06 Jun 17
Kuros (SIX:KURN) today announced it has filed the submission package for MagnetOs Putty seeking 510(k) clearance from the US Food and Drug Administration (FDA) for use as an autograft extender in posterolateral spine. MagnetOs is a novel synthetic bone graft substitute designed to support bone healing in the implanted site in the body. MagnetOs Putty is a moldable putty formulation of MagnetOs Granules, which is already cleared for commercialization in the United States of America and the European Union.
Dr. Ivan Cohen-Tanugi, Chief Executive Officer of Kuros, commented: “This FDA filing is yet another important milestone for Kuros as it eventually expands our portfolio of commercial-stage products. A similar submission for MagnetOs Putty in the EU will be filed in the next months.” He continued: “MagnetOs features a unique surface science technology that supports local bone formation. To meet surgeons’ preferences, we are developing a comprehensive product line consisting of different formulations and applications of MagnetOs. Furthermore, we plan to extend the existing labels into additional indications.”
MagnetOs Putty advantage
According to Kuros estimates, there are over 3 million procedures worldwide each year that use a bone graft material or a substitute. Patient-own bone (autograft) is still considered the gold standard bone grafting material. However, harvesting healthy bone usually requires a separate surgical procedure with associated costs, risks and morbidity. Therefore, an extender that can be used in combination with local autograft, without the need for a separate autograft harvest procedure, offers significant potential benefits. Animal testing demonstrates comparable rates of bone healing for MagnetOs when used as an extender with autograft compared to autograft alone in a rabbit posterolateral fusion model.