Kuros Biosciences announces favorable preliminary results of MagnetOs as standalone alternative to autograft in first randomized controlled trial(PresseBox) (Schlieren (Zurich), Switzerland, )
Fusion rate 78%, vs 42% for autograft and 55-71% for other synthetic bone grafts
First of five planned randomized controlled trials for MagnetOs
Data will support product approvals at hospitals and within hospital systems
Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today promising preliminary results from the first of its five planned randomized controlled trials for its MagnetOs family, comparing MagnetOs Granules to the gold standard of autograft bone.
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: "These interim results are truly exciting, exceeding our expectations for MagnetOs’ performance and validating our product as an augmented bone grafting option. Previous bone grafts have been sold on the premise of improved clinical outcomes based on data from the benchtop or preclinical setting alone. This study underlines Kuros’s commitment to a translational research approach through which we convert our ground-breaking research in the petri dish to Level I evidence of efficacy in humans, and as such is an important milestone in our Project Fusion global research program. It further demonstrates our commitment to fund research in the field of spine surgery for the benefit of patients, surgeons, and our wider society.”
The data will be used to support product approvals at hospitals and within hospital systems and will further support adoption of MagnetOs by surgeons who are looking for a reasonably priced augmented alternative to cell-based allografts, bone morphogenetic proteins and premium-priced synthetic bone grafts.
This interim data will be presented by Professor Sigurd Berven, Chief of Spine Service at University of California, San Francisco, at the 22nd Annual Meeting of the International Society for the Advancement of Spine Surgery (ISASS), taking place in the Bahamas, June 1-4, 2022.
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
Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings, and precautions.
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.
Through ongoing advocacy efforts, ISASS works to expedite acceptance of the latest innovations in spine surgery by both the insurance industry and government. Although much of this works takes place in the U.S., these successes are typically taken to countries around the globe to promote and ensure that the science and patient care is the same across nations. Throughout this time of sustained growth, ISASS has truly become the international leader for spine surgery. During the ISASS annual meeting, attendees can truly grasp the diversity of ISASS members, both in their country of origin and their skills and accomplishments.
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.