As filed with the Securities and Exchange Commission on April 15, 1997
Registration No. 333-22201
- -------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
---------------
POST-EFFECTIVE
AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
Under
THE SECURITIES ACT OF 1933
---------------
THE MED-DESIGN CORPORATION
(Exact name of registrant as specified in charter)
DELAWARE 23-2771475
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
The Med-Design Corporation
North American Building, Suite 310
121 South Broad Street
Philadelphia, Pennsylvania 19107
Telephone (215) 735-2700
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
James M. Donegan, Chief Executive Officer
The Med-Design Corporation
North American Building, Suite 310
121 South Broad Street
Philadelphia, Pennsylvania 19107
Telephone (215) 735-2700
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
---------------
With a copy to:
Alan R. Gedrich, Esq.
Stradley, Ronon, Stevens & Young, LLP
2600 One Commerce Square
Philadelphia, Pennsylvania 19103-7098
---------------
Approximate date of commencement of proposed sale to the public: From
time to time after the effective date of this Registration Statement.
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. / /
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933, other than securities offered only in connection with
dividend or interest reinvestment plans, check the following box. /X/
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. / /
If this Form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. / /
If the delivery of the Prospectus is expected to be made pursuant to
Rule 434, please check the following box. / /
---------------
<TABLE>
<CAPTION>
CALCULATION OF REGISTRATION FEE
===================================================================================================================
Proposed Proposed
Amount Maximum Maximum Amount of
Title of Each Class of to be Offering Price Aggregate Registration
Securities to Be Registered Registered Per Unit Offering Price(1) Fee
- -------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Common Stock, par value $.01 per share 1,209,000 $9.625 $11,636,625 $3,526.25(2)
===================================================================================================================
</TABLE>
(1) Estimated solely for the purpose of calculating the registration fee
pursuant to Rule 457(c) of Regulation C under the Securities Act of
1933, as amended, and based solely on the last reported sale price of
the Registrant's Common Stock on the NASDAQ SmallCap Market on February
18, 1997.
(2) Previously paid.
The registrant hereby amends this Registration Statement on such date
or dates as may be necessary to delay its effective date until the registrant
shall file a further amendment which specifically states that this Registration
Statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
<PAGE>
PROSPECTUS
THE MED-DESIGN CORPORATION
1,209,000 Shares of Common Stock
This Prospectus relates to 1,209,000 shares of Common Stock,
par value of $.01 per share ("Common Stock"), of The Med-Design Corporation, a
Delaware corporation (the "Company"), which may be offered for sale to the
public from time to time by the security holders of the Company named herein
("Selling Security Holders"), or by their pledgees, donees, transferees or other
successors in interest, to or through underwriters or directly to other
purchasers or through brokers or agents in one or more transactions at varying
prices determined at the time of sale or at fixed or negotiated prices. See
"Selling Security Holders" and "Plan of Distribution".
The Company will not receive any of the proceeds from the sale
of the 1,209,000 shares of Common Stock (the "Shares") offered hereby. The
aggregate proceeds to the Selling Security Holders will be the offering price of
the Shares sold, less applicable commissions or discounts, if any. See "Selling
Security Holders" and "Plan of Distribution".
The Common Stock is traded on the NASDAQ SmallCap Market under
the symbol "MEDC." On April 8, 1997, the last reported sale price of the
Common Stock was $7.125 per share.
---------------
THE SECURITIES OFFERED HEREBY INVOLVE A HIGH DEGREE
OF RISK. SEE "RISK FACTORS."
---------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
---------------
<TABLE>
<CAPTION>
Underwriting Proceeds to
Price to Discounts and Proceeds to the Selling Security
Securities to be Registered Public (1) Commissions (2) Company (3) Holders (4)
- --------------------------- ---------- --------------- --------------- -----------
<S> <C> <C> <C> <C>
Common Stock, par value
$.01 per share $9.625 --- --- $11,636,625
</TABLE>
- ----------------
(1) Represents the last reported sale price per share of Common Stock on
the NASDAQ SmallCap Market on February 18, 1997.
(2) Cannot be estimated at this time.
(3) The Company will not receive any proceeds from the offering of the Shares.
(4) Before applicable underwriting discounts or commissions which cannot be
estimated at this time.
---------------
The Date of this Prospectus is April 15, 1997
<PAGE>
No dealer, salesperson or other person has been authorized to give any
information or to make any representations other than those contained in this
Prospectus and, if given or made, such information or representations must not
be relied upon as having been authorized by the Company. Neither the delivery of
this Prospectus nor any sale made hereunder shall, under any circumstances,
create any implication that there has been no change in the affairs of the
Company since the date hereof or that the information contained herein is
correct as of any date subsequent to the date hereof. This Prospectus does not
constitute an offer to sell or a solicitation of an offer to buy any securities
offered hereby by anyone in any jurisdiction in which such offer or solicitation
is not authorized or in which the person making such offer or solicitation is
not qualified to do so or to anyone to whom it is unlawful to make such offer or
solicitation.
---------------
TABLE OF CONTENTS
Page
Available Information........................................................2
Incorporation of Certain Documents by Reference..............................3
Risk Factors.................................................................4
The Company.................................................................14
Use of Proceeds.............................................................17
Selling Security Holders....................................................18
Plan of Distribution........................................................19
Legal Matters...............................................................20
Experts.....................................................................21
---------------
AVAILABLE INFORMATION
The Company has filed with the Securities and Exchange Commission (the
"Commission") a Registration Statement on Form S-3 (the "Registration
Statement") under the Securities Act of 1933, as amended (the "Securities Act")
with respect to the Shares of Common Stock offered by this Prospectus. This
Prospectus, filed as part of the Registration Statement, does not contain all of
the information set forth in the Registration Statement and the exhibits
thereto. For further information about the Company and the Common Stock,
reference is made to the Registration Statement and to the exhibits and
schedules filed therewith. Statements contained in this Prospectus as to the
contents of any contract or other document referred to are not necessarily
complete, and in each instance reference is made to the copy of such contract or
other document filed as an exhibit to the Registration Statement, each such
statement being qualified in all respects by such reference. A copy of the
Registration Statement may be inspected without charge at the Commission's
principal offices, and copies of all or any part of the Registration Statement
may be obtained from such office upon the payment of the fees prescribed by the
Commission.
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended (the "Exchange Act") and, in
accordance therewith, files reports, proxy and information statements and other
information with the Commission. Such reports, proxy and information statements
and other information filed by the Company with the Commission can be inspected
and copied at the Public Reference section of the Commission at Room 1024,
Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549, and at the
regional offices of the Commission located at 7 World Trade Center, New York,
New York 10048 and 500 West Madison Street, Suite 1400, Chicago, Illinois 60661.
Copies of such material can be obtained from the Public Reference section of the
Commission at Room 1024, Judiciary Plaza, 450 Fifth Street, N.W., Washington,
D.C. 20549 at prescribed rates. Reports and other information filed by the
Company with the Commission after May 6, 1996 are available on-line through
EDGAR.
2
<PAGE>
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents and information filed with the Commission (File
No. 0-25852) pursuant to the Exchange Act or the Securities Act are hereby
incorporated by reference into this Prospectus: (1) the Company's Annual Report
on Form 10-KSB for the fiscal year ended December 31, 1996, filed with the
Commission on March 27, 1997; (2) the Company's Proxy Statement, filed with the
Commission on April 16, 1996 for the Annual Meeting of Security Holders held on
May 15, 1996; (3) the Company's Quarterly Report on Form 10-QSB for the quarter
ended March 31, 1996, filed with the Commission on May 13, 1996; (4) the
Company's Quarterly Report on Form 10-QSB for the quarter ended June 30, 1996,
filed with the Commission on August 7, 1996; (5) the Company's Quarterly Report
on Form 10-QSB for the quarter ended September 30, 1996, filed with the
Commission on November 8, 1996; (6) the Company's Report on Form 8-K filed with
the Commission on February 10, 1996; (7) the Company's Report on Form 8-K filed
with the Commission on February 7, 1997; and (8) the description of the
Company's Common Stock contained in the Company's Registration Statement on Form
8-A filed with the Commission on April 7, 1995.
All documents filed by the Company pursuant to Sections 13(a), 13(c),
14 or 15(d) of the Exchange Act after the date of this Prospectus and prior to
termination of the offering made hereunder shall be deemed to be incorporated by
reference into this Prospectus to be a part of this Prospectus from the
respective dates of the filing of such documents. Any statement contained in a
document incorporated by reference herein shall be deemed to be modified or
superseded for purposes of this Prospectus to the extent that a statement
contained herein or in any other document subsequently filed and incorporated
herein by reference modifies or supersedes such prior statement. Any statement
so modified or superseded shall not be deemed, except as modified or superseded,
to constitute a part of this Prospectus.
The Company will provide without charge to each person, including any
beneficial owner, to whom a copy of this Prospectus has been delivered, upon
written or oral request of such person, a copy of any or all information that
has been incorporated by reference in this Prospectus, other than exhibits to
such information that are not specifically incorporated by reference into such
information. Requests for information incorporated by reference in this
Prospectus should be made in writing to The Med-Design Corporation, North
American Building, 121 South Broad Street, Suite 310, Philadelphia,
Pennsylvania, 19107, Attn.: Patrick E. Rodgers, Chief Financial Officer.
Telephone requests may be directed to Mr. Rodgers at (215) 735-2700.
3
<PAGE>
RISK FACTORS
AN INVESTMENT IN THE COMPANY'S COMMON STOCK IS SPECULATIVE IN NATURE;
AND INVOLVES A HIGH DEGREE OF RISK INCLUDING, BUT NOT NECESSARILY LIMITED TO,
THE RISK FACTORS DESCRIBED BELOW. SHARES OF COMMON STOCK SHOULD NOT BE PURCHASED
BY INVESTORS WHO CAN NOT AFFORD THE LOSS OF THEIR ENTIRE INVESTMENT. PROSPECTIVE
INVESTORS SHOULD CAREFULLY REVIEW AND CONSIDER THE FOLLOWING RISKS AS WELL AS
THE OTHER INFORMATION CONTAINED IN THIS PROSPECTUS IN EVALUATING AN INVESTMENT
IN THE SHARES OF COMMON STOCK OFFERED HEREBY.
Development Stage Company/No Revenues/Uncertain Profitability/History of Losses
Since its inception, the Company has been principally engaged
in developmental and organizational activities. To date, the Company has
generated no revenues from operations. The Company does not anticipate any
significant revenues from product sales during the next twelve months. In
addition, under certain conditions, commercial marketing of any products may
prove to be contingent upon the Company obtaining various governmental
approvals, including clearances from the U.S. Food and Drug Administration
("FDA"). The approval procedure will be extremely time consuming, expensive and
uncertain. Accordingly, there can be no assurance that the Company will be able
to generate sufficient revenues to operate on a profitable basis in the future.
The Company is in the development stage and its business is
subject to all of the risks inherent in the establishment of a new business
enterprise. The likelihood of the success of the Company must be considered in
light of the problems, expenses, complications and delays frequently encountered
in connection with the formation of a new business, the development of new
products, the competitive and regulatory environment in which the Company may be
operating, and the possibility that its activities will not result in the
development of any commercially viable products. There can be no assurance that
the Company's activities will ultimately result in the development of
commercially saleable or useful products.
The Company has experienced annual operating losses and
negative operating cash flow since inception. At December 31, 1996, the Company
had a deficit accumulated during the development stage of $13,747,408. Unless
and until the Company's product development and marketing activities are
successful and its product(s) are sold directly or under licensing agreements,
and through other forms of joint ventures, none of which is expected to occur,
if at all, before the end of the second quarter of 1997, the Company will not
have revenues to apply to operating expenses and the Company will continue to
incur losses. Additionally, as a result of the start-up nature of its business
and the fact that it has not commercially marketed any products, the Company
expects to sustain substantial operating losses and negative cash flows in the
future.
Requirements for Additional Funds
At April 8, 1997, the Company had a $6,750,000 revolving
line of credit ("Loan Agreement") with its principal lending institution and
a $535,000 equipment financing facility with a second commercial bank
("Equipment Facility"). The Loan Agreement provides for a credit facility which
can be used to (1) fund working capital needs and (2) finance capital
equipment purchases; provided, however, that advances for capital equipment
financing cannot exceed $600,000 of the $6,750,000. Pursuant to the terms of the
Loan Agreement, all borrowings must be fully collateralized by available-for-
sale securities, cash equivalents, equipment financed, and general intangibles
of the Company. Under the terms of the Equipment Facility, all borrowings
must be fully collateralized by a short-term investment in the form of a
certificate of deposit and applicable equipment financed. The Loan Agreement
expires on June 30, 1997. At April 8, 1997, the Company had $2,017,266
additional availability on its Loan Agreement and $173,350 on its Equipment
Facility. In addition, in 1995, the Company
4
<PAGE>
issued warrants to purchase 400,000 shares of Common Stock in connection with
the Initial Public Offering ("IPO") of its Common Stock ("IPO Warrants") of
which IPO Warrants to purchase 136,000 shares have been exercised as of April
8, 1997. The Company has received an aggregate of $676,200 upon the exercise of
the IPO Warrants. If the remainder of the IPO Warrants are exercised, the
Company would receive additional funds of approximately $1,491,300, net of the
registration and other costs to be paid by the Company as required under the
terms of the IPO Warrants.
In January, 1997, the Company completed a private placement of
1,000,000 shares of its Common Stock to certain "accredited investors" (as that
term is defined in Regulation D of the Securities Act) at a gross sales price of
$5.00 per share. See "Selling Security Holders - Private Placement of Common
Stock".
The Company believes that its current cash on hand will be
sufficient to support its planned operations and capital expenditures through
March, 1998, but thereafter will need to raise additional funds through public
or private financings to support its planned operations and capital
expenditures. Additional financings may consist of the sale of debt or equity
securities. The sale of additional equity securities could result in dilution to
the purchasers in this offering. The Company believes that it will require
additional capital before it reaches profitability and positive cash flow, if at
all. If other external sources of funds are not available to the Company to
satisfy short-term or long-term capital requirements, the Company may be
required to reduce the compensation of its officers, office staff and other
personnel and substantially reduce, or eliminate, certain areas of its product
development activities, limit its operations significantly, or otherwise modify
its business strategy. The Company has not made any specific plans or entered
into any agreements to reduce the level of its expenditures in the event that
such reductions become necessary.
Dependence on Patents and Proprietary Rights
The Company's success will depend in part on its ability to
obtain and maintain patent protection for its products, to preserve its trade
secrets and to operate without infringing the proprietary rights of third
parties. The Company's policy is to attempt to protect its intellectual property
and maintain the proprietary nature of its technology by, among other things,
filing patent applications for technology that it considers important to the
development of its business and requiring certain employees and key consultants
to execute non-disclosure and non-compete agreements.
The Company's patent rights currently consist of three United
States patents, one relating to the Retractable Needle Hypodermic Syringe (the
"Safety Syringe"), another relating to the Retractable Needle Vacuum Tube
Phlebotomy Set (the "Safety Phlebotomy Set") and the third relating to the
Retractable Needle Intravenous Catheter Insertion Device (the "Safety
Catheter"). The Company has been granted a patent relating to the Safety Syringe
in Japan, Australia and Romania. Corresponding regional and national patent
applications relating to the Safety Syringe are pending in the European Patent
Office, designating twelve countries, and in eight other member countries of the
Patent Cooperation Treaty.
In 1995, the Company filed an international patent
application, and a corresponding Taiwanese patent application, directed to its
Safety Catheter, which incorporates several modifications and changes from the
original design on which it obtained a U.S. Patent. Also in 1995, the Company
filed a U.S. patent application and a corresponding Taiwanese patent application
directed to its retractable needle In-Line Y-Port Injector Access Needle. In
1996, the Company filed a U.S. patent application directed to its Pre-Filled
Ampule Injector and its Self-Contained Pre-Filled Syringe and its Closed
Injector System. Also, in 1996, the Company filed a U.S. patent application
relating to a new and improved version of its Safety Phlebotomy Set and a U.S.
provisional patent application directed to its Pre-Filled Vial Injector System.
5
<PAGE>
There can be no assurance that the Company's current patent
applications will result in patents being issued.
As the Company proceeds toward final designs for its Safety
Syringe, Safety Phlebotomy Set and Safety Catheter devices, the Company is
having searches conducted in the United States for unexpired patents owned by
others that may conflict with any final product designs. The Company, however,
has not conducted any infringement searches in any foreign country for the
purpose of finding unexpired patents or pending patent applications that might
raise a possibility of infringement or conflict with the Company's planned
activities. Furthermore, the Company is considering appropriate modifications to
the product designs to optimize the final products and to avoid conflicts with
patents of others. To the extent that such final product designs may not be
protected by the Company's existing patents and patent applications, the Company
will file new patent applications relative to its final products. There can be
no assurance that all of the potentially relevant patents of others have been
identified or that the Company will be able to obtain patent protection for the
designs for its products.
There can also be no assurance that any patents owned by or
issued to the Company, or that may issue to the Company in the future, will
provide a competitive advantage or will afford protection against competitors
with similar technology, or that competitors of the Company will not circumvent
or challenge the validity of any patents issued to the Company. There also can
be no assurance that any patents issued to or licensed by the Company will not
be infringed upon or designed around by others, that others do not have or will
not obtain patents that the Company will need to license or design around, that
the Company's products will not inadvertently infringe upon the patents of
others, or that others will not make the Company's patented devices upon
expiration of such patents. There can be no assurance that existing or future
patents of the Company will not be invalidated. Moreover, although the Company
utilizes non-disclosure agreements and other safeguards to protect its
proprietary information and trade secrets, there can be no assurance that they
will protect such information or provide adequate remedies for the Company in
the event of unauthorized use or disclosure of such information, or that others
will not be able to independently develop such information. As is the case with
the Company's patent rights, the enforcement by the Company of its
non-disclosure agreements can be lengthy and costly, with no guarantee
of success.
If the Company becomes involved with patent infringement
litigation, either to enforce the Company's patents or defend against patent
infringement suits, such litigation would be lengthy and expensive, and if it
occurs, would divert Company resources from planned uses. Further, any adverse
outcome in such litigation could have a material adverse effect on the Company.
If any of the Company's products are found to infringe upon the patents or
proprietary rights of another party, the Company may be required to obtain
licenses under such patents or proprietary rights. No assurance can be given
that any such licenses would be made available on terms acceptable to the
Company, if at all. In addition, patent applications filed in foreign countries
and patents granted in such countries are subject to laws, rules and procedures
which differ from those in the United States. Patent protection in such
countries may be different from patent protection provided by United States laws
and may not be as favorable to the Company. There can be no assurance that the
Company's program of patent protection and non-disclosure agreements will be
sufficient to protect the Company's proprietary technology from competitors.
Dependence on a Single Technology
As of this date, all of the Company's products that have been
designed and developed are based upon the Company's proprietary retraction
technology. In addition, several of the products the Company intends to design
and develop will also be based upon such proprietary retraction technology.
While the Company intends to develop additional products that are not based upon
the proprietary retraction technology, the Company's present narrow focus on a
particular technology makes the Company vulnerable to the development of
superior competing products and changes in technology which could eliminate the
need for the Company's products. While the Company believes there will be no
significant change in the foreseeable future in the need for the Company's
products or the desirability of those products, there can be no assurance that
such change will not occur.
6
<PAGE>
Dependence on Continued Research and Development
The Company is exploring other applications for its
proprietary retraction technology beyond the Safety Syringe, Safety Phlebotomy
Set, the Safety Catheter (collectively, the "Core Products"), the In-Line Y-Port
Injector Access Needle, the Pre-Filled Ampule Injector, the MDC Closed Injection
System Injector, the Self-Contained Pre-Filled Syringe and the Pre-Filled Vial
Injector (collectively, the "New Products") under development. The development
of additional applications and additional products may be important to the
longer-term success of the Company. There can be no assurance that any of such
applications or products will be developed or, if developed, that they will be
successful.
Reliance on Single Source Suppliers
The Company may, in the future, obtain certain of the
components and subassemblies required for its products from a single source. The
disruption or termination of any single-source supplier could have a material
adverse effect on the Company's operations. Certain of the components have lead
times and changes in any suppliers could disrupt production schedules, either of
which could materially adversely affect the Company's business and results of
operations.
Lack of Market Acceptance
The use of safety needles is relatively new. Although the
market for syringes, phlebotomy sets and intravenous catheters is large, actual
sales of the Company's products, if and when they are produced, may be much less
than the market's potential. Market acceptance of the Company's products will
depend in large part upon the Company's ability to demonstrate the operational
advantages, safety and cost effectiveness of its products compared to standard
syringes, phlebotomy sets and intravenous catheters and its competitors' safety
medical devices. The higher cost of safety medical devices, including those of
the Company, relative to standard medical devices may be an impediment to their
market acceptance. There can be no assurance that the Company's products will
achieve market acceptance. In addition, there can be no assurance that the
development of the Core Products or the New Products will be completed on
schedule, if at all, or that there will be a significant demand for the products
once development is completed.
No Manufacturing Experience/Limited Manufacturing Facilities/No Agreements to
Manufacture Products
The Company has not yet manufactured any products on a
commercial basis. Certain members of management have had experience in the
design and manufacturing of other products, including medical devices, but there
can be no assurance that such managers will be successful in designing and
manufacturing the Company's products. For the Company to be successful, it must
manufacture or contract with third parties to manufacture its products in
sufficient quantities, to rigorous quality control standards and at a reasonable
cost. The Company's failure to do so would have a material adverse effect on the
Company.
The Company has leased approximately 26,000 square feet of
space in Ventura, California where it houses a research and development
laboratory, a machine shop and a 3,130 square foot, class 100,000 clean room for
assembly of prototypes and products. The Company, however, currently has no
automated manufacturing facilities. The Company had originally planned to
install in the cleanroom a fully automated robotic assembly system to pilot
manufacture its products. The Company, however, elected not to install a fully
automated robotic assembly system. Instead, it elected to install a
semi-automated assembly system to pilot manufacture its products. The assembly
system will produce only one of the Company's products at a time, but will have
the capability of being converted at a reasonable cost with minimal delay to
manufacture a different product at such time as the Company may desire. During
the fourth quarter of 1996, the Company partially completed the installation of
the semi-automated assembly system for the production of one of the Company's
products. The Company intends to have the system fully operational during the
second quarter of 1997. To the extent the Company cannot or does not manufacture
sufficient quantities of the Company's products to satisfy the demand therefor,
the Company will be required to contract with third parties to manufacture such
products. The Company is currently investigating opportunities with third
parties in the United States and abroad to manufacture
7
<PAGE>
the Safety Syringe, the Safety Phlebotomy Set and Safety Catheter and certain of
its other products under development either on a contract manufacturing basis,
under licensing agreements or through other forms of joint ventures. The Company
has entered into several confidentiality agreements with other companies for the
purpose of exploring such opportunities. The Company has not to date entered
into any agreements for the manufacture of its products and there can be no
assurance the Company will be able to enter into any such agreements on
acceptable terms. Delays in engaging third parties to manufacture its products
could have a material adverse effect on the Company's manufacturing plans and
timetable. In addition, there can be no assurance that the third party
manufacturers will meet the Company's requirements for quality, quantity and
timeliness, or comply with requirements imposed by the FDA or other governmental
agencies, or that the Company would be able to find substitute manufacturers, if
necessary.
Limited Marketing Staff
Other than a Senior Vice President, Marketing, the Company has
no other staff dedicated solely to marketing and, if commercial products are
developed, it will have to employ a sales force or retain marketing and
distribution services from other parties. If the Company attempts to employ a
sales force, there can be no assurance that qualified individuals can be hired.
If the marketing and distribution services of other parties are sought, there
can be no assurance that it will be able to enter into such marketing and
distribution agreements on acceptable terms.
Limited Number of Employees
The Company anticipates increasing the number of employees in
the areas of product development, manufacturing, sales and marketing. The number
of employees that the Company will need to hire will vary according to the
progress made in the development of the Company's pilot manufacturing plant and
the extent to which the Company undertakes the manufacture, marketing and
distribution of its products. There can, however, be no assurance that, if the
need arises, the Company will have the resources or ability to engage qualified
employees or outside independent consultants.
Dependence on Key Personnel
The success of the Company depends upon the skills, experience
and efforts of its executive officers and certain marketing and technical
people. The Company is particularly dependent upon the services of James M.
Donegan, its Chairman, Chief Executive Officer and President, Michael J. Botich,
its Senior Vice President, Research and Development and Thor R. Halseth, its
Senior Vice President, Design. The loss of the services of Mr. Donegan,
Mr. Botich or Mr. Halseth or any of the Company's other key personnel could have
a material adverse effect on the Company. Each of Messrs. Donegan, Botich and
Halseth have entered into an employment agreement with the Company which expires
in 2000, 1998 and 1998, respectively. The Company is the sole beneficiary of a
key person life insurance policy on the lives of each of Messrs. Donegan, Botich
and Halseth in the amount of $1,000,000 per policy.
Product Liability
The manufacture and sale of medical devices entails an
inherent risk of liability in the event of product failure or claim of harm
caused by product operation. Although the Company currently maintains product
liability insurance coverage ($5,000,000 per occurrence and in the aggregate),
there can be no assurance that such coverage will remain available at a
reasonable cost and in amounts sufficient to protect the Company against claims
or recalls that could have a material adverse effect on the financial condition
and prospects of the Company.
Government Regulation
As medical devices, the Company's products are subject to
regulation by the FDA under the Federal Food, Drug, and Cosmetic Act ("FD&C
Act") and implementing regulations. Pursuant to the FD&C Act, the FDA
8
<PAGE>
regulates, among other things, the manufacture, labeling, distribution, and
promotion of the Company's products in the United States. The FD&C Act requires
that a medical device must (unless exempted by regulation) be cleared or
approved by the FDA before being commercially distributed in the United States.
The FD&C Act also requires manufacturers of medical devices to, among other
things, comply with labeling and promotion requirements and to manufacture
devices in accordance with Good Manufacturing Practices ("GMPs"), which require
that companies manufacture their products and maintain related documentation in
a prescribed manner with respect to manufacturing, testing and quality control
activities. The FDA inspects medical device manufacturers and distributors, and
has broad authority to order recalls of medical devices, to seize noncomplying
medical devices, to enjoin and/or impose civil penalties on manufacturers and
distributors marketing noncomplying medical devices, and to criminally prosecute
violators.
The FD&C Act provides that, unless exempted by regulation,
medical devices may not be commercially distributed in the United States unless
they have been approved or cleared by the FDA. Some products may qualify for
clearance pursuant to Section 510(k) of the FD&C Act, under which the
manufacturer submits to FDA a pre-market notification that it intends to begin
marketing the product, and shows that the product is substantially equivalent to
another legally marketed product (i.e., that it has the same intended use and
that it is as safe and effective as a legally marketed device, and does not
raise different questions of safety and effectiveness than does a legally
marketed device). In some cases, the 510(k) pre-market notification must include
data from human clinical studies. Marketing may commence when the FDA issues a
510(k) clearance finding such substantial equivalence.
On December 28, 1995, the Company submitted a 510(k)
pre-market notification to the FDA for its Safety Catheter. On February 13,
1996, the FDA issued a 510(k) clearance for the Safety Catheter, permitting the
Company to market the product. The Company believes that the Safety Syringe and
the Safety Phlebotomy Set also will be eligible for clearance through the 510(k)
pre-market notification procedure based upon their substantial equivalence to
previously marketed devices. The Company presently intends to submit to FDA a
510(k) pre-market notification for the Safety Phlebotomy Set in the first
quarter of 1997 and for the Safety Syringe in the second quarter of 1997.
However, there can be no assurance that the Company will meet its target dates
for 510(k) pre-market notification submission, that such products are eligible
for a 510(k) clearance, that the Company will not be required to submit
additional data or meet additional FDA requirements that may substantially delay
a 510(k) clearance and add to the Company's expenses, or that the Company will
obtain 510(k) clearance to market the Safety Phlebotomy Set or Safety Syringe.
If any of the Company's products do not qualify for the 510(k)
clearance procedure, the FDA must approve a pre-market approval application
("PMA application") before marketing can begin. PMA applications must
demonstrate, among other matters, that the medical device is safe and effective.
A PMA application is typically a complex submission usually including the
results of clinical studies, and preparing an application is a detailed and
time-consuming process. Once a PMA application has been submitted, there can be
no assurance that a PMA application will be approved in a timely fashion or at
all.
The process of obtaining FDA clearances or approvals can be
time-consuming and expensive, and there can be no assurance that the Company
will be able to obtain required regulatory clearances or approvals. Clearances
or approvals, if obtained, may include significant limitations on the uses
promoted for the product in question. Further, changes to the product may
require additional clearances or approvals. In addition, once a product has been
cleared or approved, the FD&C Act imposes continuing obligations, including,
among others, the requirement that devices be manufactured in accordance with
GMPs and that they be labeled and promoted in compliance with FDA regulations.
Changes in existing regulations or guidelines or the adoption of new regulations
or guidelines could make regulatory compliance by the Company more difficult in
the future. The failure to obtain needed clearances or approvals or the
resolution of enforcement action based on failure to comply with applicable
regulations would be likely to have a material adverse effect on the Company.
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Distribution of the Company's products in countries other than
the United States may be subject to regulation in those countries. There can be
no assurance that the Company will be able to obtain the approvals necessary to
market the Safety Syringe, the Safety Phlebotomy Set, the Safety Catheter or any
other product outside of the United States.
Competition
The needle market is highly competitive. The Company will
compete in the United States and abroad with medical product companies,
including Becton Dickinson and Company, Sherwood Medical (a division of American
Home Products) Terumo Medical Corporation, Johnson and Johnson, U.S. Medical
Laboratories and Bio-Plexus, Inc. Many of the Company's competitors have name
recognition in the market and have longer operating histories and in many cases
are substantially larger and better financed than the Company. Such competitors
may use their economic strength to influence the market to continue to buy their
existing products or new products developed by them. One or more of these
competitors also could use such resources to improve their current products or
develop additional products which may compete more effectively with the
Company's products. New competitors may arise and may develop products which
compete with the Company's products. In addition, new technologies may arise
which could lower or eliminate the demand for the Company's products.
Control by Directors and Officers
As of April 8, 1997, Directors and officers of the Company
beneficially owned or controlled approximately 36.7% of the issued and
outstanding Common Stock and have the right to acquire 389,000 additional shares
of Common Stock upon exercise of outstanding options, when vested. By virtue of
their ownership of Common Stock and options to purchase Common Stock, such
executive officers and directors may, as a group, have the ability to exert
significant control over the election of the Company's Board of Directors and to
determine corporate actions requiring stockholder approval including mergers,
consolidations and the sale of all or substantially all of the Company's assets,
and to prevent or cause a change in control of the Company.
In addition, 200,000 shares of the Company's Common Stock
owned by Mr. James Donegan has been pledged as collateral for a loan. In the
event of a default by Mr. Donegan, such lender would then take title to such
shares, which would have the effect of reducing the control over the Company by
such directors and officers.
Volatility of Stock Price
Historically, the trading price of the Company's Common Stock
has fluctuated widely, and it may be subject to similar future fluctuations in
response to quarter-to-quarter variations in operating results, announcements
regarding technological innovations, the formation of joint ventures and
strategic alliances, governmental regulatory approvals of its products, the
development of new products by the Company or its competitors, general
conditions in the medical device industry and other events or factors, including
factors such as analysts' expectations which are beyond the Company's control.
In addition, in recent years, broad stock market indices, and the securities of
NASDAQ SmallCap Market companies, in general, and development stage companies,
in particular, have experienced substantial price fluctuations. Such market
fluctuations also may adversely affect the future trading price of the Company's
Common Stock, and there can be no assurance that the trading price of the
Company's Common Stock will not decline from its current level.
Potential Dilutive Effect of Convertible Securities
As of April 8, 1997, the Company has 7,924,570 shares of
Common Stock issued and outstanding. In addition, an aggregate of 897,000
additional shares of Common Stock are issuable by the Company based on the
following: (i) stock options granted under the Company's Non-Qualified Stock
Option Plan to purchase an aggregate of 433,000 shares of Common Stock;
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(ii) warrants issued by the Company in connection with the IPO to purchase an
aggregate of 264,000 shares of Common Stock; (iii) warrants issued by the
Company in connection with the Private Placement to Fine Equities, Inc.
("Placement Agent") to purchase 100,000 shares of Common Stock; and (iv)
warrants to purchase 100,000 shares of Common Stock issued by the Company to
John F. Kelley, a director of the Company, in consideration for services
rendered to the Company by Mr. Kelley.
As of April 8, 1997, the exercise price of stock options and
warrants to purchase 490,000 shares at or below the current fair market
value of the Company's Common Stock. The issuance of Common Stock upon the
exercise of such stock options and warrants may have an adverse effect upon the
market price for the Company's Common Stock.
No Cash Dividends and None Anticipated
No cash dividends have been paid on the Common Stock of the
Company. It is anticipated that income received from operations, if any, will be
devoted to the Company's future operations. Accordingly, no cash dividends are
anticipated in the future.
Barriers to Takeover
The Company has an authorized class of 5,000,000 shares of
preferred stock. The Board has the authority, without shareholder approval, to
issue preferred stock in one or more series and to fix the relative rights and
preferences thereof including their redemption, dividend and conversion rights.
The ability of the Company to issue the authorized but unissued shares of such
preferred stock, depending upon the rights, preferences and designations
thereof, may have the effect of delaying, deterring or preventing a change in
control of the Company.
Future Sales of Common Stock by Existing Security Holders; Potential Adverse
Effect on Market Price
Of the 7,924,570 shares of Common Stock issued and outstanding
as of April 8, 1997, 3,270,662 shares have not been registered under the
Securities Act of 1933 (excluding 1,000,000 of the shares of Common Stock
registered pursuant to this Prospectus), as amended (the "Securities Act") and
are "restricted securities" as that term is defined by Rule 144 promulgated
under the Securities Act. In addition, as of February 18, 1997, an additional
207,665 shares of stock which are owned by "affiliates" of the Company have been
registered under the Securities Act, but are considered "restricted securities"
under Rule 144 of the Securities Act. In the future, such restricted securities
may be sold in compliance with the limitations of Rule 144, or otherwise.
Generally, under Rule 144, a person who has held fully-paid-for "restricted
securities" for a period of two years may, every 90 days, sell to a market
maker, or in an ordinary broker's transaction, an amount that does not exceed
the greater of one percent (1%) of the Company's then outstanding stock or the
average weekly trading volume during the four calendar weeks preceding the sale.
Rule 144 also permits a person who is not an affiliate of the Company, and who
has held fully-paid-for "restricted securities" for a period of three years, to
sell such securities without compliance with the limitations on quantity and
manner of sale.
In connection with the sale of 1,000,000 shares of Common
Stock by the Company effected in January, 1997, five individuals who are
officers and/or directors of the Company, agreed not to offer, sell or otherwise
dispose of an aggregate of 1,307,912 of their shares (with certain exceptions)
for a period which commenced on January 23, 1997 and extends until the Company
has entered into three material corporate alliances relating to the Company's
products, although any of those five individuals may offer, sell or otherwise
dispose of their shares after the Company has entered into two material
corporate alliances relating to the Company's products if Mr. James Donegan so
consents in writing. Mr. Donegan has also agreed not to offer, sell or otherwise
dispose of 1,230,000 of the shares beneficially owned by him for a period
commencing on the date of this Offering and continuing until the Company has
entered into three material corporate alliances relating to the Company's
products, without the prior written consent of the Placement Agent for the sale
of such shares. See "Selling Security Holders - Private Placement of Common
Stock".
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Taking into account the above referenced lock-up agreements
and assuming that the Placement Agent does not release any stockholders from
such agreements, of the 7,924,570 shares of Common Stock outstanding as of
April 8, 1997, approximately 306,668 shares are currently eligible under
Rule 144 for sale in the public market and approximately 3,268,327 shares of
Common Stock will be eligible under Rule 144 for sale in the public market after
April 8, 1996 through May 31, 1997. The future sale of any "restricted
securities" by stockholders of the Company or the issuance of Common Stock upon
the exercise of the outstanding options or warrants may have an adverse effect
upon the market price of the Common Stock (which includes the Common Stock to be
sold in connection by the Selling Security Holders) and the ability of the
Company to raise capital. Holders of options to purchase 81,000 shares are
presently fully vested and upon exercise of such options are eligible to sell
such shares under rule 701. Holders of outstanding warrants (including the
Warrants as hereinafter defined) have the right to purchase 264,000 shares of
Common Stock and to require the Company to register the resale of such shares of
Common Stock. Of the 1,209,000 shares of Common Stock being registered pursuant
in this Registration Statement, 209,000 of those shares represent shares of
Common Stock underlying the outstanding warrants.
Anti-Takeover Provisions
The Company is governed by the provisions of Section 203 of
the Delaware General Corporation Law, an anti-takeover law enacted in 1988. In
general, the law prohibits a public Delaware corporation from engaging in a
"business combination" with an "interested stockholder" for a period of three
years after the date of the transaction in which the person became an interested
stockholder, unless the business combination is approved in a prescribed manner.
"Business combination" is defined to include mergers, asset sales and certain
other transactions resulting in a financial benefit to the stockholders. An
"interested stockholder" is defined as a person who, together with affiliates
and associates, owns, (or, within the prior three years, did own) 15% or more of
a corporation's voting stock. As a result of the application of Section 203,
potential acquirors of the Company may be discouraged from attempting to effect
an acquisition transaction with the Company, thereby possibly depriving holders
of the Company's securities of certain opportunities to sell or otherwise
dispose of such securities at above market prices pursuant to such transactions.
Risks of Low-Priced Stocks
The Commission has adopted regulations which define a "penny
stock" to be an equity security that has a market price (as therein defined) of
less than $5.00 per share or an exercise price of less than $5.00 per share,
subject to certain exceptions. For any transaction involving a penny stock,
unless exempt, the rules require the delivery, prior to any transaction in a
penny stock, of a disclosure schedule prepared by the Commission relating to the
penny stock market. Disclosure is also required to be made about commissions
payable to both the broker-dealer and the registered representative and current
quotations for the securities. Finally, monthly statements are required to be
sent disclosing recent price information for the penny stock held in the account
and information on the limited market in penny stocks. The foregoing penny stock
restrictions will not apply to the Company's securities if such securities
continue to be listed on the NASDAQ SmallCap Market, as to which there can be no
assurance, and have certain price and volume information provided on a current
and continuing basis or meet certain minimum net tangible assets or average
revenue criteria. In any event, even if the Company's securities were exempt
from such restrictions, it would remain subject to Section 15(b)(6) of the
Exchange Act, which gives the Commission the authority to prohibit any person
engaged in unlawful conduct while participating in a distribution of penny stock
from associating with a broker-dealer or participating in a distribution of
penny stock, if the Commission finds that such a restriction would be in the
public interest. If the Company's securities were to be removed from listing on
the NASDAQ SmallCap Market or otherwise become subject to the existing rules on
penny stocks, the market liquidity for the Company's securities could be
severely adversely affected.
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IMPORTANT FACTORS RELATED TO FORWARD-LOOKING STATEMENTS
AND ASSOCIATED RISKS
The statements contained in this Prospectus or which are
incorporated herein that are not purely historical are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended,
including statements regarding the Company's expectations, hopes, intentions or
strategies regarding the future. All forward-looking statements included herein
are based on information available to the Company on the date hereof, and the
Company assumes no obligation to update any such forward-looking statements. It
is important to note that the Company's actual results could differ materially
from those in such forward-looking statements. Among the factors that could
cause actual results to differ materially are the risk factors which may be
listed from time to time in the Company's Form 10-QSB, 10-KSB and registration
statements filed under the Securities Act of 1933, as amended, including this
Registration Statement. Forward-looking statements encompass the expectation
that (i) the Company will develop commercially saleable and useful products,
(ii) the Company will be successful in raising additional capital, (iii) the
Company will be successful in obtaining patent protection, (iv) there will not
be superior products which compete with the Company's own products, (v) the
Company will be successful in developing its existing products and will develop
new products, and (vi) there will be other applications for the technology which
the Company has developed.
The forward-looking statements included herein are based on
current expectations that involve a number of risks and uncertainties.
Assumptions relating to the foregoing involve judgments with respect to, among
other things, future economic, competitive, regulatory and market conditions,
and future business conditions, all of which are difficult or impossible to
predict accurately and many of which are beyond the control of the Company.
Although the Company believes that the assumptions underlying the
forward-looking statements are reasonable, any of the assumptions could prove
inaccurate and, therefore, there can be no assurance that the forward-looking
information will prove to be accurate. In light of the significant uncertainties
in the forward-looking information included herein, the inclusion of such
information should not be regarded as a representation by the Company or any
other person that the objectives or plans of the Company will be achieved.
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THE COMPANY
Overview
The Company, incorporated in Delaware on November 14, 1994,
designs and develops safety medical devices intended to reduce the incidence of
accidental needlesticks. The Company has three core products under development:
the Safety Syringe, the Safety Phlebotomy Set and the Safety Catheter. These
products are similar in appearance and size to the standard devices in use. Such
products incorporate the Company's novel proprietary retraction technology that
enables a health care professional, with no substantial change in operating
technique and using one hand, to permanently retract the needle into the body of
the device that can be safely discarded.
The Company also has several new products which are in the
beginning stages of development. These new product developments include the
In-Line Y-Port Injector Access Needle, the Pre-Filled Ampule Injector, the MDC
Closed Injection System Injector, the Self-Contained Pre-Filled Syringe and the
Pre-Filled Vial Injector. These products also incorporate the Company's
proprietary retraction technology and are designed to reduce the incidence of
accidental needlesticks. The Company has developed various sizes and designs of
these products to accommodate the specific requirements of potential strategic
allies for medical and dental applications.
The Company believes that its safety medical devices can
assist employers in meeting standards promulgated by Occupational Safety and
Health Administration ("OSHA") to help eliminate or minimize occupational
exposure to bloodborne pathogens. The Company has patent rights and patents
pending with respect to certain of its products in the United States and certain
foreign countries.
The Company's headquarters are located at Suite 310, North
American Building, 121 South Broad Street, Philadelphia, Pennsylvania 19107. The
Company's telephone number is (215) 735-2700.
Products Under Development
The Company is completing the development and design of the
Safety Syringe, Safety Phlebotomy Set and Safety Catheter. The Company continues
to modify and enhance the design of such products in order to improve
manufacturability and to reduce manufacturing costs. The Company has developed
prototypes for such products, but the additional modifications to their design
will require the development of a second generation of prototypes. A description
of each product appears below.
Safety Syringe. The Safety Syringe consists of a cylindrical
syringe barrel, holding an injection needle which with no substantial change in
operating technique and using one hand can be safely retracted automatically
within a specifically designed syringe plunger. The Safety Syringe is similar in
appearance, size and performance to a standard disposable syringe. The operation
of the Safety Syringe is conventional up to the point where the plunger has
reached its full travel, and all the medication has been delivered. Then, when
the syringe device is actuated to have the plunger move beyond the normal stop,
the needle automatically and fully retracts into the body of the syringe. The
needle is held in place and is rendered harmless and inoperable. The syringe and
needle cannot thereafter be used again. The entire retraction procedure takes
only a fraction of a second to complete. The Safety Syringe then may be safely
handled so that disposal does not pose a health risk. The Safety Syringe is easy
to use and provides visual and audible confirmation that the needle has been
safely retracted after injection. The Safety Syringe can be manufactured with
needles of various gauges and sizes and with barrel sizes one through sixty
cubic centimeters.
Safety Phlebotomy Set. Phlebotomy sets are used to obtain from
a patient a sufficient volume of blood for a variety of diagnostic procedures.
The Company's Safety Phlebotomy Set is similar in appearance, size and
performance to a standard phlebotomy set and works with substantially all
standard phlebotomy set accessories. The
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Safety Phlebotomy Set consists of a barrel holding a retractable phlebotomy
needle, which can be safely and easily retracted within a specifically designed
holder. The operation of the Safety Phlebotomy Set is conventional up to the
point where sufficient fluids have been extracted. Then, when the phlebotomy
device is actuated for the vacuum tube to be moved beyond the normal stop, the
needle automatically and fully retracts into the device. The needle is held in
place and is rendered harmless and inoperable. The Safety Phlebotomy Set and
needle cannot thereafter be used again. The entire retraction procedure takes
only a fraction of a second to complete. The Safety Phlebotomy Set then may be
safely handled so that disposal does not pose a health risk. The Safety
Phlebotomy Set is easy to use and provides visual and audible confirmation that
the needle has been safely retracted after use.
Safety Catheter. An intravenous catheter insertion device
includes a flexible tube that is used to inject or continuously deliver fluids
into a patient. Intravenous catheters are inserted by catheter insertion devices
into a patient by a needle within the flexible catheter tube. The Safety
Catheter device consists of a barrel, holding a retractable insertion needle
that can be safely and easily retracted within a specifically designed plunger.
The Safety Catheter device is similar in appearance, size and performance to a
standard disposable device. The operation of the Safety Catheter device is
conventional until after the insertion needle is removed from the flexible
catheter. Then, when the catheter device is actuated to have the triggering
mechanism move in the device, the needle automatically and fully retracts into
the body of the Safety Catheter mechanism. The needle is held in place and is
rendered harmless and inoperable. The Safety Catheter device and needle cannot
thereafter be used again. The entire retraction procedure takes only a fraction
of a second to complete. The Safety Catheter device then may be safely handled
so that disposal does not pose a health risk. The Safety Catheter device is easy
to use and provides visual and audible confirmation that the needle has been
safely retracted after use. The Company received notification from the FDA
during 1996 that it is permitted to market the Safety Catheter.
In addition, the Company has several new products under
development, including the Inline Y-Port Injector Access Needle, the Pre-Filled
Ampule Injector, the MDC Closed Injection System Injector, the Self-Contained
Pre-Filled Syringe and the Pre-Filled Vial Injector System. Each of these
products are in the initial stages of development, design and prototyping and
will require significant further development and modification. A description of
each of these products appear below.
Inline Y-Port Injector Access Needle. Y-Ports are devices used
in intravenous therapy as a means to deliver secondary fluids into a primary
intravenous fluid line for delivery into a patient's vein. The retractable
needle Inline Y-Port Injector Access Needle device provides a means for a
healthcare worker to access an intravenous fluid line with a needle, and also
provides a means to protect the healthcare worker from an accidental needle
stick injury when withdrawing the needle from the intravenous line port. The
Company's In Line Y-Port Injector Access Needle consists of a cylindrical
barrel, holding an injection needle which can be safely retracted automatically
within a specially designed plunger. The barrel of the Inline Y-Port Injector
Access Needle is fitted with a barbed tube fitting, which protrudes from the
barrel at an angle for connection of a tubing line for delivery of the secondary
fluid. A needle assembly is fixed to the front end of the barrel, and is
inserted into an injection port on the primary intravenous line for delivery of
the secondary fluid. After completion of the delivery of the secondary fluid,
the Y-Port injector device is actuated to have the plunger move forward and the
needle automatically and fully retracts into the plunger. The needle is held in
place and is rendered harmless and inoperable, and the device cannot be used
again. The Inline Y-Port Injector Access Needle then may be safely handled so
that disposal does not pose a health risk. The Inline Y-Port Injector Access
Needle is easy to use and provides visual and audible confirmation that the
needle has been safely retracted after use.
Pre-Filled Ampule Injector. Pre-filled ampules are commonly
used in the dental profession for administering local anesthetics to a patient.
The retractable needle Pre-Filled Ampule Injector device provides a means for a
healthcare worker to inject medicinal fluid into a patient from a pre-filled
ampule using a conventional injector/holder, and also provides a means to
protect the healthcare worker from an accidental needle stick injury when
withdrawing the needle from the patient. The Pre-Filled Ampule Injector consists
of a tubular barrel (glass or plastic) containing a medicinal fluid in an amount
sufficient for a single dose, with a sealing and sliding piston in the rear end
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of the barrel for containing and delivering the fluid through a tubular needle
extending from the forward end of the barrel. The sliding piston is moved
forward for delivery of the medication by using a conventional (Tubex type)
injector/holder which is slip-fitted to the rear end of the barrel, with the
plunger rod threaded onto the rear end of the piston. A needle assembly is fixed
to the front end of the barrel, containing a spring to provide retracting force
on the needle when activated. The operation of the Ampule Injector is identical
to the operation of a conventional syringe up the point where the plunger rod
has reached its full travel, and all the medication has been delivered. When the
Ampule Injector device is actuated to have the plunger rod move further forward,
the needle automatically and fully retracts into the body of the ampule. The
needle is held in place and is rendered harmless and inoperable, and the Ampule
Injector cannot be used again. The Ampule Injector then may be safely handled so
that disposal does not pose a health risk. The Ampule Injector is easy to use
and provides visual and audible confirmation that the needle has been safely
retracted after injection. The Ampule Injector can be manufactured with barrels
and needles of various sizes.
MDC Closed Injection System. Pre-filled ampules are commonly
used in the dental profession for administering local anesthetics to a patient.
The retractable needle MDC Closed Injection System device provides a means for a
healthcare worker to inject medicinal fluid into a patient from a pre-filled
ampule using a special injector/holder, and also provides a means to protect the
healthcare worker from an accidental needle stick injury when withdrawing the
needle from the patient. The MDC Closed Injection System is similar to the
Pre-Filled Ampule Injector and consists of a tubular barrel (glass or plastic)
containing a medicinal fluid in an amount sufficient for a single dose, with a
sealing and sliding piston in the rear end of the barrel for containing and
delivering the fluid through a tubular needle extending from the forward end of
the barrel. The sliding piston is moved forward for delivery of the medication
by using a specially configured injector/holder which is threaded to the rear
end of the barrel, with the plunger rod slipped onto the rear end of the piston.
A needle assembly is fixed to the front end of the barrel, containing a spring
to provide retracting force on the needle when activated. The operation of the
Injection System is identical to the operation of a conventional syringe up to
the point where the plunger rod has reached its full travel, and all the
medication has been delivered. When the injection system device is actuated to
have the plunger rod move further forward, the needle automatically and fully
retracts into the body of the ampule. The needle is held in place and is
rendered harmless and inoperable, and the Injection System cannot be used again.
The Injection System then may be safely handled so that disposal does not pose a
health risk. The Injection System is easy to use and provides visual and audible
confirmation that the needle has been safely retracted after injection. The
Injection System can be manufactured with barrels and needles of various sizes.
Self-Contained Pre-Filled Syringe. The Self-Contained
Pre-Filled Syringe consists of a tubular barrel (glass or plastic) containing a
medicinal fluid in an amount sufficient for a single dose, with a sealing and
sliding piston in the rear end of the barrel for containing and delivering the
fluid through a tubular needle extending from the forward end of the barrel. The
Self-Contained Pre-Filled Syringe is self-contained because a separate injector
assembly is not required for operation. The function of a plunger rod for
pushing the piston is provided by a special needle cap. The sliding piston is
moved forward for delivery of the medication by using the special needle cap
(plunger rod) threaded onto the rear end of the piston. A needle assembly is
fixed to the front end of the barrel, containing a spring to provide retracting
force on the needle when activated. The operation of the Syringe is similar to
the operation of a conventional syringe up to the point where the plunger rod
has reached its full travel, and all the medication has been delivered. When the
syringe device is actuated to have the plunger rod move further forward, the
needle automatically and fully retracts into the body of the Syringe. The needle
is held in place and is rendered harmless and inoperable, and the Syringe cannot
be used again. The Self-Contained Syringe then may be safely handled so that
disposal does not pose a health risk. The Self-Contained Syringe is easy to use
and provides visual and audible confirmation that the needle has been safely
retracted after injection. The Self-Contained Syringe can be manufactured with
barrels and needles of various sizes.
Pre-Filled Vial Injector System. The Pre-Filled Vial Injector
System consists of a main cylindrical housing with a stationary plunger for
holding a slidable piston in a fixed position as a glass pre-filled vial is
pushed into the main housing. The pre-filled vial is an existing product
produced by several pharmaceutical manufacturers and contains fluid medication
with an elastomeric piston comprising a slidable fluid seal within the forward
end of the vial. The slidable piston is threaded onto the rear end of the
stationary plunger and is moved rearward into the vial by pushing the vial
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forward into the main housing and delivering the fluid through a tubular needle
extending from the forward end of the main housing. A needle assembly is fixed
to the front end of the barrel, containing a spring to provide retracting force
on the needle when activated. The operation of the Vial Injector System is
similar to the operation of a conventional syringe up the point where the vial
has reached its full travel, and all the medication has been delivered. When the
injector system device is actuated to have the vial move further forward, the
needle automatically and fully retracts into the body of the vial. The needle is
held in place and is rendered harmless and inoperable, and the Vial Injector
System cannot be used again. The Vial Injector System may be safely handled so
that disposal does not pose a health risk. The Vial Injector System is easy to
use and provides visual and audible confirmation that the needle has been safely
retracted after injection. The Vial Injector System can be manufactured for
vials and needles of various sizes.
In addition to the Company's three Core Products and the New
Products, the Company has identified several additional product applications
where its proprietary retraction technology can be incorporated and plans to
devote research and development resources during 1997 and beyond in order to
research and develop such products.
On April 8, 1997, the closing bid price of the Common
Stock was $7.125 per share.
USE OF PROCEEDS
The net proceeds from the sale of the Shares will be received
by the Selling Security Holders. The Company will not receive any of the
proceeds from the sale of the Shares by the Selling Security Holders.
17
<PAGE>
SELLING SECURITY HOLDERS
Private Placement of Common Stock
In January, 1997, the Company sold to certain of the Selling
Security Holders listed in the chart below, a total of 1,000,000 shares of the
Company's Common Stock for a gross purchase price of $5,000,000. The sale of the
Shares of Common Stock by the Company to those Selling Security Holders was
exempt from registration under the Securities Act and effected by a "private
placement" of securities arranged by the Placement Agent ("Private Placement").
The Company received net proceeds approximating $4,672,500 from the sale of such
Common Stock, net of placement agent commissions and expenses of the Placement
Agent. The Company agreed to file the Registration Statement of which this
Prospectus is a part in order to register the Shares of Common Stock for resale
by the Selling Security Holders.
In addition, for nominal consideration, the Placement Agent
received warrants from the Company to purchase a total of 100,000 shares of
Common Stock at an exercise price of $5.50 per share ("Warrants"), and certain
demand and piggyback registration rights with respect to the Common Stock
underlying the Warrants, together with the right to designate one individual to
serve as a member of the Board of Directors of the Company during the period
from January 23, 1997 through January 22, 2002, or if no such person is
designated, then to have the right to receive all communications to Board
members and to attend all such meetings of the Board. Simultaneously with the
closing of the Private Placement, the Placement Agent assigned Warrants to
purchase (i) 80,000 shares of Common Stock to N. Scott Fine, (ii) 10,000 shares
of Common Stock to M. Troy Duncan, (iii) 5,000 shares of Common Stock to Sharon
Bronte, and (iv) 5,000 shares of Common Stock to William A. Jolly. All of the
100,000 shares of Common Stock underlying the Warrants will be registered
pursuant to this Registration Statement. Each of Messrs. Fine, Duncan and Jolly,
and Ms. Bronte is, an executive officer and shareholder of the Placement Agent.
In addition, the Placement Agent has designated Mr. Jolly to serve as a member
of the Board of Directors of the Company, and the Company shall so nominate Mr.
Fine for election to its Board of Directors prior to the Company's 1997 Annual
Meeting of Stockholders.
Selling Security Holder Table
The table below sets forth information as of April 8, 1997
with respect to each of the Selling Security Holders, their respective names,
the holdings of record of shares of the Company's Common Stock before the
offering of the Shares, the number of Shares being offered for each of their
respective accounts, and the number of shares of Common Stock to be owned of
record by each of the Selling Security Holders immediately following the sale of
the Shares and, if one percent or more, the percentage of outstanding shares of
Common Stock to be owned of record by such Selling Security Holder following the
offering. The table assumes that all of the Warrants offered hereby and all of
the Options granted to Messrs. Crocker and Marr are exercised and all of the
shares offered hereby are sold.
<TABLE>
<CAPTION>
=============================================================================================================================
Name of Selling Shares of Common Stock Shares of Common Stock Common Stock to be
Security Holders Owned Before Offering Being Offered Owned After the
Offering
- -----------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C>
Hathaway Partners 200,000 200,000 0
Investment L.P.
- -----------------------------------------------------------------------------------------------------------------------------
Valor Capital Management 100,000 100,000 0
L.P.
- -----------------------------------------------------------------------------------------------------------------------------
Woodstead Associates II, 100,000 100,000 0
L.P.
- -----------------------------------------------------------------------------------------------------------------------------
Europa International, Inc. 100,000 100,000 0
- -----------------------------------------------------------------------------------------------------------------------------
Lagunitas Partners, L.P. 223,000 80,000 143,000 (1.7%)
- -----------------------------------------------------------------------------------------------------------------------------
Gary L. Crocker(1) & 186,394 50,000 136,394 (1.7%)
Ann S. Crocker
- -----------------------------------------------------------------------------------------------------------------------------
Steven G. Lampe 107,800 50,000 57,800
- -----------------------------------------------------------------------------------------------------------------------------
Ivan C. Frederickson 50,000 50,000 0
- -----------------------------------------------------------------------------------------------------------------------------
Dennis B. Poster 50,000 50,000 0
</TABLE>
18
<PAGE>
<TABLE>
- ------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C>
The Fisher Fund 40,000 40,000 0
- ------------------------------------------------------------------------------------------------------------------------
Gruber & McBaine 49,700 30,000 19,700
International
- ------------------------------------------------------------------------------------------------------------------------
Jon D. Gruber & Linda 73,000 20,000 53,000
W. Gruber
- ------------------------------------------------------------------------------------------------------------------------
J. Patterson McBaine 44,800 20,000 24,800
- ------------------------------------------------------------------------------------------------------------------------
Edward M. Blair, Jr. 20,000 20,000 0
- ------------------------------------------------------------------------------------------------------------------------
Jeffrey Tindell 20,000 20,000 0
- ------------------------------------------------------------------------------------------------------------------------
Carl E. Hathaway 50,000 20,000 30,000
- ------------------------------------------------------------------------------------------------------------------------
Damon Navarro & Brian 10,000 10,000 0
Navarro
- ------------------------------------------------------------------------------------------------------------------------
Edward T. Kennedy & 10,000 10,000 0
Julie M. Kennedy
- ------------------------------------------------------------------------------------------------------------------------
Karen Cooper 10,000 10,000 0
- ------------------------------------------------------------------------------------------------------------------------
Thomas J. O'Neill 10,000 10,000 0
- ------------------------------------------------------------------------------------------------------------------------
John S. Marr(2) 42,000(2) 10,000 32,000(2)
- ------------------------------------------------------------------------------------------------------------------------
N. Scott Fine 189,000(3) 189,000 0
- ------------------------------------------------------------------------------------------------------------------------
M. Troy Duncan 10,000(4) 10,000 0
- ------------------------------------------------------------------------------------------------------------------------
Sharon Bronte 5,000(5) 5,000 0
- ------------------------------------------------------------------------------------------------------------------------
William A. Jolly 9,000(5) 5,000 4,000
- ------------------------------------------------------------------------------------------------------------------------
Total Shares 1,709,694 1,209,000 500,694
============================================================================================================================
</TABLE>
- ----------------
(1) Until March 17, 1997, Mr. Crocker served as a member of the Board of
Directors of the Company. This amount reflects options to purchase 32,000 shares
of Common Stock granted by the Company to Mr. Crocker as compensation for his
service on the Company's Board of Directors pursuant to the Company's
Non-Qualified Stock Option Plan.
(2) Mr. Marr is a member of the Board of Directors of the Company. This amount
reflects options to purchase 32,000 shares of Common Stock granted by the
Company to Mr. Marr as compensation for his service on the Company's Board of
Directors pursuant to the Company's Non-Qualified Stock Option Plan.
(3) This amount reflects Warrants to purchase 80,000 shares of Common Stock
assigned by the Placement Agent to Mr. Fine in connection with the Private
Placement, together with 109,000 shares of Common Stock previously assigned
by Gilford Securities, Inc. to Mr. Fine in connection with the IPO.
(4) This amount reflects Warrants to purchase 10,000 shares of Common Stock
assigned by the Placement Agent in connection with the Private Placement.
(5) This amount reflects Warrants to purchase 5,000 shares of Common Stock
assigned by the Placement Agent in connection with the Private Placement.
PLAN OF DISTRIBUTION
Any distribution of the Shares by the Selling Security
Holders, or by their pledgees, donees, transferees or other successors in
interest, may be effected from time to time in one or more of the following
transactions: (a) to underwriters who will acquire Shares for their own account
and resell them in one or more transactions, including negotiated transactions,
at a fixed public offering price or at varying prices determined at the time of
sale (any public offering price and any discount or concessions allowed or
reallowed or paid to dealers may be changed from time to time); (b) through
brokers, acting as principal or agent, in transactions (which may involve block
transactions) on the Nasdaq SmallCap Market or on one or more exchanges on which
the Shares are then listed, in special offerings, exchange distributions
pursuant to the rules of the applicable exchanges or in the over-the-counter
market, or otherwise, at market prices prevailing at the time of sale, at prices
related to such prevailing market prices, at negotiated prices or at fixed
prices; (c) directly or through brokers or agents in private sales at negotiated
prices; or (d) by any other legally available means.
19
<PAGE>
The Company will not receive any proceeds from the sale of the
Shares offered hereby. The aggregate proceeds to the Selling Security Holders
from the Shares offered hereby will be the offering price less applicable
commissions or discounts, if any. There is no assurance that the Selling
Security Holders will sell any of the Shares offered hereby.
The Selling Security Holders and such underwriters, brokers,
dealers or agents, upon effecting a sale of Shares, may be considered
"underwriters" as that term is defined by the Securities Act. Sales effected
through agents, brokers or dealers will ordinarily involve payment of customary
brokerage commissions although some brokers or dealers may purchase such shares
as agents for others or as principals for their own account. The Selling
Security Holders will pay any sales commissions or other sellers' compensation
applicable to such transactions. A portion of any proceeds of sales and
discounts, commissions or other seller's compensation may be deemed to be
underwriting compensation for purposes of the Securities Act.
Under applicable rules and regulations under the Exchange Act,
any person engaged in the distribution of the Shares of Common Stock offered
hereby may not simultaneously engage in market making activities for the Common
Stock for a period of two business days prior to the commencement of such
distribution. In addition, each Selling Security Holder and any other person who
participates in a distribution of the Shares will be subject to applicable
provisions of the Exchange Act and the rules and regulations thereunder,
including Rules 10b-2, 10b-6 and 10b-7, which provisions may limit the timing of
purchases of the Exchange Act and the rules and regulations thereunder may
affect the marketability of the Shares of Common Stock and the ability of any
person to engage in market making activities for the Shares of Common Stock.
At the time a particular offering of Shares is made, to the
extent required, a Prospectus Supplement will be distributed which will set
forth the number of Shares being offered and the terms of the offering,
including the purchase price or public offering price, the name or names of any
underwriters, dealers or agents, the purchase price paid by any underwriter for
Shares purchased from the Selling Security Holders, any discounts, commissions
and other items constituting compensation from the Selling Security Holders and
any discounts, commissions or concessions allowed or reallowed or paid to
dealers.
In order to comply with the securities laws of certain states,
if applicable, the Shares will be sold in such jurisdictions, if required, only
through registered or licensed brokers or dealers. In addition, in certain
states the Shares may not be sold unless the Shares have been registered or
qualified for sale in such state or an exemption from registration or
qualification is available and the conditions of such exemption have been
satisfied.
The Company has agreed that it will bear all costs, expenses
and fees in connection with the registration or qualification of the Shares
under federal and state securities laws, with the exception of any discounts or
commissions payable with respect to the sales of such Shares. The Company and
each of the Selling Security Holders have agreed to indemnify each other and
certain other persons against certain liabilities in connection with the
offering of the Shares, including liabilities arising under the Securities Act.
LEGAL MATTERS
The validity of the Shares offered hereby are being passed
upon by Stradley, Ronon, Stevens & Young, LLP, Philadelphia, Pennsylvania.
20
<PAGE>
EXPERTS
The consolidated balance sheet as of December 31, 1996 and the
consolidated statements of operations, stockholders' equity and cash flows for
each of the two years in the period ended December 31, 1996, incorporated by
reference in this prospectus, have been incorporated herein in reliance on the
report of Coopers & Lybrand L.L.P., independent accountants, given on authority
of that firm as experts in accounting and auditing.
21
<PAGE>
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following is a list of the expenses the Registrant expects to pay
in connection with the issuance and distribution of the Shares registered
hereby. All amounts are estimated except the Securities and Exchange Commission
Registration Fee.
Filing and Registration Fees................................. $ 3,526
Legal Fees and Expenses.......................................$15,000
Cost of Printing..............................................$ 2,000
Accounting Fees and Expenses..................................$ 2,000
Blue Sky Fees and Expenses....................................$ 1,000
Miscellaneous Expenses........................................$ 1,000
-------
TOTAL.........................................................$24,526
Item 15. Indemnification of Directors and Officers
The Delaware General Corporation Law authorizes the Registrant
to grant indemnities to directors and officers in terms sufficiently broad to
permit indemnification under certain circumstances for liabilities (including
reimbursement for expenses incurred) arising under the Securities Act.
Article VII of the Registrant's By-Laws provides as follows:
INDEMNIFICATION OF DIRECTORS, OFFICERS AND OTHER PERSONS
Section A. The Corporation shall, to the fullest extent now or
hereafter permitted by law, indemnify any person who was or is a party or is
threatened to be made a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative
(other than an action by or in the right of the Corporation) by reason of the
fact that he is or was a director or officer of the Corporation, or is or was
serving at the request of the Corporation as a director or officer of another
corporation, partnership, joint venture, trust or other enterprise, against
expenses, including attorneys' fees, judgments, fines and amounts paid in
settlement actually and reasonably incurred by him in connection with such
action, suit or proceeding if he acted in good faith and in a manner he
reasonably believed to be in, or not opposed to, the best interests of the
Corporation and, with respect to any criminal action or proceeding, had no
reasonable cause to believe his conduct was unlawful. The termination of any
action, suit or proceeding by judgment, order, settlement, conviction, or upon a
plea of nolo contendere or its equivalent shall not, of itself, create a
presumption that the person did not act in good faith and in a manner which he
reasonably believed to be in, or not opposed to, the best interests of the
Corporation and, with respect to any criminal action or proceeding, had
reasonable cause to believe that his conduct was unlawful.
Section B. The Corporation shall, to the fullest extent now or
hereafter permitted by law, indemnify any person who was or is a party or is
threatened to be made a party to any threatened, pending or completed action or
suit by or in the right of the Corporation to procure a judgment in its favor by
reason of the fact that he is or was a director
22
<PAGE>
or officer of the Corporation, or is or was serving at the request of the
Corporation as a director or officer of another corporation, partnership, joint
venture, trust or other enterprise against expenses, including attorneys' fees
actually and reasonably incurred by him in connection with the defense or
settlement of such action or suit if he acted in good faith and in a manner he
reasonably believed to be in, or not opposed to, the best interests of the
Corporation. No such indemnification against expenses shall be made, however, in
respect of any claim, issue or matter as to which such person shall have been
adjudged to be liable to the Corporation unless and only to the extent that the
Court of Chancery or the court in which such action or suit was brought shall
determine upon application that despite the adjudication of liability, but in
view of all the circumstances of the case, such person is fairly and reasonably
entitled to indemnity for such expenses which the Court of Chancery or such
other court shall deem proper.
Section C. Indemnification under Sections A and B of this
Article shall be made by the Corporation when ordered by a court or upon a
determination that indemnification of the director or officer is proper in the
circumstances because he has met the applicable standard of conduct set forth in
those Sections. Such determination shall be made (a) by the board of directors
by a majority vote of a quorum consisting of directors who were not parties to
such action, suit, or proceeding, or (b) if such quorum is not obtainable or,
even if obtainable, a quorum of disinterested directors so directs, by
independent legal counsel in a written opinion, or (c) by the stockholders.
Section D. Expenses incurred in defending a civil or criminal
action, suit or proceeding of the kind described in Sections A and B of this
Article shall be paid by the Corporation in advance of the final disposition of
such action, suit or proceeding upon receipt of an undertaking, by or on behalf
of the person who may be entitled to indemnification under those Sections, to
repay such amount if it shall ultimately be determined that he is not entitled
to be indemnified by the Corporation.
Section E. The indemnification provided in this Article shall
continue as to a person who has ceased to be a director or officer of the
Corporation and shall inure to the benefit of the heirs, executors and
administrators of such a person.
Section F. Nothing herein contained shall be construed as
limiting the power or obligation of the Corporation to indemnify any person in
accordance with the Delaware General Corporation Law, as amended from time to
time, or in accordance with any similar law adopted in lieu thereof. The
indemnification and advancement of expenses provided by, or granted pursuant to,
this Article shall not be deemed exclusive of any other rights to which those
seeking indemnification or advancement of expenses may be entitled under any
by-law, agreement, vote of stockholders or disinterested directors or otherwise,
both as to action in his official capacity and as to action in another capacity
while holding such office.
Section G. The Corporation shall also indemnify any person
against expenses, including attorneys' fees, actually and reasonably incurred by
him in enforcing any right to indemnification under this Article, under the
Delaware General Corporation Law, as amended from time to time, or under any
similar law adopted in lieu thereof.
Section H. Any person who shall serve as a director, officer,
employee or agent of the Corporation or who shall serve, at the request of the
Corporation, as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise, shall be deemed to do so
with knowledge of and in reliance upon the rights of indemnification provided in
this Article, in the Delaware General Corporation Law, as amended from time to
time, and in any similar law adopted in lieu thereof.
The Company also maintains directors' and officers' liability
insurance coverage which insures directors and officers of the Company against
certain losses arising from claims made, and for which the Company has not yet
provided reimbursement, by reason of their being directors and officers of the
Company or its subsidiaries.
23
<PAGE>
Item 16. Exhibits
Exhibit No. Description
- ----------- -----------
5 Opinion of Stradley, Ronon, Stevens & Young, LLP
23.1 Consent of Coopers & Lybrand, L.L.P.
23.4 Consent of Stradley, Ronon, Stevens & Young, LP
(see Exhibit 5 above)
Item 17. Undertakings
The undersigned registrant hereby undertakes:
(1) to file, during any period in which it offers or sells securities,
a post-effective amendment to this registration statement to:
(i) include any prospectus required by section 10(a)(3) of the
Securities Act;
(ii) reflect in the prospectus any facts or events which,
individually or together, represent a fundamental change in the information in
the registration statement; and
(iii) include any additional or changed material information
on the plan of distribution;
provided, however, registrant does not need to give the
statements in paragraphs (i) and (ii) above if the registration statement is on
Form S-3 or S-8, and the information required in a post-effective amendment is
incorporated by reference from periodic reports filed by the registrant under
the Exchange Act.
(2) for determining any liability under the Securities Act, to treat
each post-effective amendment as a new registration statement of the securities
offered, and the offering of such securities at that time to be the initial bona
fide offering.
(3) to file a post-effective amendment to remove from registration any
of the securities that remain unsold at the end of the offering.
(4) Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the foregoing provision, or otherwise, the
registrant has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the Act
and is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the registrant of expense
incurred or paid by a director, officer, or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question of whether such indemnification by it is against
public policy as expressed in the Act and will be governed by the final
adjudication of such issue.
24
<PAGE>
SIGNATURE
Pursuant to the requirements of the Securities Act of 1933,
the Registrant certifies that it has reasonable grounds to believe that it meets
all of the requirements of filing on Form S-3 and has duly caused this
Post-Effective Amendment No. 1 to the Registration Statement to be signed on its
behalf by the undersigned, thereunto duly authorized, in the City of
Philadelphia, Commonwealth of Pennsylvania, on this 14th day of April, 1997.
THE MED-DESIGN CORPORATION
By: /s/ James M. Donegan
-------------------------------------
President and Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933,
this Post-Effective Amendment No. 1 to the Registration Statement has been
signed below by the following persons in the capacities and on the dates
indicated.
<TABLE>
<CAPTION>
Signature Title Date
<S> <C> <C>
/s/ James M. Donegan Chairman of the Board, President and Chief April 14, 1997
- ------------------------------ Executive Officer (Principal Executive Officer)
James M. Donegan
/s/ Patrick E. Rodgers Executive Vice President, Finance and Chief April 14, 1997
- -------------------------------- Financial Officer (Principal Financial Officer
Patrick E. Rodgers and Principal Accounting Officer)
/s/ Joseph N. Bongiovanni, III Director April 14, 1997
- ------------------------------
Joseph N. Bongiovanni, III
/s/ John A. Botich Director April 14, 1997
- ---------------------------------
John A. Botich
Director April __, 1997
- ---------------------------------
John F. Kelley
Director April __, 1997
- ------------------------------
John S. Marr, M.D.
/s/ Gilbert M. White Director April 14, 1997
- --------------------------------
Gilbert M. White
</TABLE>
25
<PAGE>
EXHIBIT INDEX
Exhibit No. Description
5 * Opinion of Stradley, Ronon, Stevens & Young, LLP
23.1* Consent of Coopers & Lybrand, L.L.P.
23.2* Consent of Stradley, Ronon, Stevens & Young, LLP
(see Exhibit 5 above)
*Previously filed.
26
