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ORTN - O/S 5.6 Million

Moving nice on diabetes related news!
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FDA Completes Review of Ortec's Diabetic Foot Ulcer Protocol And Gives Clearance to Initiate Diabetic Foot Ulcer Trial
Wednesday February 9, 1:41 pm ET


NEW YORK--(BUSINESS WIRE)--Feb. 9, 2005--Ortec International, Inc. (ORTN) today announced that the Food and Drug Administration (FDA) has completed a review of the modified Diabetic Foot Ulcer (DFU) Protocol submitted to the FDA on January 6, 2005 and has given Ortec permission to initiate a pivotal trial evaluating OrCel® in the treatment of diabetic foot ulcers. Ortec expects to initiate patient enrollment shortly after receiving approval of its Premarket Approval (PMA) application for the use of OrCel in the treatment of venous leg ulcers (VLU) currently under FDA review. The DFU trial is expected to be conducted at up to 25 clinical centers and involve up to approximately 200 patients.
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The results of Ortec's multicentered controlled pilot study assessing the effectiveness of it's product, OrCel®, in treating diabetic foot ulcers, was featured in the July 2003 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 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.

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 lifetime. In addition, approximately 800,000 people in the United States require treatment for diabetic foot ulcers annually.

As a follow up to last month's press release which updated shareholders on the Premarket Approval (PMA) process for use of OrCel® in the treatment of Venous Leg ulcers, Ortec also announced today that ,as part of the continued dialogue with the Food and Drug Administration (FDA), the agency has asked Ortec to provide further clarification of information submitted in its PMA application. Ortec has responded to the FDA and expects to meet with the agency shortly to review the information submitted.

Ron Lipstein, CEO and Vice Chairman of Ortec, said, "The questions recently communicated by the FDA are indicative of the agency's thorough review of all relevant information filed in the PMA. As part of our continuous interaction with the FDA, we may receive other requests for additional information or clarification of information previously submitted. As we have throughout this approval process, we expect to be able to provide the FDA with responses to any requests for additional information it may have, and will continue to work closely with the agency to complete the PMA review process and look forward to our beginning the DFU trial. In parallel to our completing the PMA process, we and our marketing partner have initiated steps in preparation for the commercial launch of OrCel."

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® (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 a PMA has been filed. In addition, 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.