FDA Notifies Ortec of PMA Acceptance; Completion of First Step in PMA Approval Process Achieved.

Business Editors/Health/Medical Writers

BIOWIRE2K

NEW YORK--(BUSINESS WIRE)--March 31, 2004

Ortec International, Inc. (ORTN) announced today that it has received an acceptance letter from the Food and Drug Administration (FDA) indicating that the FDA has completed its review of the technical elements and clinical data submitted in support of Ortec's PreMarket Approval (PMA) application for OrCel(R), its tissue engineered advanced wound care product, for the treatment of venous stasis leg ulcers. The issuance of this letter acknowledges that the FDA has determined that Ortec's PMA application appears to contain valid scientific evidence, is suitable for filing and sufficiently complete for the FDA to begin a substantive review. The receipt of this letter signifies the completion of the first critical step in the PMA review process.

During this stage of the review process, the FDA assessed the adequacy of the technical elements of the PMA including the details of the manufacturing process and the clinical data sections. The issuance of the letter indicates the FDA has concluded that the manufacturing process and the clinical data submitted in support of PMA approval were collected and analyzed consistent with the major elements of the clinical protocol (i.e., objectives, study population, endpoints, study design, hypothesis, sample size, and follow-up duration).

As the review process continues, the FDA may communicate requests for additional information and clarification. The culmination of the review process is a 100-day meeting with the FDA at which time Ortec and the FDA will review the entire PMA application and finalize any remaining labeling issues.

Ron Lipstein, Vice Chairman and CEO of Ortec, commenting on the FDA accepting Ortec's PMA application, said, "Advancing the review process to this stage is a significant step towards the goal of obtaining FDA approval for the venous leg ulcer indication. We look forward to working closely with the FDA during the next few months with the goal of making OrCel available to patients suffering from venous leg ulcers".

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.