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Ortec International Inc. (ORTN.OB) Files PMA for OrCel(R) for VLU Indication


10/23/2007 8:24:32 AM

NEW YORK, NY--(Marketwire - October 23, 2007) - Ortec International, Inc. (OTCBB: OTCI), a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, announced today that it has filed the final safety and efficacy data required by the Food and Drug Administration (FDA) to evaluate its Pre-Market Approval (PMA) application for the use of OrCel® in the treatment of Venous Leg Ulcers (VLU). Ortec had filed the Chemistry, Manufacturing and Control (CMC) section of the current PMA earlier in the year. Ortec also previously developed a statistical plan with FDA for combining the data from its original, 2004 PMA filing with the additional data from this confirmatory trial in order to effectively double the number of patients evaluated. The combined data show a significant improvement in wound healing in the OrCel®-treated patients. The efficacy and safety results of the study show the following results for the OrCel® treated patients as compared to the standard of care (SC):

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