71% of Patients Treated with OrCel Achieve 100% Wound Closure in Ortec's Venous Ulcer Trial; 92% Improvement Over Standard of Care Therapy Achieved on Hard to Heal Ulcers.

Business Editors & Health/Medical Writers

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NEW YORK--(BW HealthWire)--Feb. 5, 2002

Ortec International, Inc. (NASDAQ: ORTC), a tissue engineering company, announced today the results of a six-month follow up of all 36 patients enrolled in its venous ulcer pilot trial completed in August 2000.

The results, which are to be submitted in a final report to the Food and Drug Administration (FDA) later this month, show that 71% of the patients treated with a non-frozen version of OrCel(TM) achieved 100% wound closure in comparison to 37% for the control group, representing a 92% improvement using OrCel in the treatment of hard to heal ulcers over standard of care therapy. In addition, the rate of wound closure for the OrCel treated group was double that of the control group and the OrCel treated group consistently required fewer days to heal.

In August 2000, Ortec submitted to the FDA a final report of an interim analysis of patients in this same trial. In particular, that report showed that at two months, 47.1% of the OrCel treated patients achieved 100% wound closure in comparison to 26.3% for the control group, and at three months the percentage of the OrCel treated group that achieved 100% wound closure increased to 52.9%, whereas the standard of care treated group remained constant at 26.3%.(1)

This past October, Ortec announced the results of a preliminary review of the first 13 patients completing its pivotal venous leg ulcer trial using its frozen (cryopreserved) form of OrCel. These results showed that 69.2% of the patients achieved 100% wound closure in 3 months with the balance of the patients achieving 90% wound closure or higher.(2)

The pilot study from where this new data was generated was a 36-patient, eight center controlled study. Patients treated were pre-screened to ensure inclusion of only hard to heal ulcers. Those ulcers which responded to standard of care therapy by closing by more than 30% after two weeks of treatment were excluded from the study. The median size of the ulcers treated for both the OrCel and control groups was 4.5 cm(2) with the median age of the ulcers being nine months for the OrCel group and ten months for the control group.

Steven Katz, Ph.D., Chairman and CEO of Ortec, commenting on the newly released venous ulcer results said, "Our clinical data continues to be second to none. The differential between the competition and ourselves continues to widen and I trust in time will be more fully recognized by the capital markets. We believe that our outstanding clinical data in venous and diabetic ulcers(3) continues to position OrCel to become the therapy of choice in the treatment of chronic wounds."

About Ortec International, Inc.

Ortec International, Inc. 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 OrCel to heal chronic and acute wounds. In addition to having received FDA approvals during 2001 for OrCel for treatment of Epidermolysis Bullosa and donor sites in burn patients, Ortec is also pursuing FDA approvals for venous and diabetic skin ulcers and is in the midst of clinical trials for these indications. Overall, these indications are estimated to be in excess of $1 billion. Ortec believes, as well, that its platform technology extends 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.

(1) "Ortec's CCS Continues To Demonstrate Superiority Over Standard Of Care In Treatment Of Venous Ulcers In Final Interim Report Filed With FDA" - Press Release, August 24th, 2000

(2) "Ortec's Preliminary Data Using Frozen Form of OrCel(TM) in Venous Leg Ulcers Demonstrates 69% of Patients Achieved 100% Wound Closure in 12 Weeks" - Press Release, October 31st, 2001

(3) "Ortec's OrCel(TM) Demonstrates More Effective And Faster Healing of Diabetic Ulcers Compared to Standard of Care" - Press Release, November 13th, 2001