“This FDA clearance of CsC is a significant milestone for Amedica. CsC reflects a truly unique technology. In addition to being the first structural porous bioceramic available in a medical implant, our published clinical data from the CASCADE clinical trial have shown that CsC can achieve spinal fusion sua sponte, i.e., in the absence of added bone grafts, and with success rates at least as favorable as bone autograft, i.e., the gold standard in bone fusion. The European device design was submitted earlier to the FDA, and the approved version is a design modification of the same material, based on feedback provided by the FDA.” stated Dr. Sonny Bal, Chairman and Chief Executive Officer for Amedica. |