Cartilage Repair Device (CRD)
Kensey Nash Announces CE Mark Approval for Cartilage Repair Device EXTON, Pa., Feb 16, 2010 -- Kensey Nash 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<