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C O R R E C T I O N -- Osteotech, Inc.
Date:7/29/2009

n programs focused on highlighting the superior characteristics of our broad technology platforms and product portfolios. From a trajectory perspective, we are looking forward to the release of our new product pipeline in the second half in 2009."

Recent 2009 Corporate Developments

  • Osteotech completed the 60-patient enrollment for its DuraTech clinical trial. In the initial feedback from physicians participating in the trial, DuraTech was characterized as a unique, easy to use solution that possesses several important characteristics making it ideal as an onlay graft. Based upon this timely completion of trial enrollment, the Company remains on track to file a 510(k) with the U.S. Food and Drug Administration in the third quarter of this year to secure marketing clearance for DuraTech. The Company also continues to expect to unveil DuraTech at the 2009 Annual Meeting of the Congress of Neurological Surgeons in October. DuraTech is the first of several products under development based upon Osteotech's proprietary human collagen technology (HCT(TM)) platform.

  • During the second quarter, the Company completed its six month posterolateral fusion study of its proprietary MagniFuse Bone Graft in primates. The Company also completed its six month sheep study focused on interbody fusion, comparing MagniFuse directly with INFUSE(R) Bone Graft distributed by Medtronic, Inc. The initial analysis of the data indicates that MagniFuse was able to produce robust bone formation in both models. Of particular significance was the ability of MagniFuse to produce similar results against INFUSE in interbody fusion. Osteotech is currently compiling the histological results for both studies for inclusion in a clinical data package to be available later this year. These studies support the Company's strategy to introduce application-specific products with documented scientific and te
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