SINTX Technologies, Inc. (NASDAQ: SINT) (the “Company”), an
original equipment manufacturer (OEM) ceramics company that
develops and commercializes silicon nitride, today announced
preliminary financial results for the year ended December 31, 2019
and provided a business update.
YEAR END 2019 FINANCIAL
RESULTS
SINTX reported revenue of $0.7 million for the
year ended December 31, 2019 as compared to $0.1 million for the
year ended December 31, 2018. Further, the Company reported
generally accepted accounting principles (GAAP) basic net loss from
continuing operations for the year ended December 31, 2019 of $3.08
per share, compared to a basic net loss from continuing operations
of $26.57 per share for the year ended December 31, 2018. The
Company’s cash and cash equivalents were $1.8 million as of
December 31, 2019, a decrease of $3.7 million from December 31,
2018.
The Company also announced that as of the end of
February 2020, there were 7,563,549 shares of common stock
outstanding.
BUSINESS UPDATE AND RECAP
Dr. B. Sonny Bal, Chairman and CEO provided the
following update.
Recap of the past year-
In 2019, SINTX transitioned from a spine implant
manufacturer and seller to a technical ceramic materials company,
with the goal of identifying new markets for its silicon nitride.
We were well-positioned to do so because of our established
knowledge equity, and because of the superior quality of our
material platform.
Spine Sales-
SINTX continues to supply our spine implants
retail partner, CTL-Amedica. Sales of silicon nitride implants
increased in the 4th quarter. SINTX is helping CTL-Amedica develop
new implants and designs to drive future sales, and new
markets.
Over 130 scientific papers in peer-reviewed
journals back up our technology. Recently published multi-center
clinical studies have shown superb outcomes in lumbar and cervical
fusion, respectively. We are wrapping up several other clinical
studies, including one showing favorable lumbar fusion outcomes
from the European SNAP clinical trial.
OEM Strategy-
Our peers in the medical and industrial markets
acknowledge that SINTX has an advanced technology platform that is
thoroughly validated. Our focus is now on top line growth through
new customers, and/or through strategic opportunities.
Our VP of Business Development, Don Bray, is an
industry veteran charged with finding industrial opportunities,
such as in cutting tools and machine parts. SINTX recently became
ITAR-compliant (International Treaty on Arms Reduction) and
completed the Stage 1 audit for AS9100 certification; both are
predicate steps toward seeking defense orders. We took these steps
because the market for advanced ceramics is expected to grow,
driven by defense needs in ballistics, and in hypersonic
projectiles.
In addition to defense, both the transportation
and energy sectors will require high-performance materials to meet
future standards. To address these new markets, SINTX has hired an
investment bank to identify strategic targets that will broaden our
materials and customer profile.
Our dental implant program is far enough along
that we have an investment bank seeking partners for this product
line. SINTX has developed both zirconia and silicon nitride dental
implants, and our metals coating technology is close to the
commercial stage. The combination of enhanced bone growth with
bacterial resistance is unique to our material and ideal for dental
implants.
The orthopaedic space is a significant
opportunity for SINTX. Recognizing this, we added Dr. Mark
Froimson, an industry leader, to our Board. Our recent capital
raise will be invested back into the business, specifically to
bring new technologies to commercialization, and expand our
customer base. We have an active collaboration to develop silicon
nitride coatings and anti-bacterial composite spacers and expect to
move several other discussions toward formal development
projects.
Consumer products in the general hygiene space,
such as anti-bacterial surfaces and products, are another opening
for SINTX. Like industrial products, market entry is easier with
less regulatory burden than implantable devices. We will
collaborate with Nissin Manufacturing Company and with other
similar partners to explore these opportunities.
Future Outlook-
Turning our knowledge and skill toward
addressing customer needs is the overarching goal for 2020. Several
key technologies are at near-commercialization stage. These include
3-D printing of silicon nitride, metals-coating, polymer- and
PMMA-ceramic composites, and dental implants. Our particular
silicon nitride composition is some of the strongest and toughest
available.
During the transition from a silicon nitride
R&D powerhouse toward commercial opportunities, we expect
modest revenue growth in 2020. We have enough science to back up
our claims. During 2019, several independent and international
papers replicated our work, suggesting new entrants into the
silicon nitride biomaterials space. This potential competition, in
our view, is both healthy and entirely welcome. We have trimmed up
and targeted our R&D accordingly, to ensure our leading
position in silicon nitride, with new technologies and intellectual
property filings.
Compared to medical devices, industrial parts
are easier to develop, with fewer regulatory barriers. We have
already received two small orders to build prototypes of industrial
parts for third party manufacturers. We are hopeful that these
early orders, though small, will result in high-volume
opportunities that are essential for near-term revenue growth.
Fortunately, silicon nitride is used in diverse applications all
over our planet, and even beyond, such that the range of
opportunities is immense.
For the first time, outside companies are
scrutinizing SINTX as an interesting and differentiated technology
play that is coming into the limelight. We have well-established
investment banking relationships, a broad technology portfolio,
several new technologies at near-commercial stage, and a seasoned
team that can execute. We believe that SINTX Technologies has an
exciting and promising future.
About SINTX Corporation
SINTX Technologies is an OEM ceramics company
that develops and commercializes silicon nitride for medical and
non-medical applications. The core strength of SINTX Technologies
is the manufacturing, research, and development of silicon nitride
ceramics for external partners. The Company presently manufactures
silicon nitride spinal implants in its ISO 13485 certified
manufacturing facility for CTL-Amedica, the exclusive retail
channel for silicon nitride spinal implants.
For more information on SINTX
Technologies or its silicon nitride material platform, please visit
www.sintx.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 (PSLRA) that are subject to a number of risks
and uncertainties. Readers are cautioned not to place undue
reliance on the forward-looking statements, which speak only as of
the date on which they are made and reflect management’s current
estimates, projections, expectations and beliefs. Such forward
looking statements include our statements regarding: acceleration
of the pace of innovation, executing a strategic event,
transitioning our metals coating technology from the development to
the commercial stage, our expectation to move other discussions
into formal projects, development of new products with CTL-Amedica,
our OEM Strategy and statements in the Future Outlook section,
including the development of new applications and new products, and
that we expect to build recent orders into high-volume
opportunities that are essential for near-term revenue growth.
There can be no assurance that any of the anticipated results will
occur on a timely basis or at all due to certain risks and
uncertainties, a discussion of which can be found in SINTX’s Risk
Factors disclosure in its Annual Report on Form 10-K, filed with
the Securities and Exchange Commission (SEC) on March 11, 2019, and
in SINTX’s other filings with the SEC. SINTX disclaims any
obligation to update any forward-looking statements. SINTX
undertakes no obligation to publicly revise or update the
forward-looking statements to reflect events or circumstances that
arise after the date of this report.
Contact:SINTX
Technologies801.839.3502IR@sintx.com
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