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KENSEY NASH Receives FDA 510(k) Clearance for ECM Product, Meso BioMatrix Surgical Mesh

EXTON, Pa., May 26 /PRNewswire-FirstCall/ -- 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.  

About Kensey Nash Corporation. Kensey Nash Corporation is a medical device company primarily focused on regenerative medicine utilizing its proprietary collagen and synthetic polymer technology.  The Company is recognized as a leader for innovative product development and unique technology in the field of resorbable biomaterials.  The Company has an extensive range of products, which are sold through strategic partners in multiple medical markets, including, the cardiology, orthopaedic, sports medicine, spine, endovascular and general surgery markets.

Cautionary Note for Forward-Looking Statements.  This press release contains forward-looking statements that reflect the Company's current expectations about its prospects and opportunities.  The Company has tried to identify these forward looking statements by using words such as "expect," "anticipate," "estimate," "plan," "will," "would," "forecast," "believe," "guidance," "projection" or similar expressions, but these words are not the exclusive means for identifying such statements.  The Company cautions that a number of risks, uncertainties and other important factors could cause the Company's actual results to differ materially from those in the forward-looking statements including, without limitation, the Company's continued success in its research and development efforts in its cartilage repair and extracellular matrix technologies programs, the Company's ability to enter into new partnering relationships with respect to its extracellular matrix products and the success of existing and new partners in selling the Company's extracellular matrix products, the completion of additional clinical trials in both the U.S. and Europe to support regulatory approval of future generations of its products and competition from other technologies, current economic conditions, and foreign currency fluctuations. For a detailed discussion of factors that could affect the Company's future operating results, please see the Company's SEC filings, including the disclosures under "Risk Factors" in those filings.  Except as expressly required by the federal securities laws, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.

SOURCE Kensey Nash Corporation
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