Langhorne, PA – May 4, 2009 . . . . Xylos Corporation (“Xylos” or the “Company”), a leader in biocellulose technology for medical applications, announced today that the Company received FDA 510(k) clearance for its new implantable device to be marketed under the trade name “MTA™ Protective Sheet”. The indications for use include the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The MTA™ Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures.
This FDA notification represents the fourth 510(k) clearance received by the Company for its implantable biomaterial; three of which were received within the last 10 months.