Kuros Biosciences (SIX: KURN) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for extending MagnetOs Putty indications to use as a stand-alone bone graft in extremities and pelvis. This is in addition to the existing clearance for use of MagnetOs Granules and MagnetOs Putty as an autograft extender in posterolateral spine.
Joost de Bruijn, Chief Executive Officer of Kuros, commented: “This FDA clearance is another major milestone for us as it allows Kuros to expand the commercial reach of MagnetOs into new orthopedic applications such as reconstructive surgery. It also consolidates Kuros’ strategy to expand into indications in which MagnetOs is utilized as a replacement for, rather than supplement to, autologous bone graft”.
Several studies have shown that MagnetOs leads to progressive bone formation comparable to the current gold standard autograft. The search for suitable alternatives to autograft could give the Company the opportunity to become a leading player in the area of total bone graft substitutes, with products that can compete in the majority of the markets growing to an estimated US $3.4 billion by 2030.