Amedica announces FDA Clearance of the Valeo C+CSC with Lumen Interbody Fusion Device
March 06 2018 - 9:00AM
Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial
company that develops and commercializes silicon nitride as a
platform for biomedical applications, is pleased to announce the
U.S. Food and Drug Administration (FDA) clearance of the Valeo
C+CsC with Lumen Interbody Fusion Device.
The Valeo C+CsC with Lumen Interbody Fusion
Device is a composite spinal fusion implant that combines
different densities of Amedica's proprietary medical grade silicon
nitride ceramic. An outer shell of solid silicon nitride is
manufactured around a porous core, called CsC (Cancellous
structured Ceramic). The Valeo C+CsC device is already used in
Europe, and the Valeo C+CsC with Lumen is the introduction of this
porous technology in the USA.
“This FDA clearance of CsC is a
significant milestone for Amedica. CsC reflects a truly
unique technology. In addition to being the first structural
porous bioceramic available in a medical implant, our published
clinical data from the CASCADE clinical trial have shown that CsC
can achieve spinal fusion sua sponte, i.e., in the absence of added
bone grafts, and with success rates at least as favorable as bone
autograft, i.e., the gold standard in bone fusion. The European
device design was submitted earlier to the FDA, and the approved
version is a design modification of the same material, based on
feedback provided by the FDA.” stated Dr. Sonny Bal, Chairman
and Chief Executive Officer for Amedica.
“Since developing silicon nitride for spinal
fusion, Amedica has investigated this highly-differentiated
biomaterial platform extensively, and its most recent scientific
data show that under appropriate experimental conditions, silicon
nitride induces the expression of hydroxyapatite and collagen, the
key constituents of bone, even in the absence of living
cells. Medical-grade titanium, and polymers like PEEK, which
are widely used in spinal fusion, do not exhibit this
osteoinductive property” added Dr. Bal.
“In addition to attracting new surgeon users and
investigators, approval of the Valeo C+CsC with Lumen Interbody
Fusion Device in the U.S. market opens the door to new designs of
spinal fusion devices that may reduce or eliminate the need for
added bone grafts. In the value-based economic climate of
health care today, the ability of CsC to achieve bone healing
without the added expense and complexity of bone grafts is a
practical advantage. When combined with the other
well-established attributes of silicon nitride, i.e., ease of
viewing on every radiographic imaging modality available today, and
bacteriostatic properties against a variety of bacterial species,
CsC is truly without parallel among biomaterials”
Dr. Bal further stated that “beyond CsC, Amedica
will continue its commitment to a strong R&D program that
remains focused on developing additional key technologies related
to silicon nitride.”
The Valeo C+CsC with Lumen Interbody Fusion
Device is indicated for intervertebral body fusion of the
cervical spine in skeletally mature patients. Additional
information about Amedica's complete line of products can be found
at www.amedica.com.
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. 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.
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 include: the statement that approval of
the Valeo C+CsC with Lumen Interbody Fusion Device CsC in the U.S.
market opens the door to new designs of spinal fusion devices; that
when combined with the other well-established attributes of silicon
nitride, CsC is truly without parallel among biomaterials. 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/A, filed with the Securities and Exchange
Commission (SEC) on December 27, 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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