<Page>

                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549
                               ------------------

                                   FORM 10-K/A
                                   (Mark One)
[X]      ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
         EXCHANGE ACT OF 1934

                     For the fiscal year ended December 31, 2003

                                     OR

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

For the transition period from              to

                         Commission file number 0-27046

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

            Delaware                         11-3068704
 (State or other jurisdiction             (I.R.S. Employer
     of incorporation or                 Identification No.)
        organization)

         3960 Broadway                          10032
      New York, New York                      (Zip Code)
    (Address of principal
     executive offices)

       (212) 740-6999 Issuer's telephone number, including area code

<TABLE>
<S>                                                           <C>
Securities registered pursuant to Section 12(b) of the Act:            None
Securities registered pursuant to Section 12(g) of the Act:   Common Stock,  $.001 par value
</TABLE>

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

         Indicate by check mark if disclosure of delinquent filers pursuant to
Item 405 of Regulation S-K ('SS'229.405 of this chapter) is not contained
herein, and will not be contained, to the best of Registrant's knowledge, in
definitive proxy or information statements incorporated by reference in
Part III of this Form 10-K or any amendment to this Form 10-K.

         The number of shares outstanding of the Registrant's common stock is
5,422,665 (as of March 23, 2004) (giving effect to issuance of 242,931 shares as
a result of conversion of 60.7309 shares of Series B preferred stock for which
the Series B preferred stock certificates have not been surrendered.) The
aggregate market value of the voting stock held by nonaffiliates of the
Registrant was $13,620,053 (as of March 23, 2004, based upon a closing price of
the Company's Common Stock on the Nasdaq Bulletin Board on such date of $2.53).

                       DOCUMENTS INCORPORATED BY REFERENCE
None.





<Page>







                            ORTEC INTERNATIONAL, INC.
                       INDEX TO ANNUAL REPORT ON FORM 10-K
                FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
                   FOR THE FISCAL YEAR ENDED DECEMBER 31, 2003

                              ITEMS IN FORM 10-K/A

<TABLE>
<CAPTION>
                                                                                                               Page
                                                                                                               ----
Facing page
Part I
------
<S>           <C>                                                                                                <C>
         Item 1.  Business........................................................................................1
         Item 2.  Properties....................................................................................N/A
         Item 3.  Legal Proceedings.............................................................................N/A
         Item 4.  Submission of Matters to a Vote of Security Holders...........................................N/A
Part II
         Item 5.  Market for the Registrant's Common Equity and Related
                       Stockholder Matters......................................................................N/A
         Item 6.  Selected Financial Data.......................................................................N/A
         Item 7.  Management's Discussion and Analysis of Financial
                  Condition and Results of Operations...........................................................N/A
         Item 7A. Quantitative and Qualitative Disclosures About
                  Market Risk...................................................................................N/A
         Item 8.  Financial Statements and Supplementary Data...................................................N/A
         Item 9.  Changes in and Disagreements with Accountants
                  on Accounting and Financial Disclosure........................................................N/A
Part III
         Item 10. Directors and Executive Officers of the Registrant............................................N/A
         Item 11. Executive Compensation........................................................................N/A
         Item 12. Security Ownership of Certain Beneficial Owners
                    and Management and Related Stockholder Matters..............................................N/A
         Item 13. Certain Relationships and Related Transactions................................................N/A
         Item 14. Controls and Procedures.......................................................................N/A
Part IV
         Item 15. Exhibits, Financial Statement Schedules and Reports on Form 8-K................................11
Signatures.......................................................................................................14
</table>





<Page>





PART I

Item 1.           BUSINESS

Overview

         We are a development stage tissue engineering company that has
developed a proprietary and patented technology that we call "OrCel", which is
used to stimulate the repair and regeneration of human skin. OrCel is a two
layered tissue engineered dressing that consists of human derived skin cells,
both dermal and epidermal, supported within a porous collagen matrix. The
composite matrix is seeded with keratinocytes for epidermal growth and
fibroblasts for dermal growth. When OrCel is applied to the wound site, it
produces a mix of growth factors that stimulates wound closure.

         In 2001 the FDA granted our application for the commercial sale of
OrCel for the treatment of donor site wounds. A donor site wound is created in
an area of the patient's body from which the patient's skin was taken to cover a
wound at another part of such patient's body. In 2001 the FDA also granted our
application for the commercial sale of OrCel for use on patients with recessive
dystrophic epidermolysis bullosa undergoing hand reconstruction, as well as to
treat the donor site wounds created during the surgery. Recessive dystrophic
epidermolysis bullosa is a condition in which a newborn infant's skin instantly
blisters and can peel off at the slightest touch and leave painful ulcerations
and permanent scarring resulting in deformity of the hands and feet. From
December 2001 through December 2002, our gross revenues from the sale of OrCel
were $265,665. We discontinued our sales efforts and the manufacture of OrCel
for commercial sale because of our need to use our limited financial resources
for the completion of our clinical trial for the use of OrCel in the treatment
of venous stasis ulcers, which is a larger potential market. Venous stasis
ulcers are open lesions on the legs which result from the poor circulation of
the blood returning from the legs to the heart.

         We completed a pivotal clinical trial for the use of OrCel in its
cryopreserved form for the treatment of venous stasis ulcers. The study was
conducted at 19 clinical sites and 136 patients were treated in the trial. One
half of the patients were a control group and were treated with standard of care
currently being used for treatment of venous stasis ulcers. In February 2004, we
completed the filing with the Food and Drug Administration (FDA) of our
application for premarket approval to market OrCel for the treatment of venous
leg ulcers.

         We have developed the technology for the cryopreservation of OrCel
without diminishing its effectiveness. Cryopreservation is the freezing of our
product which gives it a minimum shelf life of six months, as opposed to only a
few days when our product is not cryopreserved.

         Due to budgetary constraints we are encountering in this difficult
investment climate, we have deferred conducting a pivotal clinical trial for the
use of OrCel in the treatment of diabetic foot ulcers (although the FDA granted
clearance for us to conduct that pivotal trial) until after FDA determination of
whether we may make commercial sales of cryopreserved OrCel to treat venous
stasis ulcers. We completed a pilot clinical trial for the use of OrCel, in its
fresh, not


                                       1



<Page>

cryopreserved, form in the treatment of diabetic foot ulcers in the latter part
of 2001. People with diabetic foot ulcers also constitute a large patient
population and therefore also a large potential market for OrCel.

         Our target patient population for the use of OrCel are persons with
venous stasis and diabetic foot ulcers which we believe are large potential
markets for the use of OrCel. We also believe that OrCel can be used to treat
other medical conditions, such as decubitis ulcers, and for cosmetic surgery.
Decubitis ulcers are pressure sores, commonly known as bed sores. Decubitis
ulcers range from a small wound to a very deep wound extending to and sometimes
through a bone into internal organs.

         Our cash on hand as of December 31, 2003, an additional $650,000 in
loans repayable June 30, 2004 which we received in January and a $250,000 loan
payable on demand which we received in March 2004, all from some of the holders
of our convertible preferred stock, will enable us to continue our operations
through approximately March 31, 2004, assuming that we will not incur unexpected
costs. Before March 31, 2004, we will be required to raise additional funds
(through the sale of our securities or debt financing) to complete our clinical
trials, to produce and market OrCel and to pay our accumulated debt. Our failure
to receive additional financing will make it impossible for us to continue our
business.

         Ortec was organized in 1991 under the laws of the State of Delaware for
the purpose of acquiring, developing, testing and marketing our skin replacement
product. Our executive offices are located at 3960 Broadway, New York, New York,
and our telephone number is (212) 740-6999. Our website address is
www.ortecinternational.com.

The Product

         OrCel is produced from cells derived from infant foreskins obtained
during routine circumcisions. The immature, neonatal cells are highly
reproductive and provide enhanced proliferation and rapid remodeling of the
human skin. We separate the epidermis from the dermis and treat each of these
layers to release individual keratinocyte (epidermal) and fibroblast (dermal)
cells, which are the primary cellular components of human skin. We grow the
fibroblast and keratinocyte cells in culture in large quantities, then freeze
and store them as a cell bank, ready for use. Prior to the use of each cell
line, we conduct extensive testing and screening in accordance with current FDA
guidelines to ensure that the cells are free of presence of bacterial
contaminants, viruses, pathogens, tumorigenicity or other transmittable
diseases. We then apply the dermal fibroblast cells to a proprietary,
cross-linked bovine collagen sponge to form the dermal layer matrix and we grow
the epidermal keratinocyte cells on a separate non-porous layer of collagen. We
then incubate and supply this composite matrix with the proper nutrients to
allow the cells to multiply and for the fibroblasts to permeate inside and
anchor to the porous collagen sponge. The top layers of keratinocyte cells and
bottom layers of fibroblast cells in the collagen matrix, together, constitute
our proprietary OrCel, which we can then deliver to customers in a fresh or
cryopreserved state.



                                       2





<Page>




Original Research

         Our technology was developed by Dr. Mark Eisenberg, a physician in
Sydney, Australia. Dr. Eisenberg is a director and one of the founders of Ortec.
He has been involved in biochemical and clinical research at the University of
New South Wales in Australia for over twenty five years, focusing primarily on
treating the symptoms of epidermolysis bullosa. In 1987, through his work on
epidermolysis bullosa, Dr. Eisenberg first succeeded in growing epidermal layers
of human skin, which he successfully applied as an allograft on an epidermolysis
bullosa patient. An allograft is a transplant other than with the patient's own
skin. Dr. Eisenberg continued his research which eventually led to the
development of OrCel - a tissue-engineered dressing which consists of both the
dermal and epidermal layers.

The FDA Clearance Process

         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. OrCel is considered by the
FDA to be a medical device and is therefore regulated by the FDA. We must
receive pre-market clearance from the FDA for any commercial sale of our
product. Before receiving such clearance we must provide proof in human clinical
trials of the safety and efficacy of OrCel. Pre-market clearance is a lengthy
and expensive process.

         The steps in the FDA clearance process may be summarized as follows:

         o    The sponsor (such as Ortec) prepares a protocol which sets forth
              in detail all aspects of the proposed clinical trial. The
              information includes the number of patients to be treated, the
              number of sites (hospitals and clinics) at which the patients in
              the clinical trial are to be treated, the then current standard of
              care with which the patients in the control group (in comparable
              medical condition as the patients to be treated with the medical
              device which is the subject of the clinical trial) are to be
              treated, the treatment frequency and the statistical plan that
              will be utilized to analyze the data derived from the clinical
              trial.

         o    The protocol also has to establish the safety of the use of the
              medical device to be studied in the trial. Safety can be
              established in a number of ways. One is by showing the results of
              use of the medical device in treatments in other clinical trials,
              in hospital approved treatments elsewhere in the world or by use
              in animal clinical trials and/or in an FDA cleared "pilot"
              clinical trial in which far fewer patients are treated than in the
              definitive "pivotal" clinical trial.

         o    The sponsor submits the protocol to the FDA.

         o    The FDA staff give their comments, objections and requirements on
              the submitted protocol.

         o    The sponsor redrafts the protocol and otherwise responds to the
              FDA's comments.


                                       3





<Page>



         o    The sponsor recruits hospitals and clinics as sites at which the
              patients in the study are to be treated. Such recruitment begins
              with or prior to the preparation of the protocol.

         o    After the FDA clears the protocol the trial sites and the sponsor
              recruit the patients to be treated in the study.

         o    The patients are treated at not more than the number of trial
              sites specified in the protocol. One half of the patients are
              treated with the medical device being studied and the other half,
              the control group, with the then current standard of care for
              treatment of the same medical condition.

         o    The sites follow up each treated patient (for the period and the
              number of times provided in the FDA cleared protocol) to determine
              the efficacy of the medical device being studied in the treatment
              of the medical condition identified in the protocol, as against
              the efficacy of the standard of care used in the study.

         o    The sponsor assists and monitors compliance with the protocol's
              requirements in each site's conduct of the study.

         o    The sponsor collects the clinical data of each patient's treatment
              and progress from the sites.

         o    The data is analyzed by or for the sponsor. The sponsor prepares a
              report of the results of the study and submits the report and the
              supporting clinical data to the FDA staff reviewers for their
              comments and questions.

         o    After staff review of the submitted data, the sponsor responds to
              the FDA's comments and questions.

         o    After completion of its review the FDA staff may submit a report
              of the results of the trial to an advisory medical panel
              consisting of experts in the treatment of the medical condition
              which the studied medical device is intended to treat.

         o    The panel submits its advice as to the efficacy and safety of the
              device to the FDA official who is the Director of the FDA Division
              to which the protocol and the results of the pivotal trial were
              originally submitted. If no advisory panel is required the FDA
              staff reviewers submit their recommendation directly to the
              Division Director.

         o    The FDA Division Director is the FDA official who determines
              whether or not to clear the medical device for commercial sale for
              treatment of that medical condition. The sponsor may appeal a
              Division Director's negative determination through appeal levels
              within the FDA, up to the Commissioner of the FDA.


                                       4





<Page>



         o    After FDA clearance the sponsor must submit all labeling
              information for the medical device to the FDA to make certain that
              the claims on the label accurately state the uses for which the
              medical device has been cleared.

         We have completed the treatment and follow-up of 136 patients in the
pivotal clinical trial of the use of OrCel in its cryo-preserved form for the
treatment of venous stasis ulcers. We have also collected the clinical data of
treatment and patient follow up from all the 19 sites that participated in the
study. In February 2004 we completed the filing of our Premarket Approval (PMA)
application with the Food and Drug Administration (FDA) to market OrCel for the
treatment of venous stasis ulcers. We submitted the Manufacturing and Controls
section of our PMA application in December 2003 and in February 2004 we filed
the final section of our PMA, which included the summary of safety and
effectiveness in the clinical studies and device labeling.

         Although we have completed an FDA cleared pilot clinical trial for the
use of the fresh form of OrCel for the treatment of diabetic foot ulcers, we do
not have the funds available to conduct a pivotal clinical trial for the use of
OrCel in its cryo-preserved form for the treatment of diabetic foot ulcers. We
will not begin the FDA clearance process for a pivotal trial for cryo-preserved
OrCel for the treatment of diabetic foot ulcers until we believe that we can
secure financing for the conduct of that trial.

         Although we have already received FDA clearance for the commercial sale
of the fresh version of OrCel for the treatment of donor site wounds and the
treatment of recessive dystrophic epidermolysis bullosa during reconstructive
hand surgery, due to our limited resources we decided to discontinue the sale of
the fresh version of OrCel preferring to sell the cryo-preserved form of OrCel
when cleared to do so by the FDA.

         Based on published information we believe that the use of OrCel for the
treatment of patients suffering from venous stasis ulcers, and of patients
suffering from diabetic foot ulcers, each represents a significantly larger
potential market than the use of OrCel for the treatment of donor site wounds.
Published reports and studies indicate that the epidermolysis bullosa patient
population is a small one.

Regulatory Strategies, Product Development and Sales

         We employ a team of regulatory and clinical professionals, both full
time employees and consultants, with extensive knowledge in strategic regulatory
and clinical trial planning to support our product development efforts through
every stage of the development and FDA approval process. We also employ persons
with extensive knowledge and experience in the marketing and sale of new FDA
approved products for treatment of many medical conditions, including experience
in securing approval of insurance companies to reimburse their insured patients
for the cost of the use of new medical products used in medical treatments. We
have secured approval for Medicare payments for the use of OrCel under
Medicare's Outpatient Prospective Payment System (OPPS). This approval covers
the use of OrCel in hospitals, other hospital-owned facilities and for hospital
outpatient treatment. This OPPS approval expires December 31, 2005. However, we
will still need to secure the approval of Medicare designated



                                       5




<Page>




contractors in different parts of the country for approval of the different
medical conditions for which Medicare reimbursement of the use of OrCel will be
made. We can only secure that further approval after we have received FDA
clearance for use of OrCel for the treatment of that medical condition. We will
also seek to secure approval for private health insurance providers'
reimbursement for the cost of OrCel. We believe that securing Medicare
reimbursement approval for OrCel will be of significant assistance to us in
securing reimbursement approval by private health insurance companies.

Production and Supply

         In October 2003 we entered into an agreement with Cambrex Bio Science
Walkersville, Inc., a subsidiary of Cambrex Corporation, for Cambrex to
manufacture OrCel in its cryo-preserved form in Cambrex's Walkersville, Maryland
facilities. The Cambrex manufacturing facility is required to meet FDA's good
manufacturing processes standards. Cambrex is experienced in the manufacture of
cell-based medical products such as our OrCel.

         Our agreement with Cambrex requires us to pay Cambrex $1,200,000 a year
for the use of a Cambrex production facility in Walkersville, Maryland. The
annual payments we will make to Cambrex will increase to $2,100,000 per year if
we require Cambrex to build us a larger production facility to meet our
requirements for the production of OrCel. Such annual payments we are required
to make will increase by a small percentage each year. Such annual payments
include some services and overhead expenses provided and paid for by Cambrex. We
are required to pay a portion of the cost of the construction of that larger
production facility. However, the amount we contribute to the construction of
that larger facility will be repaid to us by credits against a portion of the
future annual payments of $2,100,000 and of certain other payments we are
required to make to Cambrex after the larger facility is in use. We are also
required to pay specified hourly charges for the Cambrex employees engaged in
the production of OrCel as well as certain other charges. After construction of
the larger production facility we are required to acquire from Cambrex virtually
all of our requirements for OrCel that Cambrex can produce. Prior to our
election to have Cambrex construct the larger production facility for us, either
we or Cambrex may terminate the agreement on six months notice by us and twelve
months notice by Cambrex, except that such termination will not be effective
prior to November 1, 2004. If we elect to have Cambrex construct the larger
production facility for us the agreement will continue for six years after the
larger production facility is constructed. However, even after such construction
we and Cambrex may elect to scale down over the following three years the
portion of our requirements for OrCel that Cambrex will produce for us. We may
elect the scale down period at any time after one year after the larger
production facility is constructed and in operation in which event there are
additional payments we must make to Cambrex. If we elect the scale down period
after one year we must pay Cambrex $2,625,000 and if we elect the scale down
period after two years we must pay Cambrex $1,050,000. If we elect the scale
down periods in either of those two years, we forfeit our right to receive any
further credits (up to the amount of our contribution to the cost of the larger
production facility) against payments we are thereafter required to make to
Cambrex. Either Cambrex or we may elect the scale down period later than three
years after that facility is in operation and neither of us will be required to
make any additional payments to the other because of that election. If after the
construction of the larger production facility, we breach a material


                                       6





<Page>

term of our agreement with Cambrex, or elect to terminate the agreement, we will
have to pay Cambrex the following amounts:


<TABLE>
<CAPTION>
           If termination occurs after the
      following anniversary of the construction
          of the larger production facility                         Amount of Payment
          ---------------------------------                         -----------------
<S>           <C>                                                    <C>
              6 years                                                $1,050,000
              5 years, but less than 6 years                          1,575,000
              4 years, but less than 5 years                          2,625,000
              3 years, but less than 4 years                          3,675,000
              2 years, but less than 3 years                          5,250,000
              1 year but less than 2 years                            6,300,000
</TABLE>

         In addition, upon such termination we will forfeit our right to receive
any further credits (up to the amount of our contribution to the cost of the
larger production facility) against future payments we may have to make to
Cambrex.

         The raw materials that we use to manufacture OrCel come from a limited
number of key suppliers. We purchase bovine collagen sponges, a key component of
OrCel, from one supplier who produces the sponges to our specifications. We have
no written agreement with that supplier obligating it to supply sponges to us.
While there are other manufacturers from whom we could purchase bovine collagen
sponges, with one of whom we are discussing such supply arrangement, if we are
required to secure another source for bovine collagen sponges we would encounter
delay and expense in manufacturing OrCel. We also rely on a limited number of
outside suppliers to supply other materials that we use in the manufacture and
testing of OrCel. While there are other sources from whom we could purchase such
other materials, as with bovine collagen sponges, if we are required to replace
any or all of our suppliers we would encounter delay and expense in
manufacturing OrCel.

Competition

         We are aware of several companies that are actively engaged in the
research and development of products for the repair and regeneration of skin.
There are currently three primary and distinct approaches to the repair and
regeneration of skin: the acellular (no cell) approach, including the use of
cadaver based products; the cell-based unilayered (epidermal or dermal cell)
approach, and the cell based bi-layered (epidermal and dermal cell) approach. A
cell based approach makes use of donor cells. The approach we believe to be the
most advanced and effective is the cell based bi-layered approach, making use of
donor cells. The production of OrCel consists of a top layer of epidermal cells
and a bottom layer of dermal cells in a collagen matrix, that is a bi-layered
approach utilizing donor cells.

         There are many products available for treating skin wounds. However, as
already noted, we believe that the use of donor cells on a collagen sponge
matrix is the most effective process


                                       7





<Page>



for healing skin wounds and in particular hard to heal skin wounds. Therefore,
we consider only products using donor cells on a collagen sponge matrix would
compete with OrCel.

         We previously considered Organogenesis, Inc. and Advanced Tissue
Sciences, Inc. to be our principal competitors because each of them was
previously manufacturing and selling an FDA approved product using donor cells
on a collagen sponge matrix, as we do, for the treatment, in the case of
Organogenesis' Apligraf, of both venous stasis and diabetic foot ulcers, and in
the case of Advanced Tissue Sciences' Dermagraft for the treatment of diabetic
foot ulcers. Advanced Tissue Sciences' Dermagraft was manufactured in a
cryopreserved form while Organogenesis' Apligraf was not. However, in 2002 both
Organogenesis and Advanced Tissue Sciences filed for bankruptcy protection and,
at least temporarily, discontinued the sale of their products. We believe that
sales of both Dermagraft and Apligraf have been resumed. We believe that sales
of Apligraf are now being made directly by Organogenesis and that sales of
Dermagraft are being made by Smith & Nephew, a major pharmaceutical company
which, we believe, purchased Advance Tissue Science's interest in Dermagraft.
Smith & Nephew is substantially larger than we are and has significantly greater
resources than we have.

         The biomedical field is continually undergoing rapid and significant
technological changes. Other companies may succeed in developing other products
that are more effective than OrCel. If such new products are accepted by the
medical community, or if those products receive FDA approval for treatment of
venous stasis and diabetic foot ulcers before OrCel does, or if other companies
develop products that are more effective than OrCel, any such developments could
impede our ability to continue our operations.

Patents and Proprietary Rights

         We have four United States patents, one European patent covering
thirteen countries and nine patents in nine other countries, issued. We also
have one United States and eight international patent applications (filed under
the Patent Cooperation Treaty) pending, for our technology and processes:

         o    The first of these patents covers the method for the production of
              OrCel. It is an epidermal layer of cultured epidermal cells and a
              bilayered collagen sponge structure that includes a layer of
              highly purified, non-porous collagen on top of a porous
              cross-linked collagen sponge containing cultured dermal cells.
              This patent expires on February 1, 2011. This is also the
              technology covered by the European and other foreign patents which
              have been issued to us. These foreign patents also expire in 2011.

         o    Another United States patent provides for the extension of the use
              of the collagen sponge structure described above which may contain
              cells other than epidermal and/or dermal cells, such as cells for
              regenerating such organs and tissues as heart muscle, blood
              vessels, ligaments, cartilage and nerves. This patent also expires
              on February 1, 2011. We have not performed, nor are we planning to
              perform in the near future, any clinical trial using our platform
              technology for use of donor cells other than epidermal and dermal
              cells.



                                       8





<Page>




         o    Another United States patent covers a manufacturing process which,
              when implemented, can reduce the cost of producing OrCel. These
              new manufacturing processes create an improvement over our
              collagen structures described above in that a third layer of
              collagen which is hospitable to cell growth is deposited on the
              non-porous collagen layer. This patent expires on December 28,
              2020.

         o    Our fourth United States patent covers a process for the
              cryo-preservation of OrCel. This patent expires on December 26,
              2021.

Despite such patents our success will depend, in part, on our ability to
maintain trade secret protection for our technology.

         Our European patent was granted to us by the European Patent Office and
was challenged by Advanced Tissue Sciences in an opposition proceeding after
grant. We successfully defeated that opposition. Advanced Tissue Sciences has
appealed that determination in our favor and the appeal is currently pending.

         The validity and breadth of claims in medical technology patents
involves complex legal and factual questions and, therefore, are highly
uncertain. We do not know if any pending patent applications or any future
patent application will issue as patents, that the scope of any patent
protection obtained will be enough to exclude competitors or that any of our
patents will be held valid if subsequently challenged in court proceedings. We
do not know if others have or will develop similar products, duplicate any of
our products or design around any of our patents issued or that may be issued in
the future. In addition, whether or not patents are issued to us, others may
hold or receive patents which contain claims having a scope that covers aspects
of our products or processes.

         Several of our competitors, including Organogenesis and Advanced Tissue
Sciences, Inc., have been granted patents relating to their particular skin
technologies which also utilize donor cells on a collagen sponge matrix. To that
extent they may be considered similar to our OrCel technology.

         We successfully defended challenges by Organogenesis to our United
States patent and by Advanced Tissue Sciences to our European patent in the
respective patent offices where those patents were issued. However, those
successful defenses do not preclude future challenges in court. The dismissal of
the challenge to our patent in Europe has been appealed. We do not know if any
of the other patents issued to us will be challenged, invalidated or
circumvented. Patents and patent applications in the United States may be
subject to interference proceeding brought by the U.S. Patent and Trademark
Office, or to opposition proceedings initiated in a foreign patent office by
third parties or to re-examination proceedings in the United States. We might
incur significant costs defending such proceedings and we might not be
successful.


                                       9




<Page>



Paul Capital Agreements

         In August 2001 and in 2002 we entered into agreements with Paul Capital
Royalty Acquisition Fund, L.P. pursuant to which we agreed in consideration of
Paul Capital paying us $10,000,000, to pay to Paul Capital 3 1/3% of the end
user sales prices paid for our OrCel product in the United States, Canada and
Mexico through the period ending in 2011. Such percentage interest in our
revenues in those three countries may be adjusted upward or downward based on
the volume of sales to end users of OrCel in those three countries. As security
for the performance of our obligations to Paul Capital, we have granted Paul
Capital a security interest in all of our U.S. patents, patent applications and
trademarks. Our agreement with Paul Capital provides that in certain events Paul
Capital may, at its option, compel us to repurchase the interest in our revenues
that we sold to Paul Capital for a price equal to the $10,000,000 Paul Capital
paid us plus an amount that would yield Paul Capital a 30% per annum internal
rate of return on its $10,000,000 investment. Among the events that would
entitle Paul Capital to compel us to repurchase its interest in our revenues at
that price is if we are insolvent or if we are unable to pay our debts as they
become due. Our agreement with Paul Capital provides that in determining such
insolvency any amount we owe to Paul Capital is excluded in calculating our net
worth (or negative net worth). As defined in our agreement with Paul Capital we
are currently insolvent. In addition, although we are currently trying to manage
our debt we are not paying our debts as they become due. Although Paul Capital
has had the right for well over a year to compel us to repurchase its interest
in our revenues at the price provided in our agreement, Paul Capital has so far
not exercised that right. If Paul Capital does exercise its right to compel us
to repurchase its interest in our revenues we would be unable to pay the
purchase price and Paul Capital could foreclose its security interest in our
U.S. patents, patent applications and trademarks and in such event we will have
to discontinue our business operations.

         In February 2003, Paul Capital purchased 50 shares of our Series B
convertible preferred stock, and in connection therewith we issued to Paul
Capital 73,077 shares of our common stock and granted Paul Capital warrants to
purchase an aggregate of 50,000 shares of our common stock, at exercise prices
of $15.00 per share for 25,000 shares and at $20.00 per share for the other
25,000 shares. The February 2003 amendments to our agreements with Paul Capital
provided, among other things, for (a) the election of one director designated by
Paul Capital, (b) the right of one observer (other than such director) selected
by Paul Capital to attend and observe all meetings of Ortec's Board of Directors
and (c) for us to use our best efforts to have independent directors who are
acceptable to both Ortec and Paul Capital, including the director designated by
Paul Capital, as a majority of Ortec's Board of Directors.

Employees

         We presently employ 39 people on a full-time basis, including three
executive officers. We also have 2 part time employees.


                                       10







<PAGE>


PART IV

Item 15.  EXHIBITS, FINANCIAL STATEMENT SCHEDULES
          AND REPORTS ON FORM 8-K

     (a)  Financial Statements and Financial Statement Schedules.

          (i)      Financial Statements:

          See Index to Financial Statements.

          (ii)     Financial Statement Schedules


          All financial statement schedules have been omitted since either (i)
the schedule or condition requiring a schedule is not applicable or (ii) the
information required by such schedule is contained in the Financial Statements
and Notes thereto or in Management's Discussion and Analysis of Financial
Condition and Results of Operation.

      (b) Reports on Form 8-K.

          We did not file any report on Form 8-K in the fourth quarter of 2003.


                                       11




<PAGE>



      (c) Exhibits.

<TABLE>
<CAPTION>
    Exhibit No.                                    Description
    -----------                                    -----------
<S>               <C>
        3.1       Restated Certificate of Incorporation (1)

        3.2       Amendment to Restated Certificate of Incorporation (2)

        3.3       Amendment to Certificate of Incorporation adopted June 28,
                  2002, being a Certificate of Designation of the Relative
                  Rights and Preferences of the Series A Convertible Preferred
                  Stock (3)

        3.4       Amendment to Certificate of Incorporation filed on August 26,
                  2002, being an Amended Certificate of Designation of the
                  Relative Rights and Preferences of the Series B Convertible
                  Preferred Stock (4)

        3.5       Amendment to Certificate of Incorporation filed on May 23,
                  2003, being the Certificate of Designation of the Relative
                  Rights and Preferences of the Series C convertible preferred
                  stock (5)

        3.6       Amendment to Certificate of Incorporation filed on June 10,
                  2003. (12)

        3.7       Amendment to Certificate of Incorporation filed on August 19,
                  2003, being the Certificate of Designation of the Relative
                  Rights and Preferences of the Series D convertible preferred
                  stock. (6)

        3.8       By-Laws (7)

        10.1      Agreement with Cambrex BioScience of Walkersville, Inc.;
                  redacted (9)

        10.2      Agreement with Paul Capital Royalty Acquisition Fund L.P.;
                  redacted (10)

        10.3      Termination of Employment Agreements between the Registrant
                  and Steven Katz, Ron Lipstein and Alain Klapholz (11)

        10.4      Lease with Audubon Biomedical Science and Technology Park (2)

         14       Code of Ethics (12)

         23.      Consent of Grant Thornton LLP (12)

        31.1      Certifications (Principal Executive Officer) (8)

        31.2      Certifications (Principal Financial Officer) (8)

        32.1      Certification of Principal Executive Officer (8)

        32.2      Certification of Principal Financial Officer (8)
</TABLE>


----------------------


                                       12




<PAGE>




(1)     Filed as an Exhibit to our Form 10-Q filed for the quarter ended
        September 30, 2001, and incorporated herein by reference.

(2)     Filed with our Annual Report on Form 10-K for the year ended December
        31, 2002, and incorporated herein by reference.

(3)     Filed as an Exhibit to our Form 10-Q for the quarter ended June 30,
        2002, and incorporated herein by reference.

(4)     Filed as an Exhibit to our Form 10-QA for the quarter ended September
        30, 2002, and incorporated herein by reference.

(5)     Filed as an Exhibit to our Form 10-Q for the quarter ended June 30,
        2003, and incorporated herein by reference.

(6)     Filed as an Exhibit to our Form 10-Q for the quarter ended September 30,
        2003, and incorporated herein by reference.

(7)     Filed as an Exhibit to our Registration Statement on Form SB-2 (File No.
        33-96090), or Amendment 1 thereto, and incorporated herein by reference.

(8)     Filed herewith.

(9)     Filed as an Exhibit to our Registration Statement No. 333-109027, or an
        amendment thereto, and incorporated herein by reference. Certain
        portions of Exhibit 10.1 marked by asterisks were omitted pursuant to a
        confidential treatment request and filed separately with the Securities
        and Exchange Commission.

(10)    Filed as an Exhibit to Amendment No. 1 to our Annual Report on Form 10-K
        for the year ended December 31, 2002, and incorporated herein by
        reference. Certain portions marked by asterisks were omitted pursuant to
        a confidential treatment request and filed separately with the
        Securities and Exchange Commission.

(11)    Filed as an Exhibit to our Form 8-K filed on December 12, 2002, and
        incorporated herein by reference.

(12)    Filed as an Exhibit to our Annual Report for our Form 10-K for the year
        ended December 31, 2003


                                       13




<PAGE>



                                   SIGNATURES


Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the Registrant has duly caused this amended report to be signed on
its behalf by the undersigned thereunto duly authorized.


Dated: June 23, 2004                          Ortec International, Inc.

                                                  By: /s/ Ron Lipstein
                                                      ----------------
                                                      Ron Lipstein
                                                      Chief Executive Officer


                                       14




                           STATEMENT OF DIFFERENCES

The section symbol shall be expressed as..............................'SS'