Amedica Announces Results of Independent Femoral Head Wear Testing
February 27 2017 - 9:00AM
Marketwired
Amedica Announces Results of Independent Femoral Head Wear
Testing
SALT LAKE CITY, UT-(Marketwired - Feb 27, 2017) - Amedica
Corporation (NASDAQ: AMDA), an innovative biomaterial company which
develops and manufactures silicon nitride as a platform for
biomedical applications, announced today that Researchers from the
Department of Orthopaedic Surgery of Tokyo Medical University
(Shinjuku-ku, Tokyo, Japan) led by Professor Kengo Yamamoto MD PhD
recently completed a five million cycle (Mc) comparative hip
simulator study examining the wear behavior of an advanced highly
cross-linked and vitamin E stabilized polyethylene (E1
Zimmer-Biomet, Warsaw, IN, USA) against two different types of
ceramic femoral heads - MC2silicon nitride (Amedica Corporation,
Salt Lake City, UT, USA) and BIOLOXdelta (CeramTec, Plochingen,
Germany). BIOLOXdelta is currently considered the "gold standard"
for ceramic femoral head materials. While the polyethylene wear
loss induced by both types of ceramic heads was extremely small
(< 0.60 mg/Mc), mean wear associated with MC2silicon nitride
heads was approximately 15% lower than the BIOLOXdelta
components.
This independent wear study was conducted in accordance with
international standards at the Medical Technology Laboratory of the
Rizzoli Orthopaedic Institute (Bologna, Italy) by Professor Aldo
Toni MD under the supervision of Dr. Saverio Affatato PhD (Rizzoli
Institute) with consultation and support from Professor Giuseppe
Pezzotti PhD (Ceramic Physics Laboratory, Kyoto Institute of
Technology, Sakyo-ku, Kyoto Japan). Amedica and Zimmer-Biomet
(Tokyo Office) provided the femoral heads and acetabular liners;
however, neither company actively sponsored the research.
The testing was independently conceived by Professors Yamamoto
and Pezzotti, and funded by the Department of Orthopaedic Surgery
of Tokyo Medical University. This is the first reported improvement
in polyethylene wear performance by a ceramic other than
BIOLOXdelta; and it is part of a series of planned comparative wear
tests that will culminate at 12 Mc. Further details of this interim
hip simulation test will be provided in a joint publication planned
for release in a scientific journal.
"We are thrilled, though not surprised, at the remarkable wear
properties of silicon nitride femoral heads," said Dr. B. Sonny
Bal, CEO and President of Amedica Corporation. "Our previous work,
already published in peer-review forums, has shown superb phase
stability of silicon nitride in vivo, plus oxygen-scavenging
properties that may confer long-term protection to polyethylene
acetabular liners, along with bacterial resistance inherent in
silicon nitride, toughness that is superior to any other
biomaterial, and resistance to corrosion. The present wear data
reflect the considerable scientific work that went into a thorough
understanding of the surface chemistry and composition of our
femoral heads, with development of engineering processes and
proprietary methods that lead to a consistent, ultra-smooth
articulating surface. Taken together, this favorable combination of
properties, supported by scientific data, reflect material science
advancements that are necessary to differentiate total hip
replacements in an otherwise commoditized market, and more
importantly, toward extending the longevity of hip replacements
beyond the second decade of life, post-implantation. These data
will contribute to our continuing work and dialogue with the FDA to
get the product approved for use clinically."
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 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. These statements are based upon our current
expectations and speak only as of the date hereof. Our actual
results may differ materially and adversely from those expressed in
any forward-looking statements as a result of various factors and
uncertainties. For example, there can be no assurance that we will
be able to maintain our listing on any NASDAQ market. Other 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.
Forward-looking statements contained in this press release speak
only as of the date of this press release. We undertake no
obligation to update any forward-looking statements as a result of
new information, events or circumstances or other factors arising
or coming to our attention after the date hereof.
Contact Information
Contact: Amedica IR 801-839-3502 IR@amedica.com
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