Kuros Biosciences (SIX: KURN) today announced that the first patient has been treated in an investigator-led multicenter randomized controlled study comparing MagnetOs with autologous bone in posterolateral spinal fusion.
The University Medical Center Utrecht (UMCU) in the Netherlands is the principal investigating site for the study, which is entitled “A Randomized Controlled Trial of MagnetOs® granules vs. Autograft in Instrumented Posterolateral Spinal Fusion”. UMCU’s Department of Orthopedics is one of the foremost orthopedic clinical research centers in the world.
Joost de Bruijn, Chief Executive Officer of Kuros, said: “It is gratifying to see this important trial get underway in spinal fusion, as this area of great medical need is the focus of our commercial activities. The study is expected to generate important data that can help further differentiate MagnetOs and improve outcomes for patients.”
The primary objective is to demonstrate non-inferiority with regard to efficacy and safety of MagnetOs compared to the current gold standard, autograft, harvested from the patient’s own body, in instrumented posterolateral spinal fusion.
Dr. Moyo Kruyt of UMCU, principal investigator of the study said: “It is a privilege to be leading this investigation of MagnetOs. MagnetOs is supported by some fantastic scientific evidence and is a treatment which has the potential to significantly improve patients’ lives. Patients own bone remains the gold standard against which all other grafts should be measured, yet very few studies have investigated synthetic alternatives side by side with autograft in a clinical setting. This study is poised to provide a level of definitive clinical evidence that surgeons have been crying out for.”
About the study
The study is designed as a patient and observer blinded, controlled, randomized, multicenter clinical trial across five centers with intra-patient comparisons. One hundred adult patients qualified for posterolateral spinal fusion in the thoracolumbar and lumbosacral region (T10-S2) will enrolled in this study. Primary endpoint is posterior spinal fusion rate after one year based on CT-scans.
MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.