Amedica Announces Regulatory Clearance to Market and Sell Valeo(R) Silicon Nitride Spinal Implants in Australia
April 24 2017 - 7:00AM
Marketwired
Amedica Announces Regulatory Clearance to Market and Sell
Valeo(R) Silicon Nitride Spinal Implants in Australia
Australian Marketing Clearance Provides Opportunities for Global
Expansion
SALT LAKE CITY, UT-(Marketwired - Apr 24, 2017) - Amedica
Corporation (NASDAQ: AMDA), an innovative medical device company
that develops and commercializes silicon nitride, is pleased to
announce it has been granted marketing clearance for its Valeo
interbody fusion devices in Australia.
The Valeo product line is made entirely of Amedica's proprietary
medical grade silicon nitride ceramic - an ideal material for
fusion because of its nanostructured surface, osteoconductivity,
osteoinductivity, anti-microbial properties, and ease of
radiographic imaging.
"The Australian clearance is a tremendous opportunity for
Amedica. Interestingly, during 1986-1988, Australian surgeons and
engineers were the first to synthesize reaction-bonded silicon
nitride, and implant the material in lumbar spine fusion patients.
Favorable outcomes in terms of pain relief and successful fusion
were reported at the 15-year follow-up time interval. Thus, the
pioneering clinical use of silicon nitride in spine fusion
originated in Australia, and we are excited to see the material
return to its place of birth," said Dr. Sonny Bal, CEO. "The
successful outcomes from Australia are now validated by 45
scientific papers published by Amedica in top-tier peer journals,
and clinical data that will be published throughout this year. We
look forward to working with Australian surgeons, and providing
them with improved options for spinal fusion surgery."
About Amedica Corporation Amedica is the only manufacturer of
medical grade silicon nitride - an innovative biomaterial
technology ideal for use in spinal fusion and across a variety of
medical applications. The Company's products are manufactured in
its ISO 13485 certified manufacturing facility located in Salt Lake
City, Utah. 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.
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. Forward-looking statements contained in this press
release include, but are not limited to, the Company's
opportunities for global expansion, and the Company's future
commercialization plans. Such statements are subject to risks and
uncertainties such as whether the FDA approves the Company's
submission, the timing of such approval and the Company's success
in commercializing its products. Additional factors that could
cause actual results to differ materially from those contemplated
within this press release can also 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 March 23, 2016, and
in Amedica's other filings with the SEC. Amedica disclaims any
obligation to update any forward-looking statements.
Contact Information
- Contacts: Amedica IR 801-839-3502 IR@amedica.com
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