EATONTOWN, N.J., June 10 /PRNewswire-FirstCall/ — Osteotech, Inc. (Nasdaq: OSTE – News), a leader in the emerging field of biologic products for regenerative healing, announced today that it has completed enrollment for the clinical trial of its DuraTech(TM) BioRegeneration Matrix. Based upon Osteotech’s proprietary HCT(TM) (human collagen technology) platform, DuraTech is used to repair dura mater (the tough, outermost membrane surrounding the brain and spinal cord) during cranial surgical procedures.
DuraTech is the first of several products that Osteotech is developing based upon its first-in-class HCT platform. A total of 60 patients were enrolled in the clinical study and 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 stemming from this trial to support its 510(k) filing for marketing clearance with the United States Food and Drug Administration later this year.
“The new dural substitute, DuraTech, provides a unique solution for surgeons,” said Dr. Carl Bruce, Consultant Neurosurgeon at the University of the West Indies, who was one of the investigating surgeons participating in the clinical trial. Dr. Bruce continued, “DuraTech is strong enough to hold sutures, but at the same time handles easily and conforms to convexity, making it ideal for onlay grafts. This important combination is not present in many other products currently on the market.” Dr. Oscar Aponte, Neurosurgeon, Professor of Rosario University and Dr. Mauricio Riveros Castillo, Chief of Neurosurgery, Samaritana University Hospital and Hospital Mayor, the two remaining surgeons participating in the clinical trial added, “DuraTech was easy to use, handled well and provided the flexibility needed for different surgical procedures quickly taking the shape of the underlying tissue.”