Schlieren ZH – Kuros Biosciences has received the green light in the USA for the use of MagnetOs products in spinal fusions. New data from the MAXA clinical trial show advantages of MagnetOs over the previous gold standard procedure.
According to a press release, Kuros Biosciences AG has received two further approvals from the Food and Drug Administration(FDA) in the USA for products from its MagnetOs product family. MagnetOs Easypack Putty was given to her for use as an intermediate vertebral body. And with FDA approval, MagnetOs Putty can now be used without the gold standard autograft procedure.
The Schlieren-based company also presented the positive results of the MAXA clinical trial (phase 1), in which MagnetOs Putty was compared with the autograft procedure. With the autograf method, the patient's own body material, a so-called autograft, is used instead of the synthetic MagnetOs products from Kuros.
In this study, MagnetOs was compared with autograft for demanding posterior spinal fusion. The data shows a fusion rate of 78 percent for MagnetOS after one year compared to 45 percent for Autograft. In the difficult-to-treat patient group of smokers, the study even shows a fusion rate of 80 percent for MagnetOs compared to 32 percent with autograft.
This additional data from smokers in the MAXA clinical trial provides "further support for MagnetOs as a stand-alone alternative to autograft," according to Kuros CEO Chris Fair. The difficult study design was chosen "to give surgeons greater confidence in our product and its ability to provide predictable fusions, even in a difficult-to-treat patient population".
Kuros Biosciences AG is a spin-off from the University of Zurich and the Swiss Federal Institute of Technology Zurich. The company is based in the Bio-Technopark Schlieren-Zurich. ce/gba