the Form
                                      of Rights Certificate,  and the summary of
                                      Rights attached  thereto as Exhibits A, B,
                                      and  C,   respectively.   Incorporated  by
                                      reference to Exhibit 99.1 to the Company's
                                      Form 10-K for the year ended September 30,
                                      1996.

                              *       Filed herewith.
                              +       Confidential treatment granted.

                  (b)      Reports on Form 8-K

                                      No reports  on Form 8-K were filed  during
                                      the  quarter  for  which  this  report  is
                                      filed.
<PAGE>



                                   SIGNATURES


Pursuant  to the  requirements  of the  Securities  Exchange  Act of  1934,  the
registrant  has duly  caused  this  report  to be  signed  on its  behalf by the
undersigned thereunto duly authorized.





                                               EXOGEN, INC.
                                               (Registrant)




August 5, 1997                     By:  /s/Patrick A. McBrayer
                                        ----------------------
                                        Patrick A. McBrayer, President and
                                        Chief Executive Officer




August 5, 1997                     By:  /s/Richard H. Reisner
                                        ---------------------
                                        Richard H. Reisner, Vice President and
                                        Chief Financial Officer (Principal
                                        Financial and Accounting Officer)

<PAGE>
                                  EXOGEN, INC.

                                  EXHIBIT INDEX

   Number                          Description         
   ------                          -----------              

     3.1    Second  Amended and Restated  Certificate  of  Incorporation  of the
            Company.  Incorporated  by reference to Exhibit 3.1 to the Company's
            Form 10-Q for the third quarter ended June 30, 1995.
     3.2    Amended  and  Restated  Bylaws  of  the  Company.   Incorporated  by
            reference  to Exhibit  3.3 to the  Company's  Form S-1  Registration
            Statement (Registration No. 33-92740).
     4.1    See  Exhibits  3.1 and  3.2 for  provisions  of the  Certificate  of
            Incorporation  and Bylaws of the Company  defining rights of holders
            of Common Stock of the Company.
     10.1   Amended  and  Restated  Investors'  Rights  Agreement  dated  as  of
            November  14,  1994  among  the  Company,  the  investors  listed on
            Schedule  A  thereto,  and the  individuals  listed  on  Schedule  B
            thereto.  Incorporated by reference to Exhibit 10.1 to the Company's
            Form S-1 Registration Statement (Registration No. 33-92740).
     10.2   Asset  Purchase  Agreement  dated as of March 1, 1993 among  Applied
            Epigenetics,   Inc.  ("AEI"),  Interpore  International,   Inc.  and
            Interpore  Orthopaedics,  Inc.  Incorporated by reference to Exhibit
            10.2 to the Company's Form S-1 Registration Statement  (Registration
            No. 33-92740).
     10.3   [RESERVED]
     10.4   Employment  Agreement dated February 3, 1994 between the Company and
            John  Bohan.  Incorporated  by  reference  to  Exhibit  10.4  to the
            Company's  Form  S-1  Registration   Statement   (Registration   No.
            33-92740).
     10.5   Form of Consulting  Agreements  between the Company and each of Drs.
            McLeod and Rubin,  as amended.  Incorporated by reference to Exhibit
            10.5 to the Company's Form S-1 Registration Statement  (Registration
            No. 33-92740).
     10.6   Form of Stock Restriction  Agreement between the Company and each of
            Drs. McLeod and Rubin and Messrs. Reisner, Ryaby, Talish,  McBrayer,
            and  Bohan.  Incorporated  by  reference  to  Exhibit  10.6  to  the
            Company's  Form S-1  Registration  Statement  (Registration  No. 33-
            92740).
     10.7   Form of Stock  Purchase  Agreement  between  the Company and each of
            Messrs.  Reisner,  Ryaby,  and Talish.  Incorporated by reference to
            Exhibit  10.7  to the  Company's  Form  S-1  Registration  Statement
            (Registration No. 33-92740).
     10.8+  Manufacturing  Agreement  dated January 20, 1994 between the Company
            and Hi-Tronics  Designs,  Inc.  Incorporated by reference to Exhibit
            10.8 to the Company's Form S-1 Registration Statement  (Registration
            No. 33-92740).
     10.9   Form of 1993 Stock  Option Plan Option  Agreement.  Incorporated  by
            reference to Exhibit  10.9 to the  Company's  Form S-1  Registration
            Statement (Registration No. 33-92740).
     10.10  1995 Stock Option / Stock Issuance Plan.  Incorporated  by reference
            to Exhibit 10.10 to the Company's  Form S-1  Registration  Statement
            (Registration No. 33-92740).
<PAGE>
                                  EXOGEN, INC.

                                  EXHIBIT INDEX

   Number                          Description         
   ------                          -----------       

     10.11  Employee Stock Purchase Plan.  Incorporated  by reference to Exhibit
            10.12 to the Company's Form S-1 Registration Statement (Registration
            No. 33-92740).
     10.12  Lease  Agreement  dated December 13, 1994 by and between the Company
            and Siemens  Medical  Systems,  Inc.  Incorporated  by  reference to
            Exhibit  10.13  to the  Company's  Form S-1  Registration  Statement
            (Registration No. 33-92740).
     10.13  License  Agreement  dated March 26, 1992 between AEI and Drs. McLeod
            and  Rubin.  Incorporated  by  reference  to  Exhibit  10.14  to the
            Company's  Form  S-1  Registration   Statement   (Registration   No.
            33-92740).
     10.14  SAFHS  Agreement  dated  November  30, 1995  between the Company and
            Teijin  Limited.  Incorporated  by reference to Exhibit 10.14 to the
            Company's Form 10-K for the year ended September 30, 1995.
     10.15+ Mechanical-Stress  Agreement  dated  November  30, 1995  between the
            Company and Teijin  Limited.  Incorporated  by  reference to Exhibit
            10.15 to the  Company's  Form 10-K for the year ended  September 30,
            1995.
     10.16  Employment  Agreement  dated  March 1, 1997  between the Company and
            Patrick A. McBrayer.  Incorporated  by reference to Exhibit 10.16 to
            the Company's Form 10-Q for the second quarter ended March 31, 1997.
     21.1   List of Subsidiary. Incorporated by reference to Exhibit 21.1 to the
            Company's Form 10-K for the year ended September 30, 1995.
     27*    Financial Data Schedule.
     99.1   Preferred Shares Rights Agreement,  dated December 6, 1996,  between
            the  Company and  Registrar  and  Transfer  Company,  including  the
            Certificate of Determination,  the Form of Rights  Certificate,  and
            the  summary of Rights  attached  thereto as  Exhibits  A, B, and C,
            respectively.  Incorporated  by  reference  to  Exhibit  99.1 to the
            Company's Form 10-K for the year ended September 30, 1996.

     *      Filed herewith.
     +      Confidential treatment granted.

<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
In thousands except share data at 6/30/97, or 9 months ended 6/30/97.
</LEGEND>
       
<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          SEP-30-1997
<PERIOD-END>                               JUN-30-1997
<CASH>                                           4,338
<SECURITIES>                                     4,532
<RECEIVABLES>                                    4,700
<ALLOWANCES>                                     1,124
<INVENTORY>                                      1,465
<CURRENT-ASSETS>                                14,401
<PP&E>                                           1,656
<DEPRECIATION>                                     868
<TOTAL-ASSETS>                                  16,462
<CURRENT-LIABILITIES>                            2,593
<BONDS>                                              0
                                0
                                          0
<COMMON>                                             1
<OTHER-SE>                                      13,868
<TOTAL-LIABILITY-AND-EQUITY>                    16,462
<SALES>                                          5,240
<TOTAL-REVENUES>                                 5,240
<CGS>                                            3,049
<TOTAL-COSTS>                                    3,049
<OTHER-EXPENSES>                                     0
<LOSS-PROVISION>                                   100
<INTEREST-EXPENSE>                                  10
<INCOME-PRETAX>                                (9,202)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                            (9,202)
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                   (9,202)
<EPS-PRIMARY>                                   (0.93)
<EPS-DILUTED>                                        0
        

</TABLE>


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