Osteotech Gets FDA Approval
BY SHELLY ACHAIBAR, DECEMBER 21, 2005
After a number of recent set backs, Osteotech is making headway with its GraftCage Product Line. Today, the Food and Drug Administration (FDA) has cleared its 510(k) application for the GraftCage TLX System, the second approval for Osteotech's Graftcage product line in the last two weeks.
Sam Owusu-Akyaw, Osteotech's President and COO, stated "We now have FDA clearance to distribute two different products in our GraftCage Product Line, the GraftCage ACX and GraftCage TLX, both of which we anticipate distributing in the first quarter of 2006. These two new products, along with additional GraftCage Product Line extensions we expect to introduce in 2006, will allow Osteotech to compete in that portion of the spinal interbody market dominated by PEEK products, which in 2005 approximates $221 million".
This product is intended to replace a collapsed, damaged or unstable vertebral body in the thoracic or lumbar spine region. The GraftCage TLX is designed to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.
