Schlieren (Zurich), Switzerland, January 30, 2020 – Kuros Biosciences (SIX: KURN) today announced the publication of data from a clinically-relevant preclinical model comparing MagnetOs with autologous bone, Vitoss® BA2X (Stryker Corp.) and Novabone Putty® (Novabone Products, LLC) in instrumented posterolateral spinal fusion in sheep.
Utilizing multiple assessments for fusion, the study concluded that MagnetOs is an appropriate alternative to autograft when used as a standalone graft and was significantly better at achieving uniform, solid and stable fusions than the comparator products.
The publication, which is entitled "MagnetOs, Vitoss & Novabone in a multi-endpoint study of posterolateral fusion: A true fusion or not?”, has been accepted for publication by Clinical Spine Surgery and is available online as an open access paper via the following link:
Joost de Bruijn, Chief Executive Officer of Kuros, said: “This robust and clinically-relevant large animal study confirms that MagnetOs really is different from other synthetic grafts on the market. Our early clinical feedback from leading spine surgeons is consistent with this dataset. Kuros has further committed to conducting at least ten post-market clinical studies to validate these encouraging outcomes.”
Professor Bill Walsh, University of New South Wales, Australia, who was principal investigator of the study and presented the data at this year’s North American Spine Society annual meeting in Chicago last September said: “I’ve investigated many of the leading synthetic bone grafts in this model and, in my experience, MagnetOs leads to the most compelling fusion outcomes of all the grafts I’ve tested.”
About the study
MagnetOs Putty was implanted stand-alone and compared to autograft bone, Vitoss BA2X and Novabone Putty. Female Merino sheep underwent posterolateral fusion at L2-3 and L4-5 levels with instrumentation. After 12 weeks, outcomes were evaluated by manual palpation, range of motion testing, micro-computed tomography, histology and histomorphometry. Fusion assessment by manual palpation 12 weeks after implantation revealed 100% fusion rates for MagnetOs Putty and autograft treated levels, whilst the fusion rate for the comparator materials was 33% for each group. No significant differences in range of motion were observed between MagnetOs Putty and autograft. Treated segments were significantly less rigid in Vitoss BA2X treated segments (Lateral bending & flexion-extension) and Novabone Putty treated segments (Lateral bending). The fusion rate, when measured through histology, was 83%, 75%, 0% and 0% respectively for MagnetOs Putty, autograft, Vitoss BA2X and Novabone Putty. There was significantly more bone (Histomorphometry) and significantly greater fusion mass (MicroCT) for MagnetOs Putty compared to Vitoss BA2X and Novabone Putty.
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About Kuros Biosciences AG
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland, Bilthoven, The Netherlands and Burlington, MA, U.S. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.
MagnetOs bone graft has an advanced submicron surface topography that leads to the formation of bone, rather than scar tissue, following implantation. In preclinical models, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, meaning that bone can be formed even in soft tissues without the need for added cells or growth factors, resulting in an osteoinductive claim in Europe. MagnetOs promotes local bone formation equivalent to current gold standard, autograft. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is now supported by over two years’ clinical experience since its launch in the United Kingdom in May 2017. For more information, see: www.magnetosbonegraft.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.