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Ortec International Inc. (ORTN.OB) Initiates Premarket Approval (PMA) Application Filing Seeking Approval for OrCel(R) in Treating Venous Leg Ulcers
2/26/2007 10:17:44 AM
NEW YORK, NY -- (MARKET WIRE) -- February 26, 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 initiated the filing of its Pre Market Approval (PMA) supplement application requesting permission from the Food and Drug Administration (FDA) to market its tissue engineered product, OrCel®, for the treatment of venous leg ulcers, an estimated $500 million market in the U.S. by submitting to the FDA the Manufacturing and Controls (CMC) section, the first of two modules of the application. The final section of the application, which will include a summary of safety and effectiveness in the clinical studies and device labeling, is expected to be filed with the FDA in the second quarter. These filings will be amendments to our PMA application filed in February 2004.
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