Form 8-K
8-K — Vivos Therapeutics, Inc.
Accession: 0001493152-26-028775
Filed: 2026-06-16
Period: 2026-06-15
CIK: 0001716166
SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)
Item: Entry into a Material Definitive Agreement
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — form8-k.htm (Primary)
EX-10.1 (ex10-1.htm)
EX-99.1 (ex99-1.htm)
XML — IDEA: XBRL DOCUMENT (R1.htm)
8-K
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0001716166
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2026-06-15
2026-06-15
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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
EX-10.1
EX-10.1
Filename: ex10-1.htm · Sequence: 2
Exhibit
10.1
COLLABORATION
AGREEMENT
This
Collaboration Agreement (this “Agreement”) is entered into as of June 9, 2026 (the “Effective Date”),
by and between Vivos Therapeutics, Inc., a Delaware corporation with principal offices at 7921 Southpark Plaza, Suite 210, Littleton,
CO 80120 (“Vivos”) and South Palm Cardiovascular Associates, LLC, a Florida limited liability company, with
principal offices at 2300 S. Congress Ave, Suite 105 Boynton Beach, FL 33426 (“SPCVA” and, together with Vivos, the
“Parties” and each individually a “Party”).
RECITALS
WHEREAS,
Vivos is a medical technology company focused on the development and commercialization of innovative treatments and diagnostics for sleep-disordered
breathing, including obstructive sleep apnea (“OSA”), among other related health conditions, and operates a network
of provider-facing management services organizations and clinical support platforms;
WHEREAS,
SPCVA is owned by board-certified cardiologists operating a multi-location private cardiology practice in the State of Florida
(the “SPCVA Physicians”);
WHEREAS,
the Parties desire to collaborate in the formation and operation of a new Arizona limited liability company to be known as AIM Florida,
LLC (the “Company”), which will function primarily as a management services organization (“MSO”)
providing administrative, operational, billing, payer contracting, marketing support, training, platform and data services, and other
non-clinical support services to one or more affiliated professional entities licensed to practice medicine and dentistry in Florida
(each, a “Clinical Entity”), which Clinical Entities will provide sleep apnea diagnostic and clinical treatment services
to patients in Palm Beach County, Florida metropolitan area (the “Territory”);
WHEREAS,
the organizational structure contemplated by the Parties envisions that (i) Vivos will hold not less than eighty percent (80%) and SPCVA
will hold up to (20%) of the membership interests in the Company, (ii) the Company will enter into management services agreements with
a medical entity (the “Medical Entity”) and a dental treatment entity (the “Dental Entity”), (iii)
the Medical Entity will employ nurse practitioners and/or physician assistants and hold payer contracts for the delivery of OSA medical
treatment services, (iv) the Dental Entity will employ dentists and support oral appliance therapy and durable medical equipment distribution,
(v) sleep disorder diagnostics will be provided by an independent diagnostic entity, and (vi) all referrals for services to Medical Entity
and Dental Entity shall be made by licensed providers exercising independent clinical judgment;
WHEREAS,
the Parties intend that the Company will be governed by a definitive Operating Agreement of AIM Florida, LLC (the “Definitive
Agreement”), substantially in the form currently being negotiated by the Parties, which will set forth the rights, obligations,
and governance structure of the members of the Company;
WHEREAS,
any SPCVA investment in the Company will be made at fair market value, and 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 patient referrals or other business generated between or among the Parties or any Clinical Entity;
WHEREAS,
the Parties acknowledge that because SPCVA is owned by licensed healthcare providers who are investing in an MSO that supports
entities providing clinical healthcare services, the arrangement must be structured in compliance with all applicable federal and state
healthcare regulatory requirements, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the physician self-referral
prohibition commonly known as the Stark Law (to the extent applicable), and Florida’s prohibitions on fee-splitting with unlicensed
persons; and
WHEREAS,
the Parties desire to enter into this Agreement to memorialize their mutual understanding and intent with respect to the formation, capitalization,
governance, and operation of the Company, to establish their respective obligations prior to the execution of the Definitive Agreement,
and to set forth certain terms and conditions governing their collaboration.
NOW,
THEREFORE, in consideration of the mutual covenants and agreements hereinafter set forth and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE
I — PURPOSE AND FORMATION OF THE COMPANY
Section
1.1 Formation. The Parties intend to cause the formation of the Company as a Florida limited liability company under the Florida
Limited Liability Company Act (the “Florida Act”) by filing Articles of Organization with the Florida Corporation
Commission. The Company shall be formed promptly following the execution of the Definitive Agreement, or at such earlier time as the
Parties may mutually agree in writing.
Section
1.2 Purpose of the Company. The Company will operate as an MSO providing non-clinical administrative, operational, technology,
marketing, billing, staffing, payer contracting, and management support services to the Clinical Entities pursuant to one or more written
management services agreements (each, an “MSA”).
Section
1.3 Clinical Entities. The Clinical Entities supported by the Company will be separately organized professional entities that
are appropriately owned and licensed in in compliance with Florida law. A medical Clinical Entity will employ nurse practitioners and/or
physician assistants and hold payer contracts for the delivery of OSA treatment services. A dental Clinical Entity will employ dentists
and will support oral appliance therapy and durable medical equipment distribution. All clinical decisions, patient care protocols, and
supervision of licensed providers shall remain exclusively within the authority of the Clinical Entities. All referrals for services
shall be made by licensed healthcare providers exercising independent medical judgment, and no referral shall be required, directed,
or incentivized by SPCVA, the Company, Vivos, or any term of this Agreement or the Definitive Agreement.
ARTICLE
II — OWNERSHIP AND CAPITAL CONTRIBUTIONS
Section
2.1 Membership Interests. The membership interests of the Company (each, a “Membership Interest”) shall
be allocated as follows:
(a) Vivos
shall hold not less than eighty percent (80%) of the outstanding Membership Interests; and
(b) SPCVA
shall hold up to twenty percent (20%) of the outstanding Membership Interests.
Section
2.2 Capital Contributions. Each Party shall make an initial capital contribution to the Company in proportion to its Membership
Interest, at a valuation that reflects the fair market value of such interest as of the date of contribution. The Parties intend to utilize
commercially reasonable methodology, consistent with applicable regulatory guidance, to establish fair market value. SPCVA capital
contribution shall not be conditioned upon, adjusted for, or otherwise tied to any past, present, or anticipated volume or value of referrals
or other business generated between the SPCVA Physicians and the Company or any Clinical Entity.
Section
2.3 No Referral-Based Consideration. The Parties expressly acknowledge and agree that the price paid by Cardiac Solutions
for its Membership Interest in the Company reflects fair market value determined without regard to the volume or value of any referrals
or other business that may be generated between the SPCVA Physicians, on the one hand, and the Company or any Clinical Entity,
on the other hand. No discount, premium, or other adjustment to SPCVA investment price or Membership Interest percentage shall
be made based on referral activity or clinical volume.
Section
2.4 Additional Capital Contributions. Additional capital contributions, if any, shall be made by the members in proportion
to their respective Membership Interests, as determined by the Manager from time to time in accordance with the terms of the Definitive
Agreement. The Definitive Agreement will include provisions addressing the consequences of a member’s failure to make a required
additional capital contribution, including the designation of such member as a “Non-Contributing Member” and the availability
of default loans by contributing members.
ARTICLE
III — DISTRIBUTIONS AND ECONOMIC RIGHTS
Section
3.1 Distributions Based Solely on Equity Interest. All distributions of cash or other property from the Company to its members
shall be made strictly in proportion to each member’s percentage Membership Interest in the Company: that is, not less than eighty
percent (80%) to Vivos and up to twenty percent (20%) to SPCVA. Under no circumstances shall distributions or any other economic
benefit from the Company be determined, in whole or in part, by reference to the volume or value of referrals, patient encounters, clinical
services rendered, or any other measure of healthcare business generated by or attributable to any member, the SPCVA Physicians,
or any affiliated person or entity.
Section
3.2 No Disguised Compensation. The Parties shall not structure or permit any payment, distribution, benefit, or other transfer
of value from the Company to Cardiac Solutions or the SPCVA Physicians that is conditioned upon, or varies with, referrals of
patients or healthcare business to any Clinical Entity, the Company, or any affiliate. Any management fees, expense reimbursements, or
other amounts payable by the Company shall be set in advance at fair market value for the services or items actually furnished, without
taking into account the volume or value of referrals.
Section
3.3 Timing and Discretion. Distributions of available cash shall be made at such times and in such amounts as determined by
the Manager in its sole discretion, subject to the Company’s obligation to make tax advance distributions to members as set forth
in the Definitive Agreement and subject to applicable restrictions under the Florida Act.
Section
3.4 Allocations of Income and Loss. Net income and net loss of the Company shall be allocated among the members pro rata in
accordance with their respective Membership Interests, subject to regulatory and special allocations required by the Treasury Regulations
under Internal Revenue Code Section 704(b), as set forth in the Definitive Agreement.
Section
3.5 Tax Treatment. The Company shall be treated as a partnership for federal, state, and local income tax purposes. Neither
the Company nor any member shall elect to classify the Company as other than a partnership pursuant to Treasury Regulations Section 301.7701-3.
Vivos shall serve as the initial Tax Matters Representative of the Company.
ARTICLE
IV — HEALTHCARE REGULATORY COMPLIANCE
Section
4.1 Anti-Kickback Statute Compliance. The Parties acknowledge that the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b))
(the “AKS”) prohibits the knowing and willful offer, payment, solicitation, or receipt of any remuneration to induce
or reward referrals of items or services payable by federal healthcare programs. The Parties intend that the structure of the Company,
including SPCVA’s investment, the allocation of Membership Interests, and the distribution of profits, will satisfy the
requirements of one or more applicable safe harbors under 42 C.F.R. § 1001.952, including, to the extent applicable, the investment
interest safe harbor set forth in 42 C.F.R. § 1001.952(a). The Parties shall cooperate in good faith to structure the Definitive
Agreement and the ongoing operations of the Company so as to meet the requirements of applicable safe harbors, including but not limited
to the following principles:
(a) Cardiac
Solutions’ investment terms, including the amount of its capital contribution, shall
be consistent with fair market value and shall not be determined in a manner that takes into
account the volume or value of referrals or other business generated by the SPCVA Physicians;
(b) Distributions
to SPCVA shall be proportional to its capital investment and Membership Interest percentage
and shall not be determined in a manner that takes into account the volume or value of referrals;
(c) SPCVA
shall not be required or expected, as a condition of its investment or continued membership,
to make or influence referrals to the Company, any Clinical Entity, or any other person or
entity; and
(d) The
Company shall not market or operate in a manner that targets patients of the SPCVA Physicians
based upon their insurance status or coverage by any federal healthcare program.
Section
4.2 Florida Corporate Practice of Medicine and Dentistry. The Parties acknowledge that Florida does not impose a statutory
prohibition on corporate entities employing or contracting with licensed physicians, and that non-physician-owned entities may generally
employ or engage physicians to deliver clinical services, provided that all licensed healthcare professionals retain exclusive authority
over clinical decision-making. The Company is originally intended to operate as an MSO and not to engage in activities that constitute
the practice of medicine or dentistry under Florida statutes. Unless otherwise agreed by the Parties, professional clinical services
shall be rendered by or under the supervision of licensed providers employed by or contracted with the Clinical Entities. The Company’s
MSAs with the Clinical Entities shall preserve the Clinical Entities’ exclusive authority over all clinical matters, including
without limitation decisions regarding diagnosis, treatment, and the supervision of clinical staff.
Section
4.3 Management Fee Structure. The management fees payable by the Clinical Entities to the Company under any MSA shall be set
at fair market value for legitimate management and administrative services actually rendered and shall not be structured as a disguised
division of professional fees for clinical services. The Parties agree that management fees may be structured on a fixed-fee basis, provided
that the fee arrangement (a) reflects fair market value for the services provided, (b) is commercially reasonable, (c) does not take
into account the volume or value of referrals between the parties, and (d) is consistent with applicable federal law, including the AKS
and applicable safe harbor requirements.
Section
4.4 Clinical Independence. Notwithstanding anything to the contrary in this Agreement or the Definitive Agreement, neither
the Company nor any member of the Company shall have the authority to direct, control, or interfere with the clinical judgment of any
licensed healthcare professional providing services through or on behalf of any Clinical Entity.
Section
4.5 No Referral Obligations. Nothing in this Agreement or the Definitive Agreement shall be construed to require, direct,
or incentivize any Party, the Cardiac Solutions Physicians, or any licensed healthcare provider to refer patients to a Clinical Entity,
or any other entity affiliated with the Company. All patient referral decisions shall be made solely by licensed healthcare providers
in the exercise of their independent medical or clinical judgment, consistent with applicable standards of care and applicable law.
Section
4.6 Ongoing Compliance Obligations. The Parties shall use commercially reasonable efforts to cause the Company to adopt and
maintain a compliance program appropriate to its operations, including policies and procedures designed to ensure ongoing compliance
with the AKS, applicable state self-referral and fee-splitting laws, and any other healthcare regulatory requirements applicable to the
Company’s operations. The Parties shall cooperate in obtaining such legal opinions, valuations, or regulatory guidance as may be
reasonably necessary to confirm the Company’s compliance posture.
ARTICLE
V — GOVERNANCE
Section
5.1 Management. The Company shall be manager-managed under the Florida Act. The initial manager of the Company (the “Manager”)
shall be Vivos Provider Network, LLC, a wholly owned subsidiary of Vivos. The Manager shall have full and complete power, authority,
and discretion to manage the business and affairs of the Company, subject to the protective provisions set forth below and in the Definitive
Agreement.
Section
5.2 Protective Provisions. The Definitive Agreement shall provide that the following actions require the prior written approval
of members holding at least sixty-five percent (65%) of the outstanding Membership Interests:
(a) Amendment
of the Articles of Organization or the Definitive Agreement;
(b) Issuance
of additional Membership Interests or admission of new members;
(c) Incurrence
of indebtedness (other than ordinary-course trade payables) exceeding $250,000 in a single
transaction or series of related transactions, or $750,000 in aggregate;
(d) Material
acquisitions or dispositions of assets exceeding $250,000;
(e) Mergers,
consolidations, dissolution, or liquidation of the Company; and
(f) Changes
to the Company’s auditors or accounting methods (other than as required by GAAP).
Section
5.3 Removal of Manager. The Manager may only be removed for Cause (as defined in the Definitive Agreement, to include fraud,
willful misconduct, gross negligence, felony conviction, material uncured breach, or conduct resulting in material regulatory sanctions)
by the approval of members holding at least seventy-five percent (75%) of the Membership Interests (excluding the Manager, if a member),
after written notice and a thirty (30)-day cure period.
Section
5.4 Replacement Manager Consent. For so long as Vivos (or its affiliates) holds at least fifty percent (50%) of the outstanding
Membership Interests, any replacement Manager shall require the consent of Vivos.
ARTICLE
VI — GOOD FAITH NEGOTIATIONS
Section
6.1 Good Faith Negotiation. The Parties shall negotiate in good faith to finalize and execute the Definitive Agreement and
all related ancillary documents (including the MSAs with the Clinical Entities) on terms consistent with the principles set forth in
this Agreement and the draft Operating Agreement currently under negotiation.
ARTICLE
VII — CONFIDENTIALITY
Section
7.1 Confidential Information. Each Party agrees that the terms of this Agreement and all non-public information exchanged
between the Parties in connection with the transactions contemplated herein, including business plans, financial statements, operating
practices, expansion plans, strategic plans, marketing plans, contracts, customer and patient lists, clinical protocols, pricing information,
intellectual property, and other business documents, in any format whatsoever (collectively, “Confidential Information”),
shall be maintained in strict confidence and shall not be disclosed to any third party without the prior written consent of the other
Party, except:
(a) to
such Party’s officers, directors, employees, attorneys, accountants, financial advisors,
and other representatives who have a need to know such information and who are bound by obligations
of confidentiality no less restrictive than those contained herein;
(b) as
required by applicable law, regulation, or legal process, provided that the receiving Party
provides prompt written notice to the disclosing Party to the extent legally permissible
and uses reasonable efforts to obtain confidential treatment; or
(c) as
permitted under Article VIII with respect to public announcements.
The
foregoing restrictions shall not apply to information that: (i) is or becomes generally available to the public other than as a result
of a disclosure by the receiving Party in violation of this Agreement; (ii) was independently developed by the receiving Party without
use of Confidential Information; or (iii) becomes available to the receiving Party from a source other than the disclosing Party, provided
that such source is not known to be bound by a confidentiality obligation.
Section
7.2 Securities Law Acknowledgment. Each Party acknowledges that the Confidential Information exchanged hereunder may constitute
material, non-public information under applicable United States securities laws. Each Party acknowledges that the common stock of Vivos
is traded on the Nasdaq Capital Market and that United States securities laws prohibit any person who has material, non-public information
about a company from purchasing or selling securities of such company, or from communicating such information to any other person under
circumstances in which it is reasonably foreseeable that such person is likely to purchase or sell such securities.
Section
7.3 Survival. This Article VII shall be binding upon the Parties and shall survive any termination of this Agreement for a
period of three (3) years.
ARTICLE
VIII — PUBLIC ANNOUNCEMENTS AND DISCLOSURE
Section
8.1 Announcements. Vivos anticipates issuing a press release or other public announcement regarding the collaboration contemplated
by this Agreement. Cardiac Solutions shall cooperate in good faith with Vivos in connection with its preparation of a press release that
describes the nature and purpose of their collaboration.
Section
8.2 SEC and Nasdaq Disclosure. Notwithstanding Section 8.1, Vivos may make such disclosures regarding this Agreement and the
transactions contemplated herein as Vivos determines in good faith are required by applicable securities laws, rules of the Securities
and Exchange Commission, or the listing requirements of the Nasdaq Capital Market, provided that Vivos shall use commercially reasonable
efforts to provide SPCVA with advance notice of and an opportunity to review any such disclosure.
ARTICLE
IX — TERM AND TERMINATION
Section
9.1 Termination. This Agreement shall terminate upon the earliest of:
(a) The
execution of the Definitive Agreement by the Parties;
(b) The
written notice from either Party to terminate after the first 90 days;
(c) Written
notice by either Party to the other that it no longer intends to proceed with the transactions
contemplated herein, provided that such notice may not be given until at least ninety (90)
days after execution of this Agreement, unless the other Party has materially breached a
binding provision of this Agreement and such breach remains uncured following thirty (30)
days’ written notice; or
(d) Written
notice by either Party to the other if, based on a written opinion of qualified healthcare
regulatory counsel, the transactions contemplated by this Agreement cannot be structured
in a manner that complies with applicable law, including the AKS and applicable Arizona healthcare
regulations.
Section
9.2 Survival. Upon termination or expiration of this Agreement, all rights and obligations of the Parties hereunder shall
terminate, except that: (a) Article VII (Confidentiality) and Article VIII (Public Announcements and Disclosure) shall survive in accordance
with their respective terms; (b) any liability for breach of a binding provision occurring prior to termination shall survive; and (c)
this Section 9.2 and Article X (Miscellaneous) shall survive termination.
ARTICLE
X — MISCELLANEOUS
Section
10.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Florida,
without giving effect to any choice of law or conflict of law provision that would cause the application of the laws of any other jurisdiction.
Section
10.2 Submission to Jurisdiction. Any suit, action, or proceeding arising out of or in connection with this Agreement shall
be brought in the United States District Court for the District of Florida or in the state courts of the State of Florida located in
Palm Beach County, Florida, and each Party hereby irrevocably submits to the exclusive jurisdiction of such courts.
Section
10.3 Expenses. Except as otherwise expressly provided herein, each Party shall bear its own costs and expenses, including
fees and disbursements of counsel, financial advisors, and accountants, incurred in connection with this Agreement and the transactions
contemplated hereby.
Section
10.4 Notices. All notices and other communications under this Agreement shall be in writing and shall be deemed given when
delivered personally, sent by nationally recognized overnight courier (receipt requested), addressed to the Parties at the addresses
set forth on the first page (or at such other address as a Party may designate by written notice):
Section
10.5 Entire Agreement. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter
hereof and supersedes all prior and contemporaneous understandings, agreements, representations, and warranties, whether written or oral,
with respect to such subject matter; provided, that this Agreement shall be superseded by the Definitive Agreement upon execution and
delivery thereof.
Section
10.6 Amendments. This Agreement may not be amended, modified, or supplemented except by a written instrument executed by both
Parties.
Section
10.7 Waiver. No waiver of any provision of this Agreement shall be effective unless in writing and signed by the Party against
whom such waiver is sought to be enforced. No failure or delay in exercising any right or remedy shall operate as a waiver thereof.
Section
10.8 Severability. If any term or provision of this Agreement is held to be invalid, illegal, or unenforceable under applicable
law, such invalidity shall not affect any other term or provision, and the Parties shall negotiate in good faith to modify this Agreement
so as to effect the original intent of the Parties as closely as possible.
Section
10.9 Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective
successors and permitted assigns. Neither Party may assign its rights or obligations under this Agreement without the prior written consent
of the other Party.
Section
10.10 Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original
and all of which together shall constitute one and the same instrument. Execution and delivery by electronic signature shall be deemed
an original execution for all purposes.
Section
10.11 No Third-Party Beneficiaries. This Agreement is for the sole benefit of the Parties and their respective successors
and permitted assigns, and nothing herein shall be construed to confer any rights or benefits upon any third party.
Section
10.12 Further Assurances. Each Party agrees to execute and deliver such additional documents, instruments, and assurances
and to take such further actions as may be reasonably required to carry out the provisions hereof and give effect to the transactions
contemplated hereby.
[SIGNATURE
PAGE FOLLOWS]
IN
WITNESS WHEREOF, the Parties hereto have caused this Collaboration Agreement to be executed as of the Effective Date by their respective
officers thereunto duly authorized.
VIVOS
THERAPEUTICS, INC.
By:
Name:
R.
Kirk Huntsman
Title:
Chief
Executive Officer
South
Palm Cardiovascular Associates, LLC
By:
Name:
Lyle
Silver
Title:
Administrative
Executive
EX-99.1
EX-99.1
Filename: ex99-1.htm · Sequence: 3
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
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