Form 8-K
8-K — Sintx Technologies, Inc.
Accession: 0001493152-26-037130
Filed: 2026-08-11
Period: 2026-08-11
CIK: 0001269026
SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)
Item: Results of Operations and Financial Condition
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
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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): August 11, 2026
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
2.02 Results of Operations and Financial Condition.
On
August 11, 2026, SINTX Technologies, Inc. (the “Company”) issued a press release providing a business update in connection
with the filing of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, including certain information regarding the
Company’s results of operations, financial condition and revenue outlook. A copy of the press release is furnished as Exhibit 99.1
to this Current Report on Form 8-K and is incorporated herein by reference.
Item
7.01. Regulation FD Disclosure.
The
information contained in the press release furnished as Exhibit 99.1 also includes updates regarding the Company’s commercialization
activities, customer purchase orders, product-development programs, strategic initiatives and other business matters.
The
information furnished pursuant to Items 2.02 and 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed
“filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities
of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as
amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item
9.01 Financial Statements and Exhibits.
Exhibit
No.
Description
99.1
Press Release dated August 11, 2026
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
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:
August
11, 2026
By:
/s/
Eric K. Olson
Eric
K. Olson
Chief
Executive Officer
EX-99.1
EX-99.1
Filename: ex99-1.htm · Sequence: 2
Exhibit
99.1
SINTX
Technologies Provides Mid-Year 2026 Business Update Highlighting Commercial Execution, Biomaterial Platform Expansion and Strategic Growth
Initiatives
SALT
LAKE CITY, Utah – August 11, 2026 – SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”),
a leader in advanced silicon nitride biomaterials and ceramics for medical and industrial applications, today provided a business update
in conjunction with the filing of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026.
During
the first half of 2026, SINTX advanced the commercialization of its FDA-cleared SiNAPTIC® Foot & Ankle Implant System,
expanded its commercial distribution network, raised additional capital, invested in advanced manufacturing capabilities, and continued
to broaden the application of its proprietary silicon nitride technology platform across multiple healthcare and industrial markets.
These
accomplishments reflect the Company’s strategic transition from technology development toward commercial execution while continuing
to build a diversified portfolio of growth opportunities designed to create long-term shareholder value.
“Our
strategy has always extended well beyond the introduction of a single medical device,” said Eric K. Olson, Chairman, President
and Chief Executive Officer of SINTX Technologies. “During the first half of 2026, we continued building the commercial infrastructure,
manufacturing capabilities, and strategic relationships necessary to support our growth strategy, while raising additional capital and
implementing measures designed to preserve liquidity and improve operating efficiency. We believe silicon nitride represents a differentiated
technology platform with the potential to address multiple high-value healthcare and industrial markets, and we remain focused on translating
these investments into increasing commercial adoption, expanding revenue opportunities and potential long-term value creation.”
Commercial
Execution Accelerates
Following
FDA 510(k) clearance in October 2025, SINTX initiated a Limited Use Release (“LUR”) of its SiNAPTIC® Foot
& Ankle Osteotomy Wedge System during the first half of 2026. The LUR is intended to support surgeon training, clinical adoption
and commercialization ahead of broader market expansion.
To
support this commercialization effort, the Company established its initial network of twelve independent orthopedic distributors specializing
in foot and ankle surgery. As surgeon adoption continues to expand, SINTX expects this commercial infrastructure to support broader market
penetration throughout the United States.
The
Company believes SiNAPTIC’s proprietary silicon nitride biomaterial offers meaningful clinical differentiation through its demonstrated
bone affinity and inherent resistance to bacterial adhesion, characteristics that position the platform for potential expansion into
additional orthopedic applications.
Multiple
Revenue Opportunities Continue to Expand
While
advancing commercialization of its medical technologies, SINTX continued to expand its established industrial ceramics business.
During
the first half of 2026, the Company received approximately $3.2 million in new industrial purchase orders from multiple contract manufacturing
customers for the production of advanced ceramic components serving demanding, high-performance applications. Initial shipments have
commenced, and the Company currently expects to recognize revenue associated with these purchase orders beginning in the third quarter
of 2026, subject to delivery schedules, customer acceptance and applicable revenue-recognition requirements.
Management
believes the industrial business provides an important commercial foundation that supports continued investment in higher-growth medical
technologies while diversifying the Company’s revenue base.
Revenue
Outlook for the Second Half of 2026
Reflecting
increased commercial activity and the commencement of production and shipments associated with previously announced customer purchase
orders, SINTX currently expects total revenue to be approximately $900,000 to $1.1 million for the third quarter of 2026 and approximately
$1.0 million to $1.3 million for the fourth quarter of 2026.
This
outlook is based on current production schedules, customer requirements and management’s expectations regarding manufacturing execution,
shipments and the timing of revenue recognition. The Company’s outlook is subject to significant uncertainty, including potential
changes in customer schedules, material availability, manufacturing yield and capacity, quality release, shipment timing, customer acceptance
and product mix. Accordingly, actual results could differ materially from these expectations.
The
Company continues to view the approximately $3.2 million of previously announced industrial purchase orders as an important source of
commercial visibility, while recognizing that purchase-order value does not represent guaranteed revenue and that the timing of revenue
recognition will depend on successful execution and satisfaction of applicable accounting criteria.
Beyond
its existing commercial businesses, SINTX continues to expand the potential applications of its silicon nitride technology platform through
multiple product development initiatives, including silicon nitride-infused sutures, advanced wound care products, SiN/PEEK composite
implants, and other next-generation orthopedic technologies.
Animal
studies evaluating the Company’s antipathogenic suture and wound care technologies are currently scheduled to begin during the
third quarter of 2026, with preliminary data expected to be available for potential licensing partners before year-end, subject to
study initiation, execution and timing.
Advanced
Manufacturing Platform Supports Future Growth
During
the first half of 2026, SINTX completed construction of its advanced 3D printing manufacturing facility intended to support the future
production of SiNERGY™ patient-specific and custom silicon nitride/PEEK orthopedic implants.
The
new manufacturing capability expands the Company’s vertically integrated production platform while positioning SINTX to pursue
future opportunities in personalized orthopedic reconstruction and other high-value medical applications.
The
Company also continues to advance development of porous silicon nitride/PEEK spinal fusion implants through its National Institutes of
Health (“NIH”) research grant. Recently, SINTX received notice from the NIH granting SINTX an additional twelve-month
period to access the approximately $745,000 remaining on the final phase of its $1.97 million NIH grant, further supporting development
of next-generation spinal implant technologies.
Capital
Resources and Cost Management Initiatives
During
the second quarter, SINTX completed financing transactions that generated approximately $5.0 million in gross proceeds, consisting primarily
of a private placement and sales under its existing At-The-Market (“ATM”) facility.
The
proceeds provided additional capital to support the Company’s commercialization activities, manufacturing operations, product development
initiatives and general corporate purposes. The Company also continues to have additional capacity available under its existing ATM facility,
subject to market conditions, applicable securities-law requirements and the terms of the program.
SINTX
continues to manage its liquidity carefully. In parallel with its commercialization and development activities, management has initiated
a capital allocation and cost optimization initiative focused on improving operating efficiency, reducing discretionary spending and
prioritizing expenditures that management believes are most directly related to commercialization and revenue generation.
The
Company’s ability to execute its business plan remains dependent on its ability to manage operating expenses, increase revenue
and obtain additional financing when needed. Management believes that disciplined capital allocation and cost management are important
to preserving liquidity and supporting the Company’s highest-priority commercial and development programs.
Strategic
Platform Continues to Attract Industry Interest
Recognizing
the expanding commercial opportunities surrounding its silicon nitride technology platform, SINTX recently engaged Chris Lyons of Southern
Metrics to coordinate and evaluate inbound strategic opportunities involving potential commercial partnerships, licensing relationships
and other business development initiatives.
The
Company believes strategic collaborations represent an important opportunity to accelerate commercialization while leveraging its intellectual
property portfolio across multiple healthcare and industrial markets.
Expanded
Equity Research Coverage
During
the first half of 2026, H.C. Wainwright & Co. and Maxim Group initiated equity research coverage of SINTX with Buy ratings. The Company
believes broader research coverage may increase investor awareness of its differentiated technology platform, commercialization strategy
and long-term growth opportunities.
Looking
Ahead
Management
believes the first half of 2026 established several important building blocks for the Company’s next phase of growth, including
commercialization of the SiNAPTIC platform, expansion of its commercial distribution network, investment in advanced manufacturing capabilities,
continued development of next-generation silicon nitride technologies, raising additional capital and implementing capital-allocation
and cost-management initiatives.
With
multiple commercial and development programs advancing simultaneously, SINTX believes its proprietary silicon nitride technology platform
will provide opportunities across orthopedic implants, industrial ceramics, personalized medical devices, silicon nitride/PEEK composites
and antipathogenic medical products.
About
SINTX
Headquartered
in Salt Lake City, Utah, SINTX Technologies, Inc. (NASDAQ: SINT) is an advanced ceramics company that develops, manufactures, and commercializes
silicon nitride biomaterials, composites, devices, and related technologies for medical and other high-value applications. SINTX’s
technologies are supported by peer-reviewed research, a patent portfolio, U.S.-based manufacturing capabilities and strategic industry
relationships. The Company’s business includes proprietary biomaterials and medical device technologies, as well as contract manufacturing
and other advanced ceramics opportunities. SINTX’s product portfolio includes the FDA-cleared SiNAPTIC® Foot &
Ankle Osteotomy Wedge System for reconstructive surgery.
NIH
Funding Acknowledgment: Research described in this press release relating to the Company’s 3D-printed silicon nitride porous
PEEK composite spinal cage program is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National
Institutes of Health under Award Number R44AR083836. The content is solely the responsibility of SINTX Technologies, Inc. and does not
necessarily represent the official views of the National Institutes of Health.
Forward-Looking
Statements
This
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including
statements regarding: the commercialization, market introduction and potential adoption of the SiNAPTIC® Foot & Ankle Osteotomy
Wedge System; the expansion and effectiveness of the Company’s distributor network; the clinical and commercial potential of silicon
nitride and the possible expansion of the Company’s technology into additional medical and industrial applications; anticipated
shipments and the timing and amount of revenue recognition associated with industrial purchase orders; the Company’s revenue guidance
and expectations regarding the amount and timing of revenue for the third and fourth quarters of 2026; the timing, conduct and results
of animal studies and other research and development activities; the availability of preliminary data to potential licensing or strategic
partners; the capabilities and potential commercial applications of the Company’s advanced manufacturing platform; the development
of patient-specific, custom and silicon nitride/PEEK implants; the identification, evaluation and consummation of potential commercial
partnerships, licensing arrangements, strategic investments, acquisitions, divestitures or other strategic transactions; the Company’s
liquidity, capital requirements, cost-management initiatives, ability to preserve liquidity, and ability to obtain additional financing;
and the Company’s growth prospects and ability to create long-term shareholder value. These forward-looking statements are based
on management’s current expectations, estimates, projections and assumptions and are subject to significant risks and uncertainties
that could cause actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking
statements. These risks and uncertainties include, among others: the Company’s ability to successfully commercialize its products
and achieve market acceptance; the timing and results of product development, preclinical and clinical activities; the performance of
distributors, suppliers and manufacturing operations; changes in customer demand, purchase orders, shipment schedules or customer acceptance;
the Company’s ability to recognize anticipated revenue; the Company’s limited liquidity and history of operating losses;
its need to obtain additional financing to continue operations and execute its business plan; the availability, timing and terms of any
additional financing; potential dilution resulting from equity financings; the Company’s ability to maintain an effective registration
statement and satisfy the conditions for sales under its ATM offering program; and substantial doubt regarding the Company’s ability
to continue as a going concern; and the other risks described under “Risk Factors” in the Company’s most recent Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q, and in the Company’s other filings with the U.S. Securities and Exchange
Commission. SINTX undertakes no obligation to update forward-looking statements except as required by law.
SINTX
Contacts:
Investor
Relations
Gregg
Honigblum, Chief Investment Officer
P:
801-839-3502
E:
IR@sintx.com
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