The 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 US 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.
Osteotech’s DuraTech will provide surgeons with greater flexibility to cut, shape and suture the material to fit each patient’s needs. Based on available data, Osteotech estimates that the annual market for dural repair substitutes is approximately $100 million.
In addition to DuraTech, which is expected to launch late this year, Osteotech plans to introduce additional tissue products based upon its HCT platform over the next several years that address patient needs and expand the addressable market for this innovative technology. These products include: rotator cuff repair, wound care applications and abdominal wall reconstruction; Osteotech estimates that this expanded addressable market opportunity will eventually be in excess of $1 billion yearly.
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, said Sam Owusu-Akyaw, Osteotech’s President and Chief Executive Officer. 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.
