<PAGE> 1
As filed with the Securities and Exchange Commission on
March 10, 1998
Registration No. _________________
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-8 REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
ORTEC INTERNATIONAL, INC.
(Exact name of issuer as specified in its charter)
DELAWARE 11-3068704
(State or other jurisdiction of (I.R.S. Employer Identification No.)
Incorporation or organization)
3960 Broadway, New York, New York 10032
(Address of principal executive offices)
A. ORTEC INTERNATIONAL, INC. 1996 STOCK OPTION PLAN
B. REOFFERING OF SHARES OF ORTEC INTERNATIONAL, INC.
HELD BY ROBERT A. ABRAHAMS, ACQUIRED UPON HIS EXERCISE
OF A WARRANT PURSUANT TO AN OPTION DATED AS OF FEBRUARY 1, 1995,
BY AND BETWEEN ORTEC INTERNATIONAL, INC. AND ROBERT A. ABRAHAMS
(FULL TITLE OF THE PLANS)
STEVEN KATZ, PHD, PRESIDENT
ORTEC INTERNATIONAL, INC.
3960 BROADWAY
NEW YORK, NEW YORK 10032
(212) 740-6999
(NAME, ADDRESS AND TELEPHONE NUMBER,
INCLUDING AREA CODE, OF AGENT FOR SERVICE)
COPY TO:
GABRIEL KASZOVITZ, ESQ.
FEDER, KASZOVITZ, ISAACSON, WEBER, SKALA & BASS LLP
750 LEXINGTON AVENUE
NEW YORK, NEW YORK 10022
(212) 888-8200
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: FROM
TIME TO TIME AFTER THE REGISTRATION STATEMENT BECOMES EFFECTIVE.
<PAGE> 2
CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
PROPOSED PROPOSED
TITLE OF MAXIMUM MAXIMUM
SECURITIES AMOUNT OFFERING AGGREGATE AMOUNT OF
TO BE TO BE PRICE OFFERING REGISTRATION
REGISTERED REGISTERED PER SHARE PRICE FEE
<S> <C> <C> <C> <C>
Common Stock 296,000(1)_ $ (2) $2,652,325(3) $ 782.44
($.001 par shares
value)
Common Stock 56,000(4) $14.00 $ 784,000(5) $ 231.28
($.001 par shares
value)
Total 352,000
shares $1,013.72
</TABLE>
- ------
(1) Shares underlying options already granted under the Company's 1996
Stock Option Plan (the "Plan").
(2) The maximum offering prices per share are equal to the various
exercise prices of the options already granted under the Plan.
(3) The product resulting from multiplying the number of shares underlying
options already granted under the Plan by the various exercise prices
at which such options may be exercised, as determined in accordance
with Rule 457(h) of the Securities Act of 1933, as amended.
(4) Includes 54,000 shares underlying the Plan for which no options have
been granted, and 2,000 shares held by Robert A. Abrahams, who
received such shares upon his exercise of a warrant issued in
connection with an option agreement dated as of February 1, 1995 by
and between the Company and Mr. Abrahams. Such 2,000 shares held by
Mr. Abrahams are being registered hereby pursuant to a reoffering
prospectus.
(5) Estimated solely for purposes of calculating the registration fee on
the basis of the product resulting from multiplying 56,000 shares of
Common Stock by $14.00, the average of the high and low prices of the
shares of Common Stock on the Nasdaq SmallCap Market on March 6, 1998.
<PAGE> 3
PROSPECTUS
PART I
INFORMATION REQUIRED IN THE SECTION 10(a) PROSPECTUS
ORTEC INTERNATIONAL, INC.
122,000 SHARES
COMMON STOCK
This Prospectus covers 122,000 shares of Common Stock, par value $.001
per share (the "Common Stock") of Ortec International, Inc., a Delaware
corporation (the "Company"), including 120,000 shares issuable by the Company
upon the exercise of options (the "Options") granted by the Company under its
1996 Employee Stock Option Plan. Other than proceeds received by the Company
from the exercise of the Options, the Company will not receive any proceeds from
the sale of the shares offered hereby. The holders of the shares covered by this
Prospectus intend to sell the shares offered hereby from time to time for their
own respective accounts in the open market at the prices prevailing therein or
in individually negotiated transactions at such prices as may be agreed upon.
Each such holder will bear all expenses with respect to the offering of shares
by him except the costs associated with preparing and printing this Prospectus.
The Common Stock of the Company is traded on the NASDAQ SmallCap Market
system under the symbol "ORTC." On March 6, 1998, the last reported sale price
of the Common Stock was $14.00.
THIS DOCUMENT CONSTITUTES PART OF A PROSPECTUS
COVERING SECURITIES THAT HAVE BEEN REGISTERED
UNDER THE SECURITIES ACT OF 1933.
---------------------
SEE "RISK FACTORS" AT PAGE 6 FOR INFORMATION THAT
SHOULD BE CONSIDERED BY PROSPECTIVE INVESTORS
---------------------
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.
THE DATE OF THIS PROSPECTUS IS MARCH 10, 1998
1
<PAGE> 4
AVAILABLE INFORMATION
Since January 20, 1996, the Company has been subject to the reporting
requirements of the Securities Exchange Act of 1934, as amended (the "Exchange
Act"). In accordance with the Exchange Act, the Company has and will continue to
file reports, proxy statements and other information with the Securities and
Exchange Commission (the "Commission"). Reports and other information filed by
the Company may be inspected and copied at the public reference facilities of
the Commission in Washington, D.C. Copies of such materials can be obtained from
the Public Reference Section of the Commission, Washington, D.C. 20549, at
prescribed rates. In addition, the Commission maintains a web site at
http://www.sec.gov that contains reports, proxy and information statements and
other information regarding registrants that file electronically with the
Commission. The Company's Common Stock is listed on the NASDAQ SmallCap Market
and reports and information concerning the Company can also be inspected through
such exchange. The Company intends to furnish its shareholders with annual
reports containing audited financial statements and such other periodic reports
as the Company deems appropriate or as may be required by law.
The Company will provide without charge to each person who receives
this Prospectus, upon written or oral request of such person, a copy of any of
the information that is incorporated by reference unless the exhibits are
themselves specifically incorporated by reference. Such requests should be
directed by mail to Mr. Ron Lipstein, Secretary, Ortec International, Inc., 3960
Broadway, New York, NY 10032, or by telephone at (212) 740-6999.
The Company has filed with the Commission a Registration Statement on
Form S-8 and all schedules and exhibits thereto under the Securities Act of
1933, as amended (the "Securities Act"), with respect to the Common Stock
offered by this Prospectus. This Prospectus does not contain all of the
information set forth in the Registration Statement, certain parts of which are
omitted in accordance with the rules and regulations of the Commission. For
further information with respect to the Company and this Offering, reference is
made to such Registration Statement, including the exhibits filed therewith,
which may be inspected without charge at the Commission's principal office at
450 Fifth Street, N.W., Washington, D.C. 20549. Copies of the Registration
Statement may be obtained from the Commission at its principal office upon
payment of prescribed fees. Statements contained in this Prospectus as to the
contents of any contract or other document are not necessarily complete and,
where the contract or other document has been filed as an exhibit to the
Registration Statement, each such statement is qualified in all respects by
reference to the applicable document filed with the Commission.
2
<PAGE> 5
PROSPECTUS SUMMARY
All the information in this summary is qualified in its entirety by the
more detailed information included elsewhere in this Prospectus. For definition
of certain terms and abbreviations used in this Prospectus, see the "Glossary"
on Page A.
THE COMPANY
ORTEC INTERNATIONAL, INC. (the "Company") has developed a proprietary
technology which consists of a biologically active dressing to stimulate the
repair and regeneration of human skin. The Company's product is intended to be
utilized for the treatment of severe burn patients as well as for other types of
wound healing and for reconstructive and cosmetic surgery. The Company believes
that the successful regeneration of human skin creates the potential for wide
commercial application.
The Company is a development stage company and to date has not sold any
products. Its activities have been limited to human clinical tests of its
product and research and development under an exclusive license relating to the
Company's biological dressing. From March 12, 1991 (inception) to September 30,
1997, the Company spent an aggregate of $4,177,871 for research and development
In order to create a clinically useful biological dressing, the Company
has duplicated the two major layers that form the human skin, the epidermis and
the dermis. Dr. Mark Eisenberg, of Sydney, Australia, an officer and director of
the Company and one of its largest shareholders, has been involved in
biochemical and clinical research at the University of New South Wales in
Australia for over twenty years, focusing primarily in treating the symptoms of
a unique disease called Epidermolysis Bullosa ("EB"). The wounds resulting from
EB are very similar to those caused by burns and require similar treatment. In
1987, through his work on EB, Dr. Eisenberg first succeeded in growing epidermal
layers of human skin, which were successfully applied as an allograft on an EB
patient. Dr. Eisenberg has since developed a biologically active dressing known
as "Composite Cultured Skin", consisting of both the dermal and epidermal
layers.
In March 1994, the Company commenced human clinical trials on burn
patients under protocols approved by the Food and Drug Administration ("FDA"),
which require testing of 120 patients. As of February 4, 1998, 16 patients have
been treated under this program at three different hospitals. More trials will
be necessary to test the safety and efficacy of the Company's product. From 1988
to 1996, the Company's product was used in skin replacement operations on 29
patients (of which 5 operations were skin replacement for burn patients) in
Sydney, Australia. None of the Australian procedures were performed in
accordance with the FDA approved protocols.
3
<PAGE> 6
In 1996, the FDA approved the protocols of Rockefeller University
Hospital in New York City for the use of the Company's Composite Cultured Skin
for the treatment of non-healing skin ulcers of patients with EB. Under this FDA
approved clinical trial protocol, ten to fifteen patients are required to be
treated under this program. Rockefeller University has, as of the date of this
Prospectus, conducted the human clinical trials on 11 EB patients under this
program and may conduct up to an additional 4 human clinical trials on EB
patients.
In December 1997 the FDA approved protocols of Washington Hospital
Center in Washington, D.C., for the use of the Company's Composite Cultured Skin
in a pilot clinical trial program for the treatment of 15 to 20 patients with
donor site wounds. Donor sites are those areas of the body from which healthy
skin is taken and transplanted onto a wound site (an "autograft" skin
transplant), thus creating an additional wound at the donor site which then has
to be treated. As of the date of this Prospectus, the human clinical trials
under this program are expected to begin shortly. The protocols require
follow-up evaluations of the patients for six months after the treatment.
The executive offices of the Company are located at 3960
Broadway, New York, New York 10032. Its telephone number is (212) 740-6999.
4
<PAGE> 7
THE OFFERING
Securities Included
in this Prospectus 122,000 shares of Common Stock.
Common Stock outstanding
as of the date hereof
(including 2,000 of the
122,000 shares included
in this Prospectus)(1) 5,766,827 Shares
Use of Proceeds Other than the proceeds received upon the
exercise of the Options, the Company will not
receive any proceeds from the sale of the shares
offered hereby. See "Use of Proceeds."
Risk Factors An investment in the shares offered hereby
involves a high degree of risk. See "Risk
Factors."
NASDAQ Trading Symbol
for Common Stock "ORTC"
- ---------------------------
(1) Unless otherwise indicated, no effect is given in this Prospectus to
(i) 1,200,000 shares reserved for issuance upon exercise of the
Company's publicly held Class B Warrants, exercisable at $15 per share,
expiring January 19, 1999; (ii) 257,072 shares reserved for issuance
upon exercise of warrants expiring January 19, 2000 exercisable at
$1.00 per share; (iii) 240,000 shares reserved for issuance upon the
exercise of the options granted to the Underwriter in the Company's
initial public offering ("IPO") and the warrants included therein,
exercisable at per share prices of $8.75 for 120,000 shares expiring
December 15, 2000, and $24.75 for the remaining 120,000 shares expiring
on January 19, 1999; (iv) 350,000 shares reserved for issuance upon the
exercise of stock options included in the Company's 1996 Stock Option
Plan, of which options to purchase 296,000 shares at prices of ranging
from $6 to $14.25 have already been granted; and (v) 556,226 shares
reserved for issuance upon the exercise of other outstanding warrants
at prices ranging from $6 to $14.25 and expiring at various times from
March 1997 to December 2002.
5
<PAGE> 8
RISK FACTORS
The purchase of the shares offered hereby involves a high degree of
risk, including, but not necessarily limited to, the risks described below.
Before subscribing for the shares, each prospective investor should consider
carefully the general investment risks enumerated elsewhere in this Prospectus
and the following risk factors, as well as the other information contained in
this Prospectus.
NEED FOR FUTURE FINANCING. The Company anticipates that its cash on
hand is sufficient to meet its cash requirements through approximately the end
of January 2000. However, there can be no assurance that unexpected costs will
not be incurred. At the end of that period the Company may be required to raise
additional funds to complete its different human clinical trials (if not
completed by then) and produce and market its Composite Cultured Skin. The
Company may then, or earlier, seek additional funds through sale of its
securities to the public and through private markets, debt financing or short
term loans. There can be no assurance that the Company will be able to obtain
additional financing on terms acceptable to it, if at all. The failure of the
Company to obtain acceptable additional financing would have a material adverse
effect on the operations of the Company. Additional financing may result in
dilution for then current shareholders. See "Forward Looking Information May
Prove Inaccurate."
DEVELOPMENT STAGE COMPANY; LIMITED OPERATING HISTORY. The Company is a
development stage company organized in March 1991. It has no products approved
for commercial sale and has not realized any operating revenues. The Company is
likely to continue to encounter difficulties which are common to development
stage companies, including unanticipated costs relating to development, delays
in the testing of products, regulatory approval and compliance and competition.
The Company will not, in all likelihood, generate any revenues until it obtains
FDA approval to sell its skin replacement product in commercial quantities for
human application. There can be no assurance that such approval will be
obtained, or if obtained, that sales of the Company's product can be made on a
profitable basis.
UNCERTAINTY OF CLINICAL TRIALS; NEED TO OBTAIN FDA PREMARKETING
APPROVAL; GOVERNMENT REGULATION. Pursuant to the Federal Food Drug and Cosmetic
Act and regulations promulgated thereunder, the FDA regulates the manufacture,
distribution and promotion of medical devices in the United States. The
Company's Composite Cultured Skin is subject to regulation as a medical device.
Prior to commercial release of the Company's product, premarket approval ("PMA")
by the FDA will be required. PMA entails proof of nontoxicity, safety and
efficacy in human clinical trials. Premarket approval is a lengthy and expensive
process and there can be no assurance that FDA approval will be obtained. In
1994, 1996 and February 1998 the Company received FDA approval to commence human
clinical trials for use of its Composite Cultured Skin for burn patients, EB
patients and for donor site wounds, respectively. The human clinical trials and
the PMA are lengthy and
6
<PAGE> 9
costly processes, the successful completion of which cannot be assured.
Moreover, even if the Company obtains FDA approval, the Composite Cultured Skin
and any manufacturing facilities used to manufacture it will continue to be
subject to review, periodic inspections and specific recordkeeping, reporting,
product testing, design, safety and labeling requirements. Accordingly, the
Company's business, financial condition and emergence from the development stage
are dependent on timely FDA approval for its product.
UNCERTAINTY OF MARKET ACCEPTANCE; RELIANCE ON ONE PRODUCT. Acceptance
of the Company's product is difficult to predict and will require substantial
marketing efforts and the expenditure of significant funds. There can be no
assurance that the Company's product will be successful in providing viable skin
replacement on a commercial basis or that it will be accepted by the medical
community. In addition, the Company's only product is its Composite Cultured
Skin. The Company does not expect its product to be available for commercial
sale for at least two years. The Company expects that its Composite Cultured
Skin will likely be, if and when commercially available, its sole product for an
indefinite period of time. Failure of the Company's product to achieve market
acceptance will have a material adverse impact on the Company's financial
condition.
TECHNOLOGICAL CHANGE; HIGHLY COMPETITIVE INDUSTRY. The biomedical field
is undergoing rapid and significant technological change. The Company's success
will depend on its ability to establish and maintain a competitive position in
this marketplace. Many companies and academic institutions have developed, or
are capable of developing products based on other technologies that are or may
be competitive with the Company's product. The Company's competitors include
Organogenesis, Inc., Genzyme Tissue Repair, Inc., Advanced Tissue Sciences,
Inc., Life Cell Corporation and Integra Life Sciences. Many of those and other
potential competitors are well established, are much larger than the Company and
have substantially greater financial and other resources than the Company and
have established reputations for success in the development, sale and service of
their products. Such companies and academic institutions may succeed in
developing products that are more effective than the Company's Composite
Cultured Skin or that will receive FDA approval more quickly than the Company's
product. The FDA panel reviewing Organogeneses' product for the treatment of
venous stasis ulcers has recommended FDA approval of such product for sale to
the public. The FDA panel reviewing Advanced Tissue Science's product for the
treatment of diabetic ulcers has recommended FDA approval of such product for
sale to the public.
ANTICIPATED DEPENDENCE ON THIRD PARTIES FOR MARKETING; LIMITED
MARKETING EXPERIENCE. The Company intends to sell its product primarily through
its own efforts and may use third party distributors on a limited basis. The
Company has no marketing experience and has limited financial and other
resources to undertake extensive independent marketing activities. There can be
no assurance that the Company will be able to market its Composite Cultured Skin
successfully or enter into agreements with third parties on acceptable terms for
such services.
7
<PAGE> 10
LIMITED SUPPLIES OF MATERIALS. The Company is currently purchasing
bovine collagen sponges, a key component of its product, from one supplier who
produces the sponges to the Company's specifications. The Company has no written
agreement with that supplier obligating the supplier to supply sponges to the
Company. If the Company were required to secure another source for its bovine
collagen sponges, the Company would encounter considerable additional delay and
expense in continuing its human clinical trials and, consequently, in marketing
its Composite Cultured Skin.
The Company will continue to rely on a limited number of outside
suppliers to supply other materials that it uses in producing and testing its
Composite Cultured Skin. No assurance can be given that the Company or its
suppliers will continue to have access to a sufficient supply of these
materials.
LIMITATIONS OF PATENT PROTECTION. The Company has been granted, and
relies on, an exclusive license from Dr. Mark Eisenberg, a major shareholder,
officer and director of the Company, who developed the Company's Composite
Cultured Skin, for worldwide rights to market the technology and any products
developed from it.
Dr. Eisenberg has been granted patents for the Company's Composite
Cultured Skin in the United States and in several foreign countries and is
prosecuting patent claims for it in others. There can be no assurance that the
United States patent will not be successfully challenged in court proceedings.
Nor can there be any assurance that any United States or foreign patents will
provide any commercial benefits to the Company.
Several of the Company's competitors, including Organogenesis, Inc.,
Advanced Tissue Sciences, Inc., Genzyme Tissue Repair Inc., Integra Life
Sciences and LifeCell Corporation have been granted patents relating to their
particular artificial skin technologies.
PRODUCT LIABILITY. The Company is exposed to the risk of product
liability claims in the event that its product causes injury or otherwise
results in adverse effects. Although the Company has obtained product liability
insurance coverage in the amount of $1,000,000, there can be no assurance that
such insurance coverage will be adequate to protect the Company against future
product liability claims or that product liability insurance will be available
to the Company in the future on terms acceptable to the Company, if at all.
DEPENDENCE ON KEY PERSONNEL. The Company is dependent on Steven Katz,
PhD, the Company's president, for managing the affairs of the Company. The
unavailability of Dr. Katz to manage such affairs would have a materially
adverse effect on the Company's business.
FUTURE SALE OF UNREGISTERED SECURITIES; REGISTRATION RIGHTS. 1,546,069
shares of the Company's presently outstanding shares of Common Stock are
"restricted securities," as that term is defined under Rule 144 ("Rule 144")
promulgated under the Act. In general, under Rule 144 a person who owns any
restricted shares of Common Stock for at least one
8
<PAGE> 11
year may sell in the public securities markets, within any three month period,
such number of those restricted shares that does not exceed the greater of one
percent of the total number of outstanding shares of the same class or the
average weekly trading volume during the four calendar weeks preceding the sale.
A person who has not been an affiliate of the Company for at least three months
immediately preceding the sale and who owns shares of Common Stock that have
been held for a period of at least two years is entitled to sell such shares
under Rule 144 without regard to any volume limitations. 1,794,750 additional
shares that are issuable upon exercise of outstanding warrants and options, or
pursuant to warrants and options that may be granted in the future under the
Company's Employee Stock Option Plan will be eligible for immediate sale into
the public securities markets after such warrants and options are exercised as
follows: In addition, 808,548 shares that are issuable upon exercise of other
outstanding warrants and options exercisable at prices ranging from $1.00 (for
257,072 shares) to $14.25, are eligible for sale in the public securities
markets one or two years after such warrants and options are exercised.
No prediction can be made as to the effect, if any, that sales of those
shares of Common Stock, or the availability of those shares for sale, will have
on the market prices of the Common Stock prevailing from time to time.
EFFECT OF OUTSTANDING OPTIONS AND WARRANTS. Sales of the Company's
Common Stock upon exercise of options and warrants may have a depressive effect
on the market price of the Common Stock, and issuance of additional Common Stock
upon the exercise of options and warrants may also dilute the proportionate
ownership of the then current stockholders of the Company.
POSSIBLE VOLATILITY OF SECURITIES PRICES. The market price of the
Company's Common Stock may be highly volatile, as has been the case with the
securities of other development stage biotechnology companies. Factors such as
announcements by the Company or its competitors concerning technological
innovations, new commercial products or procedures, proposed government
regulations and developments or disputes relating to patents or proprietary
rights may have a significant impact on the market price of the Company's Common
Stock.
NO DIVIDENDS. The Company has not paid any dividends on its shares and
does not intend to do so in the foreseeable future. It is the present intention
of the Company's Board of Directors to retain all earnings, if any, for use in
the Company's business operations.
CONCENTRATION OF OWNERSHIP; DELAWARE CORPORATE LAW PROVISIONS. The
Company's officers, directors, founders and affiliated persons beneficially own
1,985,450 shares of the Common Stock representing approximately 34% of the total
outstanding shares before the exercise of any outstanding warrants and options.
Accordingly, such persons will be able to exercise substantial control in the
election of the directors of the Company, increases in the authorized capital or
the dissolution, merger, or sale of the assets of the Company and otherwise
influence the control of the Company's affairs. Such substantial
9
<PAGE> 12
control of the Company by these persons could serve to impede or prevent a
change of control of the Company. As a result, potential purchasers may not seek
to acquire control of the Company through the purchase of Common Stock which may
tend to reduce the market price of the Common Stock. In addition, the Company is
subject to provisions of the General Corporation Law of the State of Delaware
respecting business combinations which could, under certain circumstances, also
hinder or delay a change in control. Such 1,985,450 shares do not include an
additional 813,300 shares of Common Stock (an additional 14% of the total
outstanding shares) in an investment account managed by a director of the
Company for others, over which such director has voting power subject to
termination by his investment client.
USE OF PROCEEDS
Other than the proceeds received by the Company from the exercise of
the Options, the Company will not receive any proceeds from the sale of shares
covered by this Prospectus.
In the event all of the Options are exercised, the Company will receive
proceeds of $4,136,250. Any of such proceeds may be used for general working
capital purposes, acquisitions, research and development and/or human clinical
trials. The Company has not specifically allocated the proceeds among these
uses, and actual expenditures will depend on a number of factors. The use of any
proceeds from the exercise of the Options, of which there is no assurance, and
the timing of such use, will also depend on the availability of cash from other
sources. In the event the Company's plans or assumptions change or prove to be
inaccurate, the Company may find it necessary or advisable to reallocate any net
proceeds. Proceeds not immediately required for the purposes described above
will be invested principally in United States government securities, short term
certificates of deposit, money market funds or other short term, interest
bearing investments. The Company does not have any current intentions with
respect to material acquisitions of any businesses or products.
SELLING SECURITYHOLDERS
The following table sets forth certain information with respect to the
beneficial ownership of the Company's Common Stock and as adjusted to reflect
the sale of the 122,000 shares included in this Prospectus for each of the
selling security holders.
10
<PAGE> 13
<TABLE>
<CAPTION>
AMOUNT AND
NATURE BENEFICIAL
OF BENEFICIAL SHARES OWNERSHIP
NAME AND ADDRESS OWNERSHIP REGISTERED AFTER PERCENT
OF BENEFICIAL PRIOR TO FOR SELLING COMPLETION OF
OWNER(1) OFFERING(2) SECURITYHOLDERS OF OFFERING CLASS
- ---------------- ------------ --------------- ----------- -----
<S> <C> <C> <C> <C>
Steven Katz, PhD
President,
Chief Executive
Officer and Chairman 293,257(3) 65,000 228,257(3) 4.0
Ron Lipstein,
Secretary, Treasurer
& CFO 323,606(4) 35,000 288,606(4) 5.0
Alain Klapholz,
Vice President -
Operations 318,607(5) 20,000 298,607(5) 5.1
Robert A. Abrahams
175 Primrose Lane
Fairfield, CT 06430 2,000 2,000 -0- --
</TABLE>
- ----------------------
(1) Unless otherwise listed, the addresses of all of the persons in the
foregoing table are at the Company's offices, 3960 Broadway, New York,
New York 10032.
(2) The number of Shares of Common Stock beneficially owned by each person
or entity is determined under rules promulgated by the Securities and
Exchange Commission (the "Commission"). Under such rules, beneficial
ownership includes any shares as to which the person or entity has sole
or shared voting power or investment power. The percentage of the
Company's outstanding shares is calculated by including among the
shares owned by such person any shares which such person or entity has
the right to acquire within 60 days after the date of this Prospectus.
Unless otherwise indicated, each person or entity referred to above has
sole voting and investment power with respect to the shares listed. The
inclusion herein of any shares deemed beneficially owned does not
constitute beneficial ownership of such shares.
(3) Does not include shares owned by Dr. Katz's children, their spouses and
his grandchildren. Also includes 65,000 shares offered by this
Prospectus which are issuable to Dr. Katz upon his exercise of
outstanding options.
(4) Includes 36,000 shares owned by Mr. Lipstein's minor children. Mr.
Lipstein disclaims any beneficial interest in such 36,000 shares. Also
includes the 35,000 shares offered by this Prospectus which are
issuable to Mr. Lipstein upon his exercise of outstanding options.
(5) Includes 36,000 shares owned by Mr. Klapholz' minor children. Mr.
Klapholz disclaims any beneficial interest in such 36,000 shares. Also
includes 20,000 shares offered by this Prospectus which are issuable to
Mr. Klapholz upon his exercise of outstanding options.
11
<PAGE> 14
PLAN OF DISTRIBUTION
The holders of the shares covered by this Prospectus are offering the
shares for their own account and not for the account of the Company. The Company
will not receive any proceeds from the sale of the shares by such selling
stockholders (the "Selling Stockholders"). See "Use of Proceeds."
The shares offered by the Selling Stockholders may be sold from time to
time by the Selling Stockholders directly to purchasers or, alternatively, may
be offered from time to time through agents, brokers, dealers or underwriters,
who may receive compensation in the form of concessions or commission from the
Selling Stockholders or purchasers of the shares (which compensation may be in
excess of customary commissions). Sales of the shares may be made in one or more
transactions through the Nasdaq SmallCap Market system, otherwise in the
over-the-counter market, or in privately negotiated transactions or otherwise,
and such sales may be made at the market price prevailing at the time of sale, a
price related to such prevailing market price or a negotiated price.
Under the Exchange Act and the regulations thereunder, persons engaged
in a distribution of the shares of the Company offered by this Prospectus may
not simultaneously engage in market making activities with respect to the Common
Stock of the Company during the applicable "cooling off" periods prior to the
commencement of such distribution. In addition, and without limiting the
foregoing, the Selling Stockholders will be subject to applicable provisions of
the Exchange Act and the rules and regulations thereunder including, without
limitation, Rules 10b-6 and 10b-7, which provisions may limit the timing of
purchases and sales of Common Stock by the Selling Stockholders. Further, the
amount of securities to be reoffered or resold under this Prospectus by the
Selling Stockholders, and by any other person with whom a Selling Stockholder is
acting in concert in such resale, may not exceed during any three-month period,
the amount specified in Rule 144(e) under the Securities Act.
To the extent required, the Company will use its best efforts to file,
during any period in which offers or sales are being made, one or more
supplements to this Prospectus to describe any material change to such
information in this Prospectus.
FORWARD LOOKING INFORMATION MAY PROVE INACCURATE
This Prospectus contains certain forward-looking statements and
information relating to the Company that are based on the beliefs of Management,
as well as assumptions made by and information currently available to the
Company. When used in this document, the words "anticipate," "believe,"
"estimate," and "expect" and similar expressions, as they relate to the Company,
are intended to identify forward-looking statements. Such statements reflect the
current views of the Company with respect to future events and are subject to
certain risks, uncertainties and assumptions, including those described in this
Prospectus.
12
<PAGE> 15
Should one or more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may vary materially from
those described herein as anticipated, believed, estimated or expected. The
Company does not intend to update these forward-looking statements.
DISCLOSURE OF COMMISSION POSITION ON
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
The Company's Certificate of Incorporation provides that the personal
liability of the directors of the Company shall be limited to the fullest extent
permitted by the provisions of Section 102(b)(7) of the General Corporation Law
of the State of Delaware (the "DGCL"). Section 102(b)(7) of the DGCL generally
provides that no director shall be liable personally to the Company or its
stockholders for monetary damages for breach of fiduciary duty as a director,
provided that the Certificate of Incorporation does not eliminate the liability
of a director for (i) any breach of the director's duty of loyalty to the
Company or its stockholders; (ii) acts or omissions not in good faith or that
involve intentional misconduct or a knowing violation of law; (iii) acts or
omissions in respect of certain unlawful dividend payments or stock redemptions
or repurchases; or (iv) any transaction from which such director derives
improper personal benefit. The effect of this provision is to eliminate the
rights of the Company and its stockholders (through stockholders' derivative
suits on behalf of the Company) to recover monetary damages against a director
for breach of her or his fiduciary duty of care as a director (including
breaches resulting from negligent or grossly negligent behavior) except in the
situations described in clauses (i) through (iv) above. The limitations
summarized above, however, do not affect the ability of the Company or its
stockholders to seek nonmonetary remedies, such as an injunction or rescission,
against a director for breach of her or his fiduciary duty. Insofar as
indemnification for liabilities arising under the Securities Act may be
permitted to directors, officers, or persons controlling the Company pursuant to
the foregoing provisions, the Company has been informed that in the opinion of
the Commission, such indemnification is against public policy as expressed in
the Securities Act and is therefore unenforceable.
In addition, the Certificate of Incorporation provides that the Company
shall, to the fullest extent permitted by Section 145 of the DGCL, indemnify all
persons whom it may indemnify pursuant to Section 145 of the DGCL. Section 145
of the DGCL permits a company to indemnify an officer or director who was or is
a party or is threatened to be made a party to any proceeding because of his or
her position, if the officer or director acted in good faith and in a manner he
or she reasonably believed to be in or not opposed to the best interests of the
Company and, with respect to any criminal action or proceeding, had no
reasonable cause to believe his or her conduct was unlawful.
The Company maintains a directors' and officers' liability insurance
policy covering certain liabilities that may be incurred by directors and
officers in connection with the performance of their duties. The entire premium
for such insurance is paid by the Company.
13
<PAGE> 16
SHARES ELIGIBLE FOR FUTURE SALE
1,546,069 shares of the Company's presently outstanding shares of
Common Stock are "restricted securities," as that term is defined under Rule 144
("Rule 144") promulgated under the Securities Act. In general, under Rule 144 a
person who owns any restricted shares of Common Stock for at least one year may
sell in the public securities markets, within any three month period, such
number of those restricted shares that does not exceed the greater of one
percent of the total number of outstanding shares of the same class or the
average weekly trading volume during the four calendar weeks preceding the sale.
A person who has not been an affiliate of the Company for a least three months
immediately preceding the sale and who owns shares of Common Stock that have
been held for a period of at least two years is entitled to sell such shares
under Rule 144 without regard to any volume limitations. 1,794,750 additional
shares that are issuable upon exercise of outstanding warrants and options, or
pursuant to options that may be granted in the future under the Company's
Employee Stock Option Plan, will be eligible for immediate sale into the public
securities markets after such warrants and options are exercised. In addition,
808,548 shares that are issuable upon exercise of other outstanding warrants and
options exercisable at prices ranging from $1.00 (for 257,072 shares) to $14.25,
are eligible for sale in the public securities markets one or two years after
such warrants and options are exercised.
No prediction can be made as to the effect, if any, that sales of those
shares of Common Stock, or the availability of those shares for sale, will have
on the market prices of the Common Stock prevailing from time to time.
LEGAL MATTERS
The legality of the Common Stock included in this Prospectus has been
passed upon for the Company by Feder, Kaszovitz, Isaacson, Weber, Skala & Bass
LLP, New York, New York. Gabriel Kaszovitz, a member of the firm of Feder,
Kaszovitz, Isaacson, Weber, Skala & Bass LLP, is a stockholder of the Company
and has been granted an option expiring April 1, 2000 to purchase 10,000 shares
of Common Stock at $6.00 per share.
EXPERTS
The financial statements of the Company at December 31, 1996 and for
each of the two years then ended and the period from March 12, 1991 (inception)
through December 31, 1996, have been audited by Grant Thornton LLP, Independent
Certified Public Accountants, as set forth in their report, and are incorporated
herein by reference in reliance upon such report (also incorporated herein by
reference), given on the authority of the firm as experts in accounting and
auditing.
14
<PAGE> 17
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The following documents filed with the Commission by the Company,
pursuant to the Exchange Act and the Securities Act, are incorporated by
reference in this Registration Statement:
(a) The Company's Annual Report on Form 10-KSB for the year ended
December 31, 1996.
(b) The Company's Quarterly Reports on Form 10-QSB for the quarters
ended March 31, June 30 and September 30, 1997.
(c) The description of the Common Stock set forth in the Company's
Registration Statement on Form 8-A filed December 5, 1995, and any amendment or
report filed for the purpose of updating such description.
All documents subsequently filed by the Company pursuant to Sections
13(a), 13(c), 14 and 15(d) of the Exchange Act, prior to the filing of a
post-effective amendment which indicate that all shares of Common Stock offered
hereby have been sold or which deregisters all then remaining unsold, shall be
deemed to be incorporated by reference in this Registration Statement and to be
a part hereof from the date of filing of such documents. Any statement contained
in a document incorporated or deemed to be incorporated by reference herein
shall be deemed to be modified or superseded for purposes of this Registration
Statement to the extent that a statement contained herein or in any other
subsequently filed document which also is incorporated or deemed to be
incorporated by reference herein modifies or supersedes such statement. Any
statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this Registration Statement.
15
<PAGE> 18
GLOSSARY
The following Glossary defines certain technical terms and
abbreviations used in this Prospectus.
ALLOGRAFT - replacement of damaged skin with materials, synthetic or
natural, other than a patient's own skin.
AUTOGRAFT - transplant of skin from one site of a patient's body onto a
wound site that no longer has the capacity to heal spontaneously.
COLLAGEN - an insoluble fibrous protein that occurs in vertebrates as
the chief constituent of connective tissue fibrils and in bones.
COMPOSITE CULTURED SKIN - the Company's product. Produced from cells
derived from human infant foreskins obtained during routine infant circumcisions
which are separated into dermal and epidermal cells, reproduced and the dermal
cells are then grown onto a cross linked bovine collagen sponge and the
epidermal cells are grown on top of that sponge to form the composite cultured
skin.
DERMIS - the lower layer of human skin, beneath the epidermis. A thick
fibroelastic layer that consists of cells that generate such fibroelastic
material and provide a framework for the support of blood vessels that flow
through such layer.
DONOR SITE - site of a person's body from which healthy skin is taken
in an autograft transplant.
EB - EPIDERMOLYSIS BULLOSA - a congenitally inherited disorder
characterized by fragile skin that breaks down easily, leading to infections,
ulcerations and contracture that cause deformities of the limbs.
EPIDERMIS - the upper layer of human skin. A thin multi-layered
cellular sheet of cells approximately 0.5 mm in thickness that is constantly
being regenerated through cell division.
FIBROELASTIC - composed of collagen and elastic fibers.
PMA APPLICATION - premarket approval application submitted to the FDA
for the sale of a new proposed medical device that is not substantially
equivalent to an already cleared device.
A
<PAGE> 19
No dealer, salesperson or any 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
be relied on as having been authorized by the Company. This Prospectus does not
constitute an offer to sell or a solicitation of an offer to sell or a
solicitation of an offer to buy any security other than the Common Stock offered
by this Prospectus, or an offer to sell or a solicitation of an offer to buy any
security, by any person in any jurisdiction in which such an offer or
solicitation would be unlawful. Neither the delivery of this Prospectus nor any
sale made hereunder shall, under any circumstances, imply that the information
in this Prospectus is correct as of any time subsequent to the date of this
Prospectus.
TABLE OF CONTENTS
<TABLE>
<CAPTION>
Page
----
<S> <C>
Prospectus Summary................................... 3
Risk Factors......................................... 6
Use of Proceeds...................................... 10
Selling Securityholders.............................. 10
Plan of Distribution................................. 12
Forward Looking Information May
Prove Inaccurate.................................... 12
Disclosure of Commission Position
on Indemnification for Securities
Act Liabilities..................................... 13
Shares Eligible for Future Sale...................... 14
Legal Matters........................................ 14
Experts ............................................. 14
Incorporation of Certain
Information by Reference............................ 15
Glossary.............................................. A
</TABLE>
ORTEC
INTERNATIONAL, INC.
122,000 SHARES
OF COMMON STOCK
PROSPECTUS
March 10, 1998
<PAGE> 20
PART II
INFORMATION REQUIRED IN THE REGISTRATION STATEMENT
ITEM 3. INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE.
The following documents filed with the Securities and Exchange
Commission (the "Commission") by Ortec International, Inc., a Delaware
corporation (the "Company" or the "Registrant"), pursuant to the Securities
Exchange Act of 1934, as amended (the "Exchange Act") and the Securities Act of
1933, as amended (the "Securities Act"), are incorporated by reference in this
Registration Statement:
(a) The Company's Annual Report on Form 10-KSB for the year
ended December 31, 1996.
(b) The Company's Quarterly Reports on Form 10-QSB for the
quarterly periods ended March 31, 1997, June 30, 1997 and September 30, 1997.
(c) The description of the Common Stock set forth in the
Company's Registration Statement on Form 8-A, filed December 5, 1995 and any
amendment or report filed for the purpose of updating such description.
All documents subsequently filed by the Company pursuant to
Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act, prior to the filing of
a post-effective amendment which indicate that all shares of Common Stock
offered hereby have been sold or which deregisters all then remaining unsold,
shall be deemed to be incorporated by reference in this Registration Statement
and to be a part hereof from the date of filing of such documents. Any statement
contained in a document incorporated or deemed to be incorporated by reference
herein shall be deemed to be modified or superseded for purposes of this
Registration Statement to the extent that a statement contained herein or in any
other subsequently filed document which also is incorporated or deemed to be
incorporated by reference herein modifies or supersedes such statement. Any
statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this Registration Statement.
ITEM 5. INTEREST OF NAMED EXPERTS AND COUNSEL.
The legality of the Common Stock included in this Prospectus has been
passed upon for the Company by Feder, Kaszovitz, Isaacson, Weber, Skala & Bass
LLP, New York, New York. A member of the firm of Feder, Kaszovitz, Isaacson,
Weber, Skala & Bass, LLP, owns shares of the Company's Common Stock and has been
granted an option expiring April 1, 2000 to purchase 10,000 shares of Common
Stock at $6.00 per share.
II-1
<PAGE> 21
ITEM 6. INDEMNIFICATION OF OFFICERS AND DIRECTORS.
The Company's Certificate of Incorporation provides that the personal
liability of the directors of the Company shall be limited to the fullest extent
permitted by the provisions of Section 102(b)(7) of the General Corporation Law
of the State of Delaware (the "DGCL"). Section 102(b)(7) of the DGCL generally
provides that no director shall be liable personally to the Company or its
stockholders for monetary damages for breach of fiduciary duty as a director,
provided that the Certificate of Incorporation does not eliminate the liability
of a director for (i) any breach of the director's duty of loyalty to the
Company or its stockholders; (ii) acts or omissions not in good faith or that
involve intentional misconduct or a knowing violation of law; (iii) acts or
omissions in respect of certain unlawful dividend payments or stock redemptions
or repurchases; or (iv) any transaction from which such director derives
improper personal benefit. The effect of this provision is to eliminate the
rights of the Company and its stockholders (through stockholders' derivative
suits on behalf of the Company) to recover monetary damages against a director
for breach of her or his fiduciary duty of care as a director (including
breaches resulting from negligent or grossly negligent behavior) except in the
situations described in clauses (i) through (iv) above. The limitations
summarized above, however, do not affect the ability of the Company or its
stockholders to seek nonmonetary remedies, such as an injunction or rescission,
against a director for breach of her or his fiduciary duty. Insofar as
indemnification for liabilities arising under the Securities Act may be
permitted to directors, officers, or persons controlling the Company pursuant to
the foregoing provisions, the Company has been informed that in the opinion of
the Securities and Exchange Commission (the "Commission"), such indemnification
is against public policy as expressed in the Securities Act and is therefore
unenforceable.
In addition, the Certificate of Incorporation provides that the Company
shall, to the fullest extent permitted by Section 145 of the DGCL, indemnify all
persons whom it may indemnify pursuant to Section 145 of the DGCL. Section 145
of the DGCL permits a company to indemnify an officer or director who was or is
a party or is threatened to be made a party to any proceeding because of his or
her position, if the officer or director acted in good faith and in a manner he
or she reasonably believed to be in or not opposed to the best interests of the
Company and, with respect to any criminal action or proceeding, had no
reasonable cause to believe his or her conduct was unlawful.
The Company maintains a directors' and officers' liability insurance
policy covering certain liabilities that may be incurred by directors and
officers in connection with the performance of their duties. The entire premium
for such insurance is paid by the Company.
ITEM 7. EXEMPTION FROM REGISTRATION CLAIMED.
Robert A. Abrahams, a holder of "Restricted Securities" of the Company,
as that term is defined under General Instruction C to Form S-8, is registering
such securities for reoffer and resale hereby. Mr. Abrahams is not an affiliate
of the Company. The initial
II-2
<PAGE> 22
grant, offer and sale of such securities were done without registration under
the Securities Act of 1933, as amended (the "Act"), as they did not involve any
public offering, pursuant to the provisions of Section 4(2) of the Act.
ITEM 8. EXHIBITS.
<TABLE>
<CAPTION>
NUMBER DESCRIPTION OF EXHIBIT
- ------ ----------------------
<S> <C>
**4 Ortec International, Inc. 1996 Stock Option Plan
*5 Opinion of Feder, Kaszovitz, Isaacson, Weber, Skala & Bass LLP
*24.1 Consent of Grant Thornton, LLP
*24.2 Consent of Feder, Kaszovitz, Isaacson, Weber, Skala & Bass LLP
(contained in Exhibit 5)
</TABLE>
- ----------
* Filed herewith.
** Included as an exhibit to the Registrant's Schedule 14A, the
Registrant's Proxy Statement, filed in June 1996. Modification adopted
by the Registrant's Board of Directors on December 2, 1997 filed
herewith.
ITEM 9. REQUIRED UNDERTAKINGS
The undersigned Registrant hereby undertakes, except as otherwise
specifically provided in the rules of the Securities and Exchange Commission
promulgated under the Securities Act, that:
The Registrant will:
(i) Include any additional or changed material information on the plan
of distribution.
(ii) For determining liability under the Securities Act, treat each
post-effective amendment as a new registration statement of the securities
offered, and the offering of the securities at that time shall be deemed to be
the initial bona fide offering.
(iii) File a post-effective amendment to remove from registration any
of the securities that remain unsold at the end of the offering.
II-3
<PAGE> 23
Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors, officers, or persons controlling the Company,
the Company has been informed that in the opinion of the Commission, such
indemnification is against public policy as expressed in the Securities Act and
is therefore unenforceable.
SIGNATURES
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 for filing on Form S-8 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of New York, State of New York on the 10th day of
March, 1998.
ORTEC INTERNATIONAL, INC.
By: /s/Steven Katz
Steven Katz, PHD, President, Chief
Executive Officer and Chairman
II-4
<PAGE> 24
Pursuant to the requirements of the Securities Act, this
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/ Steven Katz Chairman, Chief March 10, 1998
- ---------------------------- Executive Officer
Steven Katz, PhD and President
(Principal Executive
Officer)
/s/ Ron Lipstein Treasurer, March 10, 1998
- ---------------------------- Secretary, Chief
Ron Lipstein Financial Officer
and (Principal
Financial Officer)
- ---------------------------- Senior Vice
Dr. Mark Eisenberg President - Research
and Development and
Director
/s/ Alain Klapholz Director and Vice March 10, 1998
- -------------------------- President - Operations
Alain Klapholz
/s/ Joseph Stechler Director March 10, 1998
- ----------------------------
Joseph Stechler
- ---------------------------- Director
Steven Lilien, PhD
</TABLE>
II-5
<PAGE> 25
INDEX OF EXHIBITS
<TABLE>
<CAPTION>
NUMBER DESCRIPTION OF EXHIBIT
- ------ ----------------------
<S> <C>
**4 Ortec International, Inc. 1996 Stock Option Plan
*5 Opinion of Feder, Kaszovitz, Isaacson, Weber, Skala & Bass LLP
*24.1 Consent of Grant Thornton, LLP
*24.2 Consent of Feder, Kaszovitz, Isaacson, Weber, Skala & Bass LLP
(contained in Exhibit 5)
</TABLE>
- ----------
* Filed herewith.
** Included as an exhibit to the Registrant's Schedule 14A, the
Registrant's Proxy Statement, filed in June 1996. Modification adopted
by the Registrant's Board of Directors on December 2, 1997 filed
herewith.
<PAGE> 1
EXHIBIT 4.1
Amendment to Registrant's Stock Option Plan adopted by Registrant's
Board of Directors on December 2, 1997.
RESOLVED, that the Company's stock option plan be amended to
provide that non-employee directors be included among the persons to
whom non-statutory stock options could be granted for services rendered
by such persons as directors of the Company.
<PAGE> 1
March 9, 1998
Ortec International, Inc.
3960 Broadway
New York, New York 10032
Gentlemen:
We refer to the Registration Statement on Form S-8 (the
"Registration Statement") to be filed by Ortec International, Inc. (the
"Company") with the Securities and Exchange Commission under the Securities Act
of 1933, as amended (the "Act"), relating to the registration of 352,000 shares
of the common stock of the Company, par value, $.001 per share (the "Shares").
2,000 Shares have already been issued pursuant to the exercise of an option in
the form of a warrant granted to a consultant of the Company. The remaining
350,000 Shares may be issued upon the exercise of options granted or to be
granted by the Company pursuant to its 1996 Stock Option Plan (the "Plan").
As counsel for the Company, we have examined such corporate
records, documents and such questions of law as we have considered necessary or
appropriate for the purposes of this opinion and, upon the basis of such
examination, advise you that in our opinion, all necessary corporate proceedings
by the Company have been duly taken to authorize the issuance of the Shares upon
the exercise of the options granted pursuant to the Plan, and that the Shares
being registered pursuant to the Registration Statement, when issued in
accordance with the terms of the Plan, will be duly authorized, legally issued,
fully paid and nonassessable.
We hereby consent to the filing of this opinion as an exhibit
to the Registration Statement and to the reference to this firm under Item 5 of
Part II of the Registration Statement entitled "Interests of Named Experts and
Counsel." This consent is not to be construed as an admission that we are a
person whose consent is required to be filed with the Registration Statement
under the provisions of the Act.
Very truly yours,
Feder, Kaszovitz, Isaacson,
Weber, Skala & Bass LLP
<PAGE> 1
CONSENT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS
We have issued our report, dated March 18, 1997, accompanying the financial
statements and schedule included in the Annual Report of Ortec International,
Inc. (a development stage enterprise) on Form 10-KSB for the year ended December
31, 1996. We hereby consent to the incorporation by reference of said report in
the Registration Statement of Ortec International, Inc. on Form S-8.
GRANT THORNTON LLP
New York, New York
March 6, 1998
