Amedica Corporation Provides Update on its Clinical Studies
May 08 2018 - 9:30AM
Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial
company that develops and commercializes silicon nitride for
biomedical applications, today provided an update on its clinical
study activities.
Single Center Retrospective Comparative
Study
A clinical study comparing silicon nitride
spinal implants to allograft spacers in cervical fusion showed
faster and more effective outcomes with silicon nitride.
“While silicon nitride might have been expected to perform better
in light of its properties, the surprising finding in our study was
how good the outcomes with silicon nitride proved to be.
Significantly earlier and more effective bone fusion was observed
with silicon nitride than allograft spacers at 3- 6-, and 12-month
time points after surgery, all the way to 24 months” said Dr. Micah
Smith, orthopaedic surgeon in Fort Wayne, Indiana, who is the
principal investigator. Study findings have been submitted to
for release at the December 2018 Cervical Spine Research Society
meeting.
Multi-Center Retrospective
Study
Amedica reported completion of an exhaustive
retrospective survey of over 2,000 silicon nitride spinal implants
implanted in more than 1,000 patients over the last eight
years. The study was designed to understand clinical outcomes
from silicon nitride implants in spine fusion from four different
clinics in the US. “Preliminary data analysis toward
publication of this study is very encouraging in this large cohort
of patients derived from our long-term surgeon users. Not
only are the data consistent with our other clinical studies, but
the outcomes corroborate our basic science understanding of the
surface chemistry of the material, the key strength of silicon
nitride,” said Dr. Sonny Bal, President of Amedica.
Silicon Nitride Against PEEK
(SNAP)
SNAP, a 24-month double-blinded multicenter
randomized controlled human trial for lumbar fusion comparing
intervertebral cages from either silicon nitride or
polyetheretherketone (PEEK), has been completed. The purpose of the
study was to show that fusion using silicon nitride cages was at
least non-inferior to PEEK devices. Preliminary data at 3, 6, and
12-months on the Roland Morris Disability Questionnaire and VAS
back and leg pain scores, as well as quantitative radiographic data
at 24 months appear to confirm the study’s hypothesis of silicon
nitride’s non-inferiority. Additional detailed analyses are
currently being conducted in anticipation of publishing the overall
results in a prominent scientific journal later this year.
Goat Study
An interbody fusion study using a goat
model comparing silicon nitride to PEEK was just accepted for
publication in the Journal of Biomedical Materials Research, Part B
– Applied Biomaterials. The results of the study showed improved
fusion and greater bone volume using silicon nitride implants
versus PEEK at the study’s six-month end-point. These results also
suggest that silicon nitride is not inferior to PEEK and that
silicon nitride implants may be more effective in promoting
arthrodesis.
About Amedica
CorporationAmedica 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. 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, silicon nitride and our products may
not have the impact we expect, the outcomes of our ongoing studies
may not be positive, and the results of our studies may not come in
the anticipated timeframes. 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 29, 2018, 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: Amedica IR 801-839-3502
IR@amedica.com
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