Kuros Biosciences Receives FDA Clearance for Use of MagnetOs in Interbody Spinal Cages

Kuros Biosciences AG / Key word(s): Regulatory Approval Kuros Biosciences Receives FDA Clearance for Use of MagnetOs in Interbody Spinal Cages 28.11.2023 / 18:00 CET/CEST MagnetOs is the first open fibrillar collagen matrix bone graft substitute to receive clearance to market for interbody use MagnetOs can now be used on-label in any interbody cage cleared for use with a bone void filler The exceptional handling properties of MagnetOs Flex Matrix are uniquely applicable to interbody applications Schlieren (Zurich), Switzerland, November 28, 2023 – Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today that MagnetOs Flex Matrix has been cleared for use in the interbody space by the U.S. Food and Drug Administration (FDA). As a result, it can now be used in any interbody space (cervical, thoracic, lumbar); and in any cage approved for use with a bone void filler.

With interbody cages being used in almost half of the estimated 1.5 million instrumented spinal fusion procedures conducted annually in the USA, this news is especially significant for surgeons.^1,2 MagnetOs Flex Matrix is uniquely well suited to interbody applications. Due to its excellent granule retention, it stays strong yet flexible even when wet - for easy placement either through a funnel or packed directly into any cage, of any size.

MagnetOs Flex Matrix is the first Kuros product to receive interbody clearance, having already been cleared by the FDA for use in posterolateral fusions. Due to its unique fibrillar and flexible structure, this open matrix bone graft promotes bone growth even in soft tissue by optimizing the effect of Kuros’ established NeedleGrip^TM surface technology.

Chris Fair, Chief Executive Officer of Kuros, said: "This is an important milestone for our company, as well as for the surgical community. With this clearance, we have a substantial commercial opportunity to re-engage with surgeons who were previously unable to use our MagnetOs Flex Matrix product on-label for interbody procedures. Kuros will continue to develop our research and technology – thus further demonstrating how we are continuing to meet our strategic goals for the benefit of patients and our investors."