Kuros Biosciences announced clearance of a 510(k) submission from the U.S. Food and Drug Administration related to its MagnetOs Granules. The Company also announced clearance to market in New Zealand for MagnetOs Granules and MagnetOs Putty. The products are now commercially available through Vortek Spine Limited ("Vortek"), a high-tech orthopedic and biologics company specializing in healthcare solutions for surgeons and patients.

This further expands the MagnetOs portfolio in terms of application and accessibility. Earlier in January, Kuros announced the FDA clearance of MagnetOs Easypack Putty for interbody use and MagnetOs Putty for standalone use in the posterolateral spine, meaning it can now be used without the need for autograft (patient's own bone). The availability of MagnetOs in New Zealand marks a significant milestone for Kuros and the local medical community since patients can now benefit from an advanced bone graft that improves the overall quality of care in orthopedic and spinal procedures.

This benefit was further demonstrated with recent level 1 clinical data in which MagnetOs outperformed the gold standard autograft by 73% in posterior spinal fusion in a difficult-to-treat real life patient population, of which 20% were current smokers.