Amedica Announces Successful Completion of First Valeo® C+CSC with Lumen Interbody Fusion Surgery
August 21 2018 - 9:00AM
Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial
company that develops and commercializes silicon nitride for
biomedical applications, is pleased to announce the successful
completion of the first spine fusion surgery using the Valeo C+CSC
with Lumen Interbody Fusion Device.
The first surgery was performed by Dr. Tarek
Elalayli of Nashville, TN. “The implant, consisting of a novel
combination of solid and porous silicon nitride, is well-designed,
and the surgical implantation was straight forward. The benefits of
this new device include the potential for bone in-growth as well as
on-growth, while a central lumen gives the surgeon flexibility to
add bone graft, if needed. The device and underlying technology are
a step toward spine fusion without the need for bone graft
additives; with the advantages of good radiographic visualization,
and inherent antibacterial properties of silicon nitride. No other
spinal fusion implant combines all these properties." said Dr.
Elalayli.
The Valeo C+CsC with Lumen is Amedica’s newest
spinal implant that received FDA clearance earlier this year. The
device is a composite silicon nitride implant that combines
different densities of Amedica's proprietary medical grade silicon
nitride ceramic. A solid, outer shell of nanostructured silicon
nitride is manufactured around an inner porous layer, called CsC
(“cancellous structured ceramic). CsC is approved for clinical use
in Europe, and published clinical data from the CASCADE clinical
trial have shown that it achieves spinal fusion without added bone
grafts or fillers, at rates similar to those achieved by bone
autograft.
“Several of our published reports have
challenged the existing dogma that the surface texture of a
biomaterial alone affects bone healing. Instead, we have shown that
surface microchemistry also plays a critically important role in
promoting bone healing. In the case of silicon nitride, we can
precisely engineer both the surface nanostructure, as well as the
surface microchemistry of an implant in order to stimulate
bone-forming cells, speed up bone fusion, and discourage bacterial
adhesion. The Valeo C+CsC with Lumen device captures these
advantages by manufacturing different material densities into one
smart, bioactive implant that is already optimized for spinal
fusion. In contrast, competing implants made of inert metal and
plastic usually require enhancement with cost-added bone fillers,
surface texturing, or related gimmicks” said Dr. Sonny Bal,
Chairman of Amedica. “Unlike any other biomaterial available for
spinal fusion today, silicon nitride is in a class by itself,”
added Dr. Bal.
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
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 manufactures its
products 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 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. 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
March 29, 2018, 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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