Amedica Corporation announced that it has submitted its responses to the Food and Drug Administration (FDA) in relation to the CASCADE clinical trial.The CASCADE study compared the 24-month outcomes from single-level cervical fusion between Amedica's porous silicon nitride versus bone autograft. Data showed that porous silicon nitride achieved clinical and radiographic outcomes that were comparable to bone autograft.
"Porous silicon nitride is a synthetic platform that can achieve spinal fusion without added bone graft, based on the results of our clinical trial," said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. "These outcomes are consistent with our understanding of the surface chemistry and nano-topography of silicon nitride. We believe the composite porous silicon nitride fusion device used in the CASCADE trial, if approved by the FDA, will improve patient health. We are confident that we have addressed the questions raised by the FDA."
The Company anticipates a final determination from the FDA within the next 60 days. If approved, the Company would commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction.
