Amedica Submits Response to FDA for Clearance of Composite Interbody Spinal Device
June 13 2016 - 9:15AM
Marketwired
Amedica Submits Response to FDA for Clearance of Composite
Interbody Spinal Device
Porous Silicon Nitride Demonstrates Healing and Fusion Outcomes
Similar to Autograft Bone
SALT LAKE CITY, UT-(Marketwired - Jun 13, 2016) - Amedica
Corporation (NASDAQ: AMDA), a company that develops and
commercializes silicon nitride ceramics, announced that it has
submitted its responses to the Food and Drug Administration (FDA)
in relation to the CASCADE clinical trial.
The CASCADE study compared the 24-month outcomes from
single-level cervical fusion between Amedica's porous silicon
nitride versus bone autograft. Data showed that porous silicon
nitride achieved clinical and radiographic outcomes that were
comparable to bone autograft.
"Porous silicon nitride is a synthetic platform that can achieve
spinal fusion without added bone graft, based on the results of our
clinical trial," said Dr. Sonny Bal, chairman and CEO of Amedica
Corporation. "These outcomes are consistent with our understanding
of the surface chemistry and nano-topography of silicon nitride. We
believe the composite porous silicon nitride fusion device used in
the CASCADE trial, if approved by the FDA, will improve patient
health. We are confident that we have addressed the questions
raised by the FDA."
The Company anticipates a final determination from the FDA
within the next 60 days. If approved, the Company would commence
manufacturing, marketing and sales of the product in the United
States and its possessions subject to FDA jurisdiction.
About Amedica Corporation Amedica is focused on the development
and application of interbody implants manufactured with
medical-grade silicon nitride ceramic. Amedica markets spinal
fusion products and is developing a new generation of wear- and
corrosion-resistant implant components for hip and knee
arthroplasty as well as dental applications. The Company's products
are manufactured in its ISO 13485 certified manufacturing facility
and through its 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 its growing 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. Forward-looking statements contained in this press
release include, but are not limited to, the Company's CASCADE
study, the determination from the FDA relating to the CASCADE
study, 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.
Contacts: Mike Houston VP, Commercialization 801-839-3534
IR@amedica.com
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