CCS Shows Superiority Over Standard of Care in Interim Analysis of Ortec's Initial Venous Ulcer Trial.

Business Editors/Health & Medical Writers

NEW YORK--(BW HealthWire)--March 21, 2000

12 Week Interim Analysis Indicates 52.9% of CCS Treated Patients

Achieved 100% Wound Closure versus 26.3% in Standard of Care Group

Ortec International, Inc. (Nasdaq:ORTC) announced today the results of the interim analysis of its preliminary venous ulcer trial. The analysis of the data showed that at 12 weeks, 52.9% (9/17) of CCS treated patients achieved 100% wound closure in comparison to 26.3% (5/19) for the control group treated with standard of care. The data generated was based on planimetric analysis, a method in which computer scans of the wound are evaluated over time for percentage of wound closure. In addition, those patients who did not achieve 100% wound closure within 12 weeks achieved greater wound closure with CCS than standard of care. The differential in healing of CCS over standard of care started at week 3 (percent improvement for CCS treated patients was 62.7% vs. standard of care 28.5%), and was maintained throughout the study. Based on this data, Ortec will file with the FDA for permission to begin a pivotal trial in venous ulcers.

The study was conducted at eight clinical sites. Thirty-six patients were enrolled (17 treated with CCS and 19 treated with standard of care). The wound size of the patients treated was between 4 - 64 cm2. All patients randomized into this study were screened to have hard to heal ulcers. Patients were treated with a single application of CCS weekly, for up to four weeks.

                      Summary of Planimetric Data
              % of Patients Achieving 100% Wound Closure

         Week                 CCS           Standard of Care
          4                  17.6%                  0%
          8                  41.2%               26.3%
          12                 52.9%               26.3%

Based on the strength of this data, Ortec expects that it will be able to enroll under 200 patients (half to be treated with CCS and half with standard of care) in its pivotal trial to achieve statistical significance. Request from the FDA for permission to begin a pivotal trial is expected to be filed within the second quarter.

Steven Katz, Ph.D., President of Ortec, commenting on the interim analysis data said, "The data generated in this trial supports our belief that CCS is the dominant technology that can most effectively treat hard to heal venous ulcers. To date we are unaware of any other data relating to the treatment of venous ulcers which compares to these results. We look forward to the initiation and completion of our pivotal trial."

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 its Composite Cultured Skin (CCS) product to heal chronic and acute wounds. Ortec believes that its platform technology may extend to the development of other human tissue, such as tendons, ligaments, cartilage, bone, muscle and blood vessels.

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.