Kuros receives clearance from the US FDA for MagnetOs allowing marketing in the United States

OREANDA-NEWS. Kuros Biosciences (SIX: KURN) announces today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for MagnetOs Granules. FDA’s approval clearance allows marketing in the United States indicated for use as an autograft extender in posterolateral spine. 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 comparable to current gold standard autograft. The FDA 510(k) clearance follows CE mark certification in Europe in 2016 allowing MagnetOs to be marketed now both in the US and the EU.

Didier Cowling, Chief Executive Officer of Kuros, commented: “This FDA clearance is a major milestone for us and supports our commitment to develop and launch innovative products that meet the demands of surgeons and their patients.” He continued: “MagnetOs Granules have now been approved in the United States and Europe, which is key in building a leading orthobiologics company. Obtaining these approvals is also testament to our Group’s development capabilities and teamwork. We now look forward to rolling out our commercialization activities.”

MagnetOs promotes local bone formation comparable to current gold standard autograft

Currently, the company estimates that there are over 3 million procedures worldwide each year that use a bone graft material or substitute. Patient-own bone (autograft) is still considered the gold standard bone grafting material in terms of bone regeneration. A common issue with autograft, however, is the need for harvesting healthy bone from the patient, which may require a separate surgical procedure with associated costs, risks and morbidity. MagnetOs is a next generation synthetic bone graft substitute with a novel and unique structure that promotes progressive bone formation comparable to autograft.

MagnetOs to be extended into new formulations and applications

In 2016, MagnetOs Granules received CE mark certification as a bone void filler for orthopaedic, craniomaxillofacial and dental indications. Kuros is developing a family of MagnetOs products with different formulations and applications to meet surgeons’ needs and preferences. For example, Kuros is developing a moldable putty formulation for submission in the second half of 2017, seeking CE mark and 510(k) clearance in Europe and the United States, respectively. Kuros is also working on obtaining clearances for MagnetOs in other indications and applications.