[2023. 11. 29.][OTC:CSBTF]Kuros Biosciences Receives FDA Clearance for Use of MagnetOs in Interbody Spinal Cages

[2023. 11. 29.][OTC:CSBTF]Kuros Biosciences Receives FDA Clearance for Use of MagnetOs in Interbody Spinal Cages

ZURICH, SWITZERLAND / ACCESSWIRE / November 28, 2023 / Kuros Biosciences ("Kuros"), a pioneer in cutting-edge bone graft technologies, has received the green light from the U.S. Food and Drug Administration (FDA) to utilize MagnetOs Flex Matrix in interbody spaces, marking a significant development in the field of spinal fusion procedures.

With interbody cages playing a pivotal role in almost half of the approximately 1.5 million instrumented spinal fusion procedures carried out annually in the United States, this announcement bears great importance for surgeons and patients alike. MagnetOs Flex Matrix stands out as an ideal choice for interbody applications due to its remarkable granule retention, maintaining strength and flexibility even when wet. This versatility enables easy placement through a funnel or direct packing into cages of various sizes, approved for use with a bone void filler.

MagnetOs Flex Matrix, the latest product from Kuros to receive FDA clearance, had previously gained approval for use in posterolateral fusions. Its unique fibrillar and flexible structure complements Kuros' established NeedleGrip™ surface technology, optimizing bone growth even in soft tissues.

Chris Fair, CEO of Kuros, expressed the significance of this milestone, stating, "This clearance opens up substantial commercial opportunities for our MagnetOs Flex Matrix product, enabling us to re-engage with surgeons who were previously unable to use it for interbody procedures. Kuros remains committed to advancing our research and technology to benefit patients and investors alike."

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About MagnetOs MagnetOs is a revolutionary bone graft that boasts NeedleGrip™ surface technology, promoting bone growth even in soft tissues. This surface technology provides traction for essential 'pro-healing' immune cells (M2 macrophages), unlocking the potential to stimulate stem cells and facilitate new bone formation throughout the graft. This emerging field of science, known as osteoimmunology, ultimately translates into more predictable fusion outcomes for surgeons and patients.

U.S. Indications Statement MagnetOs Flex Matrix is designed to fill bony voids or gaps in the skeletal system, including the intervertebral disc space and posterolateral spine. These osseous defects can be surgically created or result from traumatic bone injuries but are not intrinsic to the stability of the bony structure. In intervertebral disc space and posterolateral spine applications, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When employed in intervertebral body fusion procedures, it must be used with an intervertebral body fusion device cleared by the FDA for use with a bone void filler. MagnetOs Flex Matrix is gradually resorbed and replaced with bone during the healing process.

About Kuros Biosciences Kuros Biosciences is a rapidly growing leader in the development of spinal fusion biologics, alleviating the burden of back pain. With presence in the United States, Switzerland, and the Netherlands, the company is listed on the SIX Swiss Exchange. MagnetOs, the company's debut commercial product, is a unique synthetic bone graft that has demonstrated success in over 15,000 spinal fusion surgeries across three continents. The next candidate in Kuros' pipeline is Fibrin-PTH, a groundbreaking drug-biologic combination for interbody spinal fusions, currently undergoing a Phase 2 clinical trial in the U.S.

Forward-Looking Statements This press release contains forward-looking statements that involve inherent risks and uncertainties, which could lead to materially different outcomes compared to historical or future results implied by these statements. Words such as "will" or "expect" or their negatives are used in uncertain and forward-looking contexts. Scientific, business, economic, and financial factors can contribute to actual results differing from those predicted in forward-looking statements. Given these uncertainties, reliance on forward-looking statements is discouraged. The company does not assume responsibility for updating or adjusting forward-looking statements to reflect 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.

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

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