Amedica Receives FDA Clearance for Additional Valeo(R) II Lateral Lumbar Interbody Fusion Device Offerings
August 24 2016 - 9:00AM
Marketwired
Amedica Receives FDA Clearance for Additional Valeo(R) II
Lateral Lumbar Interbody Fusion Device Offerings
Additional Sizes Provide Greater Accommodation for a Wider Range
of Patient Anatomies
SALT LAKE CITY, UT-(Marketwired - Aug 24, 2016) - 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 expanded Valeo II Lateral
Lumbar sizes. The additional sizes of the Valeo II LL interbody
fusion device will be commercially available August 29, 2016.
The Valeo II LL interbody fusion device is made entirely of
Amedica's proprietary medical grade silicon nitride ceramic - an
ideal material for fusion, due to its inherent osteoconductivity,
anti-infective properties, bone-like imaging (artifact-free &
radiotranslucent), and exceptional strength. The system includes
second generation instrumentation to improve patient safety and
surgeon ease of use.
"I'm delighted to announce the recent FDA clearance of our
expanded silicon nitride lateral lumbar implant offerings," said
Dr. Sonny Bal, Chairman and Chief Executive Officer. "It's
estimated that lateral lumbar procedures will remain one of the
fastest growing interbody fusion segments over the next five years.
The minimally invasive nature of the procedure provides patients
with benefits such as less blood loss, smaller incisions and
shorter hospital and intraoperative times. We believe these
clinical benefits, coupled with our unique silicon nitride
biomaterial will lead to an improved continuum of care for
individuals."
The recently cleared sizes allow for greater accommodation for a
wide range of patient anatomies as well as greater stability as the
shape of the implant distributes weight over a larger surface area.
The design of the interbody fusion device consists of aggressive
teeth for expulsion resistance, knurls for added stability, a
threaded insertion feature for precision implant control, and two
central cavities maximized for optimal bone graft packing.
The Valeo II LL is indicated for intervertebral body fusion of
the spine in skeletally mature patients and is designed for use
with autograft to facilitate fusion. 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
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. 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 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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