Amedica (NASDAQ: AMDA) this morning said it has re-filed an application with the FDA following encouraging 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. The new submission includes a modified CsC-based cervical implant that is comparable to Amedica’s own commercially-available Valeo®C cervical implants. “With this submission, the goal is to introduce our proprietary CsC technology platform into the U.S. market without further delay,” Dr. B. Sonny Bal, Amedica CEO and president, stated in the news release.
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About Amedica Corporation
Amedica is focused on the development and application of 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 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 U.S. and select markets in Europe and South America through its distributor network, and OEM and private label partnerships. For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com
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