Kuros Biosciences’s MagnetOs Granules cleared by FDA for expanded spinal indications
Schlieren (Zurich), Switzerland, February 3rd, 2022 – Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today that its MagnetOs Granules has been cleared by the U.S. Food and Drug Administration (FDA) for expanded indications in the spine, making it only the second-ever bone graft to achieve clearance for standalone use in the spine based on human clinical data.
The FDA clearance was attained using radiographic data, clinical outcomes and safety data from 50 patients who were enrolled in a Level 1 randomized controlled multicenter trial in which MagnetOs Granules were compared head-to-head against autograft, the gold standard for posterolateral fusion. The clearance for standalone use proves MagnetOs to be an augmented graft that can be used in place of, as well as in combination with, autograft bone.
Joost de Bruijn, Chief Executive Officer of Kuros, said: “Almost all of the more than four hundred bone grafts cleared by the FDA via 510(k) were done so based on preclinical evidence alone. In an environment in which there is increasing focus on value-based medicine, our clearance for standalone use based on human clinical data positions MagnetOs above most other 510(k)-cleared bone grafts being offered to providers and surgeons. There is a clear need for bone grafts that are supported by Level 1 evidence and cleared for multiple uses, including the most challenging such as standalone use.”
Standalone use requires the body to rely on the implanted bone graft product and not on combined autograft from the patient, which means the bar for proving standalone efficacy is higher than for bone graft extender efficacy.
Contrary to MagnetOs Granules, very few bone grafts are supported by Level 1 evidence from a randomized controlled trial. For instance, the current market-leading synthetic is supported by only one Level 1 pilot study, in which 20 patients were treated as opposed to the 50 patients treated in Kuros’s multicenter trial. Across all published studies for the market-leading synthetic, 90% of patients were from studies by a single investigator, and conducted at a single clinical site, and 96% of all patients were from non-randomized Level III/IV studies which provide a lower evidence base for clinical decision-making than Level I studies. The data package used in the FDA submission is the first Level 1 data to emerge from the Company’s Project Fusion (https://kurosbio.com/project-fusion/).