EATONTOWN, N.J., Dec. 17 /PRNewswire-FirstCall/ -- Osteotech, Inc., 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.
