Langhorne, PA – March 19, 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 expanded claims on its biocellulose surgical mesh to be marketed under the trade name “Securian(tm) Tissue Reinforcement Matrix.” The indications for use include reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. In addition, Securian(tm) Tissue Reinforcement Matrix minimizes tissue attachment to the device in case of direct contact with overlying tissues. This FDA notification is the third 510(k) clearance received by the Company on its proprietary implantable biomaterial.
The Securian(tm) Matrix is an augmentation device engineered to improve the strength of the tendon-suture interface. This interface is often the “weak link” common to many tendon repair failures. In rotator cuff repair alone, the failure rate has been reported to exceed 25%. Because of its conformability and excellent handling properties, the Securian(tm) Matrix can be placed via open or endoscopic procedures without requiring the use of new surgical techniques or instruments.