Kensey Nash Announces CE Mark Approval For Cartilage Repair Device

Exton, PA /PRNewswire-FirstCall/ -- Kensey Nash Corporation (Nasdaq: KNSY), a leading medical technology company that provides innovative resorbable biomaterial solutions for a wide range of medical procedures, announced today that it has received the CE Mark for the Company's Cartilage Repair Device. This approval allows for the marketing and sale of the Device, which incorporates a unique biomaterials technology for treating articular cartilage defects of the knee.

The Kensey Nash Cartilage Repair Device (CRD) is a biphasic, bioresorbable scaffold intended to be implanted at the site of a focal articular cartilage lesion or osteochondral defect in the knee. The CRD is intended to serve as a scaffold for cellular and matrix in-growth in osteochondral defect repair such as bone and/or cartilage, which is not intrinsic to the stability of the tissue. The product is indicated to support the regeneration of hyaline cartilage and subchondral bone by promoting the correct cellular morphology and structural organization during the healing process.

"The CE Marking of our Cartilage Repair Device represents another critical milestone in our plans to build upon Kensey Nash's leadership position as a developer of innovative regenerative medicine products," stated Douglas G. Evans, COO of Kensey Nash Corporation. "The device has the potential to benefit a large number of patients that suffer from articular cartilage injuries. We look forward to commercializing this device in the European Community and to generating data necessary for reimbursement," he concluded.

"Our R&D and Clinical and Regulatory teams are making great progress with this exciting technology and we are continuing to move forward with our plans to start a U.S. clinical trial as soon as possible. We estimate the worldwide sports medicine market for cartilage repair is approximately $2.2 billion annually. We are currently evaluating our marketing and distribution strategy options, including strategic partners," commented Joe Kaufmann, CEO of Kensey Nash Corporation.

Articular cartilage injury is commonly encountered in people with active lifestyles. Unlike other tissue types, cartilage possesses a limited capacity to heal. Surgical treatment options available today usually generate a repair tissue that is insufficient in absorbing or distributing loads and is prone to failure. Worldwide, physicians perform approximately one million procedures each year to repair damaged articular cartilage in the knee and a majority of these are repeat procedures, illustrating the ineffectiveness of current therapeutic approaches. Over time, debilitating osteoarthritis may develop in the afflicted joint, often ultimately requiring partial or total knee replacement. The Company believes that an early and successful treatment of traumatized articular cartilage may prevent or postpone the onset of long-term osteoarthritis, and consequently reduce the number of radical knee joint replacement surgeries performed each year.

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, orthopedic, 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 success in its research and development efforts in its cartilage repair and extracellular matrix technologies programs, the Company's ability to enter into strategic partnership with respect to its cartilage repair and extracellular matrix technologies, the success of Company partners in selling the Company's cartilage repair and 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, the approval of reimbursement 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