BONESUPPORT announced that the CERTiFy study (CERAMENT® Treatment of Tibia Plateau Fracture defects) of CERAMENT bone void filler met its primary endpoint of non-inferiority to autologous iliac bone graft.
The prospective, multi-center, controlled trial enrolled 137 patients with fresh traumatic depression fractures of the proximal tibia at 20 centers in Germany. Patients were randomized to receive either CERAMENT BVF or autograft.
The data will support the company's commercial strategy to increase share in the U.S. and European synthetic bone graft substitute market. BONESUPPORT commenced U.S. sales of CERAMENT BVF through independent distributors within 4Q18, and expects strong 2019 total product sales and 40% annual growth moving forward.
Researcher and Professor P.M. Rommens noted, “Bone graft substitutes are widely used for augmentation of post-traumatic bone defects. However, no direct randomized clinical comparison to autologous bone grafting, the so-called “gold-standard” in reconstruction of bone defects, has been previously conducted. CERTiFy clearly demonstrates that CERAMENT BVF is non-inferior to autograft across several key clinical parameters."
Source: BONESUPPORT AB