Vivos Therapeutics (VVOS) risk factors, FY2025 10-K

Risks Related to Our Business and Industry

1. 01We have a history of operating losses and may never achieve cash flow positive or profitable results of operations
2. 02In summary, as of December 31, 2022 we identified material weaknesses related to the operating effectiveness of our review controls in that we did not put the appropriate resources in place to be able to identify and account for technical accounting issues and perform review functions appropriately51% rewritten
3. 03We expect to derive a substantial portion of our prospective future revenue from sales of our appliances and treatment pursuant to our new strategic alliance and acquisition models, which leaves us reliant on the commercial viability of The Vivos Method and other associated products and services
4. 04Our 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
5. 05We may not be able to respond in a timely and cost-effective manner to changes in consumer preferences
6. 06Whenever practical, The Vivos Method is paid for primarily out-of-pocket by patients, with any available health insurance coverage being reimbursed if and as paid at a later date, where the patient is being treated for dentofacial abnormalities and/or mild to severe OSA55% rewritten
7. 07Our 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 internationally46% rewritten
8. 08We may not be able to protect our patents and proprietary technology and may become subject to intellectual property claims or litigation
9. 09We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business
10. 10Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws
11. 11We have engaged in and will continue to pursue acquisitions of, or affiliations with, 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
12. 12We could be subject to lawsuits for which we are not fully insured
13. 13We depend on certain key personnel
14. 14Members of our board of directors and our executive officers will have other business interests and obligations to other entities
15. 15We will need to carefully manage our expanding operations to achieve sustainable growth
16. 16We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery and anti-kickback laws with respect to our activities outside the United States

Risks Related to Our Products and Regulation

1. 17We 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
2. 18Our failure to obtain government approvals, including required FDA 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
3. 19We cannot assure that we will be able to complete any required clinical trial programs successfully within any specific time period, and if such clinical trials take longer to complete than we project, our ability to execute our current business strategy will be adversely affected
4. 20The results of our clinical trials may not support either further clinical development or the commercialization of any new product candidates or modifications to existing products
5. 21Modifications to appliances within 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
6. 22We are subject to regular inspection and market surveillance by the FDA to determine compliance with regulatory requirements33% rewritten
7. 23Treatment 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
8. 24Our medical-provider focused alliance marketing and distribution model under 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 Acquisition of the Sleep Center of Nevada (“SCN”)

1. 25As such, no assurances can be given that the SCN Acquisition or similar transactions will benefit our operating results or stock priceNew
2. 26We have incurred substantial indebtedness in connection with financing the SCN acquisition, the cost of servicing that debt could adversely affect our business, financial condition, and results of operation, and we may not be able in the future to service that debtNew
3. 27Integrating SCN’s operations may be more difficult, costly, or time-consuming than expectedNew
4. 28Changes in the structure and payment rates under private insurance, Medicare, Medicaid or other non-Medicare government-based programs or payment rates related to our business could have a material adverse effect on our business, results of operations, financial condition and cash flowsNew
5. 29If we are faced with these or similar risks, we could face material adverse consequences on our business, results of operations, financial condition and cash flowsNew

Risks Related to Our Securities Generally

1. 30We have issued a large number of shares of common stock and warrants to purchase common stock in connection with financing activities. Substantial future sales of such shares of our common stock could cause the market price of our common stock to decline or have other adverse effects on our CompanyNew
2. 31The 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
3. 32Our failure to meet the continuing listing requirements of The Nasdaq Capital Market, including the minimum stockholders’ equity requirement and minimum bid price requirements, could result in a delisting of our securities44% rewritten
4. 33If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares
5. 34Actions 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
6. 35Seneca and its affiliates own a significant percentage of our common stock and are thus able to exert significant control over matters subject to stockholder approval and otherwiseNew
7. 36We 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 initiatives87% rewritten
8. 37For as long as we remain a smaller reporting company, we may take advantage of certain exemptions from various reporting requirements as described in the preceding risk factorNew
9. 38Certain provisions of our Certificate of Incorporation may make it more difficult for a third party to effect a change-of-control
10. 39Our 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
11. 40Limitations 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
12. 41We are responsible for the indemnification of our officers and directors
13. 42Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may limited, perhaps substantially
14. 43The financial and operational projections that we may make from time to time are subject to inherent risks
15. 44If we were to dissolve, the holders of our securities may lose all or substantial amounts of their investments
16. 45An 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
17. 46Because 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
18. 47If 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