64% Improvement Over Standard of Care Therapy Achieved in Ortec's Venous Ulcer Pivotal Trial.

Business Editors/Health/Medical Writers

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NEW YORK--(BUSINESS WIRE)--Dec. 9, 2003

Ortec to Initiate Pre Market Approval (PMA) Process with

The Food and Drug Administration (FDA) by End of Year

Ortec International, Inc. (ORTN) announced today that an analysis of data from its pivotal (final stage) trial evaluating the cryopreserved (frozen) version of its tissue engineered product, OrCel(R), in the treatment of chronic hard to heal venous leg ulcers (VLU) showed statistically significant differentials between OrCel and the control group for both the primary and secondary clinical endpoints of the trial, time to 100% healing and the percentage of patients achieving 100% healing.

The data to be used to support the approval of the Pre Market Approval (PMA) by the FDA demonstrated that OrCel had a 64% improvement over standard of care at the end of the 12-week treatment phase of the study. At 12 weeks, 59% of the patients treated with OrCel achieved 100% wound closure and had a median healing time of 57 days. In comparison, 36% of the patients treated with the control group achieved 100% wound closure and had a median healing time of greater than 90 days. For the control group, the primary endpoint of median days to 100% healing was not achieved, since less than 50% of the standard of care patients healed during the 12-week evaluation period.

Based on this data, Ortec expects to initiate a PMA approval process with the FDA by the end of the year. In agreement with the FDA and in an effort to expedite the review process, Ortec will file its PMA on a modular basis, wherein each section of the PMA is filed as it is completed. The FDA initiates its review upon receiving the first module. Ortec expects to submit two such modules. The initial submission, the CMC section or manufacturing section, is expected to be filed before the end of the year. The second and final module, a summary of the safety and effectiveness demonstrated in the clinical study, is expected to be filed by the end of January 2004.

Ron Lipstein, Chief Executive Officer and Vice Chairman of Ortec International, commenting on the clinical data said, "We are obviously quite pleased by the results of the trial and believe it supports an approval of our PMA to be filed with the FDA. The performance of OrCel appears to be consistent with data generated in our earlier trials and we look forward to initiating the PMA process and working with the FDA in bringing OrCel to the market place."

About Ortec International, Inc.

Ortec International, Inc., (ORTN), is a tissue-engineering company involved in the commercialization of a proprietary and patented technology to stimulate the repair and regeneration of human tissue. Ortec's current focus is the application of its OrCel(R) (Bilayered Cellular Matrix) to heal chronic and acute wounds. OrCel is composed of a collagen sponge seeded with allogeneic epidermal and dermal cells. These cells secrete growth factors and cytokines normally found in acute human wounds and are believed to have a beneficial role in promoting tissue repair. In addition to having received FDA approvals for the treatment of Epidermolysis Bullosa and donor sites in burn patients, a pivotal clinical trial has been completed for venous ulcers and the FDA has granted Ortec approval to initiate a pivotal trial in diabetic foot ulcers. Ortec believes that its platform technology may extend to the regeneration of other human tissue such as tendons, ligaments, cartilage, bone, muscle and blood vessels. For more information, visit Ortec's website at http://www.ortecinternational.com.

Certain statements made in this news release that express the belief, potential anticipation or expectation, as well as other statements which are not historical fact, and statements relating to the clinical trials and their results, design, FDA product approvals or other marketing approvals, features, functionality and performance insofar as they may apply prospectively, are "forward looking" statements within the meaning and pursuant to the Safe Harbor provisions of the Securities Litigation Reform Act of 1995 and involve risks and uncertainties. The Company's actual results may differ significantly from the results discussed in this news release or in other "forward looking" statements presented by management. Factors that might cause such a difference include, but are not limited to, development by the Company's competitors of new technologies or products that are more effective than the Company's, risks of failure of clinical trials, dependence on and retention of key personnel, protection of proprietary technology, compliance with U.S. Food and Drug Administration regulations, continued availability of raw material for the Company's products, availability of product liability insurance in the event of commercialization of the Company's products, ability to effect transition from pilot-scale manufacturing to large-scale commercial production of products, uncertainty as to the availability of additional capital on acceptable terms, if at all, and the demand for the Company's products, if and when commercially available.