Osteotech has announced that it has completed enrollment for the clinical trial of DuraTech BioRegeneration Matrix. DuraTech, used to repair dura mater during cranial surgical procedures, is based on Osteotech’s HCT platform.
A total of 60 patients were enrolled in the clinical study. The trial will evaluate the patients at 30 and 90 days post-operatively, to assess the safety of DuraTech compared to historical surgical procedure outcomes.
Osteotech plans to utilize the results from the trial to support its 510(k) filing for marketing clearance with the FDA, later this year.
DuraTech will provide surgeons with greater flexibility to cut, shape and suture the material to fit each patient’s needs.
Sam Owusu-Akyaw, President and CEO, Osteotech, said: We remain on track to file our 510(k) for DuraTech during the third quarter of 2009 and anticipate clearance of the product before the end of the year.
We look forward to evaluating the results of the clinical trial and believe that the data will show that our first-in-class biomaterial stimulates the body’s natural healing processes and helps reduce the potential for immune reactions. Our HCT platform will support a variety of new products currently in development and we are excited about its future. We believe the technology platform will yield safe and clinically effective regenerative healing products that can satisfy the emerging needs of surgeons and the patient communities they serve, he added.