Kuros Biosciences announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for MagnetOs Putty indicated for use as an autograft extender in posterolateral spine. This market clearance allows commercialization of MagnetOs Putty in the United States and complements the existing clearance for MagnetOs Granules, which was granted by the FDA in February 2017. In addition, Kuros has filed MagnetOs Putty for CE mark certification in Europe. MagnetOs is a novel synthetic bone graft substitute designed to regenerate bone in the implanted site in the body. Numerous studies have shown that MagnetOs leads to progressive bone formation and implant resorption comparable to current gold standard autograft.
Ivan Cohan-Tanugi, Chief Executive Officer of Kuros, commented: “This FDA clearance is another major milestone for us and supports our commitment to develop and launch innovative products that meet the demands of surgeons, their patients and the payers.” He continued: “MagnetOs Putty has now been cleared or submitted in our main target markets, which is key for our strategy to build a leading orthobiologics company. It is also a testimony to our Group’s science, development capabilities and teamwork. We now look forward to rolling out our commercialization activities.”
Under the terms of the combination agreement with Xpand Biotechnology B.V., the clearance for MagnetOs Putty in the United States triggers the issue of another 0.37 million shares from Kuros’ authorized share capital to the former owners of Xpand Biotechnology B.V.
MagnetOs promotes local bone formation equivalent to current gold standard autograft
MagnetOs is a synthetic bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard autograft (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and risks associated with its harvesting from another healthy site of the patient’s body). MagnetOs is based on calcium phosphate with a novel and unique surface structure that greatly enhances its ability to promote local bone formation. The product is available as granules and as a putty formulation.