FDA regulatory clearance for Kensey Nash's ECM product

Nov 12 2009

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 for its first extracellular matrix (ECM) product, Medeor(TM) Matrix, from the U.S. Food and Drug Administration. The clearance allows for the use of Medeor Matrix in general surgery for the reinforcement and repair of soft tissue, including hernia repair and plastic and reconstructive surgical applications.

Medeor Matrix is a porcine-based dermal extracellular matrix designed to act as a biologic scaffold to stimulate the deposition of organized tissues specific to an injured site. These ECM products facilitate rapid revascularization and are therefore quickly repopulated with cells from the host tissue and ultimately converted into functional living tissue. Medeor Matrix is manufactured using Kensey Nash's proprietary Optrix(TM) process, which gently disinfects tissues, inactivates viruses and removes cells while preserving extracellular matrix components.

"This regulatory clearance represents an 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. "These are the first products developed from our new ECM biologic surgical mesh technology. With Medeor Matrix as a platform product line, we plan to develop additional devices for use in a wide range of soft tissue repair procedures. 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 are committed to developing unique and effective therapies that address the unmet clinical needs of physicians and patients around the world," he concluded.

The Company had previously announced a strategic agreement with Synthes, Inc. (SWX:SYST.VX), whereby Synthes will market and distribute porcine dermis-based ECM products for select reconstructive surgical applications. Kensey Nash is currently evaluating partnering opportunities for additional applications of the Medeor Matrix products in the urogynecology, wound care, orthopaedic and other markets. The Company anticipates that Medeor Matrix will be introduced into the market for initial indications in the second half of the current fiscal year.