Form 8-K

8-K — Vivos Therapeutics, Inc.

Accession: 0001493152-26-037173

Filed: 2026-08-11

Period: 2026-08-05

CIK: 0001716166

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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EX-99.1 (ex99-1.htm)

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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

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 ☐

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.

August 5, 2026, Vivos Therapeutics, Inc. issued a press release announcing the issuance of its new US Patent No. 12,697,190.

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:

Kirk Huntsman

Title:

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

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.”

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

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