AMEDICA PROVIDES BUSINESS UPDATE
January 25 2018 - 9:00AM
Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial
company that develops and commercializes silicon nitride for
biomedical applications, today provided a business update related
to its business strategy and certain recent developments.
BUSINESS UPDATE AND RELATED
DEVELOPMENTS
Commercialization Report
In 2017, Amedica successfully launched its
updated Taurus™ Pedicle Screw System, a pedicle screw system
designed for degenerative spine surgery. With over 250
procedures performed, this product has generated almost $1.3
million in new revenue since its introduction to the market. The
company released additional instrument sets in the fourth quarter
of 2017 to meet surgeon demand.
Other commercialization highlights include:
- 40% increase in surgeon users during 2017, predominantly from
surgeons performing lumbar fusion surgeries utilizing Valeo II
silicon nitride implants and Taurus pedicle screws.
- 14 new sales agents added in 2017, primarily to establish
representation in underrepresented areas of the United States.
- The hire of a new Area Vice President for the Western Region,
resulted in all members of the sales team having significant
experience in spine surgery related sales.
- The product pipeline was prioritized and defined for 2018 and
beyond, with the goal of launching several new products in
2018.
- Year-over-year revenue growth in Brazil from 2016 to 2017.
- Expanded sales channel in the UK in 2017.
- Identification of potential distribution partners in
Australia.
- Progress toward regulatory clearance in Japan.
The company has received feedback from the FDA
on its 510k submission for the “C+CSC with Lumen” spinal implant
and is submitting a response.
Clinical
With over 33,000 silicon nitride spinal
interbody implants implanted since 2008, Amedica is comprehensively
reviewing its large-scale clinical outcomes – a requirement under
the new European Medical Device Regulation. The resulting
data will be published later in 2018.
The company has completed the data collection
associated with its Level 1 SNAP lumbar spine clinical trial.
Initial review supports the efficacy of silicon nitride as a spine
fusion material, consistent with a large volume of data already
published by Amedica. Results of the SNAP trial are expected
to be published during 2018.
The company is planning several international
clinical investigations during 2018 to strengthen clinical evidence
of the advantages of silicon nitride, i.e., ease of imaging,
improved spinal fusion, and antibacterial properties. These
studies are expected to build upon the existing foundation of
extensive material science data supporting the use of silicon
nitride in spine fusion surgery.
Research and Development
During 2017 the company had 20 peer-reviewed
publications, 10 published conference proceedings, and participated
in 27 presentations at conferences and scientific meetings. These
R&D efforts have validated the underlying science of silicon
nitride, and contributed to increased company visibility that has
attracted inquiries and collaborations in areas outside of spine
surgery. Scientific and clinical data are critical toward
attracting new surgeons to silicon nitride implants, both in the
United States and overseas markets.
Financial Update
The company continues to focus on stabilizing
its finances, having substantially reduced its monthly cash burn
during 2014-2017. On January 3, 2018, Amedica paid off its
loan with Hercules Capital via a debt exchange transaction with
other accredited investors - a significant step in reducing
costs.
Strategic Direction
"Our strategic priorities are three-fold. The
first priority is revenue growth, while controlling expenses, with
the goal of financial self-sufficiency. Second, we will
continue to investigate the full potential of silicon nitride
ceramic and build collaborations with external partners.
Third, while we consider ourselves to be a leader in the scientific
knowledge of silicon nitride, the company is focused on building a
strong portfolio of clinical evidence. Taken together,
revenue growth, external collaborations, and clinical validation of
our products are necessary to support product acceptance, and
long-term sales growth," said B. Sonny Bal, MD, MBA, JD, PhD;
Chairman and CEO of Amedica.
About Amedica Corporation
Amedica is focused on the development and
application of spinal interbody implants made with 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 products are manufactured in its FDA
registered and ISO 13485 certified manufacturing facility, and it
has a 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, as well as 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, which include statements regarding the company’s
goal to release several new products in 2018, anticipated future
revenues, FDA clearance of our products, addition of new surgeon
users, and, results of clinical studies 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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