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Kensey Nash Receives FDA 510(k) Clearance for Porcine Dermis Biologic Product

EXTON, Pa., Nov. 11 /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 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.

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.

Cautionary Note for Forward-Looking Statements. This press release as well as other Company press releases 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, current economic conditions, foreign currency fluctuations, risks associated with the Company's continued research and development efforts with respect to the endovascular products (including the risk that those efforts will not be successful and that some of the associated milestone payments will not be received), Spectranetics' success in selling the ThromCat(TM) product, the Company's success in distributing its products into the marketplace, the Company's dependence on three major customers (St. Jude Medical, Arthrex and Orthovita) and their success in selling Kensey Nash related products in the marketplace, the impact of product recalls and other manufacturing issues, the Company's success in its research and development efforts in its cartilage repair and extracellular matrix technologies programs, Synthes' success 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. For a detailed discussion of factors that could affect the Company's future operating results, please see the Company's SEC filings, including the disclosure 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

SOURCE Kensey Nash Corporation
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