The first five patients in this 60-patient trial have already been enrolled. During the study’s initial cranial surgical procedures, the patients’ dura mater was successfully repaired by surgeons using the DuraTech BioRegeneration Matrix.
This pivotal clinical trial will evaluate 60 surgical patients at 30 and 90 days post-operatively to assess the safety and efficacy of the DuraTech BioRegeneration Matrix compared to historical surgical procedure outcomes.
Once this trial is completed, Osteotech plans to file a medical device premarket submission, or 510(k), with the FDA. Osteotech anticipates filing the 510(k) during the third quarter of 2009 to secure marketing clearance.
In addition to the DuraTech BioRegeneration Matrix, which is expected to launch in late 2009, Osteotech plans to introduce additional human collagen-based tissue products over the next several years that address patient needs and expand the addressable market for this innovative technology, including: rotator cuff repair, wound care applications and abdominal wall reconstruction.
Sam Owusu-Akyaw, president and CEO of Osteotech, said: DuraTech is the first of several extremely promising products that we have in development based on our innovative human collagen technology platform. Our human collagen platform positions Osteotech as first-in-class with this new biomaterial and enables us to respond to the growing surgeon demand, and address patient need, for safe and clinically effective regenerative healing surgical products.