Kuros Biosciences’ MagnetOs Granules FDA-Cleared for Expanded Spinal Indications

By Julie A. Vetalice

Kuros Biosciences’ MagnetOs Granules FDA-Cleared for Expanded Spinal Indications

Kuros Biosciences' MagnetOs Granules have been cleared by FDA for expanded indications in the spine, making it the second-ever bone graft to achieve clearance for standalone use in the spine based on human clinical data.

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 clearance for standalone use indicates that MagnetOs is an augmented graft that can be used in place of, as well as in combination with, autograft bone.

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’ 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.

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.”

Source: Kuros Biosciences

Product Labels: Synthetic Bone Graft

Tags: 510(k) Clearance, Regulatory