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Amedica announces positive scientific data, re-files FDA submission

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Amedica Corporation announced positive results from a study that demonstrated rapid bone growth into porous silicon nitride. The company also re-filed an application with the FDA.

According to a company press release, the study tested the company’s porous silicon nitride in a large-animal model. Explants demonstrated rapid bone healing into the material 4 weeks after implantation.

“The porous silicon nitride sample used in this study is the cancellous-structured ceramic (CsC) used in the center of our composite cervical implants that were the subject of recent FDA communications,” B. Sonny Bal, MD, JD, MBA, chief executive officer and president of Amedica Corporation, said in the release.

The company has re-filed an application with the FDA for a modified CsC-based cervical implant. According to Bal, the goal is to introduce the company’s proprietary CsC technology platform into the U.S. market as soon as possible.

Reference:

www.amedica.com