Kuros Biosciences announced that the first patient has been treated in an investigator-led, multicenter study comparing MagnetOs bone graft substitute vs. autologous bone in posterolateral spinal fusion.
The blinded, controlled, randomized multicenter trial is scheduled to enroll 100 patients in the Netherlands. Enrollment began in 2H18.
The primary objective is to demonstrate non-inferiority in efficacy and safety of MagnetOs. Primary endpoint is posterior spinal fusion rate after one year based on CT-scans.
MagnetOs comprises a biphasic calcium phosphate with a submicron surface topography that directs bone formation after implantation.
Source: Kuros Biosciences; ORTHOWORLD, Inc.