SINTX Technologies Awarded Phase II NIH Grant for Silicon Nitride-PEEK 3D Printed Composite Spinal Implants
11 10월 2023 - 10:00PM
SINTX Technologies, Inc. (www.sintx.com) (NASDAQ: SINT) (“SINTX” or
the “Company”), an original equipment manufacturer of advanced
ceramics, announced today it has been awarded a Phase II grant of
$1,972,826 by the National Institutes of Health (NIH) to develop a
3D printed (3DP) composite silicon nitride – polyetheretherketone
(SN-PEEK) spinal implant. This represents the fourth NIH grant
awarded to SINTX since the Phase I award for this project was
received in September of 2021.
Representing approximately 40% of spine implants
within the $10 billion global spine market, PEEK-based devices are
favored because of their proven clinical efficacy. Through the
development of 3DP SN-PEEK spinal implants, SINTX aims to combine
the familiarity and benefits of PEEK with the antibacterial and
osteoconductive characteristics of silicon nitride. These composite
implants will be manufactured with modern, cost-effective 3D
printing technologies.
“Our successful completion of Phase I aims has
shown the feasibility and reliability of 3DP SN-PEEK spinal
implants. These 3DP implants met minimum load thresholds in
accordance with established mechanical testing standards,
demonstrated basic biocompatibility, and resisted bacterial
adhesion. These findings established the foundation for this Phase
II Small Business Innovation Research (SBIR) award,” said Dr. Ryan
Bock, SINTX Vice President of Research and Development and
Principal Investigator for the project. “In Phase II, SINTX and
external collaborators will conduct formal design validation
activities; test static and dynamic mechanical properties of
implants 3DP according to the revised design; carry out formal
biocompatibility assessments; and assess in vivo antimicrobial
activity, biocompatibility, and osseointegration for a 3DP SN-PEEK
cervical implant against appropriate controls.”
SINTX will collaborate with the University of
Pennsylvania School of Veterinary Medicine (Penn Vet) over the next
24 months to execute this project. The NIH grant will support
resourcing and acquisition of materials as well as testing and
trials at SINTX and Penn Vet. Upon the successful execution of the
Phase II grant application goals, SINTX will have the majority of
the benchtop and large animal in vivo data needed to seek FDA
regulatory clearance using the 510(k) pathway. Additionally,
successful demonstration of infection prevention in vivo will be a
critical step towards enabling an antimicrobial device claim. These
preliminary animal data will be used to seek future funding from
NIH or other Federal agencies to further validate antimicrobial
properties of devices made from SN-PEEK.
“In the Phase I effort, Dr. Steven Kurtz of
Drexel University and Dr. Noreen Hickok of Thomas Jefferson
University were the lead university investigators while Dr. Thomas
Schaer of Penn Vet provided valued consultative support for study
and implant design. These scientists provided significant
contributions to the proposal, and we are grateful for their
continued support,” said Dr. Sonny Bal, President, and CEO. “Dr.
Schaer will be the lead investigator at Penn Vet while Drs. Kurtz
and Hickok will assume advisory roles on the project during
execution of Phase II activities. Since the NIH grant will fund the
acquisition of needed benchtop data and the first ever in vivo
performance data for SN-PEEK devices, the award represents a
critical milestone in expanding the antibacterial and
osseointegrative properties of silicon nitride into composite
structures. From a commercial standpoint, this NIH-funded project
is an important step in our strategy to introduce a new generation
of highly differentiated implants into the spine market.”
Research reported in the “3D Printed Silicon
Nitride Porous PEEK Composite Spinal Cages for Anti-Infection”
proposal was supported by the National Institute of Arthritis and
Musculoskeletal and Skin Diseases of the National Institutes of
Health under award number 2R44AR083836-02.
The content included in this release is solely
the responsibility of the authors and does not necessarily
represent the official views of the National Institutes of
Health.
About SINTX
Technologies, Inc.
SINTX Technologies is an advanced ceramics
company that develops and commercializes materials, components, and
technologies for medical and technical applications. SINTX is a
global leader in the research, development, and manufacturing of
silicon nitride, and its products have been implanted in humans
since 2008. Over the past two years, SINTX has utilized strategic
acquisitions and alliances to enter into new markets. The Company
has manufacturing facilities in Utah and Maryland.
For more information on SINTX Technologies or
its materials 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. Risks and uncertainties that may cause such
differences include, among other things: development of SN-PEEK
spinal implant products may take longer than expected and such
products may not prove to be as effective as other products
currently being commercialized or to be commercialized in the
future by competitors; risks inherent in manufacturing and scaling
up to commercial quantities while maintaining quality controls;
volatility in the price of SINTX’s common stock; the uncertainties
inherent in new product development, including the cost and time
required to commercialize such product(s); market acceptance of our
products once commercialized; SINTX’s ability to raise funding and
other competitive developments. 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. 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 29, 2023, 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.
Business and Media
Inquiries for
SINTX:SINTX Technologies
801.839.3502IR@sintx.com
Source: SINTX Technologies, Inc.
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