Amedica Submits 510(k) Application to FDA for Valeo C+CSC with Lumen
SALT LAKE CITY, Nov. 06, 2017 (GLOBE NEWSWIRE) -- Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company that develops and manufactures silicon nitride as a platform for biomedical applications, announced that the company made a 510(k) submission to the U.S Food and Drug Administration for its Valeo C+CSC with Lumen spinal implant.
The Valeo C+CSC with Lumen is a modified CSC (cancellous structured ceramic) that is similar to Amedica’s commercially available Valeo C and Valeo C+ CSC (cleared in Europe only) cervical implants. This device increases implant surface area and plays an active role in the spinal fusion process while maintaining the other benefits silicon nitride brings to patients and physicians.
“The Valeo C+CSC with Lumen submission is a key step in introducing our proprietary porous silicon nitride technology into the US market. We look forward to working with the FDA on this important company milestone,” said Dr. Sonny Bal, Amedica CEO
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.
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on September 20, 2017, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.
Contacts: Amedica IR 801-839-3502 IR@amedica.comSource: Amedica Corporation
Released November 6, 2017