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Item 1A. Risk Factors

2022-03-31 compared with 2021-03-25 · 1387 added, 1429 removed, 193 unchanged (94% 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

business has a limited operating history on which you can evaluate our past performance and future prospects.

business has a limited operating history, and we continue to refine our business model, which makes it difficult to evaluate our past

performance and future prospects.

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

This is particularly

true because our current VIP-focused business model was only commenced in mid-2018.

Therefore, you have even more limited historical

operating data on which to evaluate the results of and prospects for our current business model.

true because our current VIP-focused business model only commenced in mid-2018.

In addition, since the roll out of our VIP-focused business

model, we have continued to refine our strategies, for example by experimenting with different VIP enrollment and subscription plans

and by adding strategic offerings like OMT.

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

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

have a history of operating losses and may never achieve cash flow positive or profitable results of operations.

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

For the fiscal years

ended December 31, 2020 and 2019, we reported net losses of $12,056,877 and $10,754,319 respectively, and negative cash flow

from operating activities of $5,680,294 and $5,340,480, respectively.

As of December 31, 2020, we had an aggregate

accumulated deficit of $35,334,728.

We anticipate that we will continue to report losses and negative cash flow.

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 operate our business profitably would damage our reputation and stock price.

Our independent auditors issued

an audit opinion with respect to our consolidated financial statements for the year ended December 31, 2019 that indicated

that there was a substantial doubt about our ability to continue as a going concern, and this may occur again if we do not

achieve positive results of operations in the future.

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

Such funding, even if obtained, could result in substantial

dilution or significant debt service obligations.

We may not be able to obtain additional capital on commercially reasonable terms

in a timely manner, which could adversely affect our liquidity, financial position, and ability to continue operations.

order to fund and grow our business, we will need to obtain additional financing, either through borrowings, private offerings,

public offerings, or some type of business combination, such as a merger, or buyout, and there can be no assurance that we will

be successful in such pursuits.

We may be unable to acquire the additional funding necessary to fund our growth or to continue

Accordingly, if we are unable to generate adequate cash from operations, and if we are unable to find sources of funding,

it may be necessary for 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 operations.

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.

In addition, any

future sale of our equity securities would dilute the ownership and control of your shares and could be at prices substantially

below prices at which our shares currently trade.

Our inability to raise capital, coupled with our inability to generate adequate

cash from operations, could require us to significantly curtail or terminate our operations.

We may seek to increase our cash

reserves through the sale of additional equity or debt securities.

The sale of convertible debt securities or additional equity

securities could result in additional and potentially substantial dilution to our shareholders.

The incurrence of indebtedness

would result in increased debt service obligations and could result in operating and financing covenants that would restrict our

operations and liquidity and ability to pay dividends.

In addition, our ability to obtain additional capital on acceptable terms

is subject to a variety of uncertainties.

We cannot assure you that financing will be available in amounts or on terms acceptable

to us, if at all.

Any failure to raise additional funds on favorable terms could have a material adverse effect on our liquidity

and financial condition.

have identified a material weakness in our internal control over financial reporting.

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, 2020 and 2019, 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 arose from an accumulation of significant

deficiencies which amounted to a material weakness in internal controls.

Such significant deficiencies identified included insufficient

supporting documentation and inadequate review of certain journal entries, segregation of duties, and inadequate application of

accounting guidance.

If we are unable to remedy our material weakness, 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.

will not be successful if our Vivos System is not sufficiently adopted by the medical and dental communities, including independent

practitioners and dental service organizations (DSOs) for the treatment of craniofacial deficiencies that are often associated

with SDB and mild-to-moderate OSA.

believe that the Vivos System is the first commercially available product based on our proprietary technology for the treatment

of craniofacial deficiencies that are often associated with SDB and mild-to-moderate OSA.

Our success depends both on the sufficient

acceptance and adoption by the medical/dental community of our Vivos System as a non-invasive treatment for the treatment of craniofacial

deficiencies that are often associated with SDB and mild-to-moderate OSA, and heightening public awareness of the prevalence of

mild-to-moderate OSA to increase the number of undiagnosed patients with SDB and mild-to-moderate OSA who seek treatment.

a relatively limited number of dentists and other medical clinicians provide treatment with the Vivos System.

We cannot predict

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

us to be successful:

dentist customers and referring physicians must believe that the Vivos System 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 SDB or mild-to-moderate OSA and referring physicians must write a prescription for the

use of the Vivos System;

dentist customers must use our Vivos System to treat craniofacial deficiencies that are often associated with SDB and mild-to-moderate

OSA either as a stand-alone treatment or in combination with procedures to treat other areas of upper airway obstruction,

and achieve acceptable clinical outcomes in the patients they treat;

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

out-of-pocket for treatment in the Vivos System is the best alternative to either doing nothing or entering into another treatment

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 SDB or mild-to-moderate

OSA using the Vivos System.

have shown that a significant percentage of people who have SDB or OSA remain undiagnosed and therefore do not seek treatment,

or those who are diagnosed with SDB or OSA may be reluctant to seek treatment or incur significant costs of treatment given the

less severe nature of their condition, the potentially negative lifestyle effects of traditional treatments, and the lack of awareness

of new treatment options.

If we are unable to increase public awareness of the prevalence of SDB or OSA due to untreated craniofacial

deficiencies or if the medical/dental community is slow to adopt, or fails to adopt, the Vivos System as a treatment for individuals

with SDB or mild-to-moderate OSA, we would suffer a material adverse effect on our business, financial condition and results of

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.

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 limited experience operating our company

through this model.

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

subject to many risks associated with this new business model that we are unable to presently identify, such as pricing, competition,

marketing and regulatory risks.

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 System.

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

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

expect to derive a substantial portion of our future revenue from sales of a single product (the Vivos System) through our VIPs

and the offering of related services, which leaves us reliant on the commercial viability of the Vivos System.

our primary product is our Vivos System.

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

including Billing Intelligence Services, Airway Intelligence System, AireO 2 and VivoScore.

We expect that sales of

our Vivos System and our services to our VIPs related to the use of such product will account for a significant majority of our

revenue for the foreseeable future.

We currently market and sell our Vivos System 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.

Because the Vivos System

is different from current surgical and non-surgical treatments for SDB or OSA, we cannot assure you that dentists in corroboration

with physicians will use the Vivos System or become VIPs, and demand for our Vivos System may decline or may not increase as quickly

as we expect.

Also, we cannot assure you that the Vivos System will compete effectively as a treatment alternative to other more

well-known and well-established therapies, such as CPAP, mandibular advancement, or palatal surgical procedures.

Since our Vivos

System and other oral appliances currently represent our only products, and since our VIP program is our primary means of commercialization,

we are significantly reliant on the level of recurring sales of the Vivos System and other oral appliances, 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.

face risks relating to public health conditions such as the COVID-19 pandemic, which could adversely affect our dentist customers,

our business and our results of operations .

business and prospects has 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) or any other similar diseases in the future.

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.

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

Such funding, even if obtained, could result in substantial dilution

or significant debt service obligations.

We may not be able to obtain additional capital on commercially reasonable terms in a timely

manner or at all, which could adversely affect our liquidity, financial position, and ability to continue operations.

order to fund and grow our business, we will need to obtain additional financing, either through borrowings, private offerings, public

offerings, or some type of business combination, such as a merger, or buyout, and there can be no assurance that we will be successful

in such pursuits.

We may be unable to acquire the additional funding necessary to fund our growth or to continue operating.

if we are unable to generate adequate cash from operations, and if we are unable to find sources of funding, it may be necessary for

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.

In addition, any future

sale of our equity securities would dilute the ownership and control of your shares and could be at prices substantially below prices

at which our shares currently trade.

Our inability to raise capital, coupled with our inability to generate adequate cash from operations,

could require us to significantly curtail or terminate our operations.

We may seek to increase our cash reserves through the sale of

additional equity or debt securities.

The sale of convertible debt securities or additional equity securities could result in additional

and potentially substantial dilution to our shareholders.

The incurrence of indebtedness would result in increased debt service obligations

and could result in operating and financing covenants that would restrict our operations and liquidity and ability to pay dividends.

In addition, our ability to obtain additional capital on acceptable terms is subject to a variety of uncertainties.

We cannot assure

you that financing will be available in amounts or on terms acceptable to us, if at all.

Any failure to raise additional funds on favorable

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.

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

dentofacial abnormalities and/or mild to moderate OSA and snoring, therefore we cannot assure you that dentists in corroboration with

physicians will use The Vivos Method or become VIPs, and demand for The Vivos Method may decline or may not increase as quickly as we

Also, we cannot assure you that The Vivos Method will compete effectively as a treatment alternative to other more well-known

and well-established therapies, such as CPAP, mandibular advancement, or palatal surgical procedures.

Since The Vivos Method currently

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.

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

remain undiagnosed and therefore do not seek treatment.

Many of those patients who are diagnosed with OSA may be reluctant to seek treatment

because of the significant costs of treatment given the less severe nature of their condition, the potentially negative lifestyle effects

of traditional treatments, and the lack of awareness of new treatment options.

If we are unable to increase public awareness of the prevalence

of OSA or if the medical/dental community is slow to adopt or fails to adopt The Vivos Method as a treatment for their patients, we would

suffer a material adverse effect on our business, financial condition and results of operations.

failure of large U.S.

customers or Dental Service Organizations (DSO) to pay for their purchases of The Vivos Method products and services

on a timely basis could reduce our future sales revenue and negatively impact our liquidity.

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.

To the extent

one or more of our large U.S.

dentist customers or DSO groups fails to pay us on a timely basis, we may be required to discontinue selling

to these organizations and find new customers, which could reduce our future sales revenue and negatively impact our liquidity.

face risks relating to public health conditions such as the COVID-19 pandemic, which could adversely affect our dentist customers, our

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 U.S.

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 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

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.

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.

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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growth of our VIP base depends on our ability to execute our plan to recruit and enroll new VIPs.

Our ability to recruit and enroll

VIPs depends on many factors, including our ability to:

Our ability to recruit and enroll VIPs

depends on many factors, including our ability to:

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 System;

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;

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.

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

we may not be able to achieve our planned growth or, even if we are able to grow our VIP base as planned, any new VIPs may not

be profitable or otherwise perform as planned.

Failure to successfully implement our growth strategy would likely have an adverse

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

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

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

We take into account numerous factors in identifying target markets where we can enter or expand.

number and timing of new VIPs enrolled during any given period may be negatively impacted by a number of factors including, without

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

we may not be able to achieve our planned growth or, even if we are able to grow our VIP base as planned, any new VIPs may not be profitable

or otherwise perform as planned.

Failure to successfully implement our growth strategy would likely have an adverse impact on our business,

financial condition, and results of operations.

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

dental practices.

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:

identification and availability of attractive practices to be VIPs;

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

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 System.

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.

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 our Vivos System, together with our history of losses, make prediction of future operating results

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 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 our Vivos System for the treatment of craniofacial deficiencies that

are often associated with SDB and mild-to-moderate OSA by both physicians/dentists and patients;

success of alternative therapies and surgical procedures to treat individuals with SDB, and the possible future introduction

of new products and treatments for SDB;

ability to maintain current pricing for our Vivos System;

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.

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.

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;

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, 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 System;

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 System by dentists as a result of the data from these clinical studies;

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

relating to ongoing FDA compliance;

size and timing of orders from dentists and independent distributors;

ability to obtain reimbursement for the Vivos System for the treatment of craniofacial conditions that are often associated

with SDB and OSA in the future from third-party healthcare insurers;

willingness of patients to pay out-of-pocket for treatment in the Vivos System or other Vivos oral appliances, in the absence

of reimbursement from third-party healthcare insurers, for the treatment of craniofacial conditions that are often associated

with SDB and OSA;

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 System;

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 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, including the Vivos System, 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-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;

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

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.

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

As a result, actual results may be lower

than expected from lower than expected referrals.

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 risks.

Any such failure may have an

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

is a new technology which may not be utilized by VIPs to the degree anticipated.

is a relatively new technology.

New technologies often take longer to gain acceptance within the medical and dental communities.

As a result, our financial results may be lower than expected.

As a result, actual results may be lower than

expected due to lower than expected referrals and other factors.

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 risks.

If we fail to adequately

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.

Any such failure may have

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

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.

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

Vivos System is subject to changing consumer preferences.

A shift in consumer preferences away from the product we offer would

result in significantly reduced revenue.

Vivos Method is subject to changing consumer preferences.

A shift in consumer preferences away from the protocol and products we offer

would result in significantly reduced revenue.

Our future success depends in part on our ability to anticipate and respond to changes

in consumer preferences.

Failure to anticipate and respond to changing consumer preferences in the products we market could lead

to, among other things, lower sales of products, significant markdowns or write-offs of inventory, increased product returns and

lower margins.

If we are not successful in anticipating and responding to changes in consumer preferences, our results of operations

in future periods will be materially adversely impacted.

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

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

have conducted, and continue to conduct, a number of clinical studies of the use of our Vivos System and other Vivos oral appliances

to treat patients with SDB or mild-to-moderate OSA due to craniofacial deficiencies in the United States and Canada.

We are involved

in a number of ongoing clinical studies evaluating clinical outcomes from the use of the Vivos System and other Vivos oral appliances,

including prospective, randomized, placebo-controlled studies, as well as clinical studies that are structured to obtain additional

clearances from the FDA for expanded clinical indications for use of our Vivos System.

cannot assure you that these clinical studies will continue to demonstrate that our Vivos System provides clinical effectiveness

for individuals diagnosed with SDB or mild-to-moderate OSA, nor can we assure you that the use of our Vivos System will prove

to be safe and effective in clinical studies under United States or international regulatory guidelines for any expanded indications.

Additional clinical studies of our Vivos System may identify significant clinical, technical or other obstacles that will have

to be overcome prior to obtaining clearance from the applicable regulatory bodies to market our Vivos System for such expanded

If further studies of our Vivos System indicate that the Vivos System is not a safe and effective treatment of SDB

or mild-to-moderate OSA, our ability to market our Vivos System, and generate substantial revenue from additional sales of our

Vivos Systems, may be materially limited.

Failure to anticipate and respond to changing consumer preferences in the products we market could lead to,

among other things, lower sales of products, significant markdowns or write-offs of inventory, increased product returns and lower margins.

If we are not successful in anticipating and responding to changes in consumer preferences, our results of operations in future periods

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.

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

abnormalities and/or mild to moderate OSA in the United States and Canada.

We are involved in a number of ongoing clinical studies evaluating

clinical outcomes from the use of The Vivos Method including prospective, randomized, placebo-controlled studies, as well as clinical

studies that are structured to obtain additional clearances from the FDA for expanded clinical indications for use of The Vivos Method.

cannot assure you that these clinical studies will continue to demonstrate that The Vivos Method provides clinical effectiveness for

individuals with dentofacial abnormalities and patients diagnosed with mild to moderate OSA, nor can we assure you that the use of The

Vivos Method will prove to be safe and effective in clinical studies under United States or international regulatory guidelines for any

expanded indications.

Additional clinical studies of The Vivos Method may identify significant clinical, technical or other obstacles

that will have to be overcome prior to obtaining clearance from the applicable regulatory bodies to market The Vivos Method for such

expanded indications.

If further studies of The Vivos Method indicate that it is not a safe and effective, our ability to market The

Vivos Method, and generate substantial revenue from additional sales, may be materially limited.

selected to participate in these further clinical studies must meet certain anatomical and other criteria to participate.

assure you that an adequate number of individuals can be enrolled in clinical studies on a timely basis.

Further, we cannot assure

you that the clinical studies will be completed as planned.

A delay in the analysis and publication of the positive outcomes data

from these clinical studies, or the presentation or publication of negative outcomes data from these clinical studies, including

data related to approval of our Vivos System for expanded indications, may materially impact our ability to increase revenue through

sales and negatively impact our stock price.

business and results of operations may be impacted by the extent to which patients using the Vivos System achieve adequate

levels of third-party insurance reimbursement.

practical, the Vivos System is paid for primarily out-of-pocket by patients, with any available health insurance coverage being

reimbursed if and as paid at a later date, where the patient is being treated for SDB or mild-to-moderate OSA.

cost of treatments for SDB or OSA, such as CPAP, and most surgical procedures generally are covered and reimbursed in whole or

part by third-party healthcare insurers.

The Vivos System is a customized and highly specialized combination of oral appliances

and clinical protocols, some of which currently qualify for reimbursement for the treatment of mild-to-moderate OSA and SDB.

ability to generate revenue from additional sales of our Vivos System for the treatment of SDB or OSA may be materially limited

by the extent to which reimbursement of the Vivos System for the treatment of mild-to-moderate OSA and SDB is available in the

In addition, third-party healthcare insurers are increasingly challenging the prices charged for medical products and

In the event that we are successful in our efforts to obtain reimbursement for the Vivos System, any changes in this

reimbursement system could materially affect our ability to continue to grow our business.

We cannot assure

you that an adequate number of individuals can be enrolled in clinical studies on a timely basis.

Further, we cannot assure you that

the clinical studies will be completed as planned.

A delay in the analysis and publication of the positive outcomes data from these clinical

studies, or the presentation or publication of negative outcomes data from these clinical studies, including data related to approval

of The Vivos Method for expanded indications, may materially impact our ability to increase revenue through sales and negatively impact

our stock price.

business and results of operations may be impacted by the extent to which patients using The Vivos Method achieve adequate levels of

third-party insurance reimbursement.

practical, The Vivos Method is paid for primarily out-of-pocket by patients, with any available health insurance coverage being reimbursed

if and as paid at a later date, where the patient is being treated for dentofacial abnormalities and/or mild to moderate OSA.

cost of treatments for dentofacial abnormalities and/or mild to moderate OSA, such as CPAP, and most surgical procedures generally are

covered and reimbursed in whole or part by third-party healthcare insurers.

The Vivos Method is a customized protocol often combined

with custom oral appliance therapy, some of which currently qualify for reimbursement.

Our ability to generate revenue from additional

sales of The Vivos Method for the treatment of dentofacial abnormalities and/or mild to moderate OSA may be materially limited by the

extent to which reimbursement of The Vivos Method is available in the future.

In addition, third-party healthcare insurers are increasingly

challenging the prices charged for medical products and procedures.

If we are successful in our efforts to obtain reimbursement for the

billable procedures within The Vivos Method, any changes in this reimbursement system could materially affect our ability to continue

to grow our business.

Reimbursement

and healthcare payment systems in international markets vary significantly by country and reimbursement for the Vivos System may

not be available at all under either government or private reimbursement systems.

If we are unable to achieve reimbursement approvals

in international markets, it could have a negative impact on market acceptance of our Vivos System and potential revenue growth

and healthcare payment systems in international markets vary significantly by country and reimbursement for the billable procedures within

The Vivos Method may not be available at all under either government or private reimbursement systems.

If we are unable to achieve reimbursement

approvals in international markets, it could have a negative impact on market acceptance of The Vivos Method and potential revenue growth

in the markets in which these approvals are sought.

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

us from selling our Vivos System 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 a number of governmental agencies,

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.

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 System;

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

with the rules and regulations of these various regulatory bodies may delay or prevent us from introducing any new models of our

Vivos System 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.

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

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

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.

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.

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.

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

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 pulmonologists, who are integral to the diagnosis and treatment of sleep breathing

majority of patients being treated today for SDB or 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 SDB or OSA.

If an individual is diagnosed with SDB or OSA by a pulmonologist, the pulmonologist typically

prescribes CPAP as the therapy of choice.

Although we offer the Vivos System through our VIPs, our domestic sales organization

does not generally call on pulmonologists or third-party sleep centers to sell our Vivos System, and we do not believe that most

pulmonologists today would recommend the Vivos System to their patients with SDB or mild-to-moderate OSA.

We cannot predict the

extent to which pulmonologists will, in the future, endorse or recommend the Vivos System to their SDB or mild-to-moderate OSA

patients, even for those patients who are unwilling or unable to comply with CPAP therapy.

face significant competition in the rapidly changing market for treating sleep breathing disorders, and we may be unable to manage

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.

market for treating sleep disordered breathing, including sleep apnea in people of all ages, is highly competitive and evolving

We compete as a second-line therapy in the OSA treatment market for patients with mild to moderate OSA.

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

The Vivos System 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 of treating SDB

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 SDB or 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 our Vivos System 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

our Vivos System.

Many of our competitors have substantially greater financial and other resources than we do, including larger

research and development staffs who have more experience and capability in conducting research and development activities, testing

products in clinical trials, obtaining regulatory approvals and manufacturing, marketing, selling and distributing products.

of our competitors may achieve patent protection, regulatory approval or product commercialization more quickly than we do, which

may decrease our ability to compete.

If we are unable to be competitive in the market for OSA and SDB, our revenue will decline,

which would negatively affect our results of operations.

Vivos System may become obsolete if we are unable to anticipate and adapt to rapidly changing technology.

medical device industry is subject to rapid technological innovation and, consequently, the life cycle of any particular product

can be short.

Alternative products, procedures or other discoveries and developments to treat SDB and OSA may render our Vivos

System obsolete.

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.

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

Many of our competitors have substantially greater financial and other resources than we do, including larger research and development

staffs who have more experience and capability in conducting research and development activities, testing products in clinical trials,

obtaining regulatory approvals and manufacturing, marketing, selling, and distributing products.

Some of our competitors may achieve

patent protection, regulatory approval, or product commercialization more quickly than we do, which may decrease our ability to compete.

If we are unable to be competitive in the market for OSA, our revenue will decline, which would negatively affect our results of operations.

Vivos Method may become obsolete if we are unable to anticipate and adapt to rapidly changing technology.

medical device industry is subject to rapid technological innovation and, consequently, the life cycle of any particular product can

Alternative products, procedures or other discoveries and developments to treat dentofacial abnormalities and/or OSA may render

The Vivos Method obsolete.

Furthermore, the greater financial and other resources of many of our competitors may permit them to respond

more rapidly than we can to technological advances.

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

or improve our existing Vivos System to respond to a changing market before our competitors are able to do so, our ability to

market our products 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 our Vivos

System in international markets.

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

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

ability to obtain appropriate regulatory approvals to market the Vivos System in certain countries;

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

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 periods;

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

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

changes in regulatory requirements, tariffs or other trade barriers;

intellectual property rights protection in some countries;

● potentially

adverse tax consequences;

and economic instability.

occurrence of any of these events could seriously harm our future international sales and our ability to successfully commercialize

our products in international markets, thereby limiting our growth and revenue.

are risks associated with outsourced production that may result in a decrease in profit to us.

outsource the manufacture of substantially all of our products to third-party manufacturers on a case-by-case basis.

selection of the manufacturer is at the sole discretion of the treating dentist.

However, we select our approved and certified

manufacturers by training and screening them in advance based on their capabilities, supply capacity, reputation, regulatory registration

and compliance, and other relevant traits.

Most of these manufacturers are located in the U.S., but at least one important manufacturer

is located in South Korea, and other smaller manufacturers are located in Canada.

Nonetheless, the possibility of delivery delays,

product defects, import or customs blockages, and other production-side risks stemming from outsourcers cannot be eliminated.

In particular, inadequate production capacity among outsourced manufacturers could result in our being unable to supply enough

product amid periods of high product demand, the opportunity costs of which could be substantial.

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

Our business would

be harmed if manufacturers and service providers are unable to deliver products or provide services in a timely and cost-effective

manner, or if we are unable to timely fulfill orders.

occurrence of any of these events could seriously harm our future international sales and our ability to successfully commercialize our

products in international markets, thereby limiting our growth and revenue.

depend on a few suppliers for key components, making us vulnerable to supply shortages and price fluctuation.

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.

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

practical or feasible to do so.

To mitigate this risk, we maintain an awareness of alternate supply sources that could provide our currently

single-sourced components with minimal or no modification to the current version of The Vivos Method, practice supply chain management,

maintain safety stocks of critical components and have arrangements with our key vendors to manage the availability of critical components.

Despite these efforts, if our vendors are unable to provide us with an adequate supply of components in a timely manner, or if we are

unable to locate qualified alternate vendors for components at a reasonable cost, the cost of our products would increase, the availability

of our products to our customers would decrease and our ability to generate revenue could be materially limited.

are risks associated with outsourced production that may hurt our results of operations.

outsource the manufacture of substantially all our products to third-party manufacturers on a case-by-case basis.

By law, the selection

of the manufacturer is at the sole discretion of the treating dentist.

However, we select our approved and certified manufacturers by

training and screening them in advance based on their capabilities, supply capacity, reputation, regulatory registration and compliance,

and other relevant traits.

Most of these manufacturers are located in the U.S., but at least one important manufacturer is located in

South Korea, and other smaller manufacturers are located in Canada.

In any case, the possibility of delivery delays, product defects,

import or customs blockages, and other production-side risks stemming from outsourcers creates the risk that our expenses associated

with these issues could unexpectedly increase in any period.

In addition, inadequate production capacity among outsourced manufacturers

could result in our being unable to supply enough product amid periods of high product demand, the opportunity costs of which could be

All of these risks could have a material adverse effect on our results of operations.

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

We do not anticipate

that this will change.

Our business would be

harmed if manufacturers and service providers are unable to deliver products or provide services in a timely and cost-effective manner,

or if we are unable to timely fulfill orders.

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

6 unchanged sentences

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.

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

failure of large U.S.

customers or Dental Service Organizations (DSO) to pay for their purchases of Vivos System products and

services on a timely basis could reduce our future sales revenue and negatively impact our liquidity.

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

dentists using the Vivos System, as well as expanding the number of Vivos Systems used by these physicians/dentists.

extent one or more of our large U.S.

dentist customers or DSO groups fails to pay us for Vivos Systems on a timely basis, we may

be required to discontinue selling to these organizations and find new customers, which could reduce our future sales revenue

and negatively impact our liquidity.

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 our Vivos System components and the confidentiality

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.

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

our name and mark;

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

to preserve our trade secrets and know-how;

and to operate without infringing the intellectual property rights

cannot assure investors that we will continue to innovate and file new patent applications, or that if filed any future patent

applications will result in granted patents We cannot assure you that any of our patents pending will result in issued patents,

that any current or future patents will not be challenged, invalidated or circumvented, that the scope of any of our patents will

exclude competitors or that the patent rights granted to us will provide us any competitive advantage or protect our products.

The patent position of device companies, including ours, is generally uncertain and involves complex legal and factual considerations

and, therefore, validity and enforceability cannot be predicted with certainty.

Patents may be challenged, deemed unenforceable,

invalidated or circumvented.

We will 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.

and to operate without infringing the intellectual property rights of others.

cannot assure investors that we will continue to innovate and file new patent applications, or that if filed any future patent applications

will result in granted patents We cannot assure you that any of our patents pending will result in issued patents, that any current or

future patents will not be challenged, invalidated or circumvented, that the scope of any of our patents will exclude competitors or

that the patent rights granted to us will provide us any competitive advantage or protect our products.

The patent position of device

companies, including ours, is generally uncertain and involves complex legal and factual considerations and, therefore, validity and

enforceability cannot be predicted with certainty.

Patents may be challenged, deemed unenforceable, invalidated or circumvented.

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.

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

Both the patent application process and the process of managing patent disputes can be time consuming and expensive.

to initiate legal proceedings against a third party to enforce a patent related to one of our products, the defendant in such

litigation could counterclaim that our patent is invalid and/or unenforceable.

In patent litigation in the U.S., defendant counterclaims

alleging invalidity and/or unenforceability are commonplace, as are validity challenges by the defendant against the subject patent

or other patents before the United States Patent and Trademark Office (or USPTO).

Grounds for a validity challenge could be an

alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement, failure

to meet the written description requirement, indefiniteness, and/or failure to claim patent eligible subject matter.

an unenforceability assertion could be an allegation that someone connected with prosecution of the patent intentionally withheld

material information from the USPTO, or made a misleading statement, during prosecution.

Additional grounds for an unenforceability

assertion include an allegation of misuse or anticompetitive use of patent rights, and an allegation of incorrect inventorship

with deceptive intent.

Third parties may also raise similar claims before the USPTO even outside the context of litigation.

outcome is unpredictable following legal assertions of invalidity and unenforceability.

With respect to the validity question,

for example, we cannot be certain that no invalidating prior art existed of which we and the patent examiner were unaware during

If we were to initiate

legal proceedings against a third party to enforce a patent related to one of our products, the defendant in such litigation could counterclaim

that our patent is invalid and/or unenforceable.

In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or

unenforceability are commonplace, as are validity challenges by the defendant against the subject patent or other patents before the

United States Patent and Trademark Office (or USPTO).

Grounds for a validity challenge could be an alleged failure to meet any of several

statutory requirements, including lack of novelty, obviousness or non-enablement, failure to meet the written description requirement,

indefiniteness, and/or failure to claim patent eligible subject matter.

Grounds for an unenforceability assertion could be an allegation

that someone connected with prosecution of the patent intentionally withheld material information from the USPTO, or made a misleading

statement, during prosecution.

Additional grounds for an unenforceability assertion include an allegation of misuse or anticompetitive

use of patent rights, and an allegation of incorrect inventorship with deceptive intent.

Third parties may also raise similar claims

before the USPTO even outside the context of litigation.

The outcome is unpredictable following legal assertions of invalidity and unenforceability.

With respect to the validity question, for example, we cannot be certain that no invalidating prior art existed of which we and the patent

examiner were unaware during prosecution.

These assertions may also be based on information known to us or the USPTO.

If a defendant or third party were to

prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the claims

of the challenged patent.

If a defendant

or third party were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all,

of the claims of the challenged patent.

Such a loss of patent protection would or could have a material adverse impact on our business.

standards that the USPTO (and foreign equivalents) use to grant patents are not always applied predictably or uniformly and can

There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in device

Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that

will be allowed in any patents issued to us or to others.

there can be no assurance that our technology will not be found in the future to infringe upon the rights of others or be infringed

upon by others.

standards that the USPTO (and foreign equivalents) use to grant patents are not always applied predictably or uniformly and can change.

There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in device patents.

we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents

issued to us or to others.

there can be no assurance that our technology will not be found in the future to infringe upon the rights of others or be infringed upon

Moreover, patent applications are in some cases maintained in secrecy until patents are issued.

The publication

of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying

discoveries were made and patent applications were filed.

Because patents can take many years to issue, there may be currently

pending applications of which we are unaware that may later result in issued patents that our products or product candidates infringe.

For example, pending applications may exist that provide support or can be amended to provide support for a claim that results

in an issued patent that our product infringes.

In such a case, others may assert infringement claims against us, and should we

be found to infringe upon their patents, or otherwise impermissibly utilize their intellectual property, we might be forced to

pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties’

patent rights.

In addition to any damages we might have to pay, we may be required to obtain licenses from the holders of this intellectual property.

We may fail to obtain any of these licenses or intellectual property rights on commercially reasonable terms.

Even if we are able

to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.

that event, we may be required to expend significant time and resources to develop or license replacement technology.

unable to do so, we may be unable to develop or commercialize the affected products, which could materially harm our business

and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with

respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation.

Conversely, we may not always

be able to successfully pursue our claims against others that infringe upon our technology.

Thus, the proprietary nature of our

technology or technology licensed by us may not provide adequate protection against competitors.

The publication of discoveries

in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made

and patent applications were filed.

Because patents can take many years to issue, there may be currently pending applications of which

we are unaware that may later result in issued patents that our products or product candidates infringe.

For example, pending applications

may exist that provide support or can be amended to provide support for a claim that results in an issued patent that our product infringes.

In such a case, others may assert infringement claims against us, and should we be found to infringe upon their patents, or otherwise

impermissibly utilize their intellectual property, we might be forced to pay damages, potentially including treble damages, if we are

found to have willfully infringed on such parties’ patent rights.

In addition to any damages we might have to pay, we may be required

to obtain licenses from the holders of this intellectual property.

We may fail to obtain any of these licenses or intellectual property

rights on commercially reasonable terms.

Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors

access to the same technologies licensed to us.

In that event, we may be required to expend significant time and resources to develop

or license replacement technology.

If we are unable to do so, we may be unable to develop or commercialize the affected products, which

could materially harm our business and the third parties owning such intellectual property rights could seek either an injunction prohibiting

our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation.

we may not always be able to successfully pursue our claims against others that infringe upon our technology.

Thus, the proprietary nature

of our technology or technology licensed by us may not provide adequate protection against competitors.

addition to patents, we rely on trademarks to protect the recognition of our company and product in the marketplace.

on trade secrets, know-how, and proprietary knowledge that we seek to protect, in part, through confidentiality agreements with

employees, consultants and others.

We cannot assure you that our proprietary information will not be shared, our confidentiality

agreements will not be breached, that we will have adequate remedies for any breach, or that our trade secrets will not otherwise

become known to or independently developed by competitors.

We also rely on

trade secrets, know-how, and proprietary knowledge that we seek to protect, in part, through confidentiality agreements with employees,

consultants and others.

We cannot assure you that our proprietary information will not be shared, our confidentiality agreements will

not be breached, that we will have adequate remedies for any breach, or that our trade secrets will not otherwise become known to or

independently developed by competitors.

Confidentiality

agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information

and disclosure of our trade secrets or proprietary information could compromise any competitive advantage that we have, which

could have a materially adverse effect on our business.

agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information and disclosure

of our trade secrets or proprietary information could compromise any competitive advantage that we have, which could have a materially

adverse effect on our business.

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

clinical protocols.

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

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

against us, we may lose our technological or competitive advantage, and/or we may incur substantial litigation costs in our attempts

to recover or restrict use of our intellectual property.

In addition, others may independently develop technology similar to ours,

otherwise avoiding the confidentiality agreements, or produce patents that would materially and adversely affect our business,

prospects, financial condition and results of operations in which event and you could lose all of your investment.

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.

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

may lose our technological or competitive advantage, and/or we may incur substantial litigation costs in our attempts to recover or restrict

use of our intellectual property.

In addition, others may independently develop technology similar to ours, otherwise avoiding the confidentiality

agreements, or produce patents that would materially and adversely affect our business, prospects, financial condition and results of

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

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

has been substantial litigation regarding patent and other intellectual property rights in the medical device industry, and our

competitors and others may initiate intellectual property litigation, including as a means of competition.

Intellectual property

litigation is complex and expensive, and outcomes are difficult to predict.

We cannot assure you that we will not become subject

to patent infringement claims or litigation, or interference proceedings, to determine the priority of inventions.

or regulatory proceedings also may be necessary to enforce our patent or other intellectual property rights.

We may not always

have the financial resources to assert patent infringement suits or to defend ourselves from claims.

An adverse result in any

litigation could subject us to liabilities, or require us to seek licenses from or pay royalties to others that may be substantial.

Furthermore, we cannot predict the extent to which the necessary licenses would be available to us on satisfactory terms, if at

has been substantial litigation regarding patent and other intellectual property rights in the medical device industry, and our competitors

and others may initiate intellectual property litigation, including as a means of competition.

Intellectual property litigation is complex

and expensive, and outcomes are difficult to predict.

We cannot assure you that we will not become subject to patent infringement claims

or litigation, or interference proceedings, to determine the priority of inventions.

Litigation or regulatory proceedings also may be

necessary to enforce our patent or other intellectual property rights.

We may not always have the financial resources to assert patent

infringement suits or to defend ourselves from claims.

An adverse result in any litigation could subject us to liabilities, or require

us to seek licenses from or pay royalties to others that may be substantial.

Furthermore, we cannot predict the extent to which the necessary

licenses would be available to us on satisfactory terms, if at all.

failure to secure trademark registrations could adversely affect our ability to market our products and operate our business.

trademark applications in the United States and any other jurisdictions where we may file may not be allowed registration, and

we may not be able to maintain or enforce our registered trademarks.

During trademark registration proceedings, we may receive

Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections.

In addition, in the USPTO and in corresponding foreign agencies, third parties are given an opportunity to oppose pending trademark

applications and to seek to cancel registered trademarks.

Opposition or cancellation proceedings may be filed against our applications

and/or registrations, and our applications and/or registrations may not survive such proceedings.

Failure to secure such trademark

registrations in the United States and in foreign jurisdictions could adversely affect our ability to market our products and

our business.

trademark applications in the United States and any other jurisdictions where we may file may not be allowed registration, and we may

not be able to maintain or enforce our registered trademarks.

During trademark registration proceedings, we may receive rejections.

we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections.

In addition, in the USPTO and

in corresponding foreign agencies, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel

registered trademarks.

Opposition or cancellation proceedings may be filed against our applications and/or registrations, and our applications

and/or registrations may not survive such proceedings.

Failure to secure such trademark registrations in the United States and in foreign

jurisdictions could adversely affect our ability to market our products and our business.

may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

is common in the medical device industry, we may employ individuals who were previously employed at other companies similar to

ours, including our competitors or potential competitors.

We may become subject to claims that these employees or we have inadvertently

or otherwise used or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary

to defend against these claims.

Even if we are successful in defending against these claims, litigation could result in substantial

costs and be a distraction to management.

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

and business.

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

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

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

Our Vivos System is designed to affect, and any

future products will be designed to affect, important bodily functions and processes.

Any side effects, manufacturing defects,

misuse or abuse associated with our Vivos System 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 our Vivos System causes, or merely appears 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 Vivos System, 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:

is common in the medical device industry, we may employ individuals who were previously employed at other companies similar to ours,

including our competitors or potential competitors.

We may become subject to claims that these employees or we have inadvertently or

otherwise used or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary to

defend against these claims.

Even if we are successful in defending against these claims, litigation could result in substantial costs

and be a distraction to management.

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:

of litigation;

of management’s attention from our primary business;

inability to commercialize our Vivos System or new products;

demand and brand reputation for our Vivos System;

● distraction

of management’s attention from our primary business;

inability to commercialize our appliances or new products;

demand and brand reputation for our appliances;

recalls or withdrawals from the market;

of clinical trial participants;

● substantial

monetary awards to patients or other claimants;

recall or market withdrawal of our products may delay the supply of those products to our customers and may impact our reputation.

We can provide no assurance that we will be successful in initiating appropriate market recall or market withdrawal efforts that

may be required in the future or that these efforts will have the intended effect of preventing product malfunctions and the accompanying

product liability that may result.

Such recalls and withdrawals may also be used by our competitors to harm our reputation for

safety or be perceived by patients as a safety risk when considering the use of our products, either of which could have a material

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

can provide no assurance that we will be successful in initiating appropriate market recall or market withdrawal efforts that may be

required in the future or that these efforts will have the intended effect of preventing product malfunctions and the accompanying product

liability that may result.

Such recalls and withdrawals may also be used by our competitors to harm our reputation for safety or be perceived

by patients as a safety risk when considering the use of our products, either of which could have a material adverse effect on our business,

financial condition and results of operations.

may not be able to maintain adequate product liability insurance.

product liability and clinical study liability insurance is subject to deductibles and coverage limitations.

Our product liability

insurance may not continue to be available to us on acceptable terms, if at all, and, if available, coverage may not be adequate

to protect us against any future product liability claims.

If we are unable to obtain insurance at an acceptable cost or on acceptable

terms or otherwise protect against potential product liability claims, we could be exposed to significant liabilities.

liability claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could

have a material adverse effect on our business, financial condition and results of operations.

bear the risk of warranty claims on the Vivos System.

bear the risk of warranty claims on our Vivos System.

Our product liability insurance

may not continue to be available to us on acceptable terms, if at all, and, if available, coverage may not be adequate to protect us

against any future product liability claims.

If we are unable to obtain insurance at an acceptable cost or on acceptable terms or otherwise

protect against potential product liability claims, we could be exposed to significant liabilities.

A product liability claim, recall

or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could have a material adverse effect

on our business, financial condition and results of operations.

bear the risk of warranty claims on our appliances.

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

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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

depend on a few suppliers for key components, making us vulnerable to supply shortages and price fluctuation.

purchase components for our Vivos System from a variety of vendors on a purchase order basis;

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 practical or feasible to do so.

To mitigate this risk, we maintain an awareness of alternate supply sources that

could provide our currently single-sourced components with minimal or no modification to the current version of our Vivos System,

practice supply chain management, maintain safety stocks of critical components and have arrangements with our key vendors to

manage the availability of critical components.

Despite these efforts, if our vendors are unable to provide us with an adequate

supply of components in a timely manner, or if we are unable to locate qualified alternate vendors for components at a reasonable

cost, the cost of our products would increase, the availability of our products to our customers would decrease and our ability

to generate revenue could be materially limited.

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 Vivos System to a limited number of licensed professionals, primarily general dentists.

1% of the general dentists in the U.S.

have been trained and certified in the Vivos System.

The commercial success of our Vivos

System ultimately depends upon a number of factors, including the number of dentists who use the Vivos System, the number of Vivos

Systems used by these dentists, the number of patients who become aware of the Vivos System by self-referral or referrals by their

primary care physicians, the number of patients who elect to use the Vivos System, and the number of patients who, having successfully

used the Vivos System, endorse and refer the Vivos System to other potential patients.

The Vivos System may not gain significant

increased market acceptance among physicians/dentists who use it or who refer their patients, other patients, third-party healthcare

insurers and managed care providers.

We believe that primary care physicians typically elect to refer individuals with SDB to

pulmonologists or other physicians who treat sleep disordered breathing, and these physicians may not recommend the Vivos System

to patients for any number of reasons, including safety and clinical efficacy, the availability of alternative procedures and

treatment options, or inadequate levels of reimbursement.

In addition, while positive patient experiences can be a significant

driver of future sales, it is impossible to influence the manner in which this information is transmitted and received, the choices

potential patients may make and the recommendations that treating physicians make to their patients.

we sell our product directly to our corporate-owned and partner clinics, our experience in marketing and selling our Vivos System

or VIP program through a direct sales organization in the United States is limited.

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

general dentists.

Less than 1% of the general dentists in the U.S.

have been trained and certified in The Vivos Method.

The commercial

success of The Vivos Method ultimately depends upon a number of factors, including the number of dentists who use The Vivos Method, the

number of Vivos appliances used by these dentists, the number of patients who become aware of The Vivos Method by self-referral or referrals

by their primary care physicians, the number of patients who elect to use The Vivos Method, and the number of patients who, having successfully

used The Vivos Method, endorse and refer The Vivos Method to other potential patients.

The Vivos Method may not gain significant increased

market acceptance among physicians/dentists who use it or who refer their patients, other patients, third-party healthcare insurers and

managed care providers.

We believe that primary care physicians typically elect to refer individuals to pulmonologists or other physicians

who treat sleep disordered breathing, and these physicians may not recommend The Vivos Method to patients for any number of reasons,

including safety and clinical efficacy, the availability of alternative procedures and treatment options, or inadequate levels of reimbursement.

In addition, while positive patient experiences can be a significant driver of future sales, it is impossible to influence the manner

in which this information is transmitted and received, the choices potential patients may make and the recommendations that treating

physicians make to their patients.

we sell our product directly to our corporate-owned and independent VIP practices, our experience in marketing and selling The Vivos

Method or VIP program through a direct sales organization in the United States is limited.

We may not be able to maintain a suitable

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arrangements with others.

Our marketing and sales efforts may not be successful in increasing awareness and sales of our Vivos

Other marketing efforts like MID and VivoScore may not increase revenue as we anticipate.

failure to educate or train a sufficient number of physicians and dentists in the use of our Vivos System could reduce the market

acceptance of our Vivos System and reduce our revenue.

is critical to the success of our sales efforts that there is an increasing number of dentists familiar with, trained in, and

proficient in the use of our Vivos System.

Currently, dentists learn to use the Vivos System through hands-on, on-site training

or virtual training by our representatives.

However, to receive this training, dentists must be aware of the Vivos System as a

treatment option for SDB or mild-to-moderate OSA and be interested in using the Vivos System 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 Vivos System,

have the knowledge of or experience in the clinical outcomes of the Vivos System or feel comfortable enough using the Vivos System

to recommend it to their patients.

Even if a dentist is well versed in the Vivos System, he or she may be unwilling to require

patients to pay for the Vivos System out-of-pocket.

If dentists do not continue to accept and recommend the Vivos System, our

revenue could be materially and adversely affected.

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

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

and reduce our revenue.

is critical to the success of our sales efforts that there is an increasing number of dentists familiar with, trained in, and proficient

in the use of The Vivos Method.

Currently, dentists learn to use The Vivos Method through hands-on, on-site training or virtual training

by our representatives.

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.

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 Vivos System 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

Vivos System 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 Vivos System, 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.

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,

financial condition and results of operations.

to our reputation or our brand could negatively impact our business, financial condition, and results of operations.

must grow the value of our brand to be successful.

We intend to develop a reputation based on the high quality of our products

and services, trained clinic personnel, as well as on our particular culture and the experience of our patients with our VIPs.

If we do not make investments in areas such as marketing and advertising, as well as personnel training, the value of our brand

may not increase or may be diminished.

Any incident, real or perceived, regardless of merit or outcome, that adversely affects

our brand, such as, but not limited to, patient disability or death due to malpractice or allegations of malpractice, failure

to comply with federal, state, or local regulations, including allegations or perceptions of non-compliance or failure to comply

with ethical and operational standards, could significantly reduce the value of our brand, expose us to negative publicity and

damage our overall business and reputation.

We intend to develop a reputation based on the high quality of our products and services,

Vivos trained clinicians, as well as on our particular culture and the experience of the patients of our VIPs.

If we do not make investments

in areas such as marketing and advertising, as well as personnel training, the value of our brand may not increase or may be diminished.

Any incident, real or perceived, regardless of merit or outcome, that adversely affects our brand, such as, but not limited to, patient

disability or death due to malpractice or allegations of malpractice, failure to comply with federal, state, or local regulations, including

allegations or perceptions of non-compliance or failure to comply with ethical and operational standards, could significantly reduce

the value of our brand, expose us to negative publicity and damage our overall business and reputation.

marketing activities may not be successful.

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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.

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 revenue.

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

market for providing treatment for SDB and OSA is highly competitive.

Our VIP offices and our VIPs face competition from existing

facilities providing treatment for SDB and OSA, depending on the type of patient and geographic market.

Our VIPs compete on the

basis of our product (the Vivos System), quality, price, accessibility, and overall experience.

We compete with national, regional,

and local enterprises, many of which have greater financial and other resources available to them, greater access to dentists

and physicians or greater access to potential patients.

We also compete on the basis of our multistate, regional footprint, which

we believe will be of value to both employers and third-party payors.

As a result of the differing competitive factors within

the markets in which we operate and will operate, the individual results of our VIP offices may be volatile.

If we are unable

to compete effectively with any of these entities or groups, or we are unable to implement our business strategies, there could

be a material adverse effect on our business, prospects, results of operations and financial condition.

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

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

market for providing treatment for OSA is highly competitive.

Our VIP offices and our VIPs face competition from existing facilities

providing treatment for OSA, depending on the type of patient and geographic market.

Our VIPs compete on the basis of our protocol/products

(The Vivos Method), quality, price, accessibility, and overall experience.

We compete with national, regional, and local enterprises,

many of which have greater financial and other resources available to them, greater access to dentists and physicians or greater access

to potential patients.

We also compete on the basis of our multistate, regional footprint, which we believe will be of value to both

employers and third-party payors.

As a result of the differing competitive factors within the markets in which we operate and will operate,

the individual results of our VIP offices may be volatile.

If we are unable to compete effectively with any of these entities or groups,

or we are unable to implement our business strategies, there could be a material adverse effect on our business, prospects, results of

operations and financial condition.

have limited clinical evidence to support patient compliance with the use our products is superior to competitive products.

believe based on our experiences to date that our non-surgical treatment of limited duration is preferable relative to CPAP or

other oral appliance or surgical therapies, resulting in improved patient compliance.

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 System 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 the Vivos System 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 healthcare system.

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

reimbursement rates, which could adversely affect sales of the Vivos System and thus adversely affect our operations and financial

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

limiting costs.

The ACA substantially changes the way healthcare is financed by both governmental and commercial payors.

result of the ACA or the adoption of additional 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, the Vivos System and for dental practitioners from becoming or remaining VIPs.

believe that our non-surgical treatment of limited duration is preferable relative to mild to moderate OSA CPAP users or other oral appliance

or surgical therapies, resulting in improved patient compliance.

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.

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

healthcare system.

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.

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

The ACA substantially

changes the way healthcare is financed by both governmental and commercial payors.

As a result of the ACA or the adoption of additional

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.

uncertainty exists as to the reimbursement status of healthcare products.

The regulations that govern marketing approvals, pricing

and reimbursement for medical devices vary widely from country to country.

In the United States, the Patient Protection and Affordable

Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, is significantly changing the

way healthcare is financed by both governmental and private insurers.

While we cannot predict what impact on federal reimbursement

policies this law or any amendment to it will continue to have in general or specifically on the Vivos System or any product that

we commercialize, the ACA or any such amendment may result in downward pressure on reimbursements, which could negatively affect

market acceptance of the Vivos System.

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.

The regulations that govern marketing approvals, pricing and

reimbursement for medical devices vary widely from country to country.

In the United States, the Patient Protection and Affordable Care

Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, is significantly changing the way healthcare

is financed by both governmental and private insurers.

While we cannot predict what impact on federal reimbursement policies this law

or any amendment to it will continue to have in general or specifically on The Vivos Method or any product that we commercialize, the

ACA or any such amendment may result in downward pressure on reimbursements, which could negatively affect market acceptance of The Vivos

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.

Congress are still working to repeal the ACA.

addition, the United States Supreme Court has recently determined to hear another case challenging the constitutionality of the

President Trump and the Republican majority in the U.S.

Senate have also been seeking to repeal or replace all or portions

of the ACA but to date they have been unable to agree on any such legislation.

Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment

imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly

referred to as the “individual mandate”.

Additionally, on January 22, 2018, President Trump signed a continuing resolution

on appropriations for fiscal year 2018 that delayed the implementation of certain fees mandated by the ACA, including the so-called

“Cadillac”

tax on certain high cost employer- sponsored insurance plans, the annual fee imposed on certain health

insurance providers based on market share, and the medical device excise tax on non-exempt medical devices.

The Cadillac tax was

repealed in 2019 and is no longer simply delayed.

Congress may still consider other legislation to repeal and replace elements

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 operations and financial condition could be adversely affected.

will depend upon revenue from sales of the Vivos System, and in turn on reimbursement from third-party payors for the Vivos System.

The amount that our VIPs receive in payment for the Vivos System may be adversely affected by factors we do not control, including

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

operations and financial condition could be adversely affected.

will depend upon revenue from sales of the billable procedures from The Vivos Method, and in turn on reimbursement from third-party payors.

The amount that our VIPs receive in payment for the billable procedures may be adversely affected by factors we do not control, including

federal or state regulatory or legislative changes, cost-containment decisions and changes in reimbursement schedules of third-party

Any reduction or elimination of these payments could have a material adverse effect on our business, prospects, results

Any reduction or elimination of these reimbursements could have a material adverse effect on our business, prospects, results

of operations and financial condition.

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the reimbursement process is complex and can involve lengthy delays.

Also, third-party payors may reject, in whole or in part,

requests for reimbursement based on determinations that certain amounts are not reimbursable under plan coverage, that services

provided were not medically necessary, that additional supporting documentation is necessary, or for other reasons.

adjustments by third-party payors may be difficult or cost prohibitive to appeal, and such changes could materially reduce the

actual amount we receive from our VIPs.

Delays and uncertainties in the reimbursement process may be out of our control and may

adversely affect our business, prospects, results of operations and financial condition.

changes in our payor mix resulting from fluctuations in the types of patients seen by our VIPs could have a material adverse effect

Also, third-party payors may reject, in whole or in part, requests

for reimbursement based on determinations that certain amounts are not reimbursable under plan coverage, that services provided were

not medically necessary, that additional supporting documentation is necessary, or for other reasons.

Retroactive adjustments by third-party

payors may be difficult or cost prohibitive to appeal, and such changes could materially reduce the actual amount we receive from our

Delays and uncertainties in the reimbursement process may be out of our control and may adversely affect our business, prospects,

results of operations and financial condition.

changes in our payor mix resulting from fluctuations in the types of patients seen by our VIPs could have a material adverse effect on

our business, prospects, results of operations and financial condition.

results may change from period to period due to fluctuations in our VIPs’ payor mix.

Payor mix refers to the relative amounts we

receive from the mix of persons or entities that pay or reimburse our VIPs for healthcare services.

Because we believe that our VIPs

will receive a higher payment rate from commercial payors than from governmental payors or self-pay patients, a significant shift in

our payor mix toward a higher percentage of self-pay or patients whose treatment is paid in whole or part by a governmental payor, could

occur for reasons beyond our control and could lessen demand for The Vivos Method, which in turn could have a material adverse effect

on our business, prospects, results of operations and financial condition.

results may change from period to period due to fluctuations in our VIPs’

Payor mix refers to the relative amounts

we receive from the mix of persons or entities that pay or reimburse our VIPs for healthcare services.

Because we believe that

our VIPs will receive a higher payment rate from commercial payors than from governmental payors or self-pay patients, a significant

shift in our payor mix toward a higher percentage of self-pay or patients whose treatment is paid in whole or part by a governmental

payor, could occur for reasons beyond our control and could lessen demand for the Vivos System, which in turn could have a material

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

by our Billing Intelligence Service to bill timely or accurately for billable services rendered by participating VIP providers

could have a negative impact on our revenue and cash flow.

for medical services rendered in connection with the Vivos System treatment is often complex and time consuming.

of providing dental or medical services in advance of payment or prior to assessing a patient’s ability to pay for such

services may have a significant negative impact on a VIP provider’s patient service revenue, bad debt expense and cash flow.

Not all of our VIPs subscribe to our Billing Intelligence Service program.

For VIPs who do subscribe, we bill numerous payors,

including various forms of commercial health insurance providers on their behalf.

Billing requirements that must be met prior

to receiving payment for services rendered often vary by payor.

Self-pay patients and third-party payors may fail to pay for services

even if they have been properly billed.

Reimbursement is typically dependent on providing the proper procedure and diagnosis codes,

supportive documentation to show medical necessity.

by our Billing Intelligence Service to bill timely or accurately for billable services rendered by participating VIP providers could

have a negative impact on our revenue and cash flow.

for medical services rendered in connection with billable procedures of The Vivos Method is often complex and time consuming.

of providing dental or medical services in advance of payment or prior to assessing a patient’s ability to pay for such services

may have a significant negative impact on a VIP provider’s patient service revenue, bad debt expense and cash flow.

VIPs subscribe to our Billing Intelligence Service.

For VIPs who do subscribe, we bill numerous medical payors, including various forms

of commercial health insurance providers on their behalf.

Billing requirements that must be met prior to receiving payment for services

rendered often vary by payor.

Self-pay patients and third-party payors may fail to pay for services even if they have been properly billed.

Reimbursement is typically dependent on providing the proper procedure and diagnosis codes, supportive documentation to show medical

Medical insurance is never a guarantee of payment.

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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 our dentists to enable them to bill various payors.

complexity associated with billing for our services 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.

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.

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

we accept electronic payment cards for payments at our facilities and the facilities of our VIPs, we may incur costs resulting

from related security risks in connection with the electronic processing of confidential information by our partner banks.

several large national banks have experienced potential or actual breaches in which similar data has been or may have been stolen.

Such occurrences could cause patient dissatisfaction resulting in decreased visits or could also distract our management team

from the management of the day-to-day operations.

relationships with VIPs, other healthcare providers, and third-party payors will be subject, directly or indirectly, to federal

and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare

laws and regulations.

we accept electronic payment cards for payments at our facilities and the facilities of our VIPs, we may incur costs resulting from related

security risks in connection with the electronic processing of confidential information by our partner banks.

Recently, several large

national banks have experienced potential or actual breaches in which similar data has been or may have been stolen.

Such occurrences

could cause patient dissatisfaction resulting in decreased visits or could also distract our management team from the management of the

day-to-day operations.

relationships with VIPs, other healthcare providers, and third-party payors will be subject, directly or indirectly, to federal and state

healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations.

If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

providers (including our VIPs), physicians and third-party payors in the United States and elsewhere will play a primary role

in the recommendation of the Vivos System.

Our current and future arrangements with healthcare professionals, principal investigators,

consultants, customers and third-party payors may subject us to various federal and state fraud and abuse laws and other health

care laws, including, without limitation, the federal Anti-Kickback Statute, the federal civil and criminal false claims laws

and the law commonly referred to as the Physician Payments Sunshine Act and regulations.

These laws will impact, among other things,

our clinical research, sales, marketing and educational programs.

In addition, we may be subject to patient privacy laws by both

the federal government and the states in which we conduct or may conduct our business.

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.

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

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

providers (including our VIPs), physicians and third-party payors in the United States and elsewhere will play a primary role in the

recommendation of The Vivos Method.

Our current and future arrangements with healthcare professionals, principal investigators, consultants,

customers and third-party payors may subject us to various federal and state fraud and abuse laws and other health care laws, including,

without limitation, the federal Anti-Kickback Statute, the federal civil and criminal false claims laws and the law commonly referred

to as the Physician Payments Sunshine Act and regulations.

These laws will impact, among other things, our clinical research, sales,

marketing and educational programs.

In addition, we may be subject to patient privacy laws by both the federal government and the states

in which we conduct or may conduct our business.

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.

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 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

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

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’’

physicians and teaching hospitals;

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

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 business activities could be subject to challenge under one or more of such laws.

is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes,

regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found

to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant

civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion of our products from government

funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject

to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws and the curtailment

or restructuring of our operations.

risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted

by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations.

Efforts to ensure

that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial

Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant

legal expenses and divert our management’s attention from the operation of our business.

The shifting compliance environment

and the need to build and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance

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

misuse or off-label use of the Vivos System 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 Vivos System for uses outside of the FDA-cleared indications

for use, known as off-label uses.

We cannot, however, prevent a medical professional from using the Vivos System off label when,

in their independent professional medical judgment, he or she deems it appropriate.

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

business activities could be subject to challenge under one or more of such laws.

is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations

or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found to be in violation

of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and

administrative penalties, damages, fines, disgorgement, imprisonment, exclusion of our products from government funded healthcare programs,

such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement

or similar agreement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of our operations.

risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the

regulatory authorities or the courts, and their provisions are open to a variety of interpretations.

Efforts to ensure that our business

arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs.

against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses

and divert our management’s attention from the operation of our business.

The shifting compliance environment and the need to build

and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance and/or reporting requirements

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.

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

indications for use, known as off-label uses.

We cannot, however, prevent a medical professional from using our appliances off label

when, in their independent professional medical judgment, he or she deems it appropriate.

There may be increased risk of injury or other

side effects to patients if physicians attempt to use the Vivos System off-label.

Furthermore, the use of the Vivos System 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.

that we are aware that, notwithstanding our training guidelines, our VIPs may use our DNA device off-label, there is a risk that

we could face regulatory scrutiny as a result of such use.

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

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

that we are aware that, notwithstanding our training guidelines, our independent VIPs may use our appliances off-label, there is a risk

that we could face regulatory scrutiny because of such use.

If the FDA or any foreign regulatory body determines that our promotional

materials or training constitute promotion of an off-label use, it could request that we modify our training or promotional materials

or subject us to regulatory or enforcement actions, including the issuance or imposition of an untitled letter, which is used

(labeling) materials or training constitute promotion of an off-label use, it could request that we modify our training or promotional

materials or subject us to regulatory or enforcement actions, including the issuance or imposition of an untitled letter, which is used

for violations that do not necessitate a warning letter, injunction, seizure, civil fine or criminal penalties.

It is also possible

that other federal, state or foreign enforcement authorities might take action under other regulatory authority, such as false

claims laws, if they consider our business activities to constitute promotion of an off-label use, which could result in significant

penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion

from participation in government healthcare programs and the curtailment of our operations.

addition, dentists may misuse our Vivos System or use improper techniques if they are not adequately trained, potentially leading

to injury and an increased risk of product liability.

If our Vivos System is misused or used with improper technique, we may become

subject to costly litigation by our customers or their patients.

It is also possible that

other federal, state or foreign enforcement authorities might take action under other regulatory authority, such as false claims laws,

if they consider our business activities to constitute promotion of an off-label use, which could result in significant penalties, including,

but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government

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 Vivos System despite it being intended for a single use or may purchase reprocessed Vivos Systems from third-party processors

in lieu of purchasing a new Vivos System from us, 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.

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.

cannot guarantee that we will identify suitable acquisition candidates, that acquisitions will be completed on acceptable terms

or that we will be able to integrate successfully 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 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.

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

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.

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.

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.

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

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.

providers have become subject to an increasing number of lawsuits alleging malpractice and related legal theories such as negligent

hiring, supervision and credentialing.

providers have become subject to an increasing number of lawsuits alleging malpractice and related legal theories such as negligent hiring,

supervision and credentialing.

Some of these lawsuits involve large claim amounts and substantial defense costs.

procure professional liability insurance coverage for our affiliated medical professionals and professional and corporate entities.

We are currently insured under policies in amounts management deems appropriate, based upon the nature and risk of our business.

Our medical professionals are also required to provide their own medical malpractice insurance coverages.

Nevertheless, there

are exclusions and exceptions to coverage under each insurance policy that may make coverage for any claim unavailable, future

claims could exceed the limits of available insurance coverage, existing insurers could become insolvent and fail to meet their

obligations to provide coverage for such claims, and such coverage may not always be available with sufficient limits and at reasonable

cost to insure us adequately and economically in the future.

One or more successful claims against us not covered by, or exceeding

the coverage of, our insurance could have a material adverse effect on our business, prospects, results of operations and financial

Moreover, in the normal course of our business, we may be involved in other types of lawsuits, claims, audits and investigations,

including those arising out of our billing and marketing practices, employment disputes, contractual claims and other business

disputes for which we may have no insurance coverage.

Furthermore, for our losses that are insured or reinsured through commercial

insurance providers, we are subject to the financial viability of those insurance companies.

Although we believe our commercial

insurance providers are currently creditworthy, they may not remain so in the future.

The outcome of these matters could have

a material adverse effect on our financial position, results of operations, and cash flows.

We generally procure

professional liability insurance coverage for our affiliated medical professionals and professional and corporate entities.

We are currently

insured under policies in amounts management deems appropriate, based upon the nature and risk of our business.

Our medical professionals

are also required to provide their own medical malpractice insurance coverages.

Nevertheless, there are exclusions and exceptions to

coverage under each insurance policy that may make coverage for any claim unavailable, future claims could exceed the limits of available

insurance coverage, existing insurers could become insolvent and fail to meet their obligations to provide coverage for such claims,

and such coverage may not always be available with sufficient limits and at reasonable cost to insure us adequately and economically

in the future.

One or more successful claims against us not covered by, or exceeding the coverage of, our insurance could have a material

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

Moreover, in the normal course of our business,

we may be involved in other types of lawsuits, claims, audits and investigations, including those arising out of our billing and marketing

practices, employment disputes, contractual claims and other business disputes for which we may have no insurance coverage.

for our losses that are insured or reinsured through commercial insurance providers, we are subject to the financial viability of those

insurance companies.

Although we believe our commercial insurance providers are currently creditworthy, they may not remain so in the

The outcome of these matters could have a material adverse effect on our financial position, results of operations, and cash

depend on certain key personnel.

substantially rely on the efforts of our current senior management, including our founder and Chief Medical Officer, Dr.

Singh, our co-founder, Chairman of the Board and Chief Executive Officer, R.

Kirk Huntsman and our Chief Financial Officer, Brad

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.

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 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.

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.

of our board of directors and our executive officers will have other business interests and obligations to other entities.

our directors nor our executive officers will be required to manage our business as their sole and exclusive function and they

may have other business interests and may engage in other activities in addition to those relating to us, provided that such activities

do not compete with the business of our company or otherwise breach their agreements with us.

We are dependent on our directors

and executive officers to successfully operate our company.

Their other business interests and activities could divert time and

attention from operating our business.

our directors nor our executive officers will be required to manage our business as their sole and exclusive function and they may have

other business interests and may engage in other activities in addition to those relating to us, provided that such activities do not

compete with the business of our company or otherwise breach their agreements with us.

We are dependent on our directors and executive

officers to successfully operate our company.

Their other business interests and activities could divert time and attention from operating

our business.

will need to carefully manage our expanding operations to achieve sustainable growth.

achieve increased revenue levels, complete clinical studies and develop future products, we believe that we will be required to

periodically expand our operations, particularly in the areas of sales and marketing, clinical research, reimbursement, research

and development, manufacturing and quality assurance.

As we expand our operations in these areas, management will face new and

increased responsibilities.

To accommodate any growth and compete effectively, we must continue to upgrade and improve our information

systems, as well as our procedures and controls across our business, and expand, train, motivate and manage our work force.

future success will depend significantly on the ability of our current and future management to operate effectively.

Our personnel,

systems, procedures and controls may not be adequate to support our future operations.

If we are unable to effectively manage

our expected growth, this could have a material adverse effect on our business, financial condition and results of operations.

achieve increased revenue levels, complete clinical studies and develop future products, we believe that we will be required to periodically

expand our operations, particularly in the areas of sales and marketing, clinical research, reimbursement, research and development,

manufacturing and quality assurance.

As we expand our operations in these areas, management will face new and increased responsibilities.

To accommodate any growth and compete effectively, we must continue to upgrade and improve our information systems, as well as our procedures

and controls across our business, and expand, train, motivate and manage our work force.

Our future success will depend significantly

on the ability of our current and future management to operate effectively.

Our personnel, systems, procedures and controls may not be

adequate to support our future operations.

If we are unable to effectively manage our expected growth, this could have a material adverse

effect on our business, financial condition and results of operations.

could be adversely affected by violations of the U.S.

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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.

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.

is no guarantee that our PPP loan will be forgiven in whole or in part.

May 2020, we received loan proceeds in the amount of approximately $1,265,000 under the Paycheck Protection Program (or PPP),

established as part of the Coronavirus Aid, Relief and Economic Security (CARES) Act, which provides economic relief to businesses

in response to the COVID-19 pandemic.

The loan and accrued interest are forgivable after 24 weeks as long as we use the loan proceeds

for eligible purposes, including payroll, benefits, rent and utilities, and our employee head count remains consistent with our

baseline period over the 24-week period after the loan was received.

The amount of loan forgiveness will be reduced if we terminate

employees or reduce salaries during the 24-week period.

The unforgiven portion of the PPP loan is payable over two years at an

interest rate of 1%, with a deferral of payments for the first six months.

While we believe that our use of the loan proceeds

will meet the conditions for forgiveness of the loan, there is a risk that the loan will not be forgiven or that we will take

actions that could cause us to be ineligible for forgiveness of the loan, there is a risk that (i) the loan will not be forgiven,

in whole or in part, (ii) we will take actions that could cause us to be ineligible for forgiveness of the loan, in whole or in

part or (iii) we may be required to repay the loan, in whole or in part, upon event of default under the loan or upon a breach

of applicable PPP regulations (including upon a change of ownership in our company that may have occurred as a result of our initial

public offering).

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

depend in large part on our Vivos System technology, and the loss of access to this technology would terminate or delay the further

development of our products, injure our reputation or force us to pay higher fees.

depend, in large part, on our Vivos System 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 products until equivalent technology,

if available, is identified, licensed and integrated.

In addition, any defects in the Vivos System 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

depend in large part on The Vivos Method technology, and the loss of access to this technology would terminate or delay the further development

of our products, injure our reputation or force us to pay higher fees.

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.

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

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

and quality by numerous government authorities in the United States and abroad.

Before receiving FDA or foreign regulatory clearance

to market our products which are not presently approved, we will have to demonstrate that these products are safe and effective

in the patient population and for the diseases that are to be treated.

Clinical trials, manufacturing and marketing of medical

devices are subject to the rigorous testing and approval process of the FDA and equivalent foreign regulatory authorities.

Federal Food, Drug and Cosmetic Act and other federal, state and foreign statutes and regulations govern and influence the testing,

manufacture, labeling, advertising, distribution and promotion of medical devices.

As a result, regulatory approvals for our products

not yet approved or that we may develop in the future can take a number of years or longer to accomplish and require the expenditure

of substantial financial, managerial and other resources.

to market our future products needing approval, we will have to demonstrate that these products are safe and effective in the patient

population and for the diseases that are to be treated.

Clinical trials, manufacturing and marketing of medical devices are subject to

the rigorous testing and approval process of the FDA and equivalent foreign regulatory authorities.

The Federal Food, Drug and Cosmetic

Act and other federal, state and foreign statutes and regulations govern and influence the testing, manufacture, labeling, advertising,

distribution and promotion of medical devices.

As a result, regulatory approvals for our products not yet approved or that we may develop

in the future can take a number of years or longer to accomplish and require the expenditure of substantial financial, managerial and

other resources.

trials that may be required to support regulatory submissions in the United States are expensive.

We cannot assure that we will

be able to complete any required clinical trial programs successfully within any specific time period, and if such clinical trials

take longer to complete than we project, our ability to execute our current business strategy will be adversely affected.

We cannot assure that we will be able

to complete any required clinical trial programs successfully within any specific time period, and if such clinical trials take longer

to complete than we project, our ability to execute our current business strategy will be adversely affected.

clinical trials is a lengthy, time-consuming and expensive process.

Before obtaining regulatory approvals for the commercial sale

of any products, we must demonstrate through clinical trials the safety and effectiveness of our products.

We have incurred, and

we will continue to incur, substantial expense for, and devote a significant amount of time to, product development, pilot trial

testing, clinical trials and regulated, compliant manufacturing processes.

if completed, we do not know if these trials will produce statistically significant or clinically meaningful results sufficient

to support an application for marketing approval.

If and how quickly we complete clinical trials is dependent in part upon the

rate at which we are able to advance the rate of patient enrollment, and the rate to collect, clean, lock and analyze the clinical

trial database.

Before obtaining regulatory approvals for the commercial sale of

any products, we must demonstrate through clinical trials the safety and effectiveness of our products.

We have incurred, and we will

continue to incur, substantial expense for, and devote a significant amount of time to, product development, pilot trial testing, clinical

trials and regulated, compliant manufacturing processes.

if completed, we do not know if these trials will produce statistically significant or clinically meaningful results sufficient to support

an application for marketing approval.

If and how quickly we complete clinical trials is dependent in part upon the rate at which we

are able to advance the rate of patient enrollment, and the rate to collect, clean, lock and analyze the clinical trial database.

enrollment in trials is a function of many factors.

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the size of the patient population;

the proximity of patients to and availability of clinical sites;

proximity of patients to and availability of clinical sites;

the eligibility criteria for the study;

the perceived risks and

benefits of the product candidate under study;

the medical investigators’

efforts to facilitate timely enrollment in clinical

the patient referral practices of local physicians;

the perceived risks and benefits

of the product candidate under study;

the medical investigators’ efforts to facilitate timely enrollment in clinical trials;

patient referral practices of local physicians;

the existence of competitive clinical trials;

and whether other investigational,

existing or new products are available or cleared for the indication.

If we experience delays in patient enrollment and/or completion

of our clinical trial programs, we may incur additional costs and delays in our development programs and may not be able to complete

our clinical trials on a cost-effective or timely basis.

Accordingly, we may not be able to complete the clinical trials within

an acceptable time frame, if at all.

If we fail to enroll and maintain the number of patients for which the clinical trial was

designed, the statistical power of that clinical trial may be reduced, which would make it harder to demonstrate that the product

candidate being tested in such clinical trial is safe and effective.

Further, if we or any third party have difficulty enrolling

a sufficient number of patients in a timely or cost-effective manner to conduct clinical trials as planned, or if enrolled patients

do not complete the trial as planned, we or a third party may need to delay or terminate ongoing clinical trials, which could

negatively affect our business.

results of our clinical trials may not support either further clinical development or the commercialization of any new

product candidates or modifications to existing products.

if our ongoing or contemplated clinical trials are completed as planned, their results may not support either the further

clinical development or the commercialization of any new product candidates or modifications of existing products.

The FDA or government authorities may not agree with our conclusions regarding the results of our clinical trials.

preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and the results from

any later clinical trials may not replicate the results of prior clinical trials and pre-clinical testing.

The clinical trial

process may fail to demonstrate that our product candidates are safe and effective for indicated uses.

This failure would cause

us to abandon a product candidate or a modification to any existing product and may delay development of other product

Any delay in, or termination of, our clinical trials will delay the filing of 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

and whether other investigational, existing

or new products are available or cleared for the indication.

If we experience delays in patient enrollment and/or completion of our clinical

trial programs, we may incur additional costs and delays in our development programs and may not be able to complete our clinical trials

on a cost-effective or timely basis.

Accordingly, we may not be able to complete the clinical trials within an acceptable time frame,

If we fail to enroll and maintain the number of patients for which the clinical trial was designed, the statistical power

of that clinical trial may be reduced, which would make it harder to demonstrate that the product candidate being tested in such clinical

trial is safe and effective.

Further, if we or any third party have difficulty enrolling a sufficient number of patients in a timely

or cost-effective manner to conduct clinical trials as planned, or if enrolled patients do not complete the trial as planned, we or a

third party may need to delay or terminate ongoing clinical trials, which could negatively affect our business.

results of our clinical trials may not support either further clinical development or the commercialization of any new product candidates

or modifications to existing products.

if our ongoing or contemplated clinical trials are completed as planned, their results may not support either the further clinical development

or the commercialization of any new product candidates or modifications of existing products.

The FDA or government authorities may not

agree with our conclusions regarding the results of our clinical trials.

Success in preclinical testing and early clinical trials does

not ensure that later clinical trials will be successful, and the results from any later clinical trials may not replicate the results

of prior clinical trials and pre-clinical testing.

The clinical trial process may fail to demonstrate that our product candidates are

safe and effective for indicated uses.

This failure would cause us to abandon a product candidate or a modification to any existing product

and may delay development of other product candidates.

Any delay in, or termination of, our clinical trials will delay the filing of

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.

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.

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

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”,

and make and support their substantial equivalency claims.

The submitting company may not proceed with product marketing until

it receives an order from the FDA declaring a device substantially equivalent.

The substantially equivalent determination is usually

made within 90 days, based on the information submitted by the applicant.

addition, we or the FDA may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable

health risks or if the FDA finds deficiencies in the conduct of these trials.

A number of companies in the medical technology

industry have suffered significant setbacks in advanced clinical trials despite promising results in earlier trials.

end, we may be unable to develop marketable products.

The submitting company may not proceed with product marketing until it receives

an order from the FDA declaring a device substantially equivalent.

The substantially equivalent determination is usually made within

90 days, based on the information submitted by the applicant.

addition, we or the FDA may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable health

risks or if the FDA finds deficiencies in the conduct of these trials.

A number of companies in the medical technology industry have

suffered significant setbacks in advanced clinical trials despite promising results in earlier trials.

In the end, we may be unable to

develop marketable products.

Modifications

to the Vivos System may require additional FDA approvals which, if not obtained, could force us to cease marketing

to appliances within The Vivos Method may require additional FDA approvals which, if not obtained, could force us to cease marketing

and/or recall the modified device until we obtain new approvals.

a device receives a 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would

constitute a major change in its intended use, requires a new 510(k) clearance or could require a Premarket approval (or PMA).

PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human

health, or which present a potential, unreasonable risk of illness or injury.

Currently we do not market devices within this Class

III category nor do we intend to in the foreseeable future.

However, the FDA requires each manufacturer to make this determination

in the first instance, but the FDA can review any decision.

If the FDA disagrees with a manufacturer’s decision not to seek

a new 510(k) clearance, the agency may retroactively require the manufacturer to seek 510(k) clearance or PMA approval.

also can require the manufacturer to cease marketing and/or recall the modified devices until 510(k) clearance or PMA approval

We cannot assure you that the FDA would agree with any of our decisions not to seek 510(k) clearance or PMA approval.

If the FDA requires us to seek 510(k) clearance or PMA approval for any modification, we also may be required to cease marketing

and/or recall the modified device until we obtain a new 510(k) clearance or PMA approval.

DNA appliance®

currently has a pending 510(k) application to include additional indications of use for the treatment of mild-to-moderate

OSA, snoring, and SDB in adults.

This use would require the DNA appliance ®

to be registered as a Class II device.

We have validated this 510(k) request with retrospective clinical data.

This DNA appliance®

510(k) review and approval process

is expected to take another three to six months, meaning we would expect to hear from the FDA in 2021.

However, it is possible

that we may not receive this FDA additional clearance.

in February 2021, we submitted a 510(k) for Class II clearance to the FDA for our mmRNA device with indications to treat mild-to-moderate

OSA, SDB and Snoring in adults.

We cannot assure you that the FDA will approve our 510(k) Class II approval or we will receive

a device receives a 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute

a major change in its intended use, requires a new 510(k) clearance or could require a Premarket approval (or PMA).

PMA is the FDA process

of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Class III devices are those

that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential,

unreasonable risk of illness or injury.

Currently we do not market devices within this Class III category nor do we intend to in the

foreseeable future.

However, the FDA requires each manufacturer to make this determination in the first instance, but the FDA can review

any decision.

If the FDA disagrees with a manufacturer’s decision not to seek a new 510(k) clearance, the agency may retroactively

require the manufacturer to seek 510(k) clearance or PMA approval.

The FDA also can require the manufacturer to cease marketing and/or

recall the modified devices until 510(k) clearance or PMA approval is obtained.

We cannot assure you that the FDA would agree with any

of our decisions not to seek 510(k) clearance or PMA approval.

If the FDA requires us to seek 510(k) clearance or PMA approval for any

modification, we also may be required to cease marketing and/or recall the modified device until we obtain a new 510(k) clearance or

PMA approval.

Further, we cannot assure you that our mmRNA appliance ®

will be added to the CMS Medicare list of

approved sleep appliances , both in general and in the event that Class II approval is not obtained for the mmRNA device (which

is a prerequisite for inclusion in the CMS Medicare list of approved sleep appliances).

are subject to inspection and market surveillance by the FDA to determine compliance with regulatory requirements.

finds that we have failed to comply, the agency can institute a wide variety of enforcement actions which may materially affect

our business operations.

If the FDA finds that

we have failed to comply, the agency can institute a wide variety of enforcement actions which may materially affect our business operations.

are subject to inspection and market surveillance by the FDA to determine compliance with regulatory requirements.

finds that we have failed to comply, the agency can institute a wide variety of enforcement actions, ranging from a public warning

letter to more severe sanctions such as:

If the FDA finds that

we have failed to comply, the agency can institute a wide variety of enforcement actions, ranging from a public warning letter to more

severe sanctions such as:

injunctions and civil penalties;

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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.

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

Our failure to comply with applicable requirements could lead to an enforcement action that may have an adverse effect

on our financial condition and results of operations.

with the Vivos System has only been available for a relatively limited time, and we do not know whether there will be significant

post-treatment 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 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 this

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 System 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 dental support organization laws.

core VIP business model does not involve any form of joint ownership, operational control, or employment of licensed professionals

by our company.

Thus, we are not typically regarded as a “dental support organization”

(or DSO) under the laws of

the various states within the United States or in Canada, in which we conduct most of our business.

However, we do operate two

retail treatment clinics 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.

(“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.

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

Our failure to comply with applicable requirements could lead to an enforcement action that may have an adverse effect on our financial

condition and results of operations.

with The Vivos Method has only been available for a relatively limited time, and we do not know whether there will be significant post-treatment

regression or relapse.

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.

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

core VIP business model does not involve any form of joint ownership, operational control, or employment of licensed professionals by

Thus, we are not typically regarded as a “dental service organization” (or DSO) under the laws of the various

states within the United States or in Canada, in which we conduct most of our business.

However, we do operate two retail treatment clinics

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.

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

states and Canada), a growing number of dentists

are affiliating with corporate DSOs.

In those cases, the DSO may not allow their affiliated dentists to offer our products and

services or to become VIPs.

Thus, the overall number of dentists who are prospects to become VIPs and utilize our products and

services may be reduced, which would impair our ability to generate revenue from our core VIP business model.

new Medical Integration Division business line may implicate federal and state laws involving the practice of medicine and related

anti-kickback and similar laws.

MID was launched in 2020 to assist VIP practices in establishing clinical collaboration ties to local primary care physicians,

sleep specialists, ENTs, pediatricians and other healthcare professionals who routinely see or treat patients with sleep and breathing

The primary objective of our MID is to promote the Vivos System to the medical profession and thus facilitate more

patients being able to receive a treatment with the Vivos System.

There is a risk, however, that our MID may implicate legal or

regulatory compliance issues that may arise in the course of our activities, including various Federal healthcare statutes such

as the Stark and anti-kickback laws as well as state-by-state regulations pertaining to inter-disciplinary ownership of professional

corporations or other legal entities.

We have conducted research, including obtaining advice from outside legal counsel, regarding

the implications of these laws and regulations to MID and believe the MID’s operations will be in compliance with or will

not implicate these laws and regulations.

However, there is a risk that such laws and regulations (or similar laws and regulations

adopted in the future) might be interpreted, reinterpreted, or modified in the future in such a way so as to impede or prevent

us from continuing to develop or manage our MID, which could lead to our having to discontinue the MID and could leave us subject

to regulatory scrutiny and sanction.

No advice of counsel has been obtained with respect any potential operations of the MID in

may not be able to prohibit or limit our dentists, physicians and other healthcare professionals from competing with us in our

local markets.

certain states in which we operate or intend to operate, non-compete, non-solicitation, and other negative covenants applicable

to employment or ownership are judicially or statutorily limited in their effectiveness or are entirely unenforceable against

dentists, physicians and other healthcare professionals.

As a result, we may not be able to retain our provider relationships

or protect our market share, operational processes or procedures, or limit insiders or VIPs from using competitive information

against us or competing with us, which could have a material adverse effect on our business, financial condition and ability to

remain competitive as our arrangements with our VIPs do not contain competitive restrictions.

states and Canada), a growing number of dentists are affiliating

with corporate DSOs.

In those cases, the DSO may not allow their affiliated dentists to offer our products and services or to become

Thus, the overall number of dentists who are prospects to become VIPs and utilize our products and services may be reduced, which

would impair our ability to generate revenue from our core VIP business model.

Medical Integration Division business line may implicate federal and state laws involving the practice of medicine and related anti-kickback

and similar laws.

MID was launched in 2020 to assist VIP practices in establishing clinical collaboration ties to local primary care physicians, sleep

specialists, ENTs, pediatricians and other healthcare professionals who routinely see or treat patients with sleep and breathing disorders.

The primary objective of our MID is to promote The Vivos Method to the medical profession and thus facilitate more patients being able

to receive a treatment with The Vivos Method.

There is a risk, however, that our MID may implicate legal or regulatory compliance issues

that may arise in the course of our activities, including various Federal healthcare statutes such as the Stark and anti-kickback laws

as well as state-by-state regulations pertaining to inter-disciplinary ownership of professional corporations or other legal entities.

We have conducted research, including obtaining advice from outside legal counsel, regarding the implications of these laws and regulations

to MID and believe the MID’s operations will be in compliance with or will not implicate these laws and regulations.

However, there

is a risk that such laws and regulations (or similar laws and regulations adopted in the future) might be interpreted, reinterpreted,

or modified in the future in such a way so as to impede or prevent us from continuing to develop or manage our MID, which could lead

to our having to discontinue the MID and could leave us subject to regulatory scrutiny and sanction.

No advice of counsel has been obtained

with respect any potential operations of the MID in Canada.

may not be able to prohibit or limit our dentists, physicians and other healthcare professionals from competing with us in our local

certain states in which we operate or intend to operate, non-compete, non-solicitation, and other negative covenants applicable to employment

or ownership are judicially or statutorily limited in their effectiveness or are entirely unenforceable against dentists, physicians

and other healthcare professionals.

As a result, we may not be able to retain our provider relationships or protect our market share,

operational processes or procedures, or limit insiders or VIPs from using competitive information against us or competing with us, which

could have a material adverse effect on our business, financial condition and ability to remain competitive as our arrangements with

our VIPs do not contain competitive restrictions.

Related to Our Securities Generally

market for our common stock is new and may not develop to provide investors with adequate liquidity.

only recently conducted our initial public offering in December 2020.

market for our common stock is relatively new and may not develop to provide investors with adequate liquidity.

conducted our initial public offering in December 2020, and a follow-on offering in May 2021.

Therefore, the market for our common stock

is new, and we cannot assure you that an active trading market for our common stock will develop, or if it does develop, it may

not be maintained.

You may not be able to sell your common stock quickly or at the market price if trading in our securities is

is relatively new, and has experience periods of inactivity as well as significant volatility.

We cannot assure you that an orderly and

liquid trading market for our common stock will develop, or if it does develop, it may not be maintained.

You may not be able to sell

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 is likely to be volatile.

This volatility may prevent you from being able to sell your securities

at or above the price you paid for your securities.

Our stock price could be subject to wide fluctuations in response to a variety

of factors, which include:

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

This volatility may prevent you from

being able to sell your securities at or above the price you paid for your securities.

Our stock price could be subject to wide fluctuations

in response to a variety of factors, which include:

we achieve our anticipated corporate objectives;

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ability to implement our operational plans;

of lock-up agreements or other restrictions on the ability of our stockholders to sell shares in the future;

on the ability of our stockholders to sell shares in the future;

in the economic performance or market valuations of companies similar to ours;

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addition, the stock market in general, and the stock of publicly-traded medical technology companies in particular, have experienced

extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these

Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual

operating performance.

is a risk of significant future sales by our stockholders that are currently subject to lock-up agreements which expire in June

Such sales could cause the price of our stock price to fall considerably and may adversely impact our ability to raise funds

in new stock offerings.

Other future sales of other shares of our common stock could have a similar adverse effect on us.

Approximately

6,986,620 shares of common stock (or approximately 38% of our currently outstanding shares) held by pre-initial public offering

stockholders of our company were registered with the SEC pursuant to a resale prospectus included as part of our initial public

offering registration statement.

The holders of such shares have entered into “lock-up”

agreements in favor of the

representative of the underwriters of our initial public offering, and such lock-ups will expire on June 15, 2021.

As such, following

the expiration of such lock-ups, such holders will be free to sell their shares in the market.

Such sales, should they occur in

large volume and over a short period of time, could cause the price of our public stock to fall considerably, leading to losses

by our investors and a potential inability of to raise funds in new stock offering.

options to purchase up to 2,319,001 shares of our common stock with a weighted average exercise price of $4.86 are outstanding, and we

also have outstanding (i) a warrant issued to the representative of the underwriters of our initial public offering (exercisable for

402,500 shares of common stock), (ii) warrants associated with our previous Series B Preferred Stock (exercisable for 1,199,195

shares of common stock);

and (iii) 325,000 warrants issued to certain shareholders in November 2020 (see “Management—2020

Derivative Demand and Settlement”).

The exercise or conversion of any of these securities would result in additional dilution,

and the sale of the shares issuable upon exercise or conversion of these securities could also lower the market price of our common stock.

may also acquire or license other technologies or finance strategic alliances by issuing equity, which may result in additional

dilution to our stockholders, and the sale of such securities could adversely affect the market price for our common stock.

extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.

failure to meet the continuing listing requirements of The Nasdaq Capital Market could result in a de-listing of our securities.

we fail to satisfy the continuing listing requirements of Nasdaq, such as the corporate governance, stockholders equity or minimum

closing bid price requirements, Nasdaq may take steps to delist our common stock.

Such a delisting would likely have a negative

effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do

In the event of a delisting, we would likely take actions to restore our compliance with Nasdaq’s listing requirements,

but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize

the market price or improve the liquidity of our securities, prevent our common stock from dropping below the Nasdaq minimum bid

price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

we fail to satisfy the continuing listing requirements of Nasdaq, such as the corporate governance, stockholders equity or minimum closing

bid price requirements, Nasdaq may take steps to delist our common stock.

Such a delisting would likely have a negative effect on the

price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so.

In the event of

a delisting, we would likely take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance

that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity

of our securities, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance

with Nasdaq’s listing requirements.

our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares.

Securities and Exchange Commission (or SEC) has adopted rules that regulate broker-dealer practices in connection with transactions

in penny stocks.

Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered

on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current

price and volume information with respect to transactions in such securities is provided by the exchange or system.

obtain or retain a listing on Nasdaq and if the price of our common stock is less than $5.00, our common stock will be deemed

a penny stock.

The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from

those rules, to deliver a standardized risk disclosure document containing specified information.

In addition, the penny stock

rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must

make a special written determination that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s

written acknowledgment of the receipt of a risk disclosure statement;

(ii) a written agreement to transactions involving penny

and (iii) a signed and dated copy of a written suitability statement.

These disclosure requirements may have the effect

of reducing the trading activity in the secondary market for our common 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.

Securities and Exchange Commission (or SEC) has adopted rules that regulate broker-dealer practices in connection with transactions in

penny stocks.

Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered on certain

national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current price and volume

information with respect to transactions in such securities is provided by the exchange or system.

If we do not obtain or retain a listing

on Nasdaq and if the price of our common stock is less than $5.00, our common stock will be deemed a penny stock.

The penny stock rules

require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk

disclosure document containing specified information.

In addition, the penny stock rules require that before effecting any transaction

in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination that the penny stock

is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure

(ii) a written agreement to transactions involving penny stocks;

and (iii) a signed and dated copy of a written suitability

These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common

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.

acquisitions of medical technology companies like ours are not uncommon, potential investors are cautioned that no assurances

can be given that any form of merger, combination, or sale of our company will take place relating to our company, or that any

merger, combination, or sale, even if consummated, would provide liquidity or a profit for our investors.

You should not invest

in our company with the expectation that we will be able to sell the business in order to provide liquidity or a profit for our

officers and directors may have the ability to exert significant influence over our affairs, including the outcome of matters

requiring stockholder approval.

officers and directors and their affiliates (primarily Kirk Huntsman and Dr.

Dave Singh) currently own shares, in the aggregate,

representing approximately 29% of our outstanding voting capital stock.

As a result, if these stockholders were to choose to act

together, they have and will 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.

acquisitions of medical technology companies like ours are not uncommon, potential investors are cautioned that no assurances can be

given that any form of merger, combination, or sale of our company will take place relating to our company, or that any merger, combination,

or sale, even if consummated, would provide liquidity or a profit for our investors.

You should not invest in our company with the expectation

that we will be able to sell the business in order to provide liquidity or a profit for our investors.

officers and directors may have the ability to exert significant influence over our affairs, including the outcome of matters requiring

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.

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.

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shareholders acted to remove three independent members of our board of directors and appoint new members of our board of directors.

These shareholders could continue to exert this voting power.

of activist shareholders could be disruptive and potentially costly and the possibility that activist shareholders may seek changes

that conflict with our strategic direction could cause uncertainty about the strategic direction of our business.

investors or other stockholders who disagree with our management may attempt to effect changes in our strategic direction and

how our company is governed or may seek to acquire control over our company.

Some investors (commonly known as “activist

investors”) seek to increase short-term stockholder value by advocating corporate actions such as financial restructuring,

increased borrowing, special dividends, stock repurchases, or even sales of assets or the entire company.

Activist campaigns can

also seek to change the composition of our board of directors, and campaigns that contest or conflict with our strategic direction

could have an adverse effect on our results of operations and financial condition as responding to proxy contests and other actions

by activist shareholders can disrupt our operations, be costly and time-consuming, and divert the attention of our board of directors

and senior management from the pursuit of our business strategies.

In addition, perceived uncertainties as to our future direction

that can arise from potential changes to the composition of our board of directors sought by activists may lead to the perception

of a change in the direction of the business, instability or lack of continuity which may be exploited by our competitors, may

cause concern to our current or potential customers or other partners, may result in the loss of potential business opportunities

and may make it more difficult to attract and retain qualified personnel and business partners.

These types of actions could divert

our management’s attention from our business or cause significant fluctuations in our stock price based on temporary or

speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our

business, all of which could have a material adverse effect on our company.

are an “emerging growth company,”

and the reduced disclosure requirements applicable to emerging growth companies

may make our common stock less attractive to investors.

are an “emerging growth company,”

or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS

shareholders could continue to exert this voting power.

of activist shareholders could be disruptive and potentially costly and the possibility that activist shareholders may seek changes that

conflict with our strategic direction could cause uncertainty about the strategic direction of our business.

investors or other stockholders who disagree with our management may attempt to effect changes in our strategic direction and how our

company is governed or may seek to acquire control over our company.

Some investors (commonly known as “activist investors”)

seek to increase short-term stockholder value by advocating corporate actions such as financial restructuring, increased borrowing, special

dividends, stock repurchases, or even sales of assets or the entire company.

Activist campaigns can also seek to change the composition

of our board of directors, and campaigns that contest or conflict with our strategic direction could have an adverse effect on our results

of operations and financial condition as responding to proxy contests and other actions by activist shareholders can disrupt our operations,

be costly and time-consuming, and divert the attention of our board of directors and senior management from the pursuit of our business

In addition, perceived uncertainties as to our future direction that can arise from potential changes to the composition

of our board of directors sought by activists may lead to the perception of a change in the direction of the business, instability or

lack of continuity which may be exploited by our competitors, may cause concern to our current or potential customers or other partners,

may result in the loss of potential business opportunities and may make it more difficult to attract and retain qualified personnel and

business partners.

These types of actions could divert our management’s attention from our business or cause significant fluctuations

in our stock price based on temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying

fundamentals and prospects of our business, all of which could have a material adverse effect on our company.

are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make

our common stock less attractive to investors.

are an “emerging growth company,” or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.

We will remain an EGC until the earlier of:

(i) the last day of the fiscal year in which we have total annual gross revenue

of $1.07 billion or more;

(ii) the last day of the fiscal year following the fifth anniversary of the date of the completion of

our initial public offering;

(iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous

or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

For so long as

we remain an EGC, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to

other public companies that are not emerging growth companies.

(i) the last day of the fiscal year in which we have total annual gross revenue of $1.07

billion or more;

(ii) the last day of the fiscal year following the fifth anniversary of the date of the completion of our initial public

(iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years;

the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

For so long as we remain an EGC, we are permitted

and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging

growth companies.

These exemptions include:

being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404;

being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding

mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit

and the financial statements;

permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial

statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results

of Operations”

being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory

audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial

permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements,

with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations”

disclosure obligations regarding executive compensation;

from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden

parachute payments not previously approved.

from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute

payments not previously approved.

may choose to take advantage of some, but not all, of the available exemptions.

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in this Annual Report on Form 10-K.

In particular, we have not included all of the executive compensation information that would

be required if we were not an EGC.

We cannot predict whether investors will find our common stock less attractive if we rely on

certain or all of these exemptions.

If some investors find our common stock less attractive as a result, there may be a less active

trading market for our common stock and our stock price may be more volatile.

will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial

In particular, we have not included all of the executive compensation information that would be required

if we were not an EGC.

We cannot predict whether investors will find our common stock less attractive if we rely on certain or all of

these exemptions.

If some investors find our common stock less attractive as a result, there may be a less active trading market for

our common stock and our stock price may be more volatile.

continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial

time to new compliance initiatives.

a newly public company, and particularly after we are no longer an EGC, we will incur significant legal, accounting and other

expenses that we did not incur as a private company.

In addition, the Sarbanes-Oxley Act and rules subsequently implemented by

the SEC and Nasdaq have imposed various requirements on public companies, including establishment and maintenance of effective

disclosure and financial controls and corporate governance practices.

Our management and other personnel will need to devote a

substantial amount of time to these compliance initiatives.

Moreover, these rules and regulations will increase our legal and

financial compliance costs and will make some activities more time-consuming and costly.

For example, we expect that these rules

and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance.

a public company, and particularly after we are no longer an EGC, we will incur significant legal, accounting and other expenses that

we did not incur as a private company.

In addition, the Sarbanes-Oxley Act and rules subsequently implemented by the SEC and Nasdaq have

imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls

and corporate governance practices.

Our management and other personnel will need to devote a substantial amount of time to these compliance

Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities

more time-consuming and costly.

For example, we expect that these rules and regulations may make it more difficult and more expensive

for us to obtain director and officer liability insurance.

to Section 404, we will be required to furnish a report by our management on our internal control over financial reporting, including

an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.

However, while we remain an EGC, we will not be required to include an attestation report on internal control over financial reporting

issued by our independent registered public accounting firm.

To achieve compliance with Section 404 within the prescribed period,

we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and

an attestation report on internal control over financial reporting issued by our independent registered public accounting firm if certain

criteria are met.

However, while we remain an EGC, we will not be required to include an attestation report on internal control over

financial reporting issued by our independent registered public accounting firm.

To achieve compliance with Section 404 within the prescribed

period, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly

and challenging.

In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and

adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to

improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a

continuous reporting and improvement process for internal control over financial reporting.

Despite our efforts, there is a risk

that neither we nor our independent registered public accounting firm will be able to conclude within the prescribed timeframe

that our internal control over financial reporting is effective as required by Section 404.

This could result in an adverse reaction

in the financial markets due to a loss of confidence in the reliability of our financial statements.

adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve

control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting

and improvement process for internal control over financial reporting.

Despite our efforts, there is a risk that neither we nor our independent

registered public accounting firm will be able to conclude within the prescribed timeframe that our internal control over financial reporting

is effective as required by Section 404.

This could result in an adverse reaction in the financial markets due to a loss of confidence

in the reliability of our financial statements.

provisions of our Certificate of Incorporation may make it more difficult for a third party to effect a change-of-control.

certificate of incorporation authorizes the Board of Directors to issue up to 50,000,000 shares of preferred stock.

The preferred

stock may be issued in one or more series, the terms of which may be determined at the time of issuance by the Board of Directors

without further action by the stockholders.

These terms may include preferences as to dividends and liquidation, conversion rights,

redemption rights and sinking fund provisions.

The issuance of any preferred stock could diminish the rights of holders of our

common stock, and therefore could reduce the value of such common stock.

In addition, specific rights granted to future holders

of preferred stock could be used to restrict our ability to merge with, or sell assets to, a third party.

The ability of the Board

of Directors to issue preferred stock could make it more difficult, delay, discourage, prevent or make it more costly to acquire

or effect a change-in-control, which in turn could prevent our stockholders from recognizing a gain in the event that a favorable

offer is extended and could materially and negatively affect the market price of our common stock.

bylaws designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated

by our stockholders, which could limit our stockholders’

ability to obtain a favorable judicial forum for disputes with

us or our directors, officers, or employees.

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

(i) any derivative action or proceeding brought on behalf of the 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 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 suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder.

a result, the Delaware Forum Provision will not apply to suits brought to enforce any duty or liability created by the Exchange

Act or any other claim for which the federal courts have exclusive jurisdiction.

We note, however, that there is uncertainty as

to whether a court would enforce this provision and that investors cannot waive compliance with the federal securities laws and

the rules and regulations thereunder.

recognize that the Delaware Forum Provision and the Federal Forum Provision in our bylaws may impose additional litigation costs

on stockholders in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware.

Additionally, the Delaware Forum Provision and the Federal Forum Provision may limit our stockholders’

ability to bring

a claim in a forum that they find favorable for disputes with us or our directors, officers or employees, which may discourage

such lawsuits against us and our directors, officers and employees even though an action, if successful, might benefit our stockholders.

In addition, while the Delaware Supreme Court ruled in March 2020 that federal forum selection provisions purporting to require

claims under the Securities Act be brought in federal court were “facially valid”

under Delaware law, there is uncertainty

as to whether other courts will enforce the Federal Forum Provision.

If the Federal Forum Provision is found to be unenforceable,

we may incur additional costs associated with resolving such matters.

The Federal Forum Provision may also impose additional litigation

costs on stockholders who assert that the provision is not enforceable or invalid.

The Court of Chancery of the State of Delaware

and the United States District Court may also reach different judgments or results than would other courts, including courts where

a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments may be more

or less favorable to us than our stockholders.

on director and officer liability and indemnification of our officers and directors by us may discourage stockholders from bringing

suit against an officer or director.

certificate of incorporation and bylaws provide that, to the fullest extent permitted by Delaware law, as it presently exists

or may be amended from time to time, a director shall not be personally liable to us or our stockholders for monetary damages

for any breach of fiduciary duty as a director.

Under Delaware law, this limitation of liability does not extend to, among other

things, acts or omissions which involve intentional misconduct, fraud or knowing violation of law, or unlawful payments of dividends.

These provisions may discourage stockholders from bringing suit against a director or officer for breach of fiduciary duty and

may reduce the likelihood of derivative litigation brought by stockholders on our behalf against a director or officer.

Certificate of Incorporation authorizes our board of directors to issue up to 50,000,000 shares of preferred stock.

The preferred stock

may be issued in one or more series, the terms of which may be determined at the time of issuance by our board of directors without further

action by the stockholders.

These terms may include preferences as to dividends and liquidation, conversion rights, redemption rights

and sinking fund provisions.

The issuance of any preferred stock could diminish the rights of holders of our common stock, and therefore

could reduce the value of such common stock.

In addition, specific rights granted to future holders of preferred stock could be used

to restrict our ability to merge with, or sell assets to, a third party.

The ability of our board of directors to issue preferred stock

could make it more difficult, delay, discourage, prevent or make it more costly to acquire or effect a change-in-control, which in turn

could prevent our stockholders from recognizing a gain in the event that a favorable offer is extended and could materially and negatively

affect the market price of our common stock.

bylaws designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by

our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our

directors, officers, or employees.

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

(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.

27 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), creates exclusive federal jurisdiction over all

suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder.

As a result, the

Delaware Forum Provision will not apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim

for which the federal courts have exclusive jurisdiction.

We note, however, that there is uncertainty as to whether a court would enforce

this provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.

recognize that the Delaware Forum Provision and the Federal Forum Provision in our bylaws may impose additional litigation costs on stockholders

in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware.

Additionally, the Delaware

Forum Provision and the Federal Forum Provision may limit our stockholders’ ability to bring a claim in a forum that they find

favorable for disputes with us or our directors, officers or employees, which may discourage such lawsuits against us and our directors,

officers and employees even though an action, if successful, might benefit our stockholders.

In addition, while the Delaware Supreme

Court ruled in March 2020 that federal forum selection provisions purporting to require claims under the Securities Act be brought in

federal court were “facially valid” under Delaware law, there is uncertainty as to whether other courts will enforce the

Federal Forum Provision.

If the Federal Forum Provision is found to be unenforceable, we may incur additional costs associated with resolving

such matters.

The Federal Forum Provision may also impose additional litigation costs on stockholders who assert that the provision is

not enforceable or invalid.

The Court of Chancery of the State of Delaware and the United States District Court may also reach different

judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise

choose to bring the action, and such judgments may be more or less favorable to us than our stockholders.

on director and officer liability and indemnification of our officers and directors by us may discourage stockholders from bringing suit

against an officer or director.

Certificate of Incorporation and bylaws provide that, to the fullest extent permitted by Delaware law, as it presently exists or may

be amended from time to time, a director shall not be personally liable to us or our stockholders for monetary damages for any breach

of fiduciary duty as a director.

Under Delaware law, this limitation of liability does not extend to, among other things, acts or omissions

which involve intentional misconduct, fraud or knowing violation of law, or unlawful payments of dividends.

These provisions may discourage

stockholders from bringing suit against a director or officer for breach of fiduciary duty and may reduce the likelihood of derivative

litigation brought by stockholders on our behalf against a director or officer.

are responsible for the indemnification of our officers and directors.

our officers and/or directors require us to contribute to their defense, we may be required to spend significant amounts of our

Our certificate of incorporation and bylaws also provide for the indemnification of our directors, officers, employees,

and agents, under certain circumstances, against attorney’s fees and other expenses incurred by them in any litigation to

which they become a party arising from their association with or activities on behalf of our company.

This indemnification policy

could result in substantial expenditures, which we may be unable to recoup.

If these expenditures are significant or involve issues

which result in significant liability for our key personnel, we may be unable to continue operating as a going concern.

ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may

be subject to certain limitations.

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, or NOLs, and its research and

development credit carryforwards to offset future taxable income.

Our existing NOLs and research and development credit carryforwards

may be subject to limitations arising from previous ownership changes, and if we undergo an ownership change, our ability to utilize

NOLs and research and development credit carryforwards could be further limited by Sections 382 and 383 of the Code.

our ability to deduct net interest expense may be limited if we have insufficient taxable income for the year during which the

interest is incurred, and any carryovers of such disallowed interest would be subject to the limitation rules similar to those

applicable to NOLs and other attributes.

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 a change of control,

we may not be able to utilize a material portion of the NOLs, research and development credit carryforwards or disallowed interest

expense carryovers, even if we attain profitability.

our officers and/or directors require us to contribute to their defense, we may be required to spend significant amounts of our capital.

Our Certificate of Incorporation and bylaws also provide for the indemnification of our directors, officers, employees, and agents, under

certain circumstances, against attorney’s fees and other expenses incurred by them in any litigation to which they become a party

arising from their association with or activities on behalf of our company.

This indemnification policy could result in substantial expenditures,

which we may be unable to recoup.

If these expenditures are significant or involve issues which result in significant liability for our

key personnel, we may be unable to continue operating as a going concern.

ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may limited,

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.

financial and operational projections that we may make from time to time are subject to inherent risks.

projections that our management may provide from time to time (including, but not limited to, those relating to market sizes and

other financial or operational matters) reflect numerous assumptions made by management, including assumptions with respect to

our specific as well as general business, economic, market and financial conditions and other matters, all of which are difficult

to predict and many of which are beyond our control.

Accordingly, there is a risk that the assumptions made in preparing the projections,

or the projections themselves, will prove inaccurate.

There will be differences between actual and projected results, and actual

results may be materially different from those contained in the projections.

The inclusion of the projections in this Annual Report

should not be regarded as an indication that we or our management or representatives considered or consider the projections to

be a reliable prediction of future events, and the projections should not be relied upon as such.

projections that our management may provide from time to time (including, but not limited to, those relating to market sizes and other

financial or operational matters) reflect numerous assumptions made by management, including assumptions with respect to our specific

as well as general business, economic, market and financial conditions and other matters, all of which are difficult to predict and many

of which are beyond our control.

Accordingly, there is a risk that the assumptions made in preparing the projections, or the projections

themselves, will prove inaccurate.

There will be differences between actual and projected results, and actual results may be materially

different from those contained in the projections.

The inclusion of the projections in this Annual Report should not be regarded as an

indication that we or our management or representatives considered or consider the projections to be a reliable prediction of future

events, and the projections should not be relied upon as such.

we were to dissolve, the holders of our securities may lose all or substantial amounts of their investments.

we were to dissolve as a corporation, as part of ceasing to do business or otherwise, we may be required to pay all amounts owed

to any creditors before distributing any assets to the investors.

There is a risk that in the event of such a dissolution, there

will be insufficient funds to repay amounts owed to holders of any of our indebtedness and insufficient assets to distribute to

our other investors, in which case investors could lose their entire investment.

investment in our company may involve tax implications, and you are encouraged to consult your own advisors as neither we nor

any related party is offering any tax assurances or guidance regarding our company or your investment.

formation of our company and our financings, as well as an investment in our company generally, involves complex federal, state

and local income tax considerations.

Neither the Internal Revenue Service nor any state or local taxing authority has reviewed

the transactions described herein, and may take different positions than the ones contemplated by management.

You are strongly

urged to consult your own tax and other advisors prior to investing, as neither we nor any of our officers, directors or related

parties is offering you tax or similar advice, nor are any such persons making any representations and warranties regarding such

we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will

be your sole source of gain.

we were to dissolve as a corporation, as part of ceasing to do business or otherwise, we may be required to pay all amounts owed to any

creditors before distributing any assets to the investors.

There is a risk that in the event of such a dissolution, there will be insufficient

funds to repay amounts owed to holders of any of our indebtedness and insufficient assets to distribute to our other investors, in which

case investors could lose their entire investment.

investment in our company may involve tax implications, and you are encouraged to consult your own advisors as neither we nor any related

party is offering any tax assurances or guidance regarding our company or your investment.

formation of our company and our financings, as well as an investment in our company generally, involves complex federal, state and local

income tax considerations.

Neither the Internal Revenue Service nor any state or local taxing authority has reviewed the transactions

described herein, and may take different positions than the ones contemplated by management.

You are strongly urged to consult your own

tax and other advisors prior to investing, as neither we nor any of our officers, directors or related parties is offering you tax or

similar advice, nor are any such persons making any representations and warranties regarding such matters.

we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be

your sole source of gain.

have never declared or paid cash dividends on our capital stock.

We currently intend to retain all of our future earnings, if

any, to finance the growth and development of our business.

This means that it is very unlikely that we will pay dividends on

our shares of common stock.

We currently intend to retain all of our future earnings, if any, to

finance the growth and development of our business.

This means that it is very unlikely that we will pay dividends on our shares of common

In addition, the terms of any future debt agreements may preclude us from paying dividends.

capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or

if they change their recommendations regarding our common stock adversely, the price of our common stock and trading volume could

trading market for our common stock may be influenced by the research and reports that securities or industry analysts may publish

about us, our business, our market or our competitors.

If any of the analysts who may cover us change their recommendation regarding

our common stock adversely, or provide more favorable relative recommendations about our competitors, the price of our common

stock would likely decline.

If any analyst who may cover us was to cease coverage of our company or fail to regularly publish

reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our common stock or trading

volume to decline.

As a result, capital appreciation,

if any, of our common stock will be your sole source of gain for the foreseeable future.

securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they

change their recommendations regarding our common stock adversely, the price of our common stock and trading volume could decline.

trading market for our common stock may be influenced by the research and reports that securities or industry analysts may publish about

us, our business, our market or our competitors.

If any of the analysts who may cover us change their recommendation regarding our common

stock adversely, or provide more favorable relative recommendations about our competitors, the price of our common stock would likely

If any analyst who may cover us was to cease coverage of our company or fail to regularly publish reports on us, we could lose

visibility in the financial markets, which in turn could cause the price of our common stock or trading volume to decline.

Unresolved Staff Comments.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors