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As filed with the Securities and Exchange Commission on April 5, 1999.
Registration No. 333- 72223
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM S-3
AMENDMENT NO. 1
TO
REGISTRATION STATEMENT
Under
THE SECURITIES ACT OF 1933
CardioTech International, Inc.
(Exact name of registrant as specified in its charter)
<TABLE>
<S> <C>
Massachusetts 04-3186647
(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification Number)
</TABLE>
78E Olympia Avenue
Woburn, Massachusetts 01801
(781) 933-4772
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
John E. Mattern
Chief Operating Officer, Chief Financial Officer and Clerk
CardioTech International, Inc.
78E Olympia Avenue
Woburn, Massachusetts 01801
(781) 933-4772
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
With a copy to:
Michael L. Fantozzi, Esquire
Paul C. Levites, Esquire
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
One Financial Center
Boston, Massachusetts 02111
(617) 542-6000
Approximate date of commencement of proposed sale to the public:
As soon as practical after this Registration Statement becomes effective.
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, 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, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
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.
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PROSPECTUS
CARDIOTECH INTERNATIONAL, INC.
3,582,600 SHARES OF COMMON STOCK
. We have registered up to 3,582,600 shares of our common stock for sale by
the selling stockholders listed on pages 12 and 13 of this prospectus.
. We will not receive any of the proceeds from the selling stockholders' sale
of their common stock.
Our common stock trades on the American Stock Exchange under the symbol "CTE."
On April 1, 1999, the closing sale price of one share of our common stock as
quoted on the American Stock Exchange was $1.375.
Our address is CardioTech International, Inc., 78E Olympia Avenue, Woburn,
Massachusetts 01801, and our telephone number is (781) 933-4772.
This Investment Involves A High Degree of Risk.
You Should Purchase Shares Only If You Can Afford A Complete Loss.
See "Risk Factors" Beginning on Page 3.
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Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities, or determined if
this prospectus is truthful or complete. Any representation to the contrary is
a criminal offense.
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April 5, 1999
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CARDIOTECH'S BUSINESS
CardioTech develops and manufactures vascular grafts, or synthetic blood
vessels, made of ChronoFlex. ChronoFlex is a family of polyurethanes that has
been demonstrated to be durable, biologically compatible and non-toxic within
the human body. Vascular grafts are used to replace, bypass or provide a new
lining or arterial wall for clogged, damaged, dilated or severely diseased
arteries.
CardioTech is developing three types of vascular grafts:
. a graft to provide access for patients undergoing kidney dialysis
treatment;
. a below the knee bypass graft to restore blood flow to the legs in
persons suffering from diabetes; and
. a coronary artery bypass graft to treat the impairment of blood flow
to portions of the heart.
CardioTech is developing its grafts using specialized ChronoFlex
polyurethane materials that it believes will provide significantly improved
performance in the treatment of arterial disorders. The grafts have three
layers similar to natural arteries designed to replicate the physical
characteristics of human blood vessels.
CardioTech also develops, manufactures and markets polyurethane-based
materials for use in both short and long term implant devices such as stents,
which are tiny tubes inserted in coronary arteries to help keep them open,
artificial hearts, and vascular ports.
CardioTech was founded in 1993 as a subsidiary of PolyMedica Corporation.
In June 1996, Polymedica spun off CardioTech. The Company is headquartered in
Woburn, Massachusetts and also has production facilities in Brymbo, Wrexham,
U.K.
RECENT DEVELOPMENTS
CardioTech raised $2,332,500, including $200,000 in promissory notes from
CardioTech's executive officers, in a unit private placement which terminated on
December 15, 1998. CardioTech sold 1,866,000 units in the offering at a
purchase price of $1.25 per unit. Each unit consisted of one share of
CardioTech common stock and one warrant to purchase one share of CardioTech
common stock. Each warrant expires on December 15, 2003 and is exercisable at
$1.50 per share.
CardioTech paid Fechtor, Detwiler & Co., Inc., the exclusive placement
agent for the offering, a cash fee of $127,950, which was 6% of the amount that
they raised, along with a five-year warrant to purchase 170,600 shares of Common
Stock, which was 10% of the number of units which they sold. The exercise price
of this warrant was set at $1.475 per share, the average closing price of the
common stock for the five trading days prior to the date of the initial closing
on November 25, 1998.
Michael Szycher, John E. Mattern, Alan Edwards and Michael Adams,
CardioTech's executive officers, each purchased 40,000 units in the offering.
The officers paid for their units with promissory notes in the amount of $50,000
each, payable on December 15, 2003, with interest at a rate of 4.52 % per year
compounded annually and payable annually in arrears. The notes, which are with
recourse with respect to 25% of the initial principal amount, are secured by the
shares and warrants.
The selling stockholders were granted certain registration rights for the
resale of the shares underlying the units. They are exercising those rights
through this resale prospectus. CardioTech's executive officers are not
registering their shares for resale under this prospectus.
CardioTech is currently negotiating to purchase all of the stock of Tyndale
Plains-Hunter, a maker of specialty polyurethanes for the medical and cosmetics
industries. CardioTech anticipates that it will pay $350,000 in cash and issue
446,153 shares of its Common Stock. The purchase will be subject to a number of
conditions, including both parties' completion of their due diligence review.
There can be no assurance that CardioTech will be able to complete the
acquisition, that the terms of the acquisition will be favorable to CardioTech
or that CardioTech will be able to successfully integrate Tyndale Plains-Hunter
into its operations.
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RISK FACTORS
Investing in our common stock is very risky. You should be able to bear a
complete loss of your investment. This prospectus, including the documents
incorporated by reference, contains forward-looking statements that involve
risks or uncertainties. Actual events or results may differ materially from
those discussed in this prospectus and in the documents incorporated by
reference. Factors that could cause or contribute to such differences include,
but are not limited to, the factors discussed below as well as those discussed
elsewhere in this prospectus and in the documents incorporated by reference.
Early Stage of Development of Vascular Grafts.
CardioTech primarily develops and markets implantable synthetic vascular
grafts. Presently, CardioTech is conducting clinical testing of its first
product in development, the VascuLink Vascular Access Graft. CardioTech has not
begun to market this technology in the United States and has not generated any
revenue from the use of this technology. CardioTech recently received government
authority to sell its VascuLink Vascular Access Graft in Europe and has just
begun to market this product there. CardioTech cannot assure you that any of its
products in development:
. will be successfully developed;
. will meet applicable regulatory standards, if developed;
. will obtain required regulatory approvals;
. will be producible in commercial quantities at reasonable costs; or
. will be successfully marketed.
To succeed in this market, CardioTech will have to complete the
development of polyurethane-based vascular grafts which (1) will be safe and
effective and (2) will have benefits not available in human vein grafts or
presently available synthetic vascular grafts. CardioTech cannot assure you that
it will be successful in doing this. CardioTech's products in development will
require significant additional investment, research, development, pre-clinical
and clinical testing and regulatory approval prior to commercialization.
CardioTech will have to commit substantial additional resources to complete the
development of its synthetic grafts.
History of Operating Losses and Accumulated Deficit.
CardioTech cannot assure you that it will ever be profitable. For the nine
months ended December 31, 1998, and the years ended March 31, 1998, 1997 and
1996, CardioTech had net losses attributable to common stock holders of
$1,734,595, $1,808,955 $1,655,572 and $2,188,030, respectively, and as of
December 31, 1998, CardioTech had an accumulated deficit of $9,230,225.
CardioTech expects to incur additional operating losses over the next several
years from the development, testing and manufacturing of its vascular graft
technology as it:
. engages in additional research and development;
. conducts additional animal testing;
. continues clinical trials; and
. seeks regulatory approvals
CardioTech expects its cumulative deficit to increase for the forseeable
future as it expands its efforts in the areas indicated above.
CardioTech's ability to become profitable is dependent, in large part, on:
. completing product development and commercialization;
. obtaining regulatory approvals for its products; and
. making the transition from research and development to manufacturing
and marketing.
CardioTech cannot assure you that it will be able to achieve any of these
objectives. See "Management's Discussion and Analysis of Financial Condition
and Results of Operations" in CardioTech's filings with the Securities and
Exchange Commission, including its Form 10-K for the year ended March 31, 1998
and in the Form 10-Q for the quarter ended December 31, 1998.
Proposed Acquisition
CardioTech is currently negotiating to purchase all of the stock of Tyndale
Plains-Hunter, a maker of specialty polyurethanes for the medical and cosmetics
industries. CardioTech anticipates that it will pay $350,000 in cash and issue
446,153 shares of its Common Stock. The purchase will be subject to a number of
conditions, including both parties' completion of their due diligence review.
There can be no assurance that CardioTech will be able to complete the
acquisition, that the terms of the acquisition will be favorable to CardioTech
or that CardioTech will be able to successfully integrate Tyndale Plains-Hunter
into its operations.
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Absence of Revenue from Vascular Grafts.
CardioTech's future growth will largely depend on its ability to
commercialize its vascular graft technology. CardioTech cannot assure you that
it will be able to accomplish this goal. To date, CardioTech has not generated
any revenue from the sale of vascular grafts in Europe and cannot assure you
that it will be successful in selling this product there. CardioTech is
currently in the initial stages of introducing its VascuLink Vascular Access
Graft for sale. CardioTech cannot assure you that it will be able to generate
sufficient revenue from product sales, sales of materials or development
services to fund its continuing operations.
Limited Revenue From Other Activities.
CardioTech is also engaged in the development of other uses for its premium
polymer-based materials in collaboration with other medical-device
manufacturers. Although such activities may generate revenues from medical
device manufacturers for development services performed by CardioTech or in
connection with the sale of materials, CardioTech's primary focus will be on its
vascular graft technology. Accordingly, CardioTech expects that revenues from
these other sources will be relatively small in the short term.
Access to Capital and Additional Financing Requirements.
CardioTech's future growth also will depend on its ability to raise
additional capital to support its research and development activities.
PolyMedica provided approximately $4.5 million in funding to CardioTech from
1991 through June 1996. In addition, CardioTech raised approximately $2,590,000
through the sale of (1) convertible notes and preferred stock to Dresdner
Kleinwort Benson Private Equity Partners LP and (2) convertible notes to
Freemedic PLC, a subsidiary of the Royal Free Hospital School of Medicine
(University of London). CardioTech also raised an additional $2,332,500,
including $200,000 in promissory notes from CardioTech's executive officers,
through a unit offering private placement which terminated on December 15, 1998.
The majority of these funds is being expended for research and development.
CardioTech cannot assure you that it will be able to raise sufficient additional
funds to adequately support its research and development efforts.
As of December 31, 1998, CardioTech had cash and cash equivalents of
approximately $3,161,613, which CardioTech expects to consume at a rate of
approximately $200,000 per month, not including any cash payments to be made to
acquire Tyndale Plains-Hunter. Accordingly, such cash and cash equivalents
should be adequate to maintain CardioTech's currently planned operations until
approximately April 2000. CardioTech will need additional funding to complete
the clinical trials for, and market, its VascuLink Vascular Access Graft in
Europe and to begin clinical trials in the United States. CardioTech will
require substantial funds for:
. further research and development;
. future pre-clinical and clinical trials;
. regulatory approvals;
. establishment of commercial-scale manufacturing
capabilities; and
. the marketing of its products.
CardioTech will seek to obtain additional funds for these purposes through:
. public or private equity or debt financings;
. collaborative arrangements; or
. from other sources.
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CardioTech cannot assure you that it will be able to raise sufficient additional
funding at all or on acceptable terms to permit successful commercialization of
CardioTech's technology and products. If CardioTech cannot raise adequate
additional funds, it may be required to curtail significantly one or more of its
research or development programs, or obtain funds through arrangements with
collaborative partners or others that may require CardioTech to relinquish
rights to certain of its technologies, product candidates or products.
Registration Rights and Dilution.
Dresdner Kleinwort Benson and FreeMedic PLC have certain rights to cause
CardioTech to register under the Securities Act of 1933 (the "Act") the Common
Stock underlying the Dresdner Kleinwort Benson convertible notes and preferred
stock (currently 1,358,903 shares) and the FreeMedic PLC convertible notes
(currently 116,182 shares). Additionally, John Hancock Mutual Life Insurance
Company has certain registration rights with regard to 403,063 shares of common
stock underlying warrants which CardioTech issued to John Hancock. If these
security holders require CardioTech to register the common stock underlying
their securities and sell the common stock in the public market, or if they sell
such common stock in the public market under Rule 144, the market price of our
common stock could fall.
Possible AMEX Delisting.
The common stock is listed on the American Stock Exchange, or the AMEX, and
CardioTech is subject to the AMEX's maintenance requirements. CardioTech's
failure to meet the AMEX's maintenance requirements may result in a delisting of
the common stock. CardioTech cannot assure you that its common stock will not be
delisted by the AMEX. The determination by the AMEX to delist a company is not
based on a precise mathematical formula, but rather on a review of all relevant
facts and circumstances in light of the AMEX's policies. The AMEX will normally
consider delisting a company which:
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(1) has stockholders' equity of less than $2,000,000 if such company has
sustained losses from continuing operations and/or net losses in two of its
three most recent fiscal years; or
(2) has sustained losses which are so substantial to its overall operations
or its existing financial resources, or its financial condition has become
so impaired that it appears questionable, in the opinion of the AMEX, as to
whether such company will be able to continue operations and/or meet its
obligations as they mature.
As of December 31, 1998, CardioTech had stockholders' equity of
$1,320,805, and losses in its last three fiscal years. If CardioTech is unable
to increase its stockholders' equity and its net losses continue, CardioTech's
common stock may be delisted. CardioTech's future financing activities may not
provide the Company with sufficient stockholders' equity to avoid being
delisted.
CardioTech's failure to maintain the listing of its common stock on AMEX
would constitute an event of default under the convertible notes agreement with
Dresdner Kleinwort Benson and would entitle Dresdner Kleinwort Benson to demand
immediate payment of the $2,160,000, plus accrued interest, due under the notes.
Upon such a default, actions taken by Dresdner Kleinwort Benson might result in
a default under the approximately $429,875 loan agreement with Freemedic PLC. At
this time, repayment of its indebtedness to Dresdner Kleinwort Benson and
Freemedic PLC would deplete most of CardioTech's cash reserves.
Possible Volatility of Stock Price.
CardioTech cannot assure you of the prices at which its common stock will
trade. The market prices for securities of emerging companies historically have
been highly volatile. The following factors may have a significant impact on the
market price of the common stock:
. announcements of technological innovations or new commercial products
by CardioTech or its competitors;
. regulatory developments;
. disputes concerning patent or proprietary rights;
. publicity regarding actual or potential medical results relating to
products under development by CardioTech or its competitors;
. public concern as to the safety of CardioTech's products; and
. economic and other external factors, as well as period-to-period
fluctuations in financial results.
Limited Rights in Technology; Uncertainty of Patents and Proprietary Rights.
CardioTech owns one U.S. patent, one U.S. patent pending and one European
patent valid in 18 European countries relating to vascular graft manufacturing
technology. In addition, PolyMedica granted CardioTech a perpetual, worldwide,
royalty-free license to use certain proprietary polyurethane technologies (the
"Biomaterial Technology") in the field consisting of development, manufacture
and sale of implantable medical devices and biodurable polymer materials to
third parties for use in medical applications (the "Implantable Devices and
Materials Field"). However, PolyMedica and CardioTech each have rights to use
the Biomaterials Technology to fabricate medical products (other than
implantable medical devices) themselves or in joint ventures with third parties.
In addition, PolyMedica has retained the rights to make sales of certain
formulations of ChronoFlex and such materials for non-medical applications. As a
result, PolyMedica may compete with CardioTech if CardioTech decides to
commercialize applications of the Biomaterials Technology in fields other than
those in which it has been granted an exclusive license. Also, Thermedics, Inc.,
as joint owner with PolyMedica of a patent and patent applications relating to
certain polyurethane technology, is free to use such rights or license them to
others in any field, including the Implantable Devices and Materials Field.
CardioTech's success will depend, in large part, on the following
abilities:
. to maintain its existing patents;
. to obtain new patents;
. to maintain trade secret protection; and
. to operate without infringing on the proprietary rights of third
parties or having third parties circumvent CardioTech's rights.
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PolyMedica has filed and obtained U.S. and foreign patents covering aspects of
the Biomaterials Technology. CardioTech cannot assure you, however:
. that any of CardioTech's or PolyMedica's existing patents will not be
challenged or future patent applications will result in the issuance
of patents;
. that CardioTech will develop additional proprietary products that are
patentable;
. that any additional patents issued to CardioTech will provide
CardioTech with any competitive advantages or will not be challenged
by any third parties; or
. that the patents of others will not impede the ability of CardioTech
to do business or that third parties will not be able to circumvent
CardioTech's patents and licensed technology.
Furthermore, CardioTech cannot assure you that others will not independently
develop or duplicate similar technology or products, or, if patents are issued
or licensed to CardioTech, design around the patents issued or licensed to
CardioTech.
CardioTech might have to obtain licenses from third parties to avoid
infringing patents or other proprietary rights. CardioTech cannot assure you
that any licenses required under any such patents or proprietary rights would be
made available, if at all, on terms acceptable to CardioTech. If CardioTech does
not obtain such licenses, it could encounter delays in product introductions, or
could find that the development, manufacture or sale of products requiring such
licenses could be prohibited. In addition, CardioTech could incur substantial
costs in defending itself in suits brought against it with respect to patents it
might infringe or in filing suits against others to have such patents declared
invalid.
Some of CardioTech's know-how and technology may not be patentable. To
protect its rights, CardioTech requires employees, consultants, advisors and
collaborators to enter into confidentiality agreements. CardioTech cannot
assure you, however, that these agreements will protect CardioTech's trade
secrets, know-how or other proprietary information in the event of any
unauthorized use or disclosure. Further, CardioTech's business may be adversely
affected by competitors who independently develop competing technologies,
especially if CardioTech obtains no, or only narrow, patent protection.
Technological Change and Competition.
The medical device industry is subject to rapid and substantial
technological change. Several companies currently sell synthetic graft products
for certain specific applications in the United States and worldwide and have
done so for many years. Although CardioTech believes that the attributes of its
polyurethane-based grafts will allow its products to compete effectively, these
companies can be expected to defend their market positions vigorously. Moreover,
while CardioTech is aware of only two competitors developing polyurethane-based
vascular grafts currently, potential competitors of CardioTech in the United
States and abroad are numerous and include, among others:
. both large and small synthetic materials companies;
. medical device firms;
. universities; and
. other research institutions.
CardioTech cannot assure you that its potential competitors will not succeed in
developing technologies and products that are more effective than any that are
being developed by CardioTech or that would render CardioTech's technologies and
products obsolete or noncompetitive. Many of these potential competitors have
substantially greater financial and technical resources and production and
marketing capabilities than CardioTech.
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Additionally, many of CardioTech's competitors have significantly greater
experience than CardioTech in conducting pre-clinical testing and clinical
trials of medical devices and obtaining FDA and other regulatory approvals of
products for use in health care. Moreover, Thoratec Corporation, one of the
Company's competitors, has developed a polyurethane vascular access graft and
has begun limited clinical trials in the United States and foreign countries. In
addition, Thoratec Corporation has begun to sell its product in Japan and has
affixed a CE Mark (the approval marking of the European Community) on its
product which enables it to sell the product throughout Europe. Accordingly,
CardioTech's competitors may succeed in obtaining FDA approval for products more
rapidly than CardioTech. If CardioTech commences significant commercial sales of
its vascular graft products, it will also be competing with respect to
manufacturing efficiency and marketing capabilities, areas in which it has
limited experience.
Attraction and Retention of Key Employees and Scientific Collaborators.
CardioTech is highly dependent on the principal members of its management
and scientific staff, the loss of whose services could have a material adverse
effect on CardioTech. Furthermore, recruiting and retaining qualified
scientific personnel to perform research and development work in the future will
also be critical to CardioTech's success. Although CardioTech believes it will
be successful in attracting and retaining skilled and experienced scientific
personnel, CardioTech cannot assure you that it will be able to attract and
retain such personnel on acceptable terms given the competition among numerous
medical device companies, universities and non-profit research institutions for
experienced scientists. CardioTech's anticipated growth and expansion into areas
and activities requiring additional expertise such as clinical testing,
governmental approvals, production and marketing, are expected to place
increased demands on CardioTech's resources. These demands are expected to
require the addition of new management personnel and the development of
additional expertise by existing management personnel. The failure to acquire
such services or to develop such expertise could materially adversely affect
CardioTech's business.
Limited Manufacturing Capability.
The development and manufacture of CardioTech's products are subject to:
(1) the Quality System Requirements and other relevant requirements
prescribed by the FDA; or
(2) other standards prescribed by the appropriate regulatory agency in the
country of use.
Although CardioTech currently has the ability to produce quantities of synthetic
vascular grafts sufficient to support its current needs and its needs for early-
stage clinical trials, it may need to acquire additional manufacturing
facilities and improve its manufacturing technology to meet the volume and cost
requirements for later clinical trials. CardioTech will require additional
manufacturing facilities to undertake commercial production of vascular grafts
if it elects to do so. CardioTech cannot assure you:
. that it will be able to obtain or manufacture such products in a
timely fashion at acceptable quality and prices;
. that it or its suppliers can comply with the Quality System
Requirements or other relevant requirements prescribed by the FDA or
appropriate foreign regulatory agencies; or
. that it or its suppliers will be able to manufacture an adequate
supply of product.
Absence of Sales and Marketing Experience.
CardioTech expects to market its vascular grafts either through independent
distributors/sales agents or co-marketing arrangements with third parties. To
date, CardioTech has had no experience in sales, marketing or distribution of
vascular grafts or other implantable devices. In order to market vascular grafts
directly, CardioTech would need to develop a marketing and sales staff with
technical expertise. CardioTech cannot assure you:
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. that it will be able to build such a marketing staff or sales force;
. that the cost of establishing such a marketing staff or sales force
will not exceed any product revenue; or
. that CardioTech's direct sales and marketing efforts will be
successful.
In addition, if CardioTech succeeds in bringing one or more products to market,
it may compete with other companies that currently have extensive and well-
funded marketing and sales operations. CardioTech cannot assure you that its
marketing and sales efforts would compete successfully against such other
companies. To the extent CardioTech enters into co-marketing arrangements, any
revenue received by CardioTech will be dependent on the efforts of third parties
and CardioTech cannot assure you that such efforts will be successful.
Extensive Government Regulation.
The production and marketing of CardioTech's products and ongoing research
and development activities are subject to extensive regulation by numerous
governmental authorities in Europe, the United States and other countries.
Prior to marketing any synthetic vascular grafts developed by Cardiotech in
Europe, CardioTech must affix a CE Mark, or mark of approval from the European
Community, to its product. The CE Mark denotes conformity with European
standards and allows certified medical devices to be placed on the market in all
European countries. In order to obtain a CE Mark, CardioTech must meet:
. the essential safety requirements of the European Medical Device
Directive ("EMDD");
. maintain a technical file consisting of all research data and
information about the medical device;
. adopt a conformity route for its product; and
. choose a Notified Body, an independent third party, who will be
responsible for reviewing the manufacturer's technical file to verify
that the manufacturer has addressed the requirements of the EMDD and
has satisfied certain clinical trial requirements.
In November 1998, CardioTech was awarded the right to affix the CE Mark to
its VascuLink Vascular Access Graft. As a result of this award, CardioTech has
begun to market this product in Europe. CardioTech cannot assure you, however,
that it will be able maintain regulatory approval or clearance for the sale of
this product in Europe. Additionally, CardioTech cannot assure you that with
regard to its other products, a Notified Body will determine that CardioTech's
technical file satisfies the requirements of the EMDD or that its products other
than the VascuLink Vascular Access Graft meet the essential safety requirements
of the EMDD. As a result, CardioTech cannot assure you that it will be able to:
. affix a CE Mark to its other implantable products;
. sell such other products in Europe; or
. maintain regulatory approval or clearance for its other products in
Europe.
Failure to obtain CE Marking or maintain regulatory approval or clearance for
its products could have a material adverse effect on CardioTech's business,
financial condition and results of operations.
Furthermore, prior to marketing any synthetic vascular grafts developed by
CardioTech in the United States, such products may undergo rigorous pre-clinical
testing and clinical trials, as well as an extensive regulatory approval process
mandated by the FDA. FDA approval may take many years and require the
expenditure of substantial resources. In addition, modifications to regulations
and changes in interpretation of regulations occur regularly and can materially
and adversely affect the timing and cost of the sale of CardioTech's product
introductions.
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CardioTech has limited experience in conducting and managing the pre-
clinical and clinical trials necessary to obtain government approvals.
CardioTech cannot assure you that the results of such clinical trials will be
consistent with the results obtained in pre-clinical studies or that the results
obtained in later phases of clinical trials will be consistent with those
obtained in earlier phases. CardioTech also cannot assure you that polyurethane-
based synthetic vascular grafts or other implantable products will be shown to
be safe and effective or that regulatory approval for any such product will be
obtained on a timely basis, if at all. Delays in obtaining regulatory approvals
would adversely affect the marketing of products developed by CardioTech and
CardioTech's ability to receive product revenue or royalties.
CardioTech's activities relating to the development of uses for its
polymer-based materials and implantable medical devices in collaboration with
other medical-device manufacturers may also be subject to regulatory approval
processes similar to those described above relating to vascular grafts.
Quarterly Fluctuations.
CardioTech's quarterly operating results are likely to vary significantly
depending on factors such as the results of pre-clinical or clinical trials and,
if CardioTech is able to commercialize its vascular graft products, the timing
of significant orders for vascular grafts. CardioTech's expense levels are based
in part on its expectations as to future revenue. If revenue levels are below
expectations, operating results will be adversely affected.
Health Care Reimbursement.
CardioTech's ability to commercialize vascular grafts successfully will
depend in part on the extent to which reimbursement for the cost of such
products and related treatment will be available from government health
administration authorities, private health coverage insurers and other
organizations. Third-party payers are increasingly challenging the price of
medical products and services. Significant uncertainty exists as to the
reimbursement status of newly approved health care products, and CardioTech
cannot assure you that adequate third-party coverage will be available to
maintain price levels sufficient for an appropriate return on its investment in
product development.
Product Liability.
The testing, marketing and sale of human healthcare products entail an
inherent risk of allegations or product liability, and CardioTech cannot assure
you that substantial product liability claims will not be asserted against it.
CardioTech currently has limited product liability insurance. CardioTech cannot
assure you that a product liability claim would not materially adversely affect
its business or financial condition.
Absence of Dividends.
CardioTech has never paid cash dividends on its common stock and does not
anticipate paying any cash dividends in the foreseeable future. CardioTech's
loan agreement with Dresdner Kleinwort Benson currently prohibits the payment of
cash dividends without Dresdner Kleinwort Benson's prior written consent.
Year 2000 Issues.
The Year 2000 Issue refers to potential problems with computer systems or
any equipment with computer chips or software that use dates where the date has
been stored as just two digits (e.g., 97 for 1997). On January 1, 2000, any date
recording mechanism incorporating the date sensitive software which uses only
two digits to represent the year may recognize a date using 00 as the year 1900
rather than the year 2000. This could result in a system failure or
miscalculations causing disruption of operations, including, among other things,
a temporary inability to process transactions, send invoices, or engage in
similar business activities. To address the Year 2000 Issue, CardioTech has
implemented a program with respect to its (1) internal information technology
systems, (2) non-information technology systems, and (3) external suppliers of
goods and services.
10
<PAGE>
CardioTech has completed a review of its internal information systems to
determine the extent of any Year 2000 problem. Based on this review, CardioTech
does not currently believe that it has material exposure to the Year 2000 Issue
with respect to its own information systems, since its core existing business
information systems correctly define the year 2000. Additionally, CardioTech has
completed an evaluation of its internal non-information systems and expects to
have its remediation and testing phases for these systems completed by the end
of September 1999.
CardioTech is contacting its major customers and suppliers regarding their
Year 2000 problems. To date, CardioTech is unaware of any such problems that
would materially adversely affect its operations or financial condition.
CardioTech cannot assure you, however:
. that it will be able to identify third party Year 2000 problems;
. that third party Year 2000 problems will be corrected on a timely
basis; or
. that a failure by such entities to correct a Year 2000 problem or a
correction which is incompatible with CardioTech's information systems
would not have a material adverse affect on CardioTech's operations or
financial condition.
In addressing Year 2000 issues, CardioTech estimates that total costs will
be approximately $17,500. To date, $5,000 of such expenses have been incurred
and expensed. Total costs consist primarily of external consulting fees and
personal computer replacements. The estimated costs are based on management's
current assessment and could change in the future. CardioTech cannot assure you
that actual Year 2000 costs incurred will be equal to or less than those
estimated at this time.
Although CardioTech believes that its primary IT system correctly defines
the year 2000, prudent business practices call for the development of
contingency plans. CardioTech's contingency plans will include strategies for
dealing with Year 2000-related system failures or malfunctions due to
CardioTech's internal systems or from external parties. A Year 2000 system
failure, either internal or that of an external provider, could prevent
CardioTech from being able to continue its operations, or could disrupt
financial and management controls and reporting systems. The Company expects to
complete its contingency plans by September 30, 1999.
CardioTech does not expect the Year 2000 Issue to have a material adverse
effect on its results of operations or financial position; however, if not
effectively remediated, negative effects from Year 2000 Issues, including those
related to internal systems, vendors, or customers, could have a material
adverse effect on CardioTech's operations or financial condition. CardioTech
cannot assure you that even if all planned actions are completed, it will not
experience some adverse effects from Year 2000 related issues.
11
<PAGE>
USE OF PROCEEDS
All net proceeds from the sale of our common stock will go to the selling
stockholders who offer and sell their shares. Accordingly, we will not receive
any proceeds from the selling stockholders' sale of their common stock.
12
<PAGE>
SELLING STOCKHOLDERS
CardioTech issued 1,706,000 of the shares offered hereby to certain of the
selling stockholders in a private placement of units, each unit consisting of
one share of common stock and one warrant to purchase one share of common stock.
Sales of the units were made pursuant to Unit Purchase Agreements between
CardioTech and each of the unit purchasers, dated as of November 9, 1998 and
December 15, 1998. The private placement terminated on December 15, 1998.
Fechtor, Detwiler & Co., Inc. acted as placement agent for the offering.
CardioTech will issue 1,706,000 of the shares offered hereby to certain of
the selling stockholders upon exercise of the warrants issued to the unit
purchasers in the unit private placement. CardioTech will issue 170,600 of the
shares offered hereby to certain of the selling stockholders upon exercise of
the placement agent warrants issued to Fechtor, Detwiler & Co., Inc. These
shares are being offered hereby pursuant to certain registration rights granted
to Fechtor, Detwiler.
The following table lists the selling stockholders and other information
regarding the beneficial ownership of the common stock by each of the selling
stockholders as of January 22, 1999. The information provided in the table
below has been obtained from the selling stockholders. The selling stockholders
may sell all, some or none of their shares in this offering. See "Plan of
Distribution."
<TABLE>
<CAPTION>
Names Shares Beneficially Maximum Number Number of
of Selling Owned Prior to Offering/(1)/ of Shares Being Shares Beneficially
Stockholders Number Percent Offered Owned After Offering(2)
- ----------------------- --------------------------------- ---------------------- ------------------------------
<S> <C> <C> <C> <C>
Maho and Shinichiro 40,000 * 40,000 0
Abe
Nishan Atinizian 50,000 * 50,000 0
Anthony D. Autorino 120,000 1.9% 100,000 20,000
Richard E. Carter 100,000 1.6% 100,000 0
Steven J. Caruso 40,000 * 40,000 0
Janet R. Childs 40,000 * 40,000 0
Manuel R. Costa 40,000 * 40,000 0
Betsey L. Detwiler (3) 20,000 * 20,000 0
Robert R. Detwiler (3) 270,800 4.3% 248,000 22,800
Kenneth M. Dorros 150,000 2.4% 150,000 0
Judith H. Dorros 20,000 * 20,000 0
James P. Douglas 40,000 * 40,000 0
Richard Fechtor(4) 22,800 * 22,800 0
Sheldon Fechtor (4) 22,800 * 22,800 0
Peter Fenton (4) 55,000 * 55,000 0
Randy Fill (4) 5,000 * 5,000 0
Laurence B. Flood 50,000 * 50,000 0
Jacob Golbitz (4) 5,000 * 5,000 0
Barbara W. Hillman and 40,000 * 40,000 0
Richard A. Hillman,
JTWROS
Cathey A. Huffam 40,000 * 40,000 0
</TABLE>
13
<PAGE>
<TABLE>
<CAPTION>
Names Shares Beneficially Maximum Number Number of
of Selling Owned Prior to Offering/(1)/ of Shares Being Shares Beneficially
Stockholders Number Percent Offered Owned After Offering(2)
- ----------------------- -------------------------- --------------- --------------------------
<S> <C> <C> <C> <C>
Philip & Elizabeth 50,000 * 50,000 0
Joseph
Kester Family Trust U/A 80,000 1.3% 80,000
Linda Kester & Sharon
Kester, TTEE
William S. Kmon 62,000 1.0% 62,000 0
Lawrence Levine 50,000 * 50,000 0
Ronald Lewis 260,000 4.2% 200,000 60,000
Estate of
Frederick F. Margosian 50,000 * 50,000 0
Carmine Martignetti 40,000 * 40,000 0
Rosalba A. McShane 40,000 * 40,000 0
Barrett Morgan 40,000 * 40,000 0
Robert M. & Rose A. 50,000 * 50,000 0
Mowbray
Pequot Scout Fund, L.P. 500,000 7.8% 500,000 0
William D. Petty 120,000 1.9% 120,000 0
Berry W. Phillips 40,000 * 40,000 0
Jeffrey R. Power (5) 164,000 2.6% 164,000 0
Douglas S. Roberts and 40,000 * 40,000 0
Elise C. Roberts,
JTWROS
Michael H. Salamon 40,000 * 40,000 0
Robert D. Sayrs 40,000 * 40,000 0
Sexton Family 40,000 * 40,000 0
Irrevocable Trust
John H. Sexton, IRA 40,000 * 40,000 0
Ross E. Sherbrooke 20,000 * 20,000 0
Trust
TJJ Corporation 160,000 2.6% 160,000 0
Laura Tze and Hsiung 50,000 * 50,000 0
Chia Tze, Tenants in
Common
John T. Walsh, Jr. 40,000 * 40,000 0
David I. J. Wang 300,000 4.8% 300,000 0
Barbara Whitney 50,000 * 50,000 0
Michael Wood (4) 8,000 * 8,000 0
Eric and Brenda Wood 40,000 * 40,000 0
Joel Yanowitz 60,000 1.0% 60,000 0
Elizabeth Youngerman 40,000 * 40,000 0
</TABLE>
* Less than one percent of the outstanding shares of common stock.
(1) The number of shares of common stock issued and outstanding on March 19,
1999 was 6,138,916. The calculation of number of shares owned and
percentage ownership for each listed selling stockholder is based upon
the number of shares of common stock issued and outstanding at March 19,
1999, plus the shares of common stock issuable upon exercise of currently
exercisable warrants held by such selling stockholder. Unless otherwise
indicated, the number of shares of common stock owned by each listed
selling stockholder equals the number of shares issued in the unit
private placement and an equal number of shares issuable upon exercise of
the warrants sold in the unit private placement.
14
<PAGE>
(2) Assumes that all of the shares held by the selling stockholders and being
offered under this prospectus are sold, that the shares are sold to
unaffiliated third parties and that the selling stockholders acquire no
additional shares of common stock before the completion of this offering.
(3) Betsey L. Detwiler and Robert R. Detwiler are husband and wife. The
number of shares listed above as beneficially owned by Mrs. Detwiler
does not include those shares beneficially owned by Mr. Detwiler and visa
versa. Shares beneficially owned by Mr. Detwiler include 48,000 shares
to be issued upon exercise of the placement agent warrant.
(4) Consists of shares to be issued upon the exercise of the placement agent
warrant.
(5) Includes 4,000 shares to be issued upon the exercise of the placement
agent warrant.
15
<PAGE>
PLAN OF DISTRIBUTION
CardioTech is registering the shares on behalf of the selling stockholders.
"Selling stockholders", as used in this prospectus, includes donees, pledgees
and distributees selling shares received from a named selling stockholder after
the date of this prospectus. The selling stockholders may offer their shares at
various times in one or more of the following transactions, or in other kinds of
transactions:
. transactions on the American Stock Exchange;
. in private transactions other than through the American Stock
Exchange;
. in connection with short sales of the CardioTech shares;
. by pledge to secure debts and other obligations;
. in connection with the writing of non-traded and exchange-traded call
options, in hedge transactions and in settlement of other transactions
in standardized or over-the-counter options; or
. in a combination of any of the above transactions.
The selling stockholders may sell their shares at market prices prevailing
at the time of sale, at prices related to such prevailing market prices, at
negotiated prices or at fixed prices.
The selling stockholders may use broker-dealers to sell their shares. If
this happens, broker-dealers will either receive discounts or commissions from
the selling stockholders, or they will receive commissions from purchasers of
shares for whom they acted as agents.
Selling stockholders also may resell all or a portion of the shares in open
market transactions in reliance upon Rule 144 under the Securities Act, provided
they meet the criteria and conform to the requirements of that Rule.
LEGAL MATTERS
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. of Boston,
Massachusetts, has delivered its opinion that the shares of common stock offered
in this prospectus have been validly issued and are fully paid and non-
assessable.
EXPERTS
CardioTech's consolidated balance sheet as of March 31, 1998 and 1997 and
the consolidated statements of income, retained earnings, and cash flows for
each of the three years in the period ended March 31, 1998, incorporated in this
Prospectus by reference from CardioTech's Annual Report on Form 10-K for the
year ended March 31, 1998 have been audited by PricewaterhouseCoopers LLP,
independent accountants, as stated in their report, which includes an
explanatory paragraph which states that CardioTech was a majority owned
subsidiary of PolyMedica Corporation from inception to June 12, 1996 and which
is incorporated herein by reference, and have been so incorporated in reliance
upon the report of such firm given upon their authority as experts in accounting
and auditing.
16
<PAGE>
WHERE YOU CAN FIND MORE INFORMATION
We are a public company and file annual, quarterly and special reports,
proxy statements and other information with the Securities and Exchange
Commission. You may read and copy any document we file at the SEC's public
reference room at 450 Fifth Street, N.W., Washington, D.C. 20549. You can
request copies of these documents by writing to the SEC and paying a fee for the
copying cost. Please call the SEC at 1-800-SEC-0330 for more information about
the operation of the public reference room. Our SEC filings are also available
to the public at the SEC's web site at "http://www.sec.gov." In addition, you
can read and copy our SEC filings at the office of the American Stock Exchange
at 86 Trinity Place, New York, New York 10006.
This prospectus is only part of a Registration Statement on Form S-3 that
we have filed with the SEC under the Securities Act and therefore omits certain
information contained in the Registration Statement. We have also filed exhibits
and schedules with the Registration Statement that are excluded from this
prospectus, and you should refer to the applicable exhibit or schedule for a
complete description of any statement referring to any contract or other
document. You may:
. inspect a copy of the Registration Statement, including the exhibits
and schedules, without charge at the public reference room, or
. obtain a copy from the SEC upon payment of the fees prescribed by
the SEC.
INCORPORATION OF DOCUMENTS BY REFERENCE
The SEC allows us to "incorporate by reference" the information we file
with it, which means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is
considered to be part of this prospectus and information we file later with the
SEC will automatically update and supersede this information. We incorporate by
reference the documents listed below and any future filings made with the SEC
under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934.
The documents we are incorporating by reference are:
. Annual Report on Form 10-K for the year ended March 31, 1998, filed
on June 29, 1998, as amended on October 22, 1998;
. Definitive Proxy Statement filed on July 29, 1998;
. Current Report on Form 8-K, filed on April 15, 1998;
. Quarterly Report on Form 10-Q, for the quarter ended June 30, 1998,
filed on August 13, 1998;
. Quarterly Report on Form 10-Q, for the quarter ended September 30,
1998, filed on November 16, 1998;
. Quarterly Report on Form 10-Q, for the quarter ended December 31,
1998, filed on February 16, 1999; and
. The description of the common stock contained in our Registration
Statement on Form 10 filed with the SEC on March 20, 1996, including
any amendments or reports filed for the purpose of updating such
description.
17
<PAGE>
<TABLE>
=========================================================== ======================================================
<S> <C>
You should rely only on the information 3,582,600 shares
contained in this prospectus. We have not
authorized anyone to provide you with
information different from that contained in CardioTech International, Inc.
this prospectus. The selling stockholders are
offering to sell and seeking offers to buy
shares of our common stock only in Common Stock
jurisdictions where offers and sales are ($.01 par value per share)
permitted. The information contained in this
prospectus is accurate only as of April
5, 1999. You should not assume that this -----------------
prospectus is accurate as of any other date. PROSPECTUS
-----------------
</TABLE>
<TABLE>
<CAPTION>
TABLE OF CONTENTS
Page
--
<S> <C>
CardioTech's Business.............................. 2
Recent Developments................................ 2
Risk Factors....................................... 3
Use of Proceeds.................................... 11
Selling Stockholders............................... 12
Plan of Distribution............................... 15
Legal Matters...................................... 15
Experts............................................ 15
Where You Can Find More Information................ 16
Incorporation of Documents by Reference............ 16
April 5, 1999
=========================================================== ======================================================
</TABLE>
<PAGE>
PART II. INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The following table sets forth the Company's estimates (other than the SEC
and AMEX registration fees) of the expenses in connection with the issuance and
distribution of the shares of common stock being registered. None of the
following expenses are being paid by the selling stockholders.
<TABLE>
<CAPTION>
Item Amount
- ---- ---------
<S> <C>
SEC registration fee............................................................... $ 1,493.94
Amex listing fee................................................................... 17,500.00
Legal fees and expenses............................................................ 77,000.00
Accounting fees and expenses....................................................... 55,000.00
Placement Agent Fees............................................................... 129,656.00
Miscellaneous fees and expenses.................................................... 7,500.00
Total.............................................................................. $288,149.94
</TABLE>
Item 15. Indemnification of Directors and Officers.
Massachusetts General Laws, Chapter 156B, Section 67, empowers a
Massachusetts corporation to indemnify any person in connection with any action,
suit or proceeding brought or threatened by reason of the fact that such person
is or was a director, officer, employee or agent of the corporation or was
serving as such with respect to another corporation or other entity at the
request of such corporation, unless such person shall have been adjudicated in
any proceeding not to have acted in good faith in the reasonable belief that
such action was in the best interests of the corporation. CardioTech's Amended
and Restated Bylaws contain provisions that require the Company to indemnify its
directors and officers to the fullest extent permitted by Massachusetts law.
Item 16. Exhibits and Financial Statement Schedules
(a) Exhibits.
2 Plan and Agreement of Distribution between PMI and CardioTech,
dated May 13, 1996 (filed as Exhibit 2 to CardioTech's Form 10
filed on March 20, 1996, as amended (the "Form 10"), and
incorporated herein by reference).
4.1 Restated Articles of Incorporation (filed as Exhibit 3.1 to the
Form 10 and incorporated herein by reference).
4.2 Amended and Restated Bylaws (filed as Exhibit 3.2 to the Form
10 and incorporated herein by reference).
4.3 Certificate of Vote of Directors Establishing a Class or Series
of Stock for Series A Preferred Stock. (Filed as Exhibit 3.1
to the Registrant's Quarterly Report on Form 10-Q for the
fiscal period ended September 30, 1998 filed with the
Securities and Exchange Commission on November 16, 1998 and
incorporated herein by reference, Commission File No. 0-28034.)
*5.1 Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
regarding legality
II-2
<PAGE>
23.1 Consent of PricewaterhouseCoopers LLP
*23.2 Consent of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
*24.1 Power of Attorney (included on signature page)
*99.1 Form of Unit Purchase Agreement between CardioTech
International, Inc. and each of the selling stockholders.
*99.2 Form of Warrant to Purchase Shares of Common Stock of
CardioTech International, Inc. issued to each of the selling
stockholders.
*99.3 Form of Warrant Agreement by and among CardioTech
International, Inc., Fechtor, Detwiler & Co., Inc., and certain
of Fechtor, Detwiler's employees, and related form of Warrant
Certificate to Purchase Shares of CardioTech International, Inc.
Common Stock.
- -----------------
* Previously filed as an Exhibit to the Form S-3 filed with the Securities
and Exchange Commission on February 12, 1999, Reg. No. 333-72223, and
incorporated herein by reference.
Item 17. Undertakings
(a) The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this Registration Statement:
(i) To include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually
or in the aggregate, represent a fundamental change in the
information set forth in the registration statement.
Notwithstanding the foregoing, any increase or any decrease in
volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered)
and any deviation from the low or high end of the estimated
maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b)
if, in the aggregate, the changes in volume and price
represent no more than a 20% change in the maximum aggregate
offering price set forth in the "Calculation of Registration
Fee" table in the effective registration statement; and
(iii) To include any material information with respect to the
plan of distribution not previously disclosed in the
registration statement or any material change to such
information in the registration statement;
provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not apply if
the registration statement is on Form S-3, Form S-8 or Form F-3, and the
information required to be included in a post-effective amendment by those
paragraphs is contained in periodic reports filed with or furnished to the
Commission by the Registrant pursuant to Section 13 or Section 15(d) of the
Securities Exchange Act of 1934 that are incorporated by reference in the
registration statement.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof.
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain
unsold at the termination of the offering.
(b) 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 provisions, or
II-3
<PAGE>
otherwise, the Registrant has been advised that in the opinion
of the Securities and Exchange Commission such indemnification
is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the
payment by the Registrant of expenses incurred or paid by a
director, officer or controlling person of the Registrant in
the successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in
connection with the securities being registered, the Registrant
will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Act and will be governed by the final adjudication of such
issue.
(c) The undersigned Registrant hereby undertakes that, for purposes
of determining any liability under the Securities Act of 1933,
each filing of the Registrant's annual report pursuant to
Section 13(a) or Section 15(d) of the Securities Exchange Act
of 1934 that is incorporated by reference in the registration
statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of
such securities at that time shall be deemed to be the initial
bona fide offering thereof.
II-4
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
has duly caused this Amendment No. 1 to the Registration Statement to be signed
on its behalf by the undersigned, thereunto duly authorized, in the City of
Woburn and Commonwealth of Massachusetts on the 5th day of April, 1999.
CARDIOTECH INTERNATIONAL, INC.
By: /s/Michael Szycher
-------------------------
Michael Szycher, Ph.D.
Chairman and Chief Executive Officer
POWER OF ATTORNEY
Pursuant to the requirements of the Securities Act of 1933, this Amendment
No. 1 to the Registration Statement has been signed below by the following
persons and in the capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Title Date
- --------------------------------- -------------------------------------------------------------------------- ----------------
<S> <C> <C>
/s/ Michael Szycher Chairman of the Board of Directors, Chief Executive Officer and Treasurer
- --------------------------------- (Principal Executive Officer) April 5, 1999
Michael Szycher, Ph.D.
Chief Operating Officer, Chief Financial Officer and Clerk (Principal
- --------------------------------- Financial and Accounting Officer) April 5, 1999
John E. Mattern
Executive Vice President and Director April 5, 1999
- --------------------------------
Alan Edwards
Vice President of Regulatory Affairs and Quality Assurance April 5, 1999
- ---------------------------------
Michael Adams
Director April 5, 1999
- ---------------------------------
Michael L. Barretti
</TABLE>
*By executing his name hereto, Michael Szycher is signing this document on
behalf of the persons indicated above pursuant to powers of attorney duly
executed by such persons and filed with the Securities and Exchange Commission.
By: /s/ Michael Szycher
--------------------------
Michael Szycher
(Attorney-in-Fact)
**Each of Messrs. Mattern, Edwards, Adams and Barretti constitutes and
appoints Michael Szycher and John E. Mattern, and each of them (with full power
to each of them to act alone), his true and lawful attorneys-in-fact and agents,
with full power of substitution and resubstitution in each of them for him and
in his name, place and stead, and in any and all capacities, to sign any and all
amendments (including post-effective amendments) to this Registration Statement
(or any other Registration Statement for the same offering that is to be
effective upon filing pursuant to Rule 462(b) under the Securities Act of 1933,
as amended), and to file the same, with all exhibits thereto and other documents
in connection therewith, with the Securities and Exchange Commission, granting
unto said attorneys-in-fact and agents, and each of them, full power and
authority to do and perform each and every act and thing requisite or necessary
to be done in and about premises, as full to all intents and purposes as he
might or could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents or any of them or their or his substitute or
substitutes may lawfully do or cause to be done by virtue hereof.
II-5
<PAGE>
EXHIBIT INDEX
Exhibit
Number Exhibit
- ------ -------
2 Plan and Agreement of Distribution between PMI and CardioTech, dated
May 13, 1996 (filed as Exhibit 2 to CardioTech's Form 10 filed on
March 20, 1996, as amended (the "Form 10"), and incorporated herein
by reference).
4.1 Restated Articles of Incorporation (filed as Exhibit 3.1 of the
Form 10 and incorporated herein by reference).
4.2 Amended and Restated Bylaws (filed as Exhibit 3.2 of the Form 10 and
incorporated herein by reference).
4.3 Certificate of Vote of Directors Establishing a Class or Series of
Stock for Series A Preferred Stock. (Filed as Exhibit 3.1 to the
Registrant's Quarterly Report on Form 10-Q for the fiscal period
ended September 30, 1998 filed with the Securities and Exchange
Commission on November 16, 1998 and incorporated herein by
reference.)
* 5.1 Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
regarding legality
23.1 Consent of PricewaterhouseCoopers LLP
*23.2 Consent of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
*24.1 Power of Attorney (included on signature page)
*99.1 Form of Unit Purchase Agreement between CardioTech International,
Inc. and each of the selling stockholders.
*99.2 Form of Warrant to Purchase Shares of Common Stock of CardioTech
International, Inc. issued to each of the selling stockholders.
*99.3 Form of Warrant Agreement by and among CardioTech International,
Inc., Fechtor, Detwiler & Co., Inc., and certain of Fechtor,
Detwiler's employees, and related form of Warrant Certificate to
Purchase Shares of CardioTech International, Inc. Common Stock.
- -------------
* Previously filed as an Exhibit to the Form S-3 filed with the Securities and
Exchange Commission on February 12, 1999, Reg. No. 333-72223, and
incorporated herein by reference.
<PAGE>
EXHIBIT 23.1
CONSENT OF INDEPENDENT ACCOUNTANTS
We consent to the incorporation by reference in this Registration Statement
on Form S-3 of our report, which includes an explanatory paragraph that
CardioTech was a majority owned subsidiary of PolyMedica Corporation from
inception to June 12, 1996, dated May 27, 1998, on our audits of the
consolidated financial statements of CardioTech International, which report
is included in the Company's Annual Report on Form 10-K for the year ended
March 31, 1998. We also consent to the reference to our firm under the caption
"Experts".
/S/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Boston, Massachusetts
April 5, 1999
