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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): June 15, 2026 (June 10, 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 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
1.01. Entry into a Material Definitive Agreement.
On
June 10, 2026, Vivos Therapeutics, Inc. (the “Company”) entered into a Collaboration Agreement (the “Collaboration
Agreement”) with South Palm Cardiovascular Associates, LLC, a Florida limited liability company (“SPCVA”), pursuant
to which the parties agreed to collaborate in the formation and operation of a new management services organization to be known as AIM
Florida, LLC (“AIM Florida”). AIM Florida is intended to provide administrative, operational, billing, payer-contracting,
marketing, platform, data and other non-clinical support services to one or more affiliated professional clinical entities that will
deliver sleep apnea diagnostic and treatment services to patients, with the collaboration initially focused on the Palm Beach County,
Florida market.
Under
the Collaboration Agreement, the Company expects to hold not less than 80% of the membership interests in AIM Florida, and SPCVA expects
to hold up to 20% of the membership interests, in each case subject to the negotiation and execution of definitive documentation and
applicable regulatory requirements. AIM Florida is to be governed by a definitive operating agreement currently being negotiated by the
parties (the “Definitive Agreement”), and the Company’s wholly owned subsidiary, Vivos Provider Network, LLC, is contemplated
to serve as the initial manager of AIM Florida. The Collaboration Agreement provides that SPCVA’s investment will be made at fair
market value and that all distributions of available cash and allocations of income and loss will be made solely in proportion to each
member’s membership interest percentage, without regard to the volume or value of any patient referrals or other business generated
among the parties. The Collaboration Agreement contains customary provisions for an arrangement of this type.
The
foregoing description of the Collaboration Agreement does not purport to be complete and is qualified in its entirety by reference to
the full text of the Collaboration Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated
herein by reference.
Item
7.01. Regulation FD Disclosure.
On
June 10, 2026, the Company issued a press release announcing the Collaboration Agreement and the contemplated collaboration with SPCVA.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The
information contained in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject
to the liabilities of that Section, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933,
as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.
Cautionary
Note Regarding Forward-Looking Statements
This
Current Report on Form 8-K contains “forward-looking statements” within the meaning of the federal securities laws, including
statements regarding the Collaboration Agreement and the contemplated formation, capitalization, governance and operation of AIM Florida;
the Company’s and SPCVA’s expected membership interests in AIM Florida; the negotiation and execution of the Definitive Agreement
and related ancillary documents, including management services agreements with affiliated clinical entities; the anticipated scope, scalability
and regulatory compliance of the collaboration; and the expected strategic, operational and financial benefits of the collaboration.
These statements are based on current expectations and assumptions and are subject to risks and uncertainties, many of which are beyond
the Company’s control, including the risk that the parties may be unable to finalize definitive agreements on acceptable terms,
in a timely manner or at all; that AIM Florida may not be formed, capitalized, governed or operated as contemplated; that the collaboration
may be subject to regulatory, compliance, reimbursement or operational challenges; and that the collaboration may not achieve the anticipated
revenue, contribution margins, profitability or scalability. Actual results may differ materially from those expressed or implied by
these forward-looking statements. Additional information regarding factors that may cause actual results to differ materially is included
under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025,
and in the Company’s subsequent filings with the Securities and Exchange Commission. Except as required by applicable law, the
Company undertakes no obligation to publicly update or revise any forward-looking statements.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 10.1 |
|
Collaboration Agreement, dated as of June 10, 2026, by and between Vivos Therapeutics, Inc. and South Palm Cardiovascular Associates, LLC. |
| |
|
|
| 99.1 |
|
Press Release of Vivos Therapeutics, Inc., dated June 10, 2026 (furnished pursuant to Item 7.01). |
| |
|
|
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document). |
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. |
| |
|
|
| Date:
June 15, 2026 |
By: |
/s/
R. Kirk Huntsman |
| |
Name: |
R.
Kirk Huntsman |
| |
Title: |
Chairman
and Chief Executive Officer |
Exhibit
99.1
Vivos
Therapeutics Announces Key Collaboration Agreement with Multi-Location Florida Cardiology Group to Extend Much Needed Sleep Apnea and
Insomnia Diagnosis and Treatment to Cardiovascular Patients
LITTLETON,
Colo., June 10, 2026 - Vivos Therapeutics, Inc. (“Vivos” or the “Company”) (NASDAQ: VVOS), a leading medical
device and healthcare services company focused on the treatment of breathing-related sleep disorders and associated chronic health conditions,
including obstructive sleep apnea (“OSA”) and insomnia, today announced that it has entered into a collaboration agreement
with South Palm Cardiovascular Associates, LLC (“SPCVA”), a growing Florida-based cardiology practice with approximately 30,000 patients
of record, to support the formation and operation of AIM Florida, LLC (“AIM Florida”), a physician-aligned management services
organization intended to expand access to integrated diagnostic and therapeutic clinical treatment services for cardiovascular disease
(“CVD”) patients in Florida who also suffer from OSA and insomnia.
R.
Kirk Huntsman, Chairman and Chief Executive Officer of Vivos said, “We believe this key collaboration agreement with SPCVA represents
a unique and highly profitable model for creating additional such relationships across multiple medical specialties throughout the country.
It is based on our current successful model that we have established as a result of our 2025 acquisition of Sleep Centers of Nevada.
The key difference here is that we are partnering directly with the medical community without incurring the significant capital outlays
required in an acquisition. By creating a true collaboration with fully aligned interests, all parties expect to raise the standard of
care for patients who suffer from both OSA and CVD. By aligning our technology and services platform with an experienced Florida cardiology
group, we believe AIM Florida can create a scalable, compliant model for expanding access to comprehensive sleep and breathing health
solutions throughout the state of Florida, and eventually to the more than 2,500 similar cardiology groups throughout the country.”
The
collaboration will address the key concerns that SPCVA cardiologists have experienced with patients who have some form of CVD along with
OSA. Obstructive sleep apnea is independently associated with an increased risk of cardiovascular events and all-cause mortality, particularly
among patients with moderate-to-severe disease. Moreover, SPCVA cardiologists report that obtaining timely diagnosis and treatment for
these patients has been a longstanding concern, consistent with a recognized national shortage of board-certified sleep medicine specialists.
Vivos expects to hold not less than 80% of the membership interests in AIM Florida, with SPCVA holding up to 20%, subject to definitive
documentation and applicable regulatory requirements. SPCVA is owned by board-certified cardiologists operating a multi-location private
cardiology practice in Florida. The parties intend for the collaboration to initially focus on patients in the Palm Beach County, Florida
market, with the goal of helping identify, diagnose and support treatment of OSA and other sleep-disordered breathing conditions that
are often associated with serious cardiometabolic and chronic health conditions.
Based
on its experience in Las Vegas, Vivos believes the AIM Florida model, when fully established, will contribute to the Company’s
cash flow and profitability. The operating plan calls for the initial establishment of one fully staffed Sleep Optimization Team capable
of serving roughly 250 patients per month and generating in excess of $6,000,000 per year with contribution margins approaching 50% once
fully deployed. Additional teams can be added to meet the expected growing demand over time. SPCVA physicians have expressed a desire
to assist AIM Florida in expanding to other Florida communities and among other cardiology and specialty medical practices. The Company
expects that collaborations with additional physician groups and sleep healthcare providers can help broaden patient access to diagnostics
and treatment while supporting Vivos’ long-term commercial growth strategy.
The
collaboration is intended to operate in compliance with applicable federal and state healthcare laws, including the federal Anti-Kickback
Statute, physician self-referral rules to the extent applicable, and Florida healthcare regulatory requirements. Under the Agreement,
all clinical decisions, patient care protocols, supervision of licensed providers and referral decisions will remain exclusively within
the authority of licensed healthcare professionals and will not be directed, controlled or incentivized by Vivos, AIM Florida, SPCVA
or any other non-clinical party.
The
parties anticipate negotiating and executing definitive agreements and related ancillary documents, including management services agreements
with affiliated clinical entities. Until then, there can be no assurance that the contemplated definitive agreements will be completed
on the expected timeline or at all, and even if completed, that the terms therein would be construed as favorable to the Company, that
AIM Florida will be formed or commence operations as anticipated, or that the collaboration will generate any particular revenue, cash
flow or other operating results.
This
press release is being issued for informational purposes only and does not constitute an offer to sell or the solicitation of an offer
to buy any securities. Any securities offering, if undertaken, will be made only pursuant to applicable securities laws and definitive
offering documents.
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 first to receive clearance for treating moderate to severe OSA in children.
OSA
affects over 1 billion people worldwide, yet 80% or more remain undiagnosed and unaware of their condition. This chronic disorder is
not just a sleep issue - it is 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 of OSA.
Founded
in 2016 and based in Littleton, Colorado, Vivos is working to change this. 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
Forward-looking
statements in this press release include, without limitation, statements regarding: the Company’s collaboration agreement with
SPCVA and the contemplated formation, capitalization, governance and operation of AIM Florida; the Company’s expected ownership
of not less than 80% of the membership interests in AIM Florida, with SPCVA holding up to 20%; the negotiation and execution of definitive
agreements and related ancillary documents, including management services agreements with affiliated clinical entities; the anticipated
scope, scalability and regulatory compliance of the collaboration’s clinical and management services model; the expected establishment
of one or more Sleep Optimization Teams and their anticipated revenue-generating capacity and contribution margins; the potential expansion
of the model to additional patients, communities, medical specialties and physician groups within Florida and nationally; and the expected
strategic, operational and financial benefits of the collaboration, including its anticipated contribution to the Company’s cash
flow, profitability and long-term commercial growth strategy.
These
forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties, many of which
are beyond the Company’s control. Such risks and uncertainties include, without limitation: the risk that Vivos and SPCVA may be
unable to finalize definitive agreements or ancillary documents on acceptable terms, in a timely manner or at all; the risk that AIM
Florida may not be formed, capitalized, governed or operated as contemplated; the risk that Vivos may be unable to benefit fully or at
all from the collaboration, even if the contemplated arrangements are consummated; the risk that the Company’s collaboration model,
management services arrangements or related clinical entities may not operate as expected or may be subject to regulatory, compliance,
reimbursement or operational challenges; the risk that the AIM Florida model does not achieve the anticipated revenue, contribution margins
or profitability, or does not scale to additional patients, communities or physician groups; the risk that Vivos may be unable to implement
revenue, sales and marketing strategies and other strategies that increase revenues; the risk that some patients may not achieve the
desired results from using Vivos products; risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea treatment
sector; the Company’s ability to access capital on acceptable terms or at all, and to maintain its Nasdaq listing, including due
to any deficiency in its stockholders’ equity; and general economic, market and interest rate conditions.
Actual
results may differ materially from those expressed or implied by these forward-looking statements. Additional information regarding factors
that may cause actual results to differ materially is included under the heading “Risk Factors” in the Company’s Annual
Report on Form 10-K for the year ended December 31, 2025, when filed, and in the Company’s subsequent Quarterly Reports on Form
10-Q and other filings with the Securities and Exchange Commission, which may be obtained free of charge at https://vivos.com/investors/sec-filings/.
Except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statements
to reflect events or circumstances after the date of this press release.
Vivos
Investor Relations and Media Contact:
Jennifer
Hauser
Investor
Relations Contact
investors@vivoslife.com
