Kuros Biosciences receives European clearance for MagnetOs Putty and prepares for commercial roll-out in the U.S. and Europe
Kuros Biosciences announced today that it has received the CE Mark for MagnetOs Putty indicated for use as an osteoconductive and osteoinductive bone void filler in the skeletal system (i.e. spine, extremities, pelvis, cranium, mandible and maxilla). This market clearance allows commercialization of MagnetOs Putty in Europe, and complements the existing clearance for MagnetOs Granules, and the 510K clearance for both formulations from the U.S. Food and Drug Administration as an autograft extender in the posterolateral spine. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway. Numerous studies have shown that MagnetOs leads to progressive bone formation and implant resorption comparable to autograft (patient’s own bone), the current gold standard.