A Medical Device Daily
Kensey Nash (Exton, Pennsylvania) said it has agreed to re-acquire the distribution rights, along with the trademark, inventory and other assets associated with the OsseoFit Bone Void Filler product line.
The company and Biomet Sports Medicine (Warsaw, Indiana) agreed to terminate their existing OsseoFit distribution agreement. Following a brief transition period, Biomet will return distribution rights for the OsseoFit Bone Void Filler product line to Kensey Nash, including rights to future applications or indications for the technology. Kensey Nash will have exclusive worldwide rights to the OsseoFit Bone Void Filler product line, as well as future extensions of the technology including cartilage repair.
"The OsseoFit bone void filler is an important component of our future cartilage repair business," said Joe Kaufmann, president/CEO. "This transaction will allow us to explore a broader number of strategic alternatives with respect to the development and commercialization of our Cartilage Repair Device."
Kensey Nash has previously said it had submitted an investigational device exemption application to the FDA to study the use of its unique biomaterials technology for treating articular cartilage defects of the knee. The clinical trial, which is expected to start later this year, will utilize the company's cartilage repair device, which consists of a bi-phasic, bioresorbable implant designed to treat chondral lesions. Kensey Nash recently submitted a design dossier for CE mark approval for its cartilage repair device; approval is expected at the end of 2009, the company noted.