Kensey Nash Corporation Receives FDA 510(k) Clearance for Porcine Dermis Biologic Product Company’s First ECM Approval

EXTON, Pa., Nov. 11 /PRNewswire-FirstCall/ -- Kensey Nash Corporation , 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.

“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.

About Kensey Nash Corporation. Kensey Nash Corporation is a leader in developing, manufacturing and processing resorbable biomaterial products, incorporating its proprietary collagen and synthetic polymer technology. This expertise is used to develop and commercialize its products through strategic partners. The company has an extensive range of products, which are sold in multiple medical markets, including, the cardiology, orthopedic, sports medicine, spine, endovascular and general surgery markets. The company is known as a pioneer in the field of arterial puncture closure, as the inventor and developer of the Angio-Seal(TM) Vascular Closure Device, which is licensed to St. Jude Medical, Inc.

Kensey Nash Corporation

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