Osteotech submits Duratech BioRegeneration Matrix 510(k) application to the FDA

Dec 17 2009

Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic products for regenerative healing, announced today that it has submitted a 510(k) application to the United States Food and Drug Administration (FDA) to obtain marketing clearance for the use of its Duratech(TM) BioRegeneration Matrix to repair or replace the dura mater (the outermost membrane surrounding the brain) in various cranial surgical procedures. This filing is based, in part, on data collected during the Company's human clinical study, which demonstrated the safety and performance of Duratech compared to currently marketed predicate dura substitute devices. Based on available data, Osteotech estimates that the annual market for dura repair substitutes is approximately $100 million.

"Our 510(k) application for Duratech is another key milestone in our new product development initiatives and is the first step in the commercial development of our HCT(TM) (human collagen technology) platform," said Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer. "We believe HCT will eventually support a family of first-in-class, procedure-specific biologic products with a total addressable market opportunity in excess of $1 billion. We believe the data in our filing demonstrates Duratech's safety and performance in the challenging neurosurgical environment and that this data will pave the way in developing the HCT platform for a variety of surgical applications. Duratech was developed in response to the physician community's need for a single biomaterial that has exceptional handling, is flexible yet strong and can be cut, shaped and sutured to fit surgical needs. Once cleared by the FDA, we believe Duratech's unique characteristics will give us a competitive advantage in the marketplace."

Duratech is the first of several products that Osteotech is developing based upon its first-in-class HCT platform. The Duratech 510(k) filing included data on 60 patients who underwent a variety of cranial surgical procedures utilizing Duratech where dura mater repair or replacement was required. The patients were evaluated at 30 and 90 day time points post-operatively to assess the safety and performance of Duratech.