- Rare clearance for bone grafting for stand-alone use in the spine based on human clinical data
- Clearance obtained with evidence from a level 1 randomized controlled trial
- Positions MagnetOs above most other 510(k) bone grafts on the market
FDA clearance was obtained using radiographic data, clinical results, and safety data from 50 patients enrolled in a Tier 1, randomized, controlled, multicenter trial in which MagnetOs Pellets were compared head-to-head with autograft, the gold standard for posterolateral fusion. The stand-alone use authorization proves that MagnetOs is an augmented graft that can be used instead of or in combination with bone autograft.
Stand-alone use requires the body to rely on the implanted bone graft product and not the patient’s combined autograft, which means the bar for proving stand-alone efficacy is higher than for expander efficacy bone graft.
Unlike MagnetOs granules, very few bone grafts are supported by level 1 evidence from a randomized controlled trial. For example, the current market-leading synthetic is supported by a single Tier 1 pilot study, in which 20 patients were treated versus 50 patients treated in the Kuros multicenter trial. In all published studies of the market-leading synthetic, 90% of patients were from single-investigator, single-clinical-site studies, and 96% of all patients were from non-randomized Level III/ IV studies that provide a weaker evidence base for clinical decision-making than Tier I studies. The dataset used in the FDA submission is the first Tier 1 data to emerge from the company’s Fusion Project (https://kurosbio.com/project-fusion/).
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MagnetOs is not like other bone grafts. It grows bone even in soft tissue with its unique NeedleGrip surface technology that provides traction for our body’s vital “pro-healing” immune cells (M2 macrophages). This in turn unlocks previously untapped potential to stimulate stem cells – and form new bone throughout the transplant. The growing body of science behind NeedleGrip is called osteoimmunology. But for surgeons and their patients, it means one thing: more efficient and predictable fusion.
MagnetOs Granules is an implant intended to fill bone voids or gaps in the skeletal system, i.e. extremities, pelvis and posterolateral spine. MagnetOs pellets can be used alone or mixed with autograft, blood and/or bone marrow. These bone defects may be created surgically or result from traumatic injury to the bone and are not intrinsic to the stability of the bone structure. MagnetOs Granules resorbs and is replaced by bone during the healing process.
About Project Fusion
Today, nearly 1 in 5 spinal fusions fail. So what can we do to change this – for the benefit of patients, surgeons and our wider society? This is the question that drives us to
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