Kensey Nash has received the CE Mark for the cartilage repair device. The approval allows for the marketing and sale of the device, which incorporates a 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 organisation during the healing process.
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.
Douglas Evans, COO of Kensey Nash, said: “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. The device has the potential to benefit a large number of patients that suffer from articular cartilage injuries. We look forward to commercialising this device in the European Community and to generating data necessary for reimbursement.
Joe Kaufmann, CEO of Kensey Nash, said: “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 US clinical trial as soon as possible. We estimate the worldwide sports medicine market for cartilage repair is approximately $2.2bn annually. We are currently evaluating our marketing and distribution strategy options, including strategic partners.”