Kuros Biosciences completes enrolment in Level 1 clinical study of MagnetOs Granules

Kuros Biosciences AG / Key word(s): Study
Kuros Biosciences completes enrolment in Level 1 clinical study of MagnetOs Granules
02.11.2022 / 07:00 CET/CEST

• Preliminary data shows 78% fusion rate vs 42% for autograft and 55-71% for other synthetic bone grafts 
• Level 1 clinical study compares MagnetOs Granules to local autograft in patients undergoing posterolateral lumbar fusion 
• First of five randomized controlled Level 1 trials for MagnetOs to complete enrolment 

Schlieren (Zurich), Switzerland, November 2, 2022 – Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today the completion of enrolment in the Level 1 clinical study, comparing MagnetOs Granules to the gold standard of autograft bone in patients undergoing posterolateral lumbar fusion.

Data from the prospective, multi-center, intra-patient controlled trial showed a fusion rate for MagnetOs of 78%, compared to 42% for autograft. This compares favorably to fusion rates of 55-71% reported for other synthetic bone grafts evaluated in similar well-controlled studies of posterolateral fusion.1,2

The first consecutive 50 patients (from a total of 100) requiring up to four-level instrumented posterolateral lumbar fusion (T10 – S2), were included in this preliminary analysis. The rate of posterolateral lumbar/thoracolumbar fusion was assessed by CT-scan 12 months after surgery. Data can  be downloaded from the Kuros website.

Joost de Bruijn, Chief Executive Officer of Kuros, said: "We are pleased to complete enrolment in the trial and take another step forward in the clinical phase of Project Fusion with MagnetOs, with the aim of delivering the ideal bone graft. Previous bone grafts have been sold on the premise of improved clinical outcomes but based on benchtop or preclinical data, so we are excited to demonstrate MagnetOs’ effect in a high-level clinical setting. This further demonstrates our commitment to converting our ground-breaking research to Level 1 evidence of efficacy in humans, and to fund research in spine surgery for the benefit of patients, surgeons, and our wider society.”

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About MagnetOs
MagnetOs isn't like other bone grafts. It grows bone even in soft tissue thanks to its unique NeedleGrip surface technology which 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 efficient and predictable fusion. *†‡3-5

About Project Fusion
Today, nearly 1 in 5 spinal fusions fail. So, what can we do to change this situation – for the benefit of patients, surgeons and our wider society? This is the question that drives us at Kuros Biosciences. Every day our team works across three continents to unlock the hidden secrets of bone healing through our research, development & technology program: Project Fusion. To deliver the ideal bone graft, we believe you need the highest quality & quantity of scientific evidence behind it. Which is why Project Fusion brings together an unprecedented blend of scientific, preclinical and clinical studies – all aimed at making the unpredictable…predictable. For more information on Project Fusion, visit kurosbio.com/project-fusion.

About Kuros Biosciences
Kuros Biosciences is a fast-growing leader in the development of spinal fusion biologics that ease the burden of back pain. 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, is a unique synthetic bone graft that has already been used successfully across three continents and in over 5,000 spinal fusion surgeries. The next candidate in the Kuros pipeline is Fibrin-PTH – the first drug-biologic combination for interbody spinal fusions, currently undergoing a Phase 2 clinical trial in the US. 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.

1. Lehr, et al. Spine. 2020; 45(14):944-951; 

2. Coughlan, et al. Spine (Phila Pa 1976). 2018;1-43(15):E860-E868.

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.

*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.

End of Media Release