Amedica Submits 510(k) Application to FDA for Valeo C+CSC with Lumen
November 06 2017 - 9:00AM
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.
Forward-Looking Statements
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.com
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