Kuros Biosciences announced promising preliminary results from the first of its five planned randomized controlled trials for the MagnetOs product 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% vs. 42% for autograft. This compares favorably to fusion rates of 55% to 71% reported for other synthetic bone grafts evaluated in similar well-controlled studies of posterolateral fusion.
The first consecutive 50 patients (from a total of 100) requiring up to four-level instrumented posterolateral lumbar fusion were included in this preliminary analysis. The rate of posterolateral lumbar/thoracolumbar fusion was assessed by CT-scan 12 months after surgery.
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 seek a reasonably priced augmented alternative to cell-based allografts, bone morphogenetic proteins and premium-priced synthetic bone grafts.
Joost de Bruijn, Chief Executive Officer of Kuros, said, “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’ commitment to a translational research approach through which we convert our 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.”
Kuros Biosciences announced promising preliminary results from the first of its five planned randomized controlled trials for the MagnetOs product 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% vs. 42% for...
Kuros Biosciences announced promising preliminary results from the first of its five planned randomized controlled trials for the MagnetOs product 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% vs. 42% for autograft. This compares favorably to fusion rates of 55% to 71% reported for other synthetic bone grafts evaluated in similar well-controlled studies of posterolateral fusion.
The first consecutive 50 patients (from a total of 100) requiring up to four-level instrumented posterolateral lumbar fusion were included in this preliminary analysis. The rate of posterolateral lumbar/thoracolumbar fusion was assessed by CT-scan 12 months after surgery.
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 seek a reasonably priced augmented alternative to cell-based allografts, bone morphogenetic proteins and premium-priced synthetic bone grafts.
Joost de Bruijn, Chief Executive Officer of Kuros, said, “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’ commitment to a translational research approach through which we convert our 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.”
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