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."

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About MagnetOs
MagnetOs is a bone graft like no other: thanks to its NeedleGrip^TM surface technology, it grows bone even in soft tissues.* This surface technology provides traction for our body’s vitally important ‘pro-healing' immune cells (M2 macrophages).^†‡3,4 This in turn, unlocks previously untapped potential to stimulate stem cells - and form new bone throughout the graft.^†§5-8  The growing body of science behind NeedleGrip^TM is called osteoimmunology. But for surgeons and their patients it means one thing: a more predictable fusion.^†¶7,8

U.S. Indications Statement
MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When used in interverterbral body fusion procedures, MagnetOs Flex Matrix must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.  MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process. 

About Kuros Biosciences
Kuros Biosciences is a fast-growing leader in the development of spinal fusion biologics that ease the burden of back pain. With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange.  The company’s first commercial product, MagnetOs, is a unique synthetic bone graft that has already been used successfully across three continents and in over 15,000 spinal fusion surgeries. The next candidate in the Kuros pipeline is Fibrin-PTH – the first drug-biologic combination for interbody spinal fusions, currently undergoing a Phase 2 clinical trial in the US. For more information on the company, its products and pipeline, visit kurosbio.com. 

Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

1. iData Research, How Many Spinal Fusions are Performed Each Year in the United States? https://idataresearch.com/how-many-instrumented-spinal-fusions-are-performed-each-year-in-the-united-states/, accessed November 2023

2. AcuityMD, procedure numbers estimated by CPT code Q4 2022-Q3 2023

3. Duan, et al. eCM. 2019;37:60-73

4. Van Dijk, et al. eCM. 2021;41:756-73

5. Van Dijk, et al. JOR Spine. 2018;e1039

6. Van Dijk, et al. J Biomed Mater Res. Part B: Appl Biomater. 2019;107(6):2080-2090

7. Van Dijk, et al. Clin Spine Surg. 2020;33(6):E276–E287

8. Data on file

*In large animal models

†Results from in vivo laboratory testing may not be predictive of clinical experience in humans.

For important safety and intended use information please visit kurosbio.com

‡MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft

§For a 510(k)-cleared synthetic bone graft.

¶MagnetOs has been proven to generate more predictable fusions than two commercially available alternatives in an ovine model of posterolateral fusion.

End of Media Release