The company has announced new data from the CERTiFy (CERAMENT Treatment of Tibia Plateau Fracture defects) study comparing CERAMENT|BVF with autologous iliac bone graft (autograft).
“Successfully completing the ground-breaking CERTiFy study, to demonstrate CERAMENT BVF is non-inferior to autograft in treating tibia plateau fracture defects, is a major milestone for BONESUPPORT. We expect the results from the study to catalyse a change in the standard of care for this kind of injury given that our synthetic bone graft is now proven to be as good as autograft, which requires a second surgical procedure to harvest bone from the patient’s hip. These data, which clearly differentiate CERAMENT BVF, will play a key role in our commercial strategy to increase our share of the synthetic bone graft substitute market in both Europe and the U.S.,” said Bonesupport’s CEO Emil Billback.
CERTiFy, a prospective, multi-center, controlled, randomized trial, enrolled 137 patients with fresh traumatic depression fracture of the proximal tibia across 20 participating centers in Germany. Patients were randomized to receive either CERAMENT BVF or autograft.
The CERTiFy study met its primary endpoint with CERAMENT BVF being non-inferior to autograft in terms of Physical Component Summary (SF-12 v2) at week 26. A publication providing more complete data from the CERTiFy study is expected in Q1 2019.