FDA decision on Duratech expected on March 17 (Nasdaq:OSTE)

Duratech™ BioRegeneration Matrix is a medical device that has been devekioed by Osteotech, Inc (Nasdaq:OSTE). Now the company wants to bring this product into the market. However, it needs the approval from the United States of America’s toughest regulator – the Food and Drug Administration (FDA). For this reason, Osteotech submitted a 510(K) application to the FDA on December 17, 2009.It usually takes the FDA about 90 days to review a 510(K) submission, so the company expects to get response from the FDA on March 17, 2010. However, the FDA may not announce its decision on this date and there is no way to find out when it will, since the FDA is not bound by law to notify about decision dates for any submission, such as 510(K), related to medical devices.

According to the company, the Duratech™ BioRegeneration Matrix, which has been developed using Osteotech’s human collagen technology (HCT) platform, can be used during the replacement or the repair of the outmost brain membrane – called the dura mater. Thus the device, which promotes growth of cells in the dura mater, is helpful for those whose dura mater has been damaged due to injury or surgery.

The 510(K) submission contains results from the medical trials that the company has conducted to measure the safety and the effectiveness of Duratech. A total of 60 people having damaged dura mater participated in these trials. Cranial surgery was performed on each of these participants to replace or repair their dura mater – using Duratech.

If the 510(K) submission becomes successful in getting the FDA’s approval, it will be introduced into the market straight away. The company is also developing several other medical devices – other than Duratech – using its HCT platform.

Soon after the news of the 510(K) submission was released, Sam Owusu-Akyaw, who is the Chief Executive Officer as well as the President of Osteotech, said:

“We believe HCT will eventually support a family of first-in-class, procedure-specific biologic products with a total addressable market opportunity in excess of $1 billion. We believe the data in our filing demonstrates Duratech’s safety and performance in the challenging neurosurgical environment and that this data will pave the way in developing the HCT platform for a variety of surgical applications.”