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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 5, 2026
Vivos
Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-39796 |
|
81-3224056 |
| (State
or other jurisdiction |
|
(Commission |
|
(I.R.S.
Employer |
| of
incorporation) |
|
File
Number) |
|
Identification
No.) |
7921
Southpark Plaza, Suite 210
Littleton,
Colorado 80120
(Address
of principal executive offices) (Zip Code)
(866)
908-4867
(Registrant’s
telephone number, including area code)
N/A
(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 $0.0001 per share |
|
VVOS |
|
The
NASDAQ Stock Market LLC |
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
7.01. Regulation FD Disclosure.
On
August 5, 2026, Vivos Therapeutics, Inc. issued a press release announcing the issuance of its new US Patent No. 12,697,190.
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.
The
information furnished pursuant to Item 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,
and shall not be deemed incorporated by reference into any filing under the Securities Act, or the Exchange Act, as amended, except as
expressly set forth by specific reference in such filing.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release, dated August 5, 2026. |
| |
|
|
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
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.
| VIVOS
THERAPEUTICS, INC. |
|
| |
|
| Dated:
August 11, 2026 |
By: |
/s/
R. Kirk Huntsman |
| |
Name: |
R.
Kirk Huntsman |
| |
Title: |
Chief
Executive Officer |
Exhibit 99.1
Vivos
Therapeutics Announces Issuance of New US Patent Broadening Protection for Its Vivos CARE Oral Medical Device Technology
Continuation
Patent Secures Broader, Design Independent Claims, Building on the Company’s 2024 Foundational Patent for Its Vibrational Oral
Appliance Platform
LITTLETON,
Colo., Aug. 05, 2026 (GLOBE NEWSWIRE) — Vivos Therapeutics, Inc. (“Vivos” or “the Company”) (NASDAQ: VVOS),
a leading medical device and healthcare services company focused on developing and commercializing innovative diagnostic and treatment
modalities for patients suffering from obstructive sleep apnea (“OSA”) and other sleep related breathing disorders, today
announced that the United States Patent and Trademark Office has issued US Patent No. 12,697,190 “Vibrational Oral Appliance with
Mandibular Advancements” (the “‘190 Patent”), a continuation of the Company’s previously issued US Patent
No. 12,048,608 (the “‘608 Patent”), issued July 30, 2024.
Taken
together, these two patents broaden the patent protections around Vivos’ proprietary line of oral medical devices known as Vivos
CARE devices. In 2023 and 2024, the FDA granted two separate and unprecedented 510K clearances for these devices to treat severe OSA
in adults and moderate to severe OSA in children (ages 6-17). To date, no other oral appliances have ever received such clearances from
the FDA. Studies have shown that approximately 80% of patients treated with Vivos CARE devices achieve significant reductions or complete
resolution of OSA symptoms (as measured by industry standard AHI scores).
Given
the recently discovered and documented increased mortality and health risks associated with CPAP, and the massive FDA-mandated recalls
of over 5 million CPAP units since 2021, the clinical and commercial market for a safe and highly effective alternative technology to
treat the more severe forms of OSA has never been brighter. The Company believes that broadening the patent protections afforded by this
new continuation patent will strengthen its industry-leading position and technological advantages.
The
newly issued ‘190 Patent broadens the scope of protection first established by the ‘608 Patent, giving Vivos layered, complementary
coverage over the underlying Vivos technology. The ‘608 Patent’s more detailed, structure-specific claims remain valuable
and in force, providing focused protection for that particular design embodiment. Together, the two patents give Vivos broad, difficult-to-design-around
protection and detailed, embodiment-specific protection over its core technology.
Commenting
on the newly issued patent, Vivos Chairman and CEO Kirk Huntsman stated, “We believe this new patent meaningfully strengthens our
intellectual property position around the technology at the heart of our most important and advanced product lines. Broader, more resilient
patent claims make it harder for competitors to design around our innovations, and they reflect the continued investment we’re
making in protecting the science behind better outcomes for patients suffering from OSA.”
More
than one billion people globally and up to 90 million Americans suffer from sleep apnea, 80 percent of whom remain undiagnosed. A serious
chronic illness, sleep apnea increases the risk of comorbidities, including high blood pressure, heart failure, stroke, diabetes, dementia,
chronic pain, fibromyalgia, and other life-threatening diseases.
About
Vivos Therapeutics, Inc.
Vivos
Therapeutics, Inc. (Nasdaq: VVOS) is a medical technology and healthcare services company focused on developing and commercializing innovative
diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities
such as obstructive sleep apnea (OSA) and snoring in adults. Vivos’ devices have been cleared by the U.S. Food and Drug Administration
(FDA) for adult patients diagnosed with all severity levels of OSA and moderate-to-severe OSA in children ages 6 to 17. Vivos’
groundbreaking Complete Airway Repositioning and Expansion (CARE) devices are the only FDA 510(k) cleared technology for treating
severe OSA in adults and the flagship DNA appliance is the first to receive clearance for treating moderate to severe OSA in children.
OSA
and insomnia affect over 1 Billion adults aged 30-69 years old worldwide, yet 80% or more remain undiagnosed and unaware of their condition.
These chronic disorders are not just a sleep issue-they are closely linked to many serious chronic health conditions. While the medical
community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood.
As a result, legacy OSA treatments like CPAP are often mechanistic and fail to address the root causes. Vivos CARE oral medical devices
target the underlying physiology and anatomical deficiencies that are often associated with OSA.
Through
innovative technology, education, and acquisitions of, or commercial collaborations with, sleep healthcare providers, Vivos is empowering
healthcare providers to address the complex needs of OSA patients more thoroughly.
Vivos
calls the use of its appliances and protocols to treat OSA The Vivos Method, which offers a proprietary, clinically effective
solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope to allow patients to Breathe New Life.
For
more information, visit www.vivos.com.
Cautionary
Note Regarding Forward Looking Statements
This
press release, including statements of the Company’s management and other parties made in connection therewith, contains “forward-looking
statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended) concerning future events. Words such as “may,” “would,” “should,” “expects,”
“projects,” “potential,” “intends,” “plans,” “believes,” “anticipates,”
“hopes,” “estimates,” “goal,” “aim,” and variations of such words and similar expressions
are intended to identify forward-looking statements. In this press release, forward-looking statements include, without limitation, statements
regarding: the scope, breadth, enforceability, and durability of the claims of the ‘190 Patent and the ‘608 Patent, and the
layered, complementary protection the two patents together are expected to provide; the extent to which the ‘190 Patent may make
it more difficult for competitors to design around the Company’s mandibular advancement technology; the potential for the patented
technology to promote jaw and palate development and to provide relief from breathing and sleep disorders, sleep apnea, and snoring;
the strengthening of the Company’s intellectual property position with respect to the technology underlying certain of the Company’s
product lines; the Company’s continued investment in protecting its intellectual property; and the potential impact of the foregoing
on the Company’s competitive position, product lines, revenues, and overall growth.
These
statements involve significant known and unknown risks and are based upon a number of assumptions and estimates that are inherently subject
to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results may differ materially and
adversely from those expressed or implied by such forward-looking statements as a result of various factors, including, but not limited
to: (i) the risk that the newly issued continuation patent described herein may be of limited practical value in terms of its ability
to protect the intellectual property and claims covered therein; (ii) the risk that the ‘190 Patent or the ‘608 Patent may
be challenged, invalidated, narrowed in scope, circumvented, or held unenforceable, or that the Company may not be successful in enforcing
or defending such patents against third parties; (iii) the risk that new or competing technology may limit or extinguish the new patent’s
economic value to the Company; (iv) the risk that Vivos may be unable to effectively market the products covered by the new patent or
otherwise implement strategies that increase revenues; (v) risks associated with regulatory scrutiny of, and adverse publicity in, the
sleep apnea and sleep disorder diagnosis and treatment sector; (vi) the risk that Vivos may be unable to secure additional financing
to continue operations, acquire or affiliate with additional sleep center practices, or maintain its Nasdaq listing, when needed, if
at all; (vii) market and other conditions that could impact Vivos’ business or ability to obtain financing; and (viii) other risk
factors described in Vivos’ filings with the Securities and Exchange Commission (the “SEC”), which are available free
of charge on the SEC’s website at www.sec.gov.
Except
to the extent required by law, Vivos expressly disclaims any obligation or undertaking to release publicly any updates or revisions to
any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change
in events, conditions, or circumstances on which any such statement is based.
Vivos
Investor Relations Contact:
Jennifer
Hauser, Executive Assistant to the CEO
jhauser@vivoslife.com
720-927-3125
