Kensey Nash granted FDA 510(k) clearance for Meso BioMatrix ECM product

May 27 2010

Kensey Nash Corporation (Nasdaq: KNSY), a leading medical technology company that provides innovative resorbable biomaterial technology for a wide range of medical procedures, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its second extracellular matrix (ECM) product, the Meso BioMatrix™ product. The clearance allows for the use of Meso BioMatrix in general surgery for the reinforcement and repair of soft tissue, including hernia repair, plastic and reconstructive surgery, and urologic, gynecologic and gastroenterologic applications.

The Meso BioMatrix product is a porcine-based mesothelium (Meso) extracellular matrix designed to reinforce soft tissues where weakness exists in patients requiring soft tissue repair.   Medeor™ Matrix, the Company's previously cleared dermal matrix product, and the Meso BioMatrix product are manufactured using Kensey Nash's proprietary Optrix™ process, which gently disinfects tissues, inactivates viruses and removes cells while preserving extracellular matrix components.  Kensey Nash is currently evaluating partnering opportunities for the Meso BioMatrix products in the urogynecology, wound care, orthopaedic and other markets.  

"This regulatory clearance represents another important milestone in our plans to build upon Kensey Nash's leadership position as a developer of innovative regenerative medicine products," commented Doug Evans, Chief Operating Officer of Kensey Nash. "Meso BioMatrix and Medeor Matrix represent two distinct product platforms that put Kensey Nash in the unique position to provide surgeons multiple options with respect to tissue source and handling characteristics when selecting a biologic mesh.  We expect these efforts to yield new collaborative partners and additional products in the rapidly growing biosurgery market that will provide continued diversification and expansion of our business in the future. As a Company, we remain committed to developing unique and effective therapies that address the clinical needs of physicians and patients around the world," he concluded.  

SOURCE Kensey Nash Corporation