Vivos Therapeutics, Inc.

For the period ended Dec 31, 2024. Filed Mar 31, 2025.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Mar 31, 2025

VVOS$0.09-9.9%Stored close · as of Nov 10, 2026

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Contents

Summary of Material Risks Associated with our Business

The following is a summary of certain risks, uncertainties and other factors related to our company. These do not represent all of the risks we face. You should carefully consider all of the risk factors presented in “Item 1A. Risk Factors” (some of which are not summarized below) and all other information contained in this Report, including the financial statements which are a part of this Report, in order to a more complete picture of the risk factors we face.

Risks Related to Our Business and Industry

●	Our business has a limited operating history, and we continue to refine our business model, which makes it difficult to evaluate and compare our past performance with future prospects. Moreover, we have recently made significant strategic, operational and staffing changes to our business, and it is impossible to know how or if such changes will increase future revenue and earnings.
●	We have a history of operating losses and may never achieve cash flow positive or profitable results of operations.
●	We will need to raise additional capital to fund and grow our business. Such funding, even if obtained, could result in substantial dilution or significant debt service obligations. We may not be able to obtain additional capital on commercially reasonable terms in a timely manner, which could adversely affect our liquidity, financial position, and ability to continue operations.
●	We previously identified material weaknesses in our internal controls and may identify additional material weaknesses in the future or otherwise fail to operating effectiveness of our review controls, which may result in material misstatements of our consolidated financial statements or cause us to fail to meet our periodic reporting obligations.
●	We expect to derive a substantial portion of our prospective future revenue from sales of our appliances and treatments pursuant to our new strategic alliance and acquisition model, which leaves us reliant on the commercial viability of The Vivos Method and other associated products and services.
●	A material portion of our future revenue is expected to derive from sales of our appliances and other closely related diagnostic and therapeutic services to patients through dentists and other medical professionals, who are part of Dental Service Organizations (DSO) we may form and other Medical Service Organization (MSO), which leaves us reliant on our ability to establish, staff, and operate such operations successfully across diverse and geographically dispersed markets.
●	Our future operating results are difficult to predict and may vary significantly from quarter to quarter, which may adversely affect the price of our common stock.
●	We may not be able to respond in a timely and cost-effective manner to changes in consumer preferences.
●	Our business and results of operations may be impacted by the extent to which patients using The Vivos Method achieve adequate levels of third-party insurance reimbursement.
●	Our products and third-party contract manufacturing activities are subject to extensive governmental regulation that could prevent us from manufacturing or obtaining Vivos appliances or introducing new and/or improved products in the United States or internationally.
●	Our products are currently recommended only by a relatively small minority of medical sleep specialists, who are integral to the diagnosis and treatment of sleep breathing disorders.
●	We may not be able to protect our patents and proprietary technology and may become subject to intellectual property claims or litigation.
●	We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business.

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●	Our relationships with VIPs, other healthcare providers, and third-party payors will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied with such laws, we could face substantial penalties.
●	The misuse or off-label use of The Vivos Method or other Vivos products and services could result in injuries that lead to product liability suits or result in costly investigations, fines, or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
●	We have engaged in and will continue to pursue acquisitions of medical or dental practices or complementary businesses or technologies, which could divert the attention of management, and which may not be integrated successfully into our existing business.

Risks Related to Our Products and Regulation

●	We depend in large part on The Vivos Method technology, and the loss of regulatory approval or access to this technology would terminate or delay the further development of our products, injure our reputation or force us to pay higher fees.
●	Our failure to obtain government approvals, or to comply with ongoing, and ever increasing, governmental regulations relating to our technologies and products, could delay or limit introduction of our products and result in failure to achieve revenue or maintain our ongoing business.
●	We cannot assure that we will be able to complete any required clinical trial programs successfully within any specific time, and if such clinical trials take longer to complete than we project, our ability to execute our current business strategy will be adversely affected.
●	We are subject to regular periodic inspection and market surveillance by the FDA to determine compliance with regulatory requirements.
●	Treatment with The Vivos Method has only been available for the past fifteen years, and we do not know for certain whether there will be significant long term post-treatment regression or relapse.
●	Under our alliance marketing and distribution model, our M&A Group, formerly known as our Medical Integration Division, which will seek to acquire or create alliances with healthcare providers, may implicate federal and state laws involving the practice of medicine and related anti-kickback and similar laws.

Risks Related to Our Securities Generally

●	The market for our common stock is relatively new and may not develop to provide investors with adequate liquidity.
●	The market price of our common stock has been and may continue to be highly volatile, and you could lose all or part of your investment.
●	Our failure to meet the continuing listing requirements of The Nasdaq Capital Market could result in a de-listing of our securities.
●	If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares.
●	Actions of activist shareholders could be disruptive and potentially costly and the possibility that activist shareholders may seek changes that conflict with our strategic direction could cause uncertainty about the strategic direction of our business.
●	We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.
●	We continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
●	Certain provisions of our Certificate of Incorporation may make it more difficult for a third party to effect a change-of-control.
●	Our bylaws designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
●	Limitations on director and officer liability and indemnification of our officers and directors by us may discourage stockholders from bringing suit against an officer or director.
●	We are responsible for the indemnification of our officers and directors.
●	Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be limited, perhaps substantially.
●	The financial and operational projections that we may make from time to time are subject to inherent risks.
●	If we were to dissolve, the holders of our securities may lose all or substantial amounts of their investments.
●	An investment in our company may involve tax implications, and you are encouraged to consult your own advisors as neither we nor any related party is offering any tax assurances or guidance regarding our company or your investment.
●	Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
●	If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they change their recommendations regarding our common stock adversely, the price of our common stock and trading volume could decline.

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