Building on its MAXA Level 1 clinical study recently published in Spine, which demonstrated nearly double the fusion rate for MagnetOs compared to autograft (79% vs. 47%) in challenging PLFs and found MagnetOs to be noninferior and even indicated superiority, Kuros Biosciences continues its investment in Project Fusion.¹ Kuros Biosciences is focused on translating evidence from in vivo and in vitro studies to proven clinical outcomes, developing a superior clinical data package to prove efficacy and superiority versus alternative bone grafts. Project Fusion includes multiple Level 1 studies and Kuros Biosciences is pleased to announce the activation of three U.S. sites that are enrolling patients for the PRECISE clinical trial.

PRECISE is a Level 1 prospective, multi-center, randomized, intra-patient controlled clinical study that will assess the performance of MagnetOs Flex Matrix compared to a cellular based allograft (CBA) in up to four-level instrumented PLF. Patients are randomized to receive MagnetOs Flex Matrix on one side of the spine and a CBA on the other side. Fusion assessment will include CT-scans and radiographs at various time points up to one year.²

Kuros Biosciences also reports key milestones in the international market, with expanded commercial clearances for MagnetOs Granules and MagnetOs Putty in the UAE and Qatar. Additionally, Kuros onboarded new international partners beyond the spine market in Australia and the UK, broadening access to its technologies.

Chris Fair, Chief Executive Officer of Kuros Biosciences, said: "We are excited to report continued momentum in our business, with overachievement of our revenue targets for the period and for the first time, exceeding our cash flow breakeven in the first nine months of 2024." Mr. Fair continued, "We look forward to finishing the year strong and setting up the foundation for 2025, where we anticipate incremental growth from new markets and new non-spine opportunities, which are all internally funded by our sustainable cash flow generating business. Kuros is well positioned as a premier advanced bone healing company serving the musculoskeletal community, and we can continue to expand without the need for dilutive financing."

For further information, please contact:

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). This in turn, unlocks previously untapped potential to stimulate stem cells - and form new bone throughout the graft. The growing body of science behind NeedleGrip is called osteoimmunology. But for surgeons and their patients it means one thing: a more predictable fusion. ^{* †‡3-7}

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 fusion 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 three continents in 25,000 fusion surgeries. 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 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 has been proven to generate more predictable fusions than two commercially available alternatives in an ovine model of posterolateral fusion.

1. Stempels, et al. Spine. 2024;49(19):1323-1331.
2. U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov Identifier: NCT05037968. ClinicalTrials.gov.
https://clinicaltrials.gov/study/NCT05037968
3. Van Dijk, et al. eCM. 2021; 41:756-73.
4. Duan, et al. eCM. 2019; 37:60-73.
5. Van Dijk, et al. Clin Spine Surg. 2020;33(6): E276-E287.
6. Van Dijk, et al. JOR Spine. 2018; e1039.
7. Van Dijk, et al. J Biomed Mater Res. Part B: Appl Biomater.

SOURCE: Kuros Biosciences AG

View the original press release on accesswire.com