Amedica announces positive scientific data and re-files FDA submission

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Amedica has announced results from a recent study showing rapid bone growth into porous silicon nitride. Explants of the company’s porous silicon nitride from a large-animal model demonstrated bone healing into the material just four weeks after implantation.

“We anticipate these preliminary findings will be confirmed with additional retrieval data in the near future. The porous silicon nitride sample used in this study is the cancellous-structured ceramic (CsC) used in the centre of our composite cervical implants that were the subject of recent US Food and Drug Administration (FDA­) communications,” says B Sonny Bal, chief executive officer and president of Amedica.

Amedica has re-filed an application with the FDA, with a modified CsC-based cervical implant that is, according to a company release, comparable to Amedica’s own Valeo C cervical implants. “With this submission, the goal is to introduce our proprietary CsC technology platform into the US market without further delay,” says Bal.