Release Details

Kuros Biosciences to provide investor update
at Octavian and Baader Bank Conferences

Schlieren (Zürich), Switzerland, January 13, 2026 – Kuros Biosciences (“Kuros” or the “Company”) a leader in innovative biologic technologies, today announced a series of milestones including key IDN (Integrated Delivery Network) health system approvals, significant regulatory approval, and published preclinical evidence supporting the continued adoption and global expansion of MagnetOs™, which are going to be presented at the Octavian Seminar 2026 and Baader Bank Swiss Equities Conference 2026.

“These milestones reflect the strength and consistency of our strategy, building durable access through major U.S. health system approvals, achieving one of the most rigorous regulatory certifications globally, and continuing to expand a differentiated evidence portfolio for MagnetOs,” said Chris Fair, Chief Executive Officer of Kuros Biosciences. “Together, these achievements reinforce our position as an evidence driven biologics company and support the continued global adoption of MagnetOs as we execute on our long-term growth objectives.”

Recent U.S. Healthcare System Approvals
Kuros announced that all five MagnetOs formulations have recently received approval across multiple large IDN health systems in the U.S., a critical step for access and adoption at scale.

Health system approvals are typically granted following comprehensive evaluation by multidisciplinary stakeholders including clinical, supply chain, and value analysis teams. Such evaluations generally assess efficacy, safety, clinical performance, economic considerations, and alignment with system-wide standards of care. These approvals will enable expanded surgeon access to MagnetOs across participating facilities, subject to local hospital approval and clinical implementation processes.

“System-level approvals reflect confidence not only in a product’s performance, but in the rigor of the evidence behind it,” said John Griffin, Chief Business Officer of Kuros Biosciences. “These approvals reduce access barriers and position MagnetOs for broader adoption across major U.S. health systems, which will support the company to achieve its financial targets.”

MDR Certification Achieved
Kuros also announced that MagnetOs Granules and MagnetOs Putty received certification under the European Union Medical Device Regulation (MDR), on December 22, 2025. MDR certification is among the most stringent regulatory frameworks globally and is required to maintain market access in the European Union.

Achievement of MDR certification supports the continued commercial availability of MagnetOs in Europe and other international markets and reflects Kuros’ operational and clinical readiness to meet evolving regulatory standards.

“MDR certification represents one of the most rigorous regulatory thresholds globally,” said Philippe Saudan, Senior Vice President, Quality, Regulatory and Clinical of Kuros Biosciences. “We are proud to have achieved MDR certification for MagnetOs, underscoring the strength of our clinical evidence and supporting continued access to this technology for surgeons and patients throughout Europe and other international markets.”

Publication of Head-to-Head Preclinical Sheep PLF Study
Further strengthening the MagnetOs evidence portfolio, a newly published preclinical study in Clinical Spine Surgery evaluated MagnetOs Flex Matrix in a clinically relevant, instrumented sheep posterolateral lumbar fusion (PLF) model and compared its performance head-to-head against commercially available synthetic bone grafts, including a synthetic peptide with anorganic bone mineral in a hydrogel carrier, a synthetic silicate-substituted calcium phosphate in a hydrogel carrier, and a synthetic bioglass in a collagen matrix.^*1

At 12 weeks, MagnetOs demonstrated significantly higher fusion rates across multiple endpoints including radiography, micro-CT, biomechanics, and histology. Histological analysis showed 100% bilateral fusion in MagnetOs treated segments, while the synthetic peptide achieved fusion in 33% of segments and both the synthetic silicate-substituted calcium phosphate and synthetic bioglass demonstrated 0% bilateral fusion. Histology further confirmed continuous bridging bone formation and mature lamellar bone integrated directly with MagnetOs.^*1

This study reinforces the importance of using animal models with robust multi-endpoint analysis to distinguish true bone fusion from residual graft material, particularly in challenging PLF procedures.²

Together with previously published human biopsy findings, these results further differentiate MagnetOs from competing bone graft technologies and support its long-term positioning as an evidence-driven solution for surgeons seeking reliable fusion outcomes.*^1,3

Continued Clinical Evidence Expansion
These milestones build on Kuros’ ongoing clinical development efforts, including the recently announced ASTRA study, a global, prospective, randomized, controlled, multi-center Level I clinical trial evaluating MagnetOs compared to autograft (patient’s own bone) in patients undergoing hindfoot or ankle fusions. ASTRA represents Kuros’ continued investment in high quality clinical evidence across multiple anatomical applications.

Event Calendar
January 15, 2026 - Octavian Seminar 2026, Davos
January 16, 2026 - Baader Bank Swiss Equities Conference 2026, Bad Ragaz
March 10, 2026 - Publication Annual Report 2025
April 14, 2026 - Trading Update Q1-2026
April 15, 2026 - Annual Shareholders’ General Meeting
   
For further information, please contact:

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.^†‡4,5 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.^§¶10-14 Ready-to-use, easy to mold, and reliably staying put, MagnetOs carries no intrinsic risk of human tissue-related disease transmission and is FDA cleared for use throughout the spine, including interbody procedures. Additionally, MagnetOs Granules, MagnetOs Putty and MagnetOs Easypack Putty are also cleared for use in the extremities and pelvis.^#10-15

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 U.S., 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 vivo or in vitro laboratory testing may not be predictive of clinical experience in humans. Please refer to the Instructions for Use for a full list of indications, contraindications, precautions, and warnings.
† 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. 
§ 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. 
# 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 and mixed with autograft in posterolateral spine and intervertebral disc space. MagnetOs Granules must be hydrated with blood in the intervertebral disc space.

1. Kucko, et al. Clinical Spine Surgery. 2025;0(0).
2. Yadav S, et al. Journal of Orthopaedics, Trauma and Rehabilitation. 2020;27(2):173-178.
3. Hatfield C, et al. JOJ Case Stud. 2025; 15(2): 555910. DOI: 10.19080/JOJCS.2025.15.555910.
4. Stempels, et al. Spine. 2024;49(19):1323-1331.
5. Van Dijk, LA. 24th SGS Annual Meeting (Swiss Society of Spinal Surgery). Basel, Switzerland. Aug 2024.
6. Data on file. MagnetOs Putty and MagnetOs Easypack Putty.
7. Van Dijk, et al. eCM. 2021;41:756-73.
8. Van Dijk, et al. J Immunol Regen Med. 2023;19:100070.
9. Duan, et al. eCM. 2019; 37:60-73.
10. Instructions for Use (IFU) MagnetOs Granules.
11. Instructions for Use (IFU) MagnetOs Putty.
12. Instructions for Use (IFU) MagnetOs Easypack Putty.
13. Instructions for Use (IFU) MagnetOs Flex Matrix.
14. Instructions for Use (IFU) MagnetOs MIS.
15. Data on file. MagnetOs Putty and MagnetOs Easypack Putty.
    
     

Attachment

• Kuros Octavian and Baader Update Press Release 1-13-2025

Source: Kuros Biosciences AG