Kuros Biosciences Receives US FDA 510K Clearance for MagnetOs Granules for Interbody Use and Regulatory Clearance of MagnetOs Granules and MagnetOs Putty in New Zealand

Schlieren (Zurich), Switzerland, January 31, 2024 – Kuros Biosciences (“Kuros” or “the Company”), a leader in next generation bone graft technologies, today announced clearance of a 510(k) submission from the U.S. Food and Drug Administration (FDA) 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).

“We are very pleased that MagnetOs Granules has received marketing clearance for interbody use given the Granules technology is the foundation of the MagnetOs platform,” commented Chris Fair, Chief Executive Officer of Kuros Biosciences. “This clearance, coupled with the MagnetOs Flex Matrix and MagnetOs Easypack Putty formulations, provides our surgeons the widest variety of advanced biologic formulations available for use in the interbody space. We are also very excited to expand our international presence through a partnership with Vortek in New Zealand and to begin working with their team to introduce our clinically proven technology to this territory.”

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.