Amedica Corporation (NASDAQ:AMDA), a company that develops and commercializes silicon nitride ceramics, 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. (Original Source)
Shares of Amedica are currently trading at $1.40, up $0.07 or 5.26%. AMDA has a 1-year high of $12.59 and a 1-year low of $1.16. The stock’s 50-day moving average is $1.44 and its 200-day moving average is $1.83.
Amedica Corp. operates as a commercial biomaterial company that focuses on using its silicon nitride technology platform to develop, manufacture and sell a broad range of medical devices. It currently markets spinal fusion products and are developing products for use in total hip and knee joint replacements. The company market a complementary line of non-silicon nitride spinal fusion products which allows it to provide surgeons and hospitals with a broader range of products. These products include three lines of spinal fusion devices and five types of orthobiologics, which are used by surgeons to help promote bone growth and fusion in spinal fusion procedures.