Ortec's OrCel-TM- Demonstrates More Effective And Faster Healing of Diabetic Ulcers Compared to Standard of Care

OrCel Closes Twice As Many Diabetic Ulcers And At Twice The Daily Rate In Largest Diabetic Population Segment

New York, NY--Ortec International, Inc. (NASDAQ: ORTC) announced today interim 12-week clinical data from its pilot diabetic ulcer trial with OrCel(TM).

Key findings from the study are:

-- Greater than 100% improvement over standard of care in diabetic ulcers the size of 6 sq.cm or less (largest population of occurrence of diabetic ulcers). 47% of patients

(7/15) treated with OrCel achieved 100% wound closure in comparison to 23% of patients (3/13) for the control group treated with standard of care.

-- Daily rate of healing was twice as fast for OrCel treated patients when compared to standard of care in the <6 sq.cm population (2.2 sq.cm/day vs. 1.1 sq.cm/day).

-- 75% improvement over standard of care in the overall population of patients treated in this trial; 35% (7/20) of OrCel treated ulcers healed vs. 20% (4/20) with standard of care.

-- Daily rate of healing was significantly faster for OrCel treated wounds when compared with standard of care in the overall population (1.8 sq. cm/day vs. 1.1 sq.cm/day).

The study was conducted at eight centers involving 40 patients using the fresh version of OrCel. In order to include only difficult to heal ulcers in the study, the protocol required that all patients be subjected to a pre-screening period during which standard of care treatment was performed. If during this screening period the ulcer healed more than 30%, the patient was not included in the study. The study design provided for the OrCel treated group to receive a single application of OrCel weekly, for up to six weeks. All patients were allowed to remain ambulatory.

Commenting on these results, Steven Katz, Ph.D., Chairman and CEO of Ortec, said, "These results continue to demonstrate the efficacy of OrCel for the closure of hard-to-heal chronic wounds. The benefits that OrCel therapy offers over standard of care are even more remarkable when our data is compared to data from trials with other products approved for the treatment of diabetic foot ulcers. While different study results cannot be directly compared, what is indicative of efficacy is a product's relative performance to its own control. To our knowledge, no published data exists for any product (approved or undergoing trials) that matches OrCel's improvement over its control. We believe that our results in diabetic ulcers coupled with OrCel's previously announced results in venous leg ulcers positions OrCel as the potential leading product for the treatment of chronic wounds."

Added Ron Lipstein, Vice Chairman and CFO, "Given our recently released data that the frozen version of OrCel outperformed the fresh form in venous ulcers, we are excited about the potential implications of using frozen OrCel in the upcoming diabetic ulcer pivotal trial."

About 16 million people in the United States have diabetes. Approximately one in every seven diabetics will suffer from at least one diabetic foot ulcer in his/her lifetime. In addition, approximately 800,000 people in the United States require treatment for diabetic foot ulcers annually.

Foot complications are the most frequent cause of hospitalization among outpatient diabetics, and diabetic foot ulcers often lead to amputation. Each year, approximately 60,000 amputations are performed on diabetics in the United States.

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(TM)(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. 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.

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 property.
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