Amedica has submitted its responses to the US 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.
Sonny Bal, chairman and chief executive officer of Amedica, says, “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 plans to commence manufacturing, marketing and sales of the product in the USA and its possessions subject to FDA jurisdiction.