Amedica Becomes First to Receive FDA Clearance for Two-Level Cervical Interbody Cage Indications
February 03 2015 - 8:00AM
Amedica Corporation (Nasdaq:AMDA), a company that develops and
commercializes silicon nitride ceramics as a biomaterial platform,
announced today that the U.S. Food and Drug Administration (FDA)
has expanded the indications of Amedica's silicon nitride interbody
fusion products to include multi-level cervical treatment.
"We are very pleased to become the first company to receive FDA
clearance for multi-level cervical interbody cage indications,"
said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. "Given
the high incidence of two-level cervical procedures, we are proud
that our silicon nitride interbody fusion devices are now available
to address two-level cervical disease. This clearance allows
Amedica to support or conduct clinical studies without the need for
an IDE (Investigational Device Exemption) in two-level cervical
pathologies, which can then be used to confirm the effectiveness of
our silicon nitride technology platform. The clearance also allows
Amedica to promote this unique point of differentiation in the
marketplace."
"The FDA clearance reassures every surgeon and patient that
scientific evidence exists that silicon nitride interbody devices
can safely and effectively be used in the treatment of multi-level
cervical pathologies," said Dr. Jim A. Youssef, founder of Spine
Colorado and a fellowship-trained spine surgeon. "A material such
as silicon nitride, which contains bone on-growth properties and
participates in the fusion process, is an ideal biomaterial for
implantation into the human body. This clearance also provides
surgeons with a broad array of procedure options for high risk
patients – patients with poor bone quality, are smokers, or who
have diabetes."
The FDA's clearance of the expanded indications is based on
extensive data from a variety of studies and sources showing the
Company's silicon nitride devices used in multi-level procedures
are as safe and effective as other devices used in single level
procedures. The Valeo™ cervical fusion devices are now indicated
for use in skeletally mature patients with degenerative disc
disease at one disc level or two contiguous levels. The FDA
approval order allows for commercial sales and distribution of
these devices for multi-level procedures.
About Amedica Corporation
Amedica is focused on the development and application of
medical-grade silicon nitride ceramics. Amedica markets spinal
fusion products and is developing a new generation of wear- and
corrosion-resistant implant components for hip and knee
arthroplasty. The Company manufactures its products in its ISO
13485 certified manufacturing facility and, through its partnership
with Kyocera, the world's largest ceramic manufacturer. Amedica's
spine products are FDA-cleared, CE-marked, and are currently
marketed in the U.S. and select markets in Europe and South America
through its distributor network and its growing OEM
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 the intent,
belief or current expectations of Amedica and members of its
management team with respect to Amedica's future business
operations as well as the assumptions upon which such statements
are based. Forward-looking statements include specifically, but are
not limited to, Amedica's growing OEM partnerships, Amedica's
market opportunities, growth, future products, market acceptance of
its products, sales and financial results and such statements are
subject to risks and uncertainties such as the timing and success
of new product introductions, physician acceptance, endorsement,
and use of Amedica's products, regulatory matters, competitor
activities, changes in and adoption of reimbursement rates,
potential product recalls, effects of global economic conditions
and changes in foreign currency exchange rates. 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 31, 2014, and in Amedica's other filings with the SEC.
Amedica disclaims any obligation to update any forward-looking
statements.
CONTACT: Mike Houston
Director of Investor Relations
801-839-3534
mhouston@amedica.com
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