Clinical Results of Ortec's OrCel in Treating Foot Ulcers Featured in Peer Reviewed Journal 'Wounds'.

Business Editors/Health/Medical Writers

BIOWIRE2K

NEW YORK--(BUSINESS WIRE)--Aug. 5, 2003

The results of Ortec International's (OTCBB:ORTN) multi-centered controlled pilot study assessing the effectiveness of its product, OrCel(R), in treating diabetic foot ulcers, was featured in the July issue of the peer reviewed publication "Wounds". The article was entitled "Effectiveness of OrCel (Bilayered Cellular Matrix) in Health of Neuropthathic Diabetic Foot Ulcers: Results of a Multicenter Pilot Trial"; the lead author was Scott Lipkin, DPM, affiliated with the Department of Surgery, Lehigh Valley Hospital, Allentown Pennsylvania., and coauthored by Elliot Chaikof, MD, Ph.D, Department of Surgery, Emory University, Atlanta, Georgia, Zevi Isseroff, DPM, NorthShore Diabetes and Endocrine Research, New Hyde Park, New York, and Paul Silverstein, MD, Baptist Integris Burn and Wound Care Center, Oklahoma City, Oklahoma.

The results of the trial, as described in the article, demonstrated that in hard to heal diabetic foot ulcers that were less than or equal to 6cm(2) (approximately 70% of the ulcers in the trial were in that category), 47% of the patients treated with OrCel were completely healed compared with 23% of the control group. In addition to OrCel producing a greater percentage of patients with complete healing, the study also showed that the mean rate of reepithelization (wound closure) was significantly higher in the OrCel treated groups.

The authors of the article concluded that the OrCel treatment described in the study "augments the wound healing process in diabetes, increasing the speed of wound closure and the success rate for complete healing." Based on the data generated in the clinical trial, the Food and Drug Administration (FDA) approved the initiation of a pivotal (Phase III) trial using OrCel in diabetic foot ulcers. Ortec expects to begin that trial after submitting its Pre Market Approval (PMA) application with the FDA seeking approval to market OrCel for the treatment of venous ulcers. Ortec expects to file the PMA by the end of the year.

About Ortec International, Inc.

Ortec International, Inc. (OTCBB: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 is ongoing in 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.