Kuros Biosciences Premieres MagnetOs MIS Delivery System 

Kuros Biosciences has completed the first U.S. cases using the MagnetOs MIS Delivery System, a sterile, prefilled, single-use delivery system engineered for minimally invasive spine surgery. After the product’s U.S. Food and Drug Administration (FDA) 510(k) clearance in May, these first cases mark a significant milestone in expanding surgeon access to a more streamlined approach for graft delivery.

Orthopedic spine surgeon Dr. Daniel Park performed his first case using the new FDA-cleared system in Southfield, Mich. “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,” Dr. Park said. Kuros expects to expand the MIS system’s availability before 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

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.

“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,” Kuros Biosciences CEO Chris Fair stated. “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.”

Growing bone with MagnetOs delivers 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 comprised one in five patients, the fusion difference between MagnetOs and autograft was even more dramatic.^‡§ 4,7 MagnetOs grows bone on its own thanks to NeedleGrip, 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 put,¹² 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

Kuros Biosciences is on a mission to discover, develop, and deliver biologic technologies. With locations in the United States, Switzerland, and the Netherlands, the company is listed on the SIX Swiss Exchange.

^* 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.

References
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.