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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): October 11, 2023
SINTX
Technologies, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-33624 |
|
84-1375299 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
1885
West 2100 South
Salt
Lake City, UT 84119
(Address
of principal executive offices, including Zip Code)
Registrant’s
telephone number, including area code: (801) 839-3500
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class: |
|
Trading
Symbol(s): |
|
Name
of each exchange on which registered: |
Common
Stock, par value $0.01 per share |
|
SINT |
|
The
NASDAQ Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
8.01 Other Events.
On
October 11, 2023, the Company issued a press release announcing the award of an NIH grant. A copy of the press release is attached
as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
|
|
SINTX
Technologies, Inc. |
|
|
|
|
|
Date: |
October
11, 2023 |
|
By: |
/s/
B. Sonny Bal |
|
|
|
|
B.
Sonny Bal |
|
|
|
|
Chief
Executive Officer |
Exhibit
99.1
SINTX
Technologies Awarded Phase II NIH Grant for Silicon Nitride-PEEK 3D Printed Composite Spinal Implants
SALT
LAKE CITY, October 11, 2023 (GLOBE NEWSWIRE) — 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 801.839.3502
IR@sintx.com
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