Vivos Therapeutics Inc

For the period ended Dec 31, 2023. Filed Mar 28, 2024.

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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.

FY2023 · Filed Mar 28, 2024

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 our past performance and 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 affect future revenue and earnings.
●	We have a history of operating losses and may never achieve cash flow positive or profitable results of operations.
●	Our VIP program is a relatively new business model for us, and management has limited experience operating this model.

●	We will need to raise additional capital to bolster our stockholders’ equity and 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 have identified material weaknesses in our internal control over financial reporting.
●	A material portion of our future revenue is expected to derive from sales and enrollments of new dentists into our VIP, including dentists who are part of a dental service organization (“DSO”), which leaves us reliant on the willingness of dentists and/or DSO groups to continue to enroll.
●	We face risks from negative publicity from unregistered oral appliances which has and may continue to hurt our sales.
●	The failure to expand our market penetration with DME distribution agreements would adversely affect our revenue and results of operations.
●	We will not be successful if The Vivos Method is not sufficiently adopted by the medical and dental communities, including independent practitioners and dental service organizations.
●	We may not be able to successfully implement our growth strategies for our VIPs, which could harm our business, financial condition and results of operations.
●	The long-term success of our VIP program is highly dependent on our ability to successfully identify, recruit and enroll target dental practices as well as to convince other medical professionals to participate in the treatment of OSA with our products and services.
●	The SleepImage® home sleep test used in our VivoScore Program is a relatively new technology which may not be utilized by VIPs to the degree anticipated.
●	Further clinical studies of our products comprising The Vivos Method may adversely impact our ability to generate revenue if they do not demonstrate that The Vivos Method is effective.
●	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.

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●	Our products and third-party contract manufacturing activities are subject to extensive governmental regulation that could prevent us from selling Vivos appliances or introducing new and/or improved products in the United States or internationally.
●	We face significant competition in the market for treating sleep breathing disorders, and we may be unable to manage or respond to competitive pressures.
●	The misuse or off-label use of The Vivos Method 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.

Risks Related to Our Products and Regulation

●	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.
●	Modifications to The Vivos Method may require additional FDA approvals which, if not obtained, could force us to cease marketing and/or recall the modified device until we obtain new approvals.
●	We are subject to inspection and market surveillance by the FDA to determine compliance with regulatory requirements.
●	Treatment with The Vivos Method has only been available for a relatively limited time, and we do not know whether there will be significant post-treatment regression or relapse.
●	Our Medical Integration Division business line 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, resulting in substantial losses for investors.
●	We are presently subject to potential delisting from Nasdaq, and our failure to meet and maintain the continuing listing requirements of The Nasdaq Capital Market could result in the delisting of our securities.
●	The terms of our November 2023 private placement and February 2024 warrant exercise transaction could hamper our fundraising efforts.

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