Kuros Biosciences launches MagnetOs MIS Delivery System by completing first cases, and continues global expansion with incremental Brazil clearance

   
Kuros Biosciences launches MagnetOs MIS Delivery System by completing first cases, and continues global expansion with incremental Brazil clearance

Schlieren (Zürich), Switzerland, August 5, 2025– Kuros Biosciences (“Kuros” or the “Company”) a leader in innovative biologic technologies, today announced the completion of the first U.S. cases using the new MagnetOs^TM MIS Delivery System – a sterile, prefilled, single-use delivery system engineered for Minimally Invasive Surgery (MIS) in spine procedures. Following FDA 510(k) clearance of the MagnetOs MIS Delivery System in May, these first cases mark a significant milestone in expanding surgeon access to a more streamlined approach for graft delivery.

Dr. Daniel Park, orthopedic spine surgeon, performed his first case using the new FDA-cleared system in Southfield, Michigan. “MagnetOs MIS delivered smooth, precise graft placement in a typically challenging MIS TLIF case – no preparation, no thawing, just immediate delivery and efficiency. It pairs streamlined handling with compelling clinical data, making it a meaningful advancement for surgeons who value both efficiency and biologically robust healing,” said Dr. Park. Kuros anticipates expanding availability of the MIS system with a full commercial launch this fall.

MagnetOs MIS builds on the proven science of MagnetOs and its proprietary NeedleGrip™ submicron surface technology, which harnesses the immune system to stimulate bone growth.^*†1-3 It is engineered for precise delivery, surgical efficiency, and predictable fusion outcomes.⁴ Compared to delivering MagnetOs in a traditional, funnel-based system, MagnetOs MIS achieved graft placement three times faster, optimizing time in the operating room.⁵

The MIS system is supported by robust published clinical evidence for MagnetOs in cases where minimally invasive procedures and surgical site accessibility is crucial. In a retrospective study, MagnetOs achieved a 94.4% fusion rate across 36 levels treated in patients undergoing MIS and open transforaminal lumbar interbody fusions (TLIF), where the majority of patients had comorbidities such as obesity, smoking, diabetes, or a previous spine surgery.⁶ These results build on previously published Level I prospective, randomized, controlled human clinical data demonstrating that MagnetOs achieved nearly twice the fusion rate of autograft in posterolateral fusion (79% vs. 47%).⁴

Additionally, and following the recent ANVISA approval of MagnetOs Granules, Kuros also announced that MagnetOs Putty now has been approved by the Brazilian regulatory authority, expanding the company’s entry into the South American spine and orthopedic market. This milestone reflects the increasing global demand for MagnetOs as a proven, predictable and safe bone grafting option.

Chris Fair, CEO of Kuros Biosciences, commented: “With the first MagnetOs MIS case completed, we’re delivering what surgeons have been asking for – precision, speed, and proven outcomes when utilizing minimally invasive surgical techniques, which we know are on the rise. This unlocks access to the high-growth U.S. MIS spine segment. With the recent approval of MagnetOs Putty in Brazil, we’re accelerating access to our technology in key international markets where we see strong projected market growth.”

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About MagnetOs
Growing bone with MagnetOs^TM gives surgeons confidence where it matters most – delivering predictable fusion outcomes.⁴ In a Level I human clinical study published in Spine, MagnetOs achieved nearly twice the fusion rate of autograft (79% vs. 47%) in posterolateral fusions (PLFs).⁴ Among active smokers – who made up 1 in 5 patients – the fusion difference between MagnetOs and autograft was even more dramatic.^{‡§ 4,7} MagnetOs grows bone on its own thanks to NeedleGrip^TM – a proprietary submicron surface technology that harnesses the immune system to stimulate bone growth, without added cells or growth factors.^{* †1,2,8-11} Ready-to-use, easy to mold, and reliably staying put¹², MagnetOs carries no intrinsic risk of human tissue-related disease transmission and is FDA cleared for use throughout the spine, including interbody procedures. ^{¶ 8-11}

Indications Statement
Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings, and precautions.

About Kuros Biosciences
Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies. 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^TM, is a unique advanced bone graft that has already been used across five continents. 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.

* Results from in vitro or 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.
^‡ 19 of initial 100 patients were active smokers.
^§ Radiographic fusion data of the smoker subgroup were not statistically analyzed as a subgroup and were not included in the peer-reviewed publication of the study.^4
¶ MagnetOs must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Flex Matrix must be hydrated with BMA & mixed with autograft in posterolateral spine & intervertebral disc space. MagnetOs Granules must be hydrated with blood in the intervertebral disc space.

1. van Dijk, et al. eCM. 2021;41:756-73.
2. van Dijk, et al. J Immunol Regen Med. 2023;19:100070.
3. Duan, et al. eCM. 2019;37:60-73.
4. Stempels, et al. Spine. 2024;49(19):1323-1331.
5. Data on file. MagnetOs MIS.
6. Davis, J. et al. Orthopedic Review. 2025.
7. van Dijk, LA. 24th SGS Annual Meeting (Swiss Society of Spinal Surgery). Basel, Switzerland. Aug 2024.
8. Instructions for Use (IFU) MagnetOs Granules.
9. Instructions for Use (IFU) MagnetOs Putty.
10. Instructions for Use (IFU) MagnetOs Easypack Putty.
11. Instructions for Use (IFU) MagnetOs Flex Matrix.
12. Data on file. MagnetOs Putty and MagnetOs Easypack Putty.

Attachment

• Kuros Biosciences Press Release MIS Launch + Brazil 8-5-25

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