What changed in this filing

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Item 1A. Risk Factors

2023-03-30 compared with 2022-03-31 · 627 added, 560 removed, 1020 unchanged (54% of the section changed)

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in our common stock is highly speculative and involves a significant degree of risk.

Before you invest in our securities, you should

give careful consideration to the following risk factors, in addition to the other information included in this Annual Report on Form

10-K, including our financial statements and related notes, before deciding whether to invest in our securities.

The occurrence of any

of the adverse developments described in the following risk factors could materially and adversely harm our business, financial condition,

results of operations or prospects.

In that case, the trading price of our common stock could decline, and you may lose all or part of

your investment.

Before you invest in our securities,

you should give careful consideration to the following risk factors, in addition to the other information included in this Annual Report

on Form 10-K, including our financial statements and related notes, before deciding whether to invest in our securities.

The occurrence

of any of the adverse developments described in the following risk factors could materially and adversely harm our business, financial

condition, results of operations or prospects.

In that case, the trading price of our common stock could decline, and you may lose all

or part of your investment.

Related to Our Business and Industry

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performance and future prospects.

business was formed only in 2016, and therefore you have limited historical data on which to evaluate our company.

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.

business was formed only in 2016, and therefore there is limited historical data on which to evaluate our company.

This is particularly

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and by adding strategic offerings like OMT.

Therefore, you have limited and evolving or differing historical operating data on which

Therefore, there is limited and evolving or differing historical operating data on which

to evaluate the results of and prospects for our current business model.

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our inception, we have not been profitable and have incurred significant losses and cash flow deficits.

For the fiscal years ended December

31, 2021 and 2020, we reported net losses of $20.3 million and $12.1 million respectively, and negative cash flow from operating activities

of $15.7 million and $5.7 million, respectively.

As of December 31, 2021, we had an aggregate accumulated deficit of $55.6 million.

anticipate that we will continue to report losses and negative cash flow until we can substantially increase our revenues, which we may

be unable to do.

There is therefore a risk that we will be unable to operate our business in a manner that generate positive cash flow

or profit, and our failure to increase our revenues, generate positive cash flow and operate our business profitably would damage our

reputation and stock price.

As of December 31, 2022, the

Company had an accumulated deficit of approximately $79.5 million and ended the period with approximately $3.5 million in cash assets.

For the years ended December 31, 2022 and 2021, the Company incurred a net loss of approximately $23.8 and $20.3 million, respectively.

Net cash used in operating activities amounted to approximately $19.6 million and $15.7 million for the years ended December 31, 2022

and 2021, respectively.

As of December 31, 2022, the Company had total liabilities of approximately $8.9 million.

We anticipate that

we will continue to report losses and negative cash flow until we can substantially increase our revenues, which we may be unable to

There is therefore a risk that we will be unable to operate our business in a manner that generate positive cash flow or profit,

and our failure to increase our revenues, generate positive cash flow and operate our business profitably would damage our reputation

and stock price.

VIP program is a relatively new business model for us, and management has limited experience operating this model.

VIP program is a relatively new business model for us, and members of our management team have limited experience operating our company

through this model.

VIP program is a relatively new business model for us, and members of our management team have only a few years of experience in operating

our company through this model.

As a result, our historical financial results may not be comparable to future results.

Also, we are subject to many

risks associated with this new business model that we are unable to presently identify, such as pricing, competition, marketing and regulatory

Moreover, our ability to onboard new VIPs may be impeded by the investments VIPs must make in adapting their practices to the

use of The Vivos Method.

We cannot assure you that management will be able to recruit and adopt new VIPs.

Any such failure may have an

adverse impact on our business, financial condition and results of operations.

Also, we are subject

to many risks associated with the VIP business model, some of which we have faced and some which we may be unable to presently identify,

such as risks associated pricing, competition, marketing and regulatory matters.

Moreover, our ability to onboard new VIPs may be impeded

by the investments VIPs must make in adapting their practices to the use of The Vivos Method.

We cannot assure you that management will

be able to recruit and adopt new VIPs.

Any such failure may have an adverse impact on our business, financial condition and results of

will need to raise additional capital to fund and grow our business.

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us to sell one or more lines of business or all or a portion of our assets, enter into a business combination, or reduce or eliminate

These possibilities, to the extent available, may be on terms that result in significant dilution to our shareholders or

that result in our investors losing all of their investment in our company.

we are able to raise additional capital, we do not know what the terms of any such capital raising would be.

Any of these possibilities, to the extent available, may be on terms that result in significant dilution to our shareholders

or that result in our investors losing all of their investment in our company.

if we are able to raise additional capital, we do not know what the terms of any such capital raising would be.

In addition, any future

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terms could have a material adverse effect on our liquidity and financial condition.

We have identified a material weakness in

our internal control over financial reporting.

Prior to our initial public

offering in December 2020, we were a private company and had limited accounting and financial reporting personnel and other resources

with which to address our internal controls and related procedures.

In connection with the audit of our consolidated financial statements

for the years ended December 31, 2021 and 2020, we and our independent registered public accounting firm identified a material weakness

in our internal control over financial reporting (see Item 9A of this report for further information).

A material weakness is a deficiency,

or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material

misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

The material weakness

in our case 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 technical accounting issues and perform review functions appropriately.

Material errors were also identified in our

analysis and review of our VIP contracts for applicable factors to meet the definition of a contract under ASC 606 Contracts with

Customers , step 1, and our evaluation of our note receivable with respect to our former Orem dental clinic for impairment in accordance

with ASC 310 Receivables .

If we are unable to remedy these or similar material weakness that may arise in the future, or if we

generally fail to establish and maintain effective internal controls appropriate for a public company, we may be unable to produce timely

and accurate financial statements, and we may conclude that our internal control over financial reporting is not effective, which could

adversely impact our investors’ confidence and our stock price.

derive a substantial portion of our prospective future revenue from sales of our appliances and protocols, which leaves us reliant

on the commercial viability of The Vivos Method.

our primary product is The Vivos Method, inclusive of MyoCorrect and our SleepImage HST.

Our secondary source of revenue is our clinical

training and practice support programs, including Billing Intelligence Services, Airway Intelligence System and AireO 2 .

expect that sales of the component aspects of The Vivos Method and our services to our VIPs related to the use of such protocols will

account for a significant majority of our prospective revenue for the foreseeable future.

We currently market and sell our appliances

(which are central to The Vivos Method) primarily in the United States and Canada, with a very limited presence a in very few select

countries such as South Korea, Australia, Japan and India.

Additionally,

during 2022, we actively began a process of reducing staff, eliminating or renegotiating certain vendor contracts, strategically reorganizing

our business and revamping our business model.

Further such steps, or even more, may be required before management is satisfied that

we are positioned to succeed or even survive, and there is a risk that we will be unable to implement cost cutting programs effectively.

have identified material weaknesses in our internal control over financial reporting.

connection with the audit of our consolidated financial statements for the years ended December 31, 2022 and 2021, we and our independent

registered public accounting firm identified a material weakness in our internal control over financial reporting.

A material weakness

is a deficiency, or a combination of deficiencies, within the meaning of PCAOB Auditing Standard AS 2201, in internal control over financial

reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will

not be prevented or detected on a timely basis.

For the year ended December 31, 2021, our material weakness related to the operating

effectiveness of our review controls.

Specifically, we did not put the appropriate resources in place to be able to identify technical

accounting issues and perform review functions appropriately.

Material errors were also identified in our analysis and review of our

VIP contracts for applicable factors to meet the definition of a contract under ASC 606 Contracts with Customers, step 1, and our evaluation

of our note receivable with respect to our former Orem dental clinic for impairment in accordance with ASC 310 Receivables.

in 2022 we did not put the appropriate resources in place to be able to identify technical accounting issues and perform review functions

appropriately related to revenue recognition.

Material errors were identified in our ability to determine that its existing revenue recognition

policy was consistent with the guidance in ASC 606.

After analyzing contracts using the five-step process in ASC 606, we have determined

that for both VIP enrollment contracts and Orofacial Myofunctional Therapy (MyoCorrect), modifications to our revenue recognition policies

were required in order to identify the performance obligations and recognize the revenue as the performance obligations are satisfied

or over the customer life as applicable.

Additionally, we did not put the

appropriate resources in place to be able to identify technical accounting issues and perform review functions appropriately.

As a consequence,

we did not effectively design, implement, and operate process-level control activities related to order-to-cash (including revenue, trade

receivables, allowance for doubtful accounts, deferred revenue, and bad debt expense), procure-to-pay (including prepaid expenses), hire-to-pay

(including compensation expense), and leases.

These control deficiencies resulted in immaterial misstatements, some of which were corrected,

in the consolidated financial statements as of and for the year ended December 31, 2022.

These control deficiencies, aggregated,

create a reasonable possibility that a material misstatement to the consolidated financial statements will not be prevented or detected

on a timely basis.

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 appropriately.

we are unable to remedy these or similar material weakness that may arise in the future, or if we generally fail to establish and maintain

effective internal controls appropriate for a public company, we may be unable to produce timely and accurate financial statements, and

we may continue to conclude that our internal control over financial reporting is not effective, which could adversely impact our investors’

confidence and our stock price.

Delays in filing our periodic reports have led and could in the future lead to the loss of our ability

to use certain “short form” registration statements (including “shelf” registration statements used for more

efficient fundraising).

expect to derive a substantial portion of our prospective future revenue from sales of our appliances and treatments, which leaves us

reliant on the commercial viability of The Vivos Method.

our primary product is The Vivos Method, inclusive of MyoCorrect, our SleepImage ® HST, and our multidisciplinary protocols

for adjunctive therapy.

Our secondary source of revenue is our clinical training and practice support programs, including Billing Intelligence

Services, Airway Intelligence System and AireO 2 .

We expect that sales of the component aspects of The Vivos Method and our

services to our VIPs related to the use of such treatments will account for a significant majority of our prospective revenue for the

foreseeable future.

We currently market and sell our appliances (which are central to The Vivos Method) primarily in the United States

and Canada, with a very limited presence in Australia.

The Vivos Method is different from current surgical and non-surgical treatments

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represents our primary product, and since our VIP program is our primary means of commercialization, we are significantly reliant on

the level of recurring sales of The Vivos Method protocol and decreased or lower than expected sales or recruitment and maintenance of

new VIPs would cause us to lose all or substantially all of our revenue.

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 (DSOs) for the treatment of dentofacial abnormalities and/or mild to moderate OSA and

believe that The Vivos Method is the first commercially available protocol based on our proprietary technology for the treatment of dentofacial

abnormalities and/or mild to moderate OSA.

Our success depends both on the sufficient acceptance and adoption by the medical/dental community

of The Vivos Method as a non-invasive treatment for the treatment of dentofacial abnormalities and/or mild to moderate OSA.

a relatively limited number of dentists and other medical clinicians provide treatment with The Vivos Method.

We cannot predict how quickly,

if at all, the medical/dental community will accept The Vivos Method, or, if accepted, the extent of its use.

For us to be successful:

dentist customers and referring physicians must believe that The Vivos Method offers meaningful

clinical and economic benefits for the treating provider and for the patient as compared

to the other surgical and non-surgical procedures or devices currently being used to treat

individuals with dentofacial abnormalities and/or mild to moderate OSA and referring physicians

must write a prescription for the use of a Class II Vivos appliance;

dentist customers must believe patients will pay for The Vivos Method out-of-pocket, and

patients must believe that paying out-of-pocket for treatment in The Vivos Method is the

best alternative to either doing nothing or entering into another treatment option;

dentist customers must be willing to pay us for the right to become VIPs and to commit the

time and resources required to learn the new clinical and technical skills and invest in

the technology required to treat patients with dentofacial abnormalities and/or mild to

moderate OSA using The Vivos Method.

the level of recurring sales of The Vivos Method treatment and decreased or lower than expected sales or recruitment and integration

of new VIPs would cause us to lose all or substantially all of our revenue.

material portion of our future revenue is expected to derive from sales and enrollments of new dentists into our Vivos Integrated Practice

(VIP) program, 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.

believe that The Vivos Method is the first commercially available treatment based on our proprietary technology for the treatment of

dentofacial abnormalities and/or mild to moderate OSA.

Our success depends both on the sufficient acceptance and adoption by the medical/dental

community of The Vivos Method as a non-invasive treatment for the treatment of dentofacial abnormalities and/or mild to moderate OSA.

Currently, a relatively limited number of dentists and other medical clinicians provide treatment with The Vivos Method.

We cannot predict

how quickly, if at all, the medical/dental community will accept The Vivos Method, or, if accepted, the extent of its use.

be successful:

dentist customers and referring physicians must believe that The Vivos Method offers meaningful clinical and economic benefits for

the treating provider and for the patient as compared to the other surgical and non-surgical procedures or devices currently being

used to treat individuals with dentofacial abnormalities and/or mild to moderate OSA and referring physicians must write a prescription

for the use of a Class II Vivos appliance;

dentist customers must believe patients will pay for The Vivos Method out-of-pocket, and patients must believe that paying out-of-pocket

for treatment in The Vivos Method is the best alternative to either doing nothing or entering into another treatment option;

dentist customers must be willing to pay us for the right to become VIPs and to commit the time and resources required to learn the

new clinical and technical skills and invest in the technology required to treat patients with dentofacial abnormalities and/or mild

to moderate OSA using The Vivos Method.

Independent dentists as well as dentists affiliated with a DSO may not desire to continue

to enroll in our VIP or DSO program.

reference to the treatment of mild to moderate OSA and snoring, studies have shown that a significant percentage of people who have OSA

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timing and extent of our future growth in sales revenue depends, in part, on our ability to continue to increase the number of U.S.

using The Vivos Method, as well as expanding the number of The Vivos Method protocols used by these physicians/dentists.

using The Vivos Method, as well as expanding the number of The Vivos Method treatments used by these physicians/dentists.

To the extent

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business and our results of operations .

business and prospects have been and could be materially adversely affected by the COVID-19 pandemic or recurrences of COVID-19

(such as has occurred in the fall of 2020 and into 2021) or any other similar diseases in the future.

Material adverse effects from COVID-19

and similar diseases could result in numerous known and currently unknown ways including from quarantines and lockdowns which impair

our marketing and sales efforts to dentists or other medical professionals.

During the COVID-19 pandemic, dental offices throughout the

and Canada shut down for extended periods of time (and may be shut down again due to recurrences of COVID-19), thus negatively impacting

our product revenues.

The pandemic and reactions to the pandemic or future outbreaks of COVID-19 and variants of COVID-19 could also

impair the timing of obtaining necessary consents and approvals from the FDA, as its employees could also be under such quarantines and

lockdowns and their time could be mandatorily required to be allocated to more immediate global and domestic concerns relating to COVID-19.

In addition, we purchase materials for our products from suppliers located in affected areas, and we may not be able to procure required

components or secure manufacturing capability.

The effects of the COVID-19 pandemic have also placed travel restrictions on us and our

VIPs, as well as temporary closures of the facilities of our suppliers and our VIPs as non-essential medical and dental procedures have

been limited, which could also adversely impact our business.

In addition, a significant outbreak of contagious diseases in the human

population could result in a widespread health crisis that could adversely affect the economies and financial markets of many countries,

resulting in an economic downturn that could reduce the demand for our products and impair our business prospects including as a result

of being unable to raise additional capital on acceptable terms to us, if at all.

business and prospects have been and could continue to be materially adversely affected by the COVID-19 pandemic or recurrences of COVID-19

(such as has occurred in the fall of 2020 and into 2021 and the first half of 2022) or any other similar diseases in the future.

adverse effects from COVID-19 and similar diseases could result in numerous known and currently unknown ways including from quarantines

and lockdowns which impair our marketing and sales efforts to dentists or other medical professionals.

During the COVID-19 pandemic,

dental offices throughout the U.S.

and Canada shut down for extended periods of time (and may be shut down again due to government mandates

or lockdowns), thus negatively impacting our product revenues.

Such dental practice closures disrupted and dislodged significant portions

of the dental workforce, including many hygienists who decided to quit or retire.

Such disruptions to dental practices has had a negative

and ongoing impact on our VIP offices’ ability to educate and inform patients about their OSA and The Vivos Method.

and reactions to the pandemic or future outbreaks of COVID-19 and variants of COVID-19 could also impair the timing of obtaining necessary

consents and approvals from the FDA, as its employees could also be under such quarantines and lockdowns and their time could be mandatorily

required to be allocated to more immediate global and domestic concerns relating to COVID-19.

In addition, we purchase materials for

our products from suppliers located in affected areas, and we may not be able to procure required components or secure manufacturing

The effects of the COVID-19 pandemic have also placed travel restrictions on us and our VIPs, as well as temporary closures

of the facilities of our suppliers and our VIPs as non-essential medical and dental procedures have been limited, which could also adversely

impact our business.

In addition, a significant outbreak of contagious diseases in the human population could result in a widespread

health crisis that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn that

could reduce the demand for our products and impair our business prospects including as a result of being unable to raise additional

capital on acceptable terms to us, if at all.

may not be able to successfully implement our growth strategy for our VIPs on a timely basis or at all, which could harm our business,

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brand awareness in new and existing markets;

potential VIPs of the value of our products and services and to make the required investments

in becoming a VIP and using The Vivos Method;

potential VIPs of the value of our products and services and to make the required investments in becoming a VIP and using The Vivos

costs, which could give rise to delays or cost overruns;

train, and retain qualified dentists, dental hygienists, physicians, physician assistants,

medical technologists and other staff in our local markets;

train, and retain qualified dentists, dental hygienists, physicians, physician assistants, medical technologists and other staff

in our local markets;

favorable reimbursement rates for services rendered at VIP offices;

adequate information systems and other operational system capabilities.

convincingly that the investment of time, training, and money in becoming a VIP will have a tangible and significant ROI for the

applicable laws, rules and regulations (including licensure requirements) could negatively impact our ability to recruit and enroll VIPs.

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long-term success of our VIP program is highly dependent on our ability to successfully identify, recruit and enroll target independent

dental practices.

dental practices as well as to convince other medical professionals to participate in the treatment of OSA with our products and services.

achieve our growth strategy, we will need to identify, recruit, and enroll new VIPs and have them operate on a profitable and recurring

We consider numerous factors in identifying target markets where we can enter or expand.

The number and timing of new VIPs

enrolled during any given period may be negatively impacted by several factors including, without limitation:

The number and timing of new VIPs enrolled

during any given period may be negatively impacted by several factors including, without limitation:

identification and availability of attractive practices to be VIPs;

ability to successfully identify and address pertinent risks and benefits during the onboarding

process, including designing, implementing and as necessary modifying pricing programs for

VIP enrollment and subscription fees that are acceptable to dental practices;

ability to successfully identify and address pertinent risks and benefits during the onboarding process, including designing, implementing

and as necessary modifying pricing programs for VIP enrollment and subscription fees that are acceptable to dental practices;

proximity of VIPs to one of our or our competitors’ existing centers;

VIP’s ability to obtain required governmental licenses, permits and authorizations

on a timely basis;

VIP’s ability to recruit qualified dentists, dental hygienists, physicians, physician

assistants, medical technologists and other personnel to staff their practices using The

Vivos Method.

VIP’s ability to obtain required governmental licenses, permits and authorizations on a timely basis;

VIP’s ability to recruit qualified dentists, dental hygienists, physicians, physician assistants, medical technologists and

other personnel to staff their practices using The Vivos Method.

we are unable to find and onboard attractive VIPs in existing markets or new markets, our revenue and profitability may be harmed, we

may not be able to implement our growth strategy and our financial results may be negatively affected.

we have begun to expand marketing and related efforts to medical professional beyond the dentistry community.

We may be unable to convince

medical sleep specialists, cardiologists, pediatric sleep specialists, chiropractors, nutritionists and other professionals of the benefits

of The Vivos Method specifically and a multidisciplinary approach to treating OSA in general.

Our inability to implementing.

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.

limited history of sales of The Vivos Method and VIP enrollments and subscriptions, together with our history of losses, make

prediction of future operating results difficult.

You should not rely on our past revenue growth as any indication of future growth rates

or operating results.

Our valuation and the price of our securities likely will fall in the event our operating results (notably our

revenue growth, with the goal of achieving cash flow positive and profitable operations) do not meet the expectations of analysts and

Comparisons of our quarterly operating results are an unreliable indication of our future performance because they are likely

to vary significantly based on many factors, including:

inability to attract demand for and obtain acceptance of The Vivos Method for the treatment

of dentofacial abnormalities and/or mild to moderate OSA and snoring by both physicians/dentists

and their patients;

success of alternative therapies and surgical procedures to treat individuals, and the possible

future introduction of new products and treatments;

ability to design, implement and as necessary modifying pricing programs for VIP enrollment

and subscription fees;

limited history of sales of The Vivos Method and VIP enrollments and subscriptions, together with our history of losses, make prediction

of future operating results difficult.

You should not rely on our past revenue growth as any indication of future growth rates or operating

Our valuation and the price of our securities likely will fall in the event our operating results (notably our revenue growth,

with the goal of achieving cash flow positive and profitable operations) do not meet the expectations of analysts and investors.

of our quarterly operating results are an unreliable indication of our future performance because they are likely to vary significantly

based on many factors, including:

inability to attract demand for and obtain acceptance of The Vivos Method for the treatment of dentofacial abnormalities and/or mild

to moderate OSA and snoring by both medical professionals and their patients;

success of alternative therapies and surgical procedures to treat individuals, and the possible future introduction of new products

and treatments;

ability to design, implement and as necessary modifying pricing programs for VIP enrollment and subscription fees;

ability to expand by adding additional VIPs in leading major metro areas;

expansion and rate of success of our marketing and advertising efforts to both consumers

and dentists, and the rate of success of our direct sales force in the United States and

internationally;

of third-party contract manufacturers to deliver products or provide services in a cost effective

and timely manner;

expansion and rate of success of our marketing and advertising efforts to both consumers and dentists as well as other medical professionals,

and the rate of success of our direct sales force in the United States and internationally;

of third-party contract manufacturers to deliver products or provide services in a cost effective and timely manner;

failure to develop, find or market new products;

successful completion of current and future clinical studies, and the possibility that the

results of any future study may be adverse to our product and services, or reveal some heretofore

unknown risk to patients from treatment in The Vivos Method;

the failure by us to make professional

presentation and publication of positive outcomes data from these clinical studies, and the

increased adoption of The Vivos Method by dentists as a result of the data from these clinical

successful completion of current and future clinical studies, and the possibility that the results of any future study may be adverse

to our product and services, or reveal some heretofore unknown risk to patients from treatment in The Vivos Method;

the failure by

us to make professional presentation and publication of positive outcomes data from these clinical studies, and the increased adoption

of The Vivos Method by dentists as a result of the data from these clinical studies;

relating to ongoing FDA compliance;

size and timing of orders from dentists and independent distributors;

ability to obtain reimbursement for The Vivos Method (i.e., billable oral appliances and

orofacial myofunctional therapy) in the future from third-party healthcare insurers;

willingness of patients to pay out-of-pocket for treatment in The Vivos Method in the absence

of reimbursement from third-party healthcare insurers, for;

decisions by one or more commercial

health insurance companies to preclude, deny, limit, reduce, eliminate, or curtain reimbursement

for treatment in whole or part by The Vivos Method;

ability to obtain reimbursement for The Vivos Method (i.e., billable oral appliances and orofacial myofunctional therapy) in the

future from third-party healthcare insurers;

willingness of patients to pay out-of-pocket for treatment in The Vivos Method in the absence of reimbursement from third-party healthcare

insurers, for;

decisions by one or more commercial health insurance companies to preclude, deny, limit, reduce, eliminate, or curtain

reimbursement for treatment in whole or part by The Vivos Method;

unanticipated

delays in the development and introduction of our future products and/or our inability to

control costs;

delays in the development and introduction of our current and future products and/or our inability to control costs;

effects of global or local pandemics or epidemics and governmental responses, such as COVID-19;

fluctuations in revenue due to the elective nature of sleep-disordered breathing treatments

for mild to moderate OSA, as well as seasonal fluctuations resulting from adverse weather

conditions, earthquakes, floods or other acts of nature in certain areas or regions that

result in power outages, transportation interruptions, damages to one or more of our facilities,

food shortages, or other events which may cause a temporary or long-term disruption in patient

priorities, finances, or other matters;

fluctuations in revenue due to the elective nature of sleep related breathing disorder treatments for mild to moderate OSA, as well as seasonal fluctuations resulting from adverse weather conditions, earthquakes, floods

or other acts of nature in certain areas or regions that result in power outages, transportation interruptions, damages to one or

more of our facilities, food shortages, or other events which may cause a temporary or long-term disruption in patient priorities,

finances, or other matters;

economic conditions as well as those specific to our customers and markets.

you should expect that our results of operations will be difficult to predict, which will make an investment in our company uncertain.

MID program is a new business offering for us, and it may not perform as anticipated or may take longer than expected to gain acceptance.

MID program may not perform as anticipated or may take longer than expected to gain acceptance.

only in 2020, our MID is a new business offering for us, and the model is yet unproven.

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identify and respond to such risks in a timely manner, our financial condition and results of operations could be adversely affected.

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.

The SleepImage HST used in

our VivoScore Program is a relatively new technology which could take longer to gain acceptance within the medical and dental communities.

If medical and dental care providers do not utilize this new technology, or if the test is not as effective as anticipated, the financial

results from the program may be lower than currently expected.

Also, we are subject to many risks associated with this new technology

that we are unable to presently identify, such as pricing, competition, marketing and regulatory risks.

If we fail to adequately identify

and respond to such risks in a timely manner, on our business, financial condition and results of operations could be adversely affected.

Moreover, the design and implementation

of our VivoScore Program is new, as the current program arose following our renegotiated agreement with MyCardio LLC in early 2022.

we face the risks associated with establishing a new revenue center as the VivoScore Program itself (under which we lease the SleepImage

ring recorder to dentists) may not attract a following sufficient to make the program a successful revenue generator for us.

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.

SleepImage ® HST used in our VivoScore Program is a relatively new technology which could take longer to gain acceptance

within the medical and dental communities.

If medical and dental care providers do not utilize this new technology, or if the test is

not as effective as anticipated, the financial results from the program may be lower than currently expected.

Also, we are subject to

many risks associated with this new technology that we are unable to presently identify, such as pricing, competition, marketing and

regulatory risks.

If we fail to adequately identify and respond to such risks in a timely manner, on our business, financial condition

and results of operations could be adversely affected.

the design and implementation of our VivoScore Program is new, as the current program arose following our renegotiated agreement with

MyCardio LLC in early 2022.

Therefore, we face the risks associated with establishing a new revenue center as the VivoScore Program itself

(under which we lease the SleepImage ® ring recorder to dentists) may not attract a following sufficient to make the program

a successful revenue generator for us.

may not be able to respond in a timely and cost-effective manner to changes in consumer preferences.

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will be materially adversely impacted.

clinical studies of The Vivos Method may adversely impact our ability to generate revenue if they do not demonstrate that The Vivos Method

is clinically effective for currently specified or expanded indications or if they are not completed in a timely manner.

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 clinically effective.

have conducted, and continue to conduct, a number of clinical studies of the use of The Vivos Method to treat patients with dentofacial

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in the markets in which these approvals are sought.

Our products and third-party

contract manufacturing activities are subject to extensive governmental regulation that could prevent us from selling our appliances

or introducing new and/or improved products in the United States or internationally.

products and third-party contract manufacturing activities are subject to extensive regulation by several governmental agencies,

including the FDA and comparable international regulatory bodies.

an effort to help expand in-network insurance coverage for The Vivos Method, in December 2022, we announced a collaboration with Nexus

which effectively combines our proprietary out-of-network Billing Intelligence Service with the Nexus’ in-network medical billing

The goal is to provide both companies’ medical professional networks with greater access to both in or out-of-network

billing with all major medical insurance companies, facilitating case acceptances, insurance billing procedures and reimbursement.

our collaboration with Nexus may not achieve the result of expanding insurance coverage for The Vivos Method, which in turn could have

an adverse effect on our results of operations (particularly if our outlay of resources in connection with the Nexus collaboration exceed

the revenues, if any, generated).

products and third-party contract manufacturing activities are subject to extensive governmental regulation that could prevent us from

selling our appliances or introducing new and/or improved products in the United States or internationally.

products and third-party contract manufacturing activities are subject to extensive regulation by several governmental agencies, including

the FDA and comparable international regulatory bodies.

We are required to:

clearance from the FDA and certain international regulatory bodies before we can market and

sell our products;

all content requirements for the sales and promotional materials associated with The Vivos

rigorous inspections of our facilities, manufacturing and quality control processes, records

and documentation.

clearance from the FDA and certain international regulatory bodies before we can market and sell our products;

all content requirements for the sales and promotional materials associated with The Vivos Method;

rigorous inspections of our facilities, manufacturing and quality control processes, records and documentation.

with the rules and regulations of these various regulatory bodies have created regulatory challenges for us in the past and may delay

or prevent us from introducing any new models of The Vivos Method or other new products.

In addition, government regulations may

be adopted that could prevent, delay, modify or rescind regulatory clearance or approval of our products.

In addition, government regulations may be adopted

that could prevent, delay, modify or rescind regulatory clearance or approval of our products.

contract manufacturing labs are further required to demonstrate compliance with the FDA’s quality system regulations.

The FDA enforce their quality system regulations through pre-approval and periodic post-approval inspections by representatives from

These regulations relate to product testing, vendor qualification, design control and quality assurance, as well as the maintenance

of records and documentation.

The FDA enforce

their quality system regulations through pre-approval and periodic post-approval inspections by representatives from the FDA.

These regulations

relate to product testing, vendor qualification, design control and quality assurance, as well as the maintenance of records and documentation.

If we fail to conform to these regulations, the FDA may take actions that could seriously harm our business.

These actions include sanctions, including temporary or permanent suspension of our operations, product recalls and marketing restrictions.

A recall or other regulatory action could substantially increase our costs, damage our reputation and materially affect our operating

products are currently not recommended by most pulmonologists, who are integral to the diagnosis and treatment of sleep breathing disorders.

majority of patients being treated today for OSA, domestically and internationally, are initially referred to pulmonologists by their

primary care physicians.

Pulmonologists typically administer a polysomnogram, or overnight sleep study, to diagnose the presence and

severity of OSA.

If an individual is diagnosed with OSA by a pulmonologist, the pulmonologist typically prescribes CPAP as the therapy

Although we offer The Vivos Method through our VIPs, our domestic sales organization does not generally call on pulmonologists

or third-party sleep centers to sell The Vivos Method, and we do not believe that most pulmonologists today would recommend The Vivos

Method to their patients with mild to moderate OSA.

We cannot predict the extent to which pulmonologists will, in the future, endorse

or recommend our protocol to their patients, even for those who are unwilling or unable to comply with other alternative therapies.

face significant competition in the rapidly changing market for mild to moderate OSA and snoring in adults, and we may be unable to manage

competitive pressures.

These actions include sanctions,

including temporary or permanent suspension of our operations, product recalls and marketing restrictions.

A recall or other regulatory

action could substantially increase our costs, damage our reputation and materially affect our operating results.

products are currently not recommended by most medical sleep specialists, who are integral to the diagnosis and treatment of sleep breathing

majority of patients being treated today for OSA, domestically and internationally, are initially referred to pulmonologists or other

sleep specialists by their primary care physicians.

Pulmonologists or other sleep specialists typically administer a polysomnogram, or

overnight sleep study, to diagnose the presence and severity of OSA.

If an individual is diagnosed with OSA by a qualified medical doctor,

CPAP is typically prescribed as the therapy of choice.

Although we offer The Vivos Method through our VIPs, our domestic sales organization

does not generally call on sleep specialists or third-party sleep centers to sell The Vivos Method, and we do not believe that most qualified

sleep specialists today would recommend The Vivos Method to their patients with mild to moderate OSA.

We cannot predict the extent to

which medical doctors will, in the future, endorse or recommend our protocol to their patients, even for those who are unwilling or unable

to comply with other alternative therapies.

face significant competition in the rapidly changing market for treating mild to moderate OSA and snoring in adults, and we may be unable

to manage or respond to competitive pressures.

market for treating mild to moderate OSA and snoring in adults, is highly competitive and evolving rapidly.

According to the American

Sleep Apnea Association, over 100 different oral appliances are FDA cleared for the treatment of snoring and mild to moderate obstructive

The Vivos Method must compete with more established products, treatments and surgical procedures, which may limit our growth

and negatively affect our business.

Many of our competitors have an established presence in the field and have established relationships

with pulmonologists, sleep clinics and ear, nose and throat specialists, which play a significant role in determining which product,

treatment or procedure is recommended to the patient.

We believe certain of our competitors are attempting to develop innovative approaches

and new products for diagnosing and treating OSA and other sleep disordered breathing conditions.

We cannot predict the extent to which

ENTs, oral maxillofacial surgeons, primary care physicians or pulmonologists would or will recommend The Vivos Method over new or other

established devices, treatments or procedures.

According to the

American Sleep Apnea Association, over 100 different oral appliances are FDA cleared for the treatment of snoring and mild to

moderate obstructive sleep apnea.

The Vivos Method must compete with more established products, treatments and surgical procedures,

which may limit our growth and negatively affect our business.

Many of our competitors have an established presence in the field and

have established relationships with pulmonologists, sleep clinics and ear, nose and throat specialists, which play a significant

role in determining which product, treatment or procedure is recommended to the patient.

We believe certain of our competitors are

attempting to develop innovative approaches and new products for diagnosing and treating OSA and other sleep related breathing

disorder conditions.

We cannot predict the extent to which ENTs, oral maxillofacial surgeons, primary care physicians or

pulmonologists would or will recommend The Vivos Method over new or other established devices, treatments or procedures.

we are in the early stages of implementing our business plan and have limited resources with which to market, develop and sell The Vivos

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If we fail to develop new technologies, products, or procedures to upgrade or improve

our existing protocols to respond to a changing market before our competitors are able to do so, our ability to market our products and

protocol and generate substantial revenue may be limited.

Our international

sales are subject to a number of risks that could seriously harm our ability to successfully commercialize The Vivos Method in

international markets.

not have significant international sales outside of Canada, although we hope to more broadly introduce The Vivos Method into international

our existing treatments to respond to a changing market before our competitors are able to do so, our ability to market our products

and protocol and generate substantial revenue may be limited.

international sales are subject to a number of risks that could seriously harm our ability to successfully commercialize The Vivos Method

in international markets.

do not have significant international sales outside of Canada, although we hope to more broadly introduce The Vivos Method into international

Our ability to generate international sales is subject to several risks, including:

ability to obtain appropriate regulatory approvals to market The Vivos Method in certain

ability to identify new independent third-party distributors in international markets where

we do not currently have distributors;

ability to obtain appropriate regulatory approvals to market The Vivos Method in certain countries;

ability to identify new independent third-party distributors in international markets where we do not currently have distributors;

impact of recessions in economies outside the United States;

difficulty in negotiating with socialized medical systems, maintaining profit margins comparable

to those achieved in the United States, collecting accounts receivable, and longer collection

difficulty in negotiating with socialized medical systems, maintaining profit margins comparable to those achieved in the United

States, collecting accounts receivable, and longer collection periods;

changes in regulatory requirements, tariffs or other trade barriers;

intellectual property rights protection in some countries;

● potentially

adverse tax consequences;

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purchase components for The Vivos Method from a variety of vendors on a purchase order basis;

we have no long-term supply contracts

with any of our vendors.

we have no long-term supply contracts with

any of our vendors.

While it is our goal to have multiple sources to procure certain key components, in some cases it is not economically

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do not have any long-term contracts with contract manufacturers, suppliers or other service providers for our products.

not anticipate that this will change.

As a result, if any manufacturer or supplier is unable, either temporarily or permanently, to manufacture

or deliver products or provide services to us in a timely and cost-effective manner, it could have an adverse effect on our financial

condition and results of operations.

Our ability to provide effective customer service and efficiently fulfill orders for merchandise

depends, to a large degree, on the efficient and uninterrupted operation of the manufacturing and related call centers, distribution

centers, and management information systems, some of which are run by third parties.

Any material disruption or slowdown in manufacturing,

order processing or fulfillment systems resulting from strikes or labor disputes, telephone down times, electrical outages, mechanical

problems, human error or accidents, fire, natural disasters, adverse weather conditions or comparable events could cause delays in our

ability to receive and fulfill orders and may cause orders to be lost or to be shipped or delivered late.

As a result, these disruptions

could adversely affect our financial condition or results of operations in future periods.

We do not anticipate

that this will change.

As a result, if any manufacturer or supplier is unable, either temporarily or permanently, to manufacture or deliver

products or provide services to us in a timely and cost-effective manner, it could have an adverse effect on our financial condition

and results of operations.

Our ability to provide effective customer service and efficiently fulfill orders for merchandise depends,

to a large degree, on the efficient and uninterrupted operation of the manufacturing and related call centers, distribution centers,

and management information systems, some of which are run by third parties.

Any material disruption or slowdown in manufacturing, order

processing or fulfillment systems resulting from strikes or labor disputes, telephone down times, electrical outages, mechanical problems,

human error or accidents, fire, natural disasters, adverse weather conditions or comparable events could cause delays in our ability

to receive and fulfill orders and may cause orders to be lost or to be shipped or delivered late.

As a result, these disruptions could

adversely affect our financial condition or results of operations in future periods.

depend on our patents and proprietary technology, which we may not be able to protect.

success depends, in part, on our ability to obtain and maintain patent protection for The Vivos Method components and the confidentiality

of proprietary clinical protocols.

of proprietary clinical treatments.

Our success further depends on our ability to obtain and maintain trademark protection for our name

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be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary technologies,

protocols and any future products are covered by valid and enforceable patents or are effectively maintained as trade secrets.

treatments and any future products are covered by valid and enforceable patents or are effectively maintained as trade secrets.

patents we have obtained or do obtain may be challenged by re-examination or otherwise invalidated or eventually found unenforceable.

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success depends, in part, on our ability to protect our proprietary rights to the technologies used in our products and our proprietary

clinical protocols.

clinical treatments.

We depend heavily upon confidentiality agreements with our officers, employees, consultants and subcontractors to

maintain the proprietary nature of our technology and our proprietary clinical protocols.

These measures may not afford us complete or

even sufficient protection, and may not afford an adequate remedy in the event of an unauthorized disclosure of confidential information.

maintain the proprietary nature of our technology and our proprietary clinical treatments.

These measures may not afford us complete

or even sufficient protection, and may not afford an adequate remedy in the event of an unauthorized disclosure of confidential information.

If we fail to protect and/or maintain our intellectual property, third parties may be able to compete more effectively against us, we

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operations in which event and you could lose all of your investment.

United States Federal Trade Commission (FTC) has recently put forward a new policy proposal, currently undergoing public comment and

review, that if implemented in its current form, would ban the enforcement of restrictive covenant agreements for employees, thereby

making it almost impossible for us to protect our trade secrets and know-how.

In that event, we would likely experience a loss of control

and confidentiality over our core intellectual property, with unknown consequences.

may face intellectual property infringement claims that would be costly to resolve.

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face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business.

Our business exposes us to the

risk of product liability claims that are inherent in the testing manufacturing and marketing of medical devices.

This risk exists even

if a device is registered, cleared and approved for commercial sale by the FDA and manufactured in facilities licensed and regulated by

the FDA or an applicable foreign regulatory authority.

Any side effects, manufacturing defects, misuse or abuse associated with use of

a our appliance could result in patient injury or death.

The medical device industry has historically been subject to extensive litigation

over product liability claims, and we cannot offer any assurance that we will not face product liability suits.

We may be subject to product

liability claims if the use of a our appliance may cause, or merely appeared to have caused, patient injury or death.

In addition, an

injury that is caused by the activities of our suppliers, such as those who provide us with components and raw materials, may be the basis

for a claim against us.

Product liability claims may be brought against us by patients, healthcare providers or others selling or otherwise

coming into contact with our appliances, among others.

If we cannot successfully defend ourselves against product liability claims, we

will incur substantial liabilities and reputational harm.

In addition, regardless of merit or eventual outcome, product liability claims

may result in:

business exposes us to the risk of product liability claims that are inherent in the testing manufacturing and marketing of medical devices.

This risk exists even if a device is registered, cleared and approved for commercial sale by the FDA and manufactured in facilities licensed

and regulated by the FDA or an applicable foreign regulatory authority.

Any side effects, manufacturing defects, misuse or abuse associated

with use of our appliance could result in patient injury or death.

The medical device industry has historically been subject to extensive

litigation over product liability claims, and we cannot offer any assurance that we will not face product liability suits.

subject to product liability claims if the use of our appliance may cause, or merely appeared to have caused, patient injury or death.

In addition, an injury that is caused by the activities of our suppliers, such as those who provide us with components and raw materials,

may be the basis for a claim against us.

Product liability claims may be brought against us by patients, healthcare providers or others

selling or otherwise coming into contact with our appliances, among others.

If we cannot successfully defend ourselves against product

liability claims, we will incur substantial liabilities and reputational harm.

In addition, regardless of merit or eventual outcome,

product liability claims may result in:

of litigation;

● distraction

of management’s attention from our primary business;

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of clinical trial participants;

● substantial

monetary awards to patients or other claimants;

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bear the risk of warranty claims on our appliances.

We may not be successful in claiming recovery under any warranty or indemnity

provided to us by our suppliers or vendors in the event of a successful warranty claim against us by a customer or that any recovery

from such vendor or supplier would be adequate.

In addition, warranty claims brought by our customers related to third-party components

may arise after our ability to bring corresponding warranty claims against such suppliers expires, which could result in costs to us.

We may not be successful in claiming recovery under any warranty or indemnity provided

to us by our suppliers or vendors in the event of a successful warranty claim against us by a customer or that any recovery from such

vendor or supplier would be adequate.

In addition, warranty claims brought by our customers related to third-party components may arise

after our ability to bring corresponding warranty claims against such suppliers expires, which could result in costs to us.

sales and marketing efforts may not be successful.

currently market and sell our appliances and associated protocols and services to a limited number of licensed professionals, primarily

currently market and sell our appliances and associated treatments and services to a limited number of licensed professionals, primarily

general dentists.

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Our marketing and sales efforts may not be successful in increasing awareness and sales of The Vivos Method.

In addition, other marketing efforts like MID and our collaborations with Candid and Empower Sleep may not increase revenue to the

extent we currently anticipate.

we conduct our targeted marketing efforts in neighborhoods through channels such as direct mail, billboards, radio advertisements, physician

open houses, community sponsorships and various social media.

These marketing and sales efforts may not be successful in increasing awareness

and sales of The Vivos Method, and if we are not successful in these efforts, we will have incurred expenses without materially

increasing revenue.

Furthermore, other marketing efforts like MID and the VivoScore Program may not increase revenue to the extent

In addition, other marketing efforts like MID and our collaborations with Candid and Empower Sleep may not increase revenue to the extent

we currently anticipate.

addition, we conduct our targeted marketing efforts in neighborhoods through channels such as direct mail, billboards, radio advertisements,

physician open houses, community sponsorships and various social media.

These marketing and sales efforts may not be successful in increasing

awareness and sales of The Vivos Method, and if we are not successful in these efforts, we will have incurred expenses without materially

increasing revenue.

Furthermore, other marketing efforts like MID and the VivoScore Program may not increase revenue to the extent we

currently anticipate.

failure to educate or train a sufficient number of physicians and dentists in the use of The Vivos Method could reduce the market acceptance

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However, to receive this training, dentists must be aware of The Vivos Method as a treatment option for dentofacial

abnormalities and/or mild to moderate OSA and snoring and be interested in using the protocol in their practice.

We cannot predict the

extent to which dentists will dedicate the time and energy necessary for adequate training in the use of our proprietary protocols, have

the knowledge of or experience in the clinical outcomes or feel comfortable enough to recommend it to their patients.

Even if a dentist

is well versed in The Vivos Method, he or she may be unwilling to require patients to pay for it out-of-pocket.

If dentists do not continue

to accept and recommend The Vivos Method, our revenue could be materially and adversely affected.

abnormalities and/or mild to moderate OSA and snoring in adults and be interested in using the protocol in their practice.

predict the extent to which dentists will dedicate the time and energy necessary for adequate training in the use of our proprietary

treatments, have the knowledge of or experience in the clinical outcomes or feel comfortable enough to recommend it to their patients.

Even if a dentist is well versed in The Vivos Method, he or she may be unwilling to require patients to pay for it out-of-pocket.

dentists do not continue to accept and recommend The Vivos Method, our revenue could be materially and adversely affected.

rely on third-party suppliers and contract manufacturers for the manufacture and assembly of our products, and a loss or degradation

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and results of operations.

rely on third-party suppliers and contract manufacturers for the raw materials and components used in our appliances and

to manufacture and assemble our products.

Any of our other suppliers or our third-party contract manufacturers may be unwilling or unable

to supply the necessary materials and components or manufacture and assemble our products reliably and at the levels we anticipate or

that are required by the market.

Our ability to supply our products commercially and to develop any future products depends, in part,

on our ability to obtain these materials, components and products in accordance with regulatory requirements and in sufficient quantities

for commercialization and clinical testing.

While our suppliers and contract manufacturers have generally met our demand for their products

and services on a timely basis in the past, we cannot guarantee that they will in the future be able to meet our demand for their products,

either because of acts of nature, the nature of our agreements with those manufacturers or our relative importance to them as a customer,

and our manufacturers may decide in the future to discontinue or reduce the level of business they conduct with us.

If we are required

to change contract manufacturers due to any change in or termination of our relationships with these third parties, or if our manufacturers

are unable to obtain the materials they need to produce our products at consistent prices or at all, we may lose sales, experience manufacturing

or other delays, incur increased costs or otherwise experience impairment to our customer relationships.

We cannot guarantee that we

will be able to establish alternative relationships on similar terms, without delay or at all.

Establishing additional or replacement

suppliers for any of these materials, components or services, if required, could be time-consuming and expensive, may result in interruptions

in our operations and product delivery, may affect the performance specifications of our appliances or could require that we modify

Even if we are able to find replacement suppliers or third-party contract manufacturers, we will be required to verify that

the new supplier or third-party manufacturer maintains facilities, procedures and operations that comply with our quality expectations

and applicable regulatory requirements.

If our third-party suppliers

fail to deliver the required commercial quantities of materials on a timely basis and at commercially reasonable prices, and we are unable

to find one or more replacement suppliers capable of production at a substantially equivalent cost in substantially equivalent volumes

and quality on a timely basis, the continued commercialization of our appliances, the supply of our products to customers and

the development of any future products will be delayed, limited or prevented, which could have material adverse effect on our business,

rely on third-party suppliers and contract manufacturers for the raw materials and components used in our appliances and to manufacture

and assemble our products.

Any of our other suppliers or our third-party contract manufacturers may be unwilling or unable to supply

the necessary materials and components or manufacture and assemble our products reliably and at the levels we anticipate or that are

required by the market.

Our ability to supply our products commercially and to develop any future products depends, in part, on our ability

to obtain these materials, components and products in accordance with regulatory requirements and in sufficient quantities for commercialization

and clinical testing.

While our suppliers and contract manufacturers have generally met our demand for their products and services on

a timely basis in the past, we cannot guarantee that they will in the future be able to meet our demand for their products, either because

of acts of nature, the nature of our agreements with those manufacturers or our relative importance to them as a customer, and our manufacturers

may decide in the future to discontinue or reduce the level of business they conduct with us.

If we are required to change contract manufacturers

due to any change in or termination of our relationships with these third parties, or if our manufacturers are unable to obtain the materials

they need to produce our products at consistent prices or at all, we may lose sales, experience manufacturing or other delays, incur

increased costs or otherwise experience impairment to our customer relationships.

We cannot guarantee that we will be able to establish

alternative relationships on similar terms, without delay or at all.

additional or replacement suppliers for any of these materials, components or services, if required, could be time-consuming and expensive,

may result in interruptions in our operations and product delivery, may affect the performance specifications of our appliances or could

require that we modify its design.

Even if we are able to find replacement suppliers or third-party contract manufacturers, we will be

required to verify that the new supplier or third-party manufacturer maintains facilities, procedures and operations that comply with

our quality expectations and applicable regulatory requirements.

our third-party suppliers fail to deliver the required commercial quantities of materials on a timely basis and at commercially reasonable

prices, and we are unable to find one or more replacement suppliers capable of production at a substantially equivalent cost in substantially

equivalent volumes and quality on a timely basis, the continued commercialization of our appliances, the supply of our products to customers

and the development of any future products will be delayed, limited or prevented, which could have material adverse effect on our business,

financial condition and results of operations.

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marketing activities may not be successful.

incur costs and expend other resources in our marketing efforts to attract and retain VIPs.

Our marketing activities are principally

focused on increasing brand awareness in the communities in which we provide services.

As we onboard VIP providers, we expect to undertake

aggressive marketing campaigns to increase community awareness about our presence and our service capabilities.

We conduct our targeted

marketing efforts in neighborhoods through channels such as direct mail, billboards, radio advertisements, physician open houses, community

sponsorships and various social media.

If we are not successful in these efforts, we will have incurred expenses without materially increasing

incur costs and expend other resources in our marketing efforts to attract and retain VIPs and other medical professionals.

Our marketing

activities to date have had limited impact in terms of overall market penetration, and have been principally focused on increasing brand

awareness in the communities in which we provide services.

We expect to continue to undertake aggressive marketing campaigns to increase

medical and dental community awareness about our product and service capabilities.

We conduct our marketing efforts in local areas primarily

through various social media and online channels, radio advertisements, physician referrals, other professional referrals, and community

event sponsorships.

If we are not successful in these efforts, we will have incurred expenses without materially increasing revenue.

OSA market is highly competitive, including competition for patients, strategic relationships, and commercial payor contracts.

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However, we have limited clinical evidence to support our beliefs that

patient compliance in the use of our products is superior to competitive products.

If actual patient compliance as studied in a clinical

trial (should we conduct one) proves less than what we had anticipated, the acceptance of The Vivos Method in the marketplace,

and our revenues and overall results of operations, may be adversely impacted.

healthcare programs may reduce reimbursement rates, which could adversely affect sales of our appliances and demand for

dental practitioners from becoming or remaining VIPs.

patient compliance in the use of our products as well as actual clinical outcomes are superior to competitive products.

If actual patient

compliance as studied in a clinical trial (should we conduct one) proves less than what we had anticipated, the acceptance of

The Vivos Method in the marketplace, and our revenues and overall results of operations, may be adversely impacted.

healthcare programs may reduce reimbursement rates, which could adversely affect sales of our appliances and demand for dental practitioners

from becoming or remaining VIPs.

recent years, new legislation has been proposed and adopted at both the federal and state level that is effecting major changes in the

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Any change in the laws, regulations, or policies governing the healthcare system could adversely affect reimbursement

rates, which could adversely affect sales of the our appliances and thus adversely affect our operations and financial condition.

rates, which could adversely affect sales of our appliances and thus adversely affect our operations and financial condition.

in 2010, the Affordable Care Act (or ACA) seeks to expand healthcare coverage, while increasing quality and limiting costs.

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federal and state healthcare reforms measures there could be limits to the amounts that federal and state governments will pay for healthcare

services, which could result in reduced demand for, or profitability of our appliances and for dental practitioners from becoming

or remaining VIPs.

services, which could result in reduced demand for, or profitability of our appliances and for dental practitioners from becoming or

remaining VIPs.

uncertainty exists as to the reimbursement status of healthcare products.

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In addition, although the United States Supreme Court has upheld the constitutionality of most of the ACA, several states have

not implemented certain sections of the ACA, including 19 that have rejected the expansion of Medicaid eligibility for low-income

citizens, and some members of the U.S.

not implemented certain sections of the ACA, including 19 that have rejected the expansion of Medicaid eligibility for low-income citizens,

and some members of the U.S.

Congress are still working to repeal the ACA.

We expect that the ACA, as currently enacted

or as it may be amended or repealed in the future, and other healthcare reform measures that may be adopted in the future, could have

a material adverse effect on our industry generally and on our ability to successfully commercialize our products.

We cannot predict

the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in

the United States or abroad.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements

or policies, or if we or our collaborators are not able to maintain regulatory compliance, our products may lose any regulatory approval

that may have been obtained and we may not achieve or sustain profitability, which would adversely affect our business.

We expect that the ACA, as currently enacted or as it may

be amended or repealed in the future, and other healthcare reform measures that may be adopted in the future, could have a material adverse

effect on our industry generally and on our ability to successfully commercialize our products.

We cannot predict the likelihood, nature

or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or our

collaborators are not able to maintain regulatory compliance, our products may lose any regulatory approval that may have been obtained

and we may not achieve or sustain profitability, which would adversely affect our business.

payments from commercial or governmental payors are significantly delayed, reduced or eliminated, our business, prospects, results of

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in coverage among various payors for similar services;

difficulty of adherence to specific compliance requirements, coding and various other procedures

mandated by responsible parties;

difficulty of adherence to specific compliance requirements, coding and various other procedures mandated by responsible parties;

institution of new coding standards;

to properly credential a dentist to enable them to bill various payors.

complexity associated with billing for The Vivos Method procedures may lead to delays in cash collections by our VIPs, resulting

in increased carrying costs associated with the aging of our accounts receivable as well as the increased potential for bad debt expense.

complexity associated with billing for The Vivos Method procedures may lead to delays in cash collections by our VIPs, resulting in increased

carrying costs associated with the aging of our accounts receivable as well as the increased potential for bad debt expense.

may incur costs resulting from security risks in connection with the electronic data processing by our partner banks.

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The laws that will affect our operations include, but are not limited to:

federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from

knowingly and willfully soliciting, receiving, offering or paying any remuneration (including

any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in

kind, in return for the purchase, recommendation, leasing or furnishing of an item or service

reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs.

This statute has been interpreted to apply to arrangements between medical device manufacturers

on the one hand, and physicians and patients on the other.

federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting,

receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly,

in cash or in kind, in return for the purchase, recommendation, leasing or furnishing of an item or service reimbursable under a

federal healthcare program, such as the Medicare and Medicaid programs.

This statute has been interpreted to apply to arrangements

between medical device manufacturers on the one hand, and physicians and patients on the other.

The Patient Protection and Affordable

Care Act, as amended (or the PPACA), amended the intent requirement of the federal Anti-Kickback

Statute and, as a result, a person or entity no longer needs to have actual knowledge of

this statute or specific intent to violate it;

civil and criminal false claims laws, including, without limitation, the False Claims Act,

and civil monetary penalty laws which prohibit, among other things, individuals or entities

from knowingly presenting, or causing to be presented, claims for payment or approval from

Medicare, Medicaid or other government payors that are false or fraudulent or making a false

statement to avoid, decrease or conceal an obligation to pay money to the federal government.

The PPACA provides, and recent government cases against medical device manufacturers support,

the view that federal Anti-Kickback Statute violations and certain marketing practices, including

off-label promotion, may implicate the False Claims Act;

federal Health Insurance Portability and Accountability Act of 1996 (or HIPAA), which created

new federal criminal statutes that prohibit a person from knowingly and willfully executing

a scheme or making false or fraudulent statements to defraud any healthcare benefit program,

regardless of the payor (e.g., public or private);

as amended by the Health Information Technology for Economic and Clinical Health Act (or

HITECH), and its implementing regulations, and as amended again by the final HIPAA omnibus

rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification

Care Act, as amended (or the PPACA), amended the intent requirement of the federal Anti-Kickback Statute and, as a result, a person

or entity no longer needs to have actual knowledge of this statute or specific intent to violate it;

civil and criminal false claims laws, including, without limitation, the False Claims Act, and civil monetary penalty laws which

prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or

approval from Medicare, Medicaid or other government payors that are false or fraudulent or making a false statement to avoid, decrease

or conceal an obligation to pay money to the federal government.

The PPACA provides, and recent government cases against medical

device manufacturers support, the view that federal Anti-Kickback Statute violations and certain marketing practices, including off-label

promotion, may implicate the False Claims Act;

federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal statutes that

prohibit a person from knowingly and willfully executing a scheme or making false or fraudulent statements to defraud any healthcare

benefit program, regardless of the payor (e.g., public or private);

as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and its implementing regulations,

and as amended again by the final HIPAA omnibus Rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification

Rules Under HITECH and the Genetic Information Nondiscrimination Act;

Other Modifications

to HIPAA, published in January 2013, which imposes certain requirements relating to the privacy,

security and transmission of individually identifiable health information without appropriate

authorization by entities subject to the rule, such as health plans, health care clearinghouses

and health care providers, and their respective business associates;

transparency laws, including the federal Physician Payments Sunshine Act, which is part of

the PPACA, that require certain manufacturers of drugs, devices, biologics and medical supplies

for which payment is available under Medicare, Medicaid or the Children’s Health Insurance

Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid

Services (or CMS), information related to:

(i) payments or other “transfers of value’’

made to physicians and teaching hospitals;

and (ii) ownership and investment interests held

by physicians and their immediate family members;

and foreign law equivalents of each of the above federal laws, state laws that require manufacturers

to report information related to payments and other transfers of value to physicians and

other healthcare providers or marketing expenditures, and state laws that require medical

device companies to comply with the specific industry’s voluntary compliance guidelines

and the relevant compliance guidance promulgated by the federal government or to adopt compliance

programs as prescribed by state laws and regulations, or that otherwise restrict payments

that may be made to healthcare providers;

and foreign laws that govern the privacy and security of health information in some circumstances,

many of which differ from each other in significant ways and often are not preempted by HIPAA,

thus complicating compliance efforts.

Other Modifications to HIPAA, published in January 2013, which

imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information without

appropriate authorization by entities subject to the rule, such as health plans, health care clearinghouses and health care providers,

and their respective business associates;

transparency laws, including the federal Physician Payments Sunshine Act, which is part of the PPACA, that require certain manufacturers

of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s

Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (or CMS),

information related to:

(i) payments or other “transfers of value’’ made to physicians and teaching hospitals;

and (ii) ownership and investment interests held by physicians and their immediate family members;

and foreign law equivalents of each of the above federal laws, state laws that require manufacturers to report information related

to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, and state laws that

require medical device companies to comply with the specific industry’s voluntary compliance guidelines and the relevant compliance

guidance promulgated by the federal government or to adopt compliance programs as prescribed by state laws and regulations, or that

otherwise restrict payments that may be made to healthcare providers;

and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each

other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our

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increases the possibility that a healthcare company may run afoul of one or more of the requirements.

misuse or off-label use of our appliances and associated protocols may harm our reputation in the marketplace, 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.

misuse or off-label use of The Vivos Method may harm our reputation in the marketplace, 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.

train our marketing personnel and direct sales force to not promote the oral appliances of The Vivos Method for uses outside of the FDA-cleared

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There may be increased risk of injury or other

side effects to patients if physicians attempt to use our appliances and associated protocols off label.

side effects to patients if physicians attempt to use our appliances and associated treatments off label.

Furthermore, the use of our

appliances and associated protocols for indications other than those cleared by the FDA or cleared by any foreign regulatory body may

appliances and associated treatments for indications other than those cleared by the FDA or cleared by any foreign regulatory body may

not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and patients.

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healthcare programs and the curtailment of our operations.

addition, dentists may misuse our appliances within The Vivos Method or use improper techniques if they are not adequately trained, potentially

leading to injury and an increased risk of product liability.

If The Vivos Method is misused or used with improper technique, we may

become subject to costly litigation by our customers or their patients.

Similarly, in an effort to decrease costs, physicians may also

reuse our appliances despite them being intended for a single use or may purchase reprocessed Vivos appliances from third-party processors

in lieu of purchasing a new Vivos appliance from one of our contract manufacturers, which could result in product failure and liability.

Product liability claims could divert management’s attention from our core business, be expensive to defend and result in sizeable

damage awards against us that may not be covered by insurance.

may pursue acquisitions of complementary businesses or technologies, which could divert the attention of management and which may not

be integrated successfully into our existing business.

may pursue acquisitions or licenses of technology to, among other things, expand the scope of products services we provide.

guarantee that we will identify suitable acquisition candidates, that acquisitions will be completed on acceptable terms or that we will

be able to successfully integrate the operations of any acquired business into our existing business.

The acquisitions could be of significant

size and involve operations in multiple jurisdictions.

The acquisition and integration of another business or technology would divert

management attention from other business activities, including our core business.

This diversion, together with other difficulties we

may incur in integrating an acquired business or technology, could have a material adverse effect on our business, financial condition

addition, dentists may misuse our appliances within The Vivos Method or use improper techniques if they are not adequately trained or

if they deviate in their techniques or protocols from those we promulgate and endorse, potentially leading to injury and an increased

risk of product liability.

If The Vivos Method is misused or used with improper technique, we may become subject to costly litigation

by our customers or their patients.

Similarly, in an effort to decrease costs, physicians may also reuse our appliances despite them

being intended for a single use or may purchase reprocessed Vivos appliances from third-party processors in lieu of purchasing a new

Vivos appliance from one of our contract manufacturers, which could result in product failure and liability.

Product liability claims

could divert management’s attention from our core business, be expensive to defend and result in sizeable damage awards against

us that may not be covered by insurance.

is also possible that alternative products available in the market that make claims similar to ours may cause confusion or the impression

that such products are substantially the same, or work in substantially the same manner as our products, or that they have similar regulatory

approvals or are backed by clinical research.

If that were to occur, the company may lose market share or be unfairly lumped into any

regulatory or legal actions that may arise from such third-party claims.

have undertaken and plan to continue to explore acquisitions of complementary businesses or technologies, which could divert the attention

of management, and which may not be integrated successfully into our existing business.

have undertaken and plan to continue to explore acquisitions or licenses of technology to, among other things, expand the scope of products

services we provide.

Examples of our implementation of this strategy include our (i) late February 2023 acquisition of c ertain

and international patents, product rights, and other miscellaneous intellectual property from Advanced Facialdontics, LLC, (ii)

March 2021 acquisition certain assets related to our OMT service in March 2021 from MyoCorrect, LLC, and (iii) April 2021 acquisition

of certain medical billing and practice management software, licenses and contracts (including the software underlying AireO2) from Lyon

Management and Consulting, LLC .

The acquisition and integration of another business or technology

can divert management attention from other business activities, including our core business.

This diversion, together with other difficulties

we may incur in integrating an acquired business or technology, could have a material adverse effect on our business, financial condition

and results of operations.

In addition, we may borrow money or issue capital stock to finance acquisitions.

Such borrowings might not

be available on terms as favorable to us as our current borrowing terms and may increase our leverage, and the issuance of capital stock

could dilute the interests of our stockholders.

for future potential acquisitions, we cannot guarantee that we will identify suitable acquisition candidates, that acquisitions will

be completed on acceptable terms or that we will be able to successfully integrate the operations of any acquired business into our existing

The acquisitions could be of significant size and involve operations in multiple jurisdictions.

In addition, we may borrow

money or issue capital stock to finance acquisitions.

Such borrowings might not be available on terms as favorable to us as our current

borrowing terms and may increase our leverage, and the issuance of capital stock could dilute the interests of our stockholders.

business is seasonal, which impacts our results of operations.

believe that the patient volumes of our VIPs will be sensitive to seasonal fluctuations in urgent care and primary care activity.

winter months see a higher occurrence of influenza, bronchitis, pneumonia and similar illnesses;

however, the timing and severity of

these outbreaks vary dramatically.

Additionally, as consumers shift toward high deductible insurance plans, they are responsible for

a greater percentage of their bill, particularly in the early months of the year before other healthcare spending has occurred, which

may lead to lower than expected patient volume or an increase in bad debt expense during that period.

Our quarterly operating results

may fluctuate significantly in the future depending on these and other factors.

Historically,

our fourth quarters tend to be our best performing quarters, both in terms of new VIP enrollments as well as appliance sales from case

starts, while the first quarters have tended to be our worst.

We believe that the patient volumes of our VIPs will be sensitive to seasonal

fluctuations in urgent care and primary care activity.

Typically, winter months see a higher occurrence of influenza, bronchitis, pneumonia

and similar illnesses;

however, the timing and severity of these outbreaks vary dramatically.

Additionally, as consumers shift toward

high deductible insurance plans, they are responsible for a greater percentage of their bill, particularly in the early months of the

year before other healthcare spending has occurred, which may lead to lower than expected patient volume or an increase in bad debt expense

during that period.

Our quarterly operating results may fluctuate significantly in the future depending on these and other factors.

could be subject to lawsuits for which we are not fully insured.

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substantially rely on the efforts of our current senior management, including our Chief Executive Officer, R.

Kirk Huntsman and our Chief

Financial Officer, Brad Amman.

Kirk Huntsman, our Chief

Financial Officer, Brad Amman, Susan McCullough, our EVP of Operations, and Patrick Kircher, our EVP of Sales and Marketing, among others.

Our business would be impeded or harmed if we were to lose their services.

In addition, if we are unable

to attract, train and retain highly skilled technical, managerial, product development, sales and marketing personnel, we may be at a

competitive disadvantage and unable to develop new products or increase revenue.

The failure to attract, train, retain and effectively

manage employees could negatively impact our research and development, sales and marketing and reimbursement efforts.

In particular,

the loss of sales personnel could lead to lost sales opportunities as it can take several months to hire and train replacement sales

Uncertainty created by turnover of key employees could adversely affect our business.

In addition, if we are unable to attract, train and retain

highly skilled technical, managerial, product development, sales and marketing personnel, we may be at a competitive disadvantage and

unable to develop new products or increase revenue.

The failure to attract, train, retain and effectively manage employees could negatively

impact our research and development, sales and marketing and reimbursement efforts.

In particular, the loss of sales personnel could

lead to lost sales opportunities as it can take several months to hire and train replacement sales personnel.

Uncertainty created by

turnover of key employees could adversely affect our business.

of our Board of Directors and our executive officers will have other business interests and obligations to other entities.

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laws with respect to our activities outside the United States.

distribute our products to locations within and outside the United States in Canada.

Our business plan also anticipates VIP offices outside

the United States and Canada.

Foreign Corrupt Practices Act, and other similar anti-bribery and anti-kickback laws and regulations,

generally prohibit companies and their intermediaries from making improper payments to non-U.S.

officials for the purpose of obtaining

or retaining business.

As we expect to expand our international operations in the future, we will become increasingly subjected to these

laws and regulations.

We cannot assure you that we will be successful in preventing our agents from taking actions in violation of these

laws or regulations.

Such violations, or allegations of such violations, could disrupt our business and result in a material adverse

effect on our financial condition, results of operations and cash flows.

distribute our products to locations within and outside the United States and Canada.

Our business plan also anticipates VIP offices

outside the United States and Canada.

Foreign Corrupt Practices Act, and other similar anti-bribery and anti-kickback laws and

regulations, generally prohibit companies and their intermediaries from making improper payments to non-U.S.

officials for the purpose

of obtaining or retaining business.

As we expect to expand our international operations in the future, we will become increasingly subjected

to these laws and regulations.

We cannot assure you that we will be successful in preventing our agents from taking actions in violation

of these laws or regulations.

Such violations, or allegations of such violations, could disrupt our business and result in a material

adverse effect on our financial condition, results of operations and cash flows.

Related to Our Products and Regulation

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depend, in large part, on The Vivos Method technology.

The loss of this key technology would seriously impair our business and future

viability, and could result in delays in developing, introducing or maintaining our protocols/products until equivalent technology, if

available, is identified, licensed and integrated.

In addition, any defects in the products of The Vivos Method technology or other technologies

we gain access to in the future could prevent the implementation or impair the functionality of our products, delay new product introductions

or injure our reputation.

If we are required to acquire or enter into license agreements with third parties for replacement technologies,

we could be subject to higher fees, milestone or royalty payments, assuming we could access such technologies at all.

failure to obtain government approvals, including required FDA approvals, or to comply with ongoing 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.

The loss or dilution of the trade secrets and other intellectual property that

comprises this key technology would seriously impair our business and future viability, and could result in delays in developing, introducing

or maintaining our treatments/products until equivalent technology, if available, is identified, licensed and integrated.

any defects in the products of The Vivos Method technology or other technologies we gain access to in the future could prevent the implementation

or impair the functionality of our products, delay new product introductions or injure our reputation.

If we are required to acquire

or enter into license agreements with third parties for replacement technologies, we could be subject to higher fees, milestone or royalty

payments, assuming we could access such technologies at all.

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.

development activities and the manufacture and marketing of The Vivos Method are subject to extensive regulation for safety, efficacy

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our 510(k)’s and, ultimately, our ability to commercialize our product candidates and generate product revenue.

Each Class I and

Class II medical device marketed in the U.S.

Generally, Class

II medical device marketed in the U.S.

must receive a 510(k) clearance from the FDA.

A 510(k) is a premarket submission made to

FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent (or SE), to a

legally marketed device.

A 510(k) is a premarket submission made to FDA to

demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent (or SE), to a legally

marketed device.

Companies must compare their device to one or more similar legally marketed devices, commonly known as “predicates”,

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restrictions, partial suspension or total shutdown of production;

our requests for a 510(k) clearance of new products;

our requests for a 510(k) clearance of new products or new uses of existing products;

a 510(k) clearance already granted;

have received an FDA warning letter in the past when such a letter was received by our subsidiary BioModeling Solutions, Inc.

(“BioModeling”

or “BMS”) in January 2018 following a routine FDA audit.

In its letter, the FDA noted matters such as inadequate documentation

of certain FDA-required procedures, not keeping certain records and materials in paper format and in triplicate, and using certain descriptive

words and phrases on its website and in marketing materials that were unapproved in advance by FDA.

While we believe these issues have

been resolved, to date the FDA has made no definitive statement that the matters raised by such letter have been satisfactorily resolved.

(“BioModeling” or “BMS”) in January 2018 following a routine FDA audit.

In its letter, the FDA noted matters

such as inadequate documentation of certain FDA-required procedures, not keeping certain records and materials in paper format and

in triplicate, and using certain descriptive words and phrases on its website and in marketing materials that were unapproved in

advance by FDA.

On January 31, 2023, the FDA sent us a letter stating that, based on their evaluation, the violations contained in

warning letter were addressed, and therefore the warning letter was considered closed-out.

Future FDA inspections and regulatory

activities will further assess the adequacy and sustainability of those corrections, and we may again become subject to FDA review and scrutiny, which could adversely impact our business.

FDA also has the authority to request repair, replacement or refund of the cost of any medical device manufactured or distributed by

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regression or relapse.

treatment using the FDA registered DNA appliance began in 2009, while treatment for mild to moderate OSA using the FDA cleared mRNA

appliance began in 2014.

Both began under the prior business model of our predecessor (and now subsidiary) BMS, and well before our

Under the BMS model, the independent treating dentists generated and maintained all records of treatment and ordered

their appliances directly from one of the BMS designated labs.

Thus, with the exception of specific patients who participated in

studies, clinical trials or case reports, we have had limited visibility into patient records which might contain data on this

Therefore, we have limited empirical data to support our view that the risk of post treatment regression or relapse is not

To the extent a material number of patients who were treated with The Vivos Method were to be found to experience

post-treatment relapse or regression, it could pose a significant risk to our brand, the willingness or ability of physicians to

prescribe and dentists to use our products and the willingness of patients to engage in treatment with our products and could thus

have a material adverse effect on our results of operations.

treatment using the FDA registered DNA appliance began in 2009, while treatment for mild to moderate OSA using the FDA cleared mRNA appliance

began in 2014.

Both began under the prior business model of our predecessor (and now subsidiary) BMS, and well before our formation.

Under the BMS model, the independent treating dentists generated and maintained all records of treatment and ordered their appliances

directly from one of the BMS designated labs.

Thus, with the exception of specific patients who participated in studies, clinical trials

or case reports, we have had limited visibility into patient records which might contain data on the long-term durability and stability

of our treatment beyond just a few years.

Therefore, we have limited empirical data to support our view that the risk of post treatment

regression or relapse is not significant.

To the extent a material number of patients who were treated with The Vivos Method were to

be found to experience post-treatment relapse or regression, it could pose a significant risk to our brand, the willingness or ability

of physicians to prescribe and dentists to use our products and the willingness of patients to engage in treatment with our products

and could thus have a material adverse effect on our results of operations.

are subject to potential risks associated with the need to comply with state or other DSO laws.

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in Colorado wherein we do employ dentists under a provider network model consistent with Colorado law.

In that respect, for Colorado

only, we may be regarded as a DSO.

Nevertheless, if we were deemed to be a DSO in any jurisdiction, it could make it difficult or impossible

for us to recruit and retain qualified dentists as VIPs, as some state dental boards are sometimes adverse to corporate DSOs operating

in their states.

Moreover, where such DSO-provider relationships are permitted, such regulations may impose significant constraints on

the structure and financial arrangements that are permissible between us and our affiliated dentists in a particular state.

In that respect, we may be regarded

In addition, we have begun to strategically establish a nationwide network of professional corporations, owned by independent

licensed dentists in each state, in order to lay the regulatory groundwork for our Airway Alliance model and program.

In essence, Airway

Alliance will operate in similar fashion to a DSO, thus providing us with what we believe to be certain strategic and competitive advantages.

Nevertheless, to the extent we are deemed to be a DSO in any jurisdiction, it could make it difficult or impossible for us to recruit

and retain qualified dentists as VIPs, as some state dental boards are sometimes adverse to corporate DSOs operating in their states.

Moreover, where such DSO-provider relationships are permitted, such regulations may impose significant constraints on the structure and

financial arrangements that are permissible between us and our affiliated dentists in a particular state.

jurisdictions where laws allow DSOs to operate (which includes almost all U.S.

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your common stock quickly or at the market price if trading in our securities is not active.

market price of our common stock may be highly volatile, and you could lose all or part of your investment.

market price of our common stock has been and may continue to be highly volatile, which creates the risk of substantial losses for investors.

market price of our common stock has at times been, and is likely in the future to be, volatile.

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with Nasdaq’s listing requirements.

During 2022, we received two notices from Nasdaq informing us of our failure to comply with

two continuing Nasdaq listing requirements:

failure to timely file our reports with the SEC, and failure to achieve the Nasdaq minimum

bid price for 30 consecutive trading days.

While both of these deficiencies were cleared by January 2023, we may again become subject

to potential delisting from Nasdaq if we are unable to comply with all continued listing requirements.

terms of our January 2023 private placement could hamper our fundraising efforts.

January 2023, we engaged in an $8 million private placement with a single institutional investor.

The terms of the Securities Purchase

Agreement related to such private placement contains certain restrictions that could hamper our future fundraising efforts.

Specifically:

from January 5, 2023 until May 9, 2023, neither our company nor any subsidiary

of our company shall (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of common

stock or securities convertible into or exercisable for common stock or (ii) file any registration statement or any amendment or supplement

thereto, in each case other than as contemplated by the Registration Rights Agreement we entered into with the investor;

from January 5, 2023 until November 8, 2023, we shall be prohibited from effecting

or entering into an agreement to effect any issuance by us or any of our subsidiaries of any shares of common stock or securities convertible

into or exercisable for common stock (or a combination of units thereof) involving a “variable rate transaction”, meaning

a transaction in which we (i) issue or sell any debt or equity securities that are convertible into, exchangeable or exercisable for,

or include the right to receive, additional shares of common stock either (i) at a conversion price, exercise price or exchange rate

or other price that is based upon, and/or varies with, the trading prices of or quotations for the shares of common stock at any time

after the initial issuance of such debt or equity securities or (ii) with a conversion, exercise or exchange price that is subject to

being reset at some future date after the initial issuance of such debt or equity security or upon the occurrence of specified or contingent

events directly or indirectly related to our business or the market for the common stock or (ii) enter into, or effect a transaction

under, any agreement, including, but not limited to, an equity line of credit, whereby we may issue securities at a future determined

existence of these restrictions could reduce the number of fundraising structures available to us, or could discourage potential investors

from making offers of investment to us.

As a result, we may find it more difficult to raise required funding at times and on terms we

deem desirable, and our inability to raise necessary funding could have a material adverse effect on our company and stock price.

our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares.

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stock, and therefore stockholders may have difficulty selling their shares.

See “Certain Relationships and Related Party Transactions”

for further information on the foregoing transactions with Dr.

can be no assurance that we will ever provide liquidity to our investors through a sale of our company.

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stockholder approval.

officers and directors and their affiliates (primarily Kirk Huntsman) currently own shares, in the aggregate, representing approximately

14% of our outstanding voting capital stock.

officers and directors and their affiliates (primarily Kirk Huntsman) currently own shares of common stock, in the aggregate, representing

approximately 7.6% of our outstanding voting capital stock.

In addition, Dr.

Dave Singh, our former Chief Medical Officer and director, owns an additional

17.8% of our outstanding voting stock.

As a result, if these stockholders and any associated stockholders were to choose to act

together, they have and may continue to be able to exert significant control over certain matters submitted to our stockholders for approval

by having the ability to block certain proposals.

For example, these persons, if they choose to act collectively, would have the ability

to vote against and block a proposed merger, consolidation or sale of all or substantially all of our assets.

This concentration of voting

power could delay or prevent an acquisition of our company on terms that other stockholders may desire.

addition, this concentration of voting power was evidenced in April 2020, when Mr.

Huntsman, Dr.

Singh and a small group of additional

shareholders acted to remove three independent members of our board of directors and appoint new members of our board of directors.

shareholders could continue to exert this voting power.

Dave Singh, our former Chief Medical Officer and director,

owns an additional 10.8% of our outstanding voting stock.

As a result, if these stockholders and any associated stockholders were to

choose to act together, they have and may continue to be able to exert control over certain matters submitted to our stockholders for

approval by having the ability to block certain proposals.

For example, these persons, if they choose to act collectively, would have

the ability to vote against and block a proposed merger, consolidation or sale of all or substantially all of our assets.

This concentration

of voting power could delay or prevent an acquisition of our company on terms that other stockholders may desire.

of activist shareholders could be disruptive and potentially costly and the possibility that activist shareholders may seek changes that

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directors, officers, or employees.

bylaws provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware (or, if

the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware) will be the exclusive

bylaws provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware (or, if the

Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware) will be the exclusive forum for:

(i) any derivative action or proceeding brought on behalf of our company;

(ii) any action asserting a claim for breach of

a fiduciary duty owed by any director, officer, employee, or agent of ours to us or our stockholders;

(iii) any action

asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, the Certificate of Incorporation, or

and (iv) any action asserting a claim governed by the internal affairs doctrine (the “Delaware Forum

Our bylaws further provide that, unless we consent in writing to the selection of an alternative forum, the

federal district courts of the United States of America shall be the sole and exclusive forum for resolving any complaint asserting

a cause of action arising under the Securities Act (the “Federal Forum Provision”).

In addition, our bylaws provide that

any person or entity purchasing or otherwise acquiring any interest in shares of our common stock is deemed to have notice of and

consented to the Delaware Forum Provision and the Federal Forum Provision.

(ii) any action asserting a claim for breach of a fiduciary

duty owed by any director, officer, employee, or agent of ours to us or our stockholders;

(iii) any action asserting a claim arising

pursuant to any provision of the Delaware General Corporation Law, the Certificate of Incorporation, or the bylaws;

and (iv) any action

asserting a claim governed by the internal affairs doctrine (the “Delaware Forum Provision”).

Our bylaws further provide

that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America

shall be the sole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act (the “Federal

Forum Provision”).

In addition, our bylaws provide that any person or entity purchasing or otherwise acquiring any interest in

shares of our common stock is deemed to have notice of and consented to the Delaware Forum Provision and the Federal Forum Provision.

27 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), creates exclusive federal jurisdiction over all

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perhaps substantially.

In general, under Sections 382 and 383 of the Internal Revenue Code of

1986, as amended (or the Code), a corporation that undergoes an “ownership change,” generally defined as a greater than 50%

change by value in its equity ownership over a three-year period, is subject to limitations on its ability to utilize its pre-change net

operating losses (“NOLs”), carryforwards to offset future taxable income.

Our existing NOLs may be subject to limitations

arising from previous ownership changes.

If we undergo, or are deemed to have previously undergone, an ownership change, our ability to

utilize NOLs carryforwards could be limited (perhaps substantially) by Sections 382 and 383 of the Code.

Additionally, future changes

in our stock ownership, some of which might be beyond our control, could result in an ownership change under Section 382 of the Code.

For these reasons, in the event we experience or are deemed to have experienced an “ownership change” for these purposes,

we may not be able to utilize a material or even a substantial portion of the NOLs carryforwards, even if we attain profitability.

have not completed a Code Section 382 analysis regarding any limitation on our NOL carryforwards.

general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (or the Code), a corporation that undergoes an “ownership

change,” generally defined as a greater than 50% change by value in its equity ownership over a three-year period, is subject to

limitations on its ability to utilize its pre-change net operating losses (“NOLs”), carryforwards to offset future taxable

Our existing NOLs may be subject to limitations arising from previous ownership changes.

If we undergo, or are deemed to have

previously undergone, an ownership change, our ability to utilize NOLs carryforwards could be limited (perhaps substantially) by Sections

382 and 383 of the Code.

Additionally, future changes in our stock ownership, some of which might be beyond our control, could result

in an ownership change under Section 382 of the Code.

For these reasons, in the event we experience or are deemed to have experienced

an “ownership change” for these purposes, we may not be able to utilize a material or even a substantial portion of the NOLs

carryforwards, even if we attain profitability.

We have not completed a Code Section 382 analysis regarding any limitation on our NOL

carryforwards.

financial and operational projections that we may make from time to time are subject to inherent risks.

44 unchanged sentences

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What changed 10-K

Item 1A. Risk Factors