“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 center of our composite cervical implants that were the subject of recent FDA communications,” said Dr. B. Sonny Bal, CEO and president of Amedica Corporation.
Amedica has refiled an application with the U.S. Food and Drug Administration (FDA), with a modified CsC-based cervical implant that is comparable to Amedica’s own commercially-available ValeoC cervical implants. “With this submission, the goal is to introduce our proprietary CsC technology platform into the U.S. market without further delay,” said Bal.
Amedica develops spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Salt Lake City, Utah-based company’s products are manufactured in its ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the United States and select markets in Europe and South America through its distributor network, and OEM and private label partnerships.