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Item 1. Business

2023-03-30 compared with 2022-03-31 · 846 added, 842 removed, 570 unchanged (75% of the section changed)

We are a revenue stage medical

technology company focused on the development and commercialization of a suite of innovative diagnostic and treatment modalities for

patients with dentofacial abnormalities and/or patients with mild to moderate obstructive sleep apnea (OSA) and snoring in adults.

believe our proprietary oral appliances and associated protocols represent a significant improvement in the treatment of mild to moderate

OSA versus other treatments such as continuous positive airway pressure (or CPAP) or palliative oral appliance therapies.

OSA treatment protocol The Vivos Method .

Vivos Method is an advanced therapeutic protocol, which often combines the use of customized oral appliance specifications and

proprietary clinical protocols developed by our company and prescribed by specially trained dentists in cooperation with their medical

The Vivos Method features our proprietary clinical protocols combined with the following oral appliances:

Repositioning Nighttime Appliance (or mRNA appliance ® ) has 510(k) clearance from the FDA as a Class II

medical device for the treatment of snoring and mild to moderate OSA in adults.

are a revenue stage medical technology company focused on the development and commercialization of a suite of innovative diagnostic

and multi-disciplinary treatment modalities for patients with cranial and/or dentofacial abnormalities and the wide array of medical

conditions that may result from them, including mild to moderate obstructive sleep apnea (known as OSA) and snoring in adults.

believe our proprietary diagnostic tools, oral appliances, myofunctional therapy, clinical treatments, continuing education, and

practice solutions represent a powerful and highly effective set of resources for healthcare providers of all disciplines who treat

patients suffering from debilitating and even life-threatening breathing related sleep disorders and their comorbidities.

primary focus has been on expanding awareness of, and providing treatment options for OSA for, the dentistry market, which we believe

represents a large and relatively untapped market for OSA treatment.

As our business has evolved, we have expanded our treatment and

marketing programs to encompass a more multidisciplinary approach as we have learned even more about how OSA and its comorbidities are

diagnosed and treated.

In this Annual Report on Form 10-K, we sometimes refer to dentists and other medical professionals who treat OSA

as “providers” (including our own Vivos-trained dentists).

have shown our comprehensive and multidisciplinary approach represents a significant improvement in the treatment of mild to moderate

OSA in comparison to or when combined with other largely palliative treatments such as continuous positive airway pressure (or CPAP).

We call our solution The Vivos Method .

Products and Services

The Vivos Method comprises the following products and services:

Complete Airway Repositioning and/or Expansion (CARE) oral appliance therapy including our:

Nighttime Appliance (or DNA appliance ® ) was granted 510(k) clearance from the U.S.

Food & Drug Administration

(or FDA) as a Class II medical device in December 2022 for the treatment of snoring and mild to moderate OSA in adults.

only oral appliance ever to receive FDA clearance to treat OSA without mandibular advancement as its primary mechanism of action.

Repositioning Nighttime Appliance (or mRNA appliance ® ) has 510(k) clearance from the FDA as a Class II medical

device for the treatment of snoring and mild to moderate OSA in adults.

Mandibular Repositioning Nighttime Appliance (or mmRNA appliance), for which we were granted FDA Class II market clearance

in August 2021 for treating mild to moderate OSA, jaw reposition and snoring in adults.

Nighttime Appliance (or DNA appliance ® ) is an FDA-registered product and is currently used by Vivos-trained

clinicians accordingly.

We instruct all dentists prescribing the DNA appliance about the device’s approved indications of use

and of the fact that the DNA appliance is a Class I FDA registered oral appliance for expansion.

Guides are pre-formed, flexible, BPA-free, base polymer intraoral guide and rescue appliances.

The Guides are an FDA-registered

product for orthodontic tooth positioning.

believe The Vivos Method appliance technology and associated protocols represents the first non-surgical, non-invasive and

cost-effective treatment for people with dentofacial abnormalities and/or patients diagnosed with mild to moderate obstructive sleep

apnea (OSA) and snoring in adults.

Combining technologies and protocols that alter the size, shape and position of the tissues of a

patient’s upper airway, The Vivos Method opens oral and airway space and may significantly reduce symptoms and conditions

associated with mild to moderate OSA.

studies have shown that using our customized appliances and clinical protocols led to significantly lower Apnea Hypopnea Index scores

and improved other conditions associated with OSA, and The Vivos Method is estimated to be effective (within the scope of the U.S.

and Drug Administration (or FDA) cleared uses) in approximately 80% of cases of OSA where patients are compliant with clinical protocols.

Our patented oral appliances have been utilized in approximately 25,000 patients treated worldwide by more than 1,450 trained dentists.

Guides are pre-formed, flexible, BPA-free, base polymer, monoblock intraoral guide and rescue appliances.

The Guides are

a Class I FDA-registered product for orthodontic tooth positioning typically used by dentists in children to address malocclusions

and promote proper guided growth and development of the mouth and jaws.

Versa is an FDA 510k cleared Class II device for treating mild to moderate OSA.

It is a comfortable, easy-to-wear, medical

grade nylon, 3D printed oral appliance featuring mandibular advancement as its mechanism of action.

It is priced to be very cost

effective and offers Vivos providers and patients a comfortable and effective product at a much lower price point for treatment.

As with all other non-CARE oral appliances, the Vivos Versa must be worn nightly for life in order to remain clinically effective.

We believe many Vivos Versa patients will eventually migrate up to our proprietary Vivos CARE products.

POD ® and Night Block™

are devices we acquired in February 2023 and are described further below.

We believe these products have significant potential, and

we are currently working to integrate them into our overall offering.

MyoCorrect oral myofunctional therapy (OMT) services.

Studies have shown OMT to be a clinically valuable adjunctive treatment

for patients with breathing related sleep disorders.

When combined with Vivos’ CARE products and treatments, OMT can deliver

an enhanced effect in many patients using our appliances.

MyoCorrect treatment services are cost-effective for providers and convenient

for patients.

MyoCorrect is billable to medical insurance in most cases and constitutes an additional profit center for both Vivos

and providers.

(from SleepImage ® ), Rhinomanometry (from GM Instruments), Cone Beam Computerized Tomography or CBCT (from multiple

vendors), Joint Vibration Analysis (from BioResearch) and other key diagnostic technologies play an essential role as part

of The Vivos Method in patient assessment, proper clinical diagnosis, treatment planning, progress measurement, and optimal outcome

facilitation.

We believe the combination and integration of such diagnostic tools and equipment as particularly taught to and practiced

by Vivos-trained providers constitutes a key trade secret of our company.

AireO 2 is an Electronic Health Record (EHR) software program specifically designed for use as a full practice

management software program in a medical or dental practice environment where treating breathing related sleep disorders is performed.

The program is very well suited to handle both medical and dental billing and is integral in our Treatment Navigator program.

Navigator is our most recent program to assist a clinician’s patients who may have a breathing related sleep disorder

to get screened, diagnosed by a board-certified sleep specialist, obtain insurance verification of benefits and preauthorization

(where required), have their questions answered, and receive assistance with scheduling, financing, medical billing or any other

concerns regarding treatment options best suited to their individual situation.

Dentists typically pay set fees to us for this service.

Billing Intelligence Service (BIS) is our medical and dental billing service.

It is both a subscription and fee for service

program for healthcare practitioners who wish to optimize their insurance reimbursement by leveraging both medical and dental benefits.

We are unaware of any other software platform or service on the market that offers the same set of features or capabilities.

Airway Intelligence Service (AIS) is our technical support and advisory service that supports clinicians in their patient

data analysis, case selection, treatment planning and treatment implementation.

AIS reports and services are priced into the cost

of appliances to providers.

Vivos Institute (TVI) is widely regarded as one of the top educational and learning centers for dentofacial related breathing

and sleep disorders in North America.

Opened in 2021, TVI is housed in a state-of-the-art 18,000 square foot facility near the Denver

International Airport where doctors from around the world come to receive instruction and advanced clinical training in a wide range

of topics delivered by leading national and international medical sleep specialists, cardiologists, pediatric sleep specialists,

dentists, orthodontists, specially trained chiropractors, nutritionists, key industry business leaders, and university-based clinical

products are used in a collaborative multidisciplinary treatment model comprised of dentists, general practice physicians, sleep specialist

physicians, myofunctional therapists, nutritionists, chiropractors, physical therapists, and healthcare professionals.

Our subscription-based

program to train dentists and offer them other value-added services is called the Vivos Integrated Practice (VIP) program.

2022, we continued to expand and grow our screening and home sleep test (“HST”) program (which we call our VivoScore

Program ) featuring SleepImage ® technology, a 510(k) cleared ring-based recorder and diagnostic platform

for home sleep apnea testing.

We market and distribute our SleepImage ® HST in the U.S.

and Canada pursuant to a licensing

agreement with MyCardio LLC.

During 2022, Vivos providers performed nearly 60,000 VivoScore home sleep tests, up 99% over 2021.

the volume of business that we have generated with MyCardio LLC, we now receive pricing and terms for SleepImage ® products

and services that are well below their published retail prices.

We believe the rapid growth of our VivoScore program confirms our belief

that the SleepImage ® HST offers significant commercial advantages and ease of use over existing home sleep

apnea products and technologies in the market and allows healthcare providers to screen, diagnose and initiate treatment for OSA in their

patients more efficiently.

have not yet seen a corresponding increase in patient enrollment in The Vivos Method treatment, however, and based on feedback from our

Vivos-trained providers, we believe this to be a function of staffing turnover and labor shortages that continue to adversely impact the dental

Throughout 2022, we continued to address this by conducting additional regional dental team training sessions on integrating

Vivos products and treatments.

In addition, we drastically reduced the number of Practice Advisors who had previously been dispatched

as “boots on the ground” to help facilitate case starts and provide Vivos-trained providers with support, and we replaced

them with a new service called Treatment Navigator which we piloted and rolled out in the late summer and fall of 2022.

Navigators work effectively as extensions of the dental office, working directly with perspective patients to provide them information

on The Vivos Method, aiding in education, screening, insurance verification of benefits and preauthorization, coordination among various

professional practitioners, recordkeeping, problem solving, as well as, delivering a home sleep test and following up with scheduling

an appointment with a VIP in their area.

Dental offices who wish to avail themselves of this service pay Vivos enrollment fees and per

case fees for the service, thus adding an important new revenue line and profit center to the business.

As of December 31, 2022, there

are approximately 70 Vivos-trained (VIP) dental offices who are at some stage of onboarding with our Treatment Navigator program.

on early feedback, we expect the Treatment Navigator program to continue to grow into a material and important revenue stream as we move

June 2022, we announced an exclusive distribution agreement with GM Instruments, Ltd.

for the distribution of GM Instruments’ NR6

Rhinomanometer, the only FDA approved 4-phase rhinomanometer available in the U.S.

used to calculate nasal airway resistance by measuring

nasal flow and the pressure producing that flow.

Under this agreement, we became the exclusive U.S.

and Canadian distributor of this

specialized diagnostic equipment for evaluating nasal breathing and function in dental patients with sleep and breathing issues.

objective measurement of nasal breathing can be an essential data point in determining the appropriate breathing and sleep issue treatment

pathway as well as a predictor of potential CPAP intolerance or other treatment failure.

in the United Kingdom, GM Instruments is a global manufacturer and distributor of diagnostic technology for assessing nasal and respiratory

flow and function.

The NR6 Rhinomanometer offers a quick non-invasive test to measure the function of the nose during active breathing.

These test results are being used by Vivos-trained dentists and others to measure outcomes of improvement for pre- mid- and post-treatment

of patients undergoing a variety of treatment modalities.

Additionally, GM Instruments products are planned for use as part of research

protocols to improve and support the outcomes of Vivos products and methods for OSA diagnosis and treatment.

addition, on February 28, 2023, we acquired certain U.S.

and international patents, product rights, and other miscellaneous intellectual

property from Advanced Facialdontics, LLC (“AFD”), a company holding propriety technology on certain FDA 510(k) cleared

dental and medical devices.

With this asset purchase transaction, we acquired U.S.

patents, provisional patent applications as well as

International patents, PCT patents and patent applications, thus expanding its product portfolio and revenue potential.

flagship product, the Preventive Oral Device ® , known as the POD ® , is a custom single

arch device with an FDA 510(k) clearance for treating an estimated 40 million patients in the U.S.

and Canada with Temporomandibular

Joint Dysfunction (TMD) and/or Bruxism (teeth grinding or clenching), both known to be closely associated with OSA.

Studies have shown

that there is a clear connection between OSA and TMD.

second FDA 510(k) cleared product, known as the Night Block™ , is a custom dual-arch mandibular advancement oral appliance

that incorporates patented unilateral bite block technology, which may alleviate or eliminate many of the downsides that may be a result

of traditional oral appliance treatment such as inflammation of the TMJ, facial pain, neck pain, headaches, tension, fatigue, clenching,

and grinding.

acquisition of these novel technologies, patent portfolio and product rights further enhance our existing intellectual property and

technology base, enabling us to provide new, complementary products to many OSA patients who experience pain, discomfort, headaches,

tooth loss, and other symptoms that could be associated with TMD and Bruxism.

In addition, this acquisition will provide our

providers with an additional treatment option for patients who do not have OSA, but suffer from jaw pain, headaches, and daytime

fatigue oftentimes associated with TMD and Bruxism.

We expect to be able to manufacture the AFD products through our existing manufacturing relationships.

is a serious and chronic disease that negatively impacts a patient’s sleep, health, and quality of life.

According to a 2019 article

published in Chest Physician, it is estimated that OSA afflicts 54 million adults in the U.S.

According to a 2016 report

by Frost & Sullivan, OSA has an annual societal cost of over $149.6 billion.

According to the study “ Global Prevalence of

Obstructive Sleep Apnea (OSA) ” conducted by an international panel of leading researchers, nearly 1 billion people worldwide

have sleep apnea, and as many as 80% remain undiagnosed.

Research has shown that when left untreated, OSA can increase the risk of comorbidities,

such as high blood pressure, heart failure, stroke, diabetes, dementia, chronic pain and other debilitating, life-threatening diseases.

Unfortunately

for OSA patients, the medical profession has not been able to provide them with solutions that are both effective and desirable.

is the “Gold Standard” treatment for over 90% of OSA patients, but patients often resist having to wear those devices to

bed every night for life, and long-term compliance is reported to be around 50%.

Traditional oral appliances can be effective over limited

time frames, but often create other problems with temporomandibular joint (or TMJ) dysfunction, open bites, infections, and more.

with CPAP, they too must be worn every night for life to be effective.

More radical and invasive options such as neuro-stimulation devices,

or maxillomandibular advancement surgery are likewise viewed more as treatments of last resort.

When The Vivos Method is presented as

a viable treatment option against the alternatives discussed above, we believe it will be the preferred choice of most patients.

believe our proprietary products comprising the Vivos CARE oral appliances represent the first non-surgical, non-invasive and cost-effective

treatment for adults with dentofacial abnormalities and/or patients diagnosed with mild to moderate OSA and snoring.

Combining technologies

that typically expand the upper airway by altering the size, shape and position of its defining tissues, Vivos CARE represents a completely

new treatment modality in the treatment of dentofacial abnormalities that often lead to OSA and many other health conditions.

recently published peer reviewed study in a high impact medical journal ( Sleep Medicine ) showed that use of our CARE appliances

under the guidance of trained Vivos dentists with access to the complete Vivos Method led to significantly lower Apnea Hypopnea Index

scores, significant decreases in OSA severity categories, and significantly increased airway volumes, as measured with no appliance in

These results come from a set of 220 treated patients.

A second database review looking at a set of 786 patients undergoing

CARE treatment by providers with access to the Vivos Method was presented at the American Academy of Sleep Medicine’s annual scientific

meeting in 2022 with results largely consistent with this published set.

A peer reviewed paper on this set is currently in editorial

review and anticipated soon.

These two data sets furthermore are generally consistent with data seen in multiple smaller case series

published over the preceding decade.

Vivos Method is estimated to be indicated and potentially effective (within the scope of the FDA cleared uses) in approximately 80% of

cases of OSA where patients are compliant with clinical treatments.

Our patented oral appliances have been utilized in over 33,000 patients

treated worldwide by more than 1,700 trained dentists.

Target Customers

House of Delegates of the American Dental Association in 2017 adopted a policy statement describing the important role dentists can play

in helping identify patients at greater risk of sleep related breathing disorders.

By focusing our business model around dentists, we

fulfil this role by training dentists and providing the support to use The Vivos Method with their patients that suffer from dentofacial

abnormalities and/or mild to moderate OSA and snoring.

Our program to train dentists and offer them other value-added services

is called the Vivos Integrated Practice (VIP) program.

The VIP program provides dentists with a strong economic incentive

to provide this treatment and prescribe The Vivos Method, together with practice support services.

apnea is a serious and chronic disease that negatively impacts a patient’s sleep, health, and quality of life.

According to a 2019

article published in Chest Physician, it is estimated that OSA afflicts 54 million adults in the U.S.

alone, and according to

a 2016 report by Frost & Sullivan, OSA has an annual societal cost of over $149.6 billion.

According to the study “ Global

Prevalence of Obstructive Sleep Apnea (OSA) ” conducted by an international panel of leading researchers, nearly 1 billion people

worldwide have sleep apnea, and as many as 80% remain undiagnosed.

Research has shown that when left untreated, OSA can increase the

risk of comorbidities, such as high blood pressure, heart failure, stroke, diabetes, dementia, chronic pain and other debilitating, life-threatening

In February 2021, we launched

our screening and home sleep test (“HST”) program (which we call our VivoScore Program ) featuring SleepImage ®

technology, a 510(k) cleared ring-based recorder and diagnostic platform for home sleep apnea testing.

We market and distribute

our SleepImage HST in the U.S.

and Canada pursuant to a licensing agreement with MyCardio LLC.

We believe our SleepImage HST offers significant

commercial advantages over existing home sleep apnea products and technologies in the market and may enable healthcare providers to more

efficiently screen, diagnose and initiate treatment for OSA in their patients, which could result in more patients being treated through

The Vivos Method.

Initially, we anticipated increased revenue from our HST based on an expected increase in total patients tested for

OSA and a corresponding increase in patient enrolment in Vivos Method treatment.

Throughout 2021, we successfully conducted 15 training

sessions conducted by our personnel on the VivoScore Program and screening and home sleep testing using the SleepImage ®

HST, which were attended by approximately 800 dentists and their staff.

January 2022, we announced significant increases across several key metrics for our SleepImage HST, including in particular, for the

three-months ended December 31, 2021, versus the three-months ended December 31, 2020:

(i) an 18 times increase in the total number of

HSTs given across our VIP network, (ii) a 5.7 times increase in the number of VIPs administering HSTs via the VivoScore Program

and (iii) a 3 times increase in the average number of HSTs being administered per VIP.

We believe this performance gain in home sleep

testing allowed us to renegotiate our commercial agreement with MyCardio LLC to lower costs and convert the entire diagnostic

program from a loss leader aimed primarily at stimulating new case starts with sleep apnea treatment using The Vivos Method to a potential

recurring revenue center.

Under the revised agreement, we will lease out the SleepImage ring recorders to VIPs at a fixed price

that includes a full month’s worth of diagnostic sleep test reports.

This potential new revenue center is as yet unproven, but

we believe we will see positive results during 2022.

mission is to rid the world of OSA .

We believe we are well-positioned with what we consider to be a disruptive technology in The

Vivos Method aimed at treating dentofacial abnormalities and/or mild to moderate OSA and snoring, with a clear first-mover

strategy in penetrating the dental market as a means of treating dental conditions and OSA, compelling economics at each level

of the delivery chain, and a talented team of experienced professionals who are passionate about what we do and driven to deliver results.

By virtue of the close connection and relationship

between the oral cavity and airway form and function, properly trained dentists can play a pivotal and even leading role in the treatment

of dentofacial abnormalities which are known to impact breathing and sleep, which in turn can lead to serious health conditions.

VIP program provides dentists with compelling clinical reasons coupled with strong economic incentives to provide their breathing and

sleep disordered patients the best care possible.

have recently expanded our mission and product line positioning to extend the reach and scope of The Vivos Method beyond the dental profession

and to allow for greater collaboration and mutual referrals from other healthcare practitioners, including primary care physicians, medical

specialists, chiropractors, nutritionists, physical therapists, and others who see and treat patients with breathing and sleep disorders.

We believe this extension of our approach will broaden the knowledge among various professions as to what our technology and products

can do for their patients, ultimately leading more patients into treatment with Vivos products and services.

We also incorporate courses

and curricula at The Vivos Institute into our Vivos Method training that provides information, tools, techniques, and systems that enable

other healthcare professionals to engage directly with dentists and actively contribute to the best possible clinical outcome for patients.

mission is to rid the world of sleep apnea by being a leading technology platform and go-to resource for the latest and most effective

treatment modalities, products, and clinical education available to healthcare providers of all specialties who treat patients suffering

from breathing related sleep disorders and their comorbidities.

We fully recognize that breathing related sleep disorders, including

OSA, are often complex conditions with multiple contributing factors that require more than a single solution.

To that end, we have broadened

our product and services lines that comprise The Vivos Method to go beyond the proprietary technologies featured in our CARE oral appliances,

and now offer providers far greater optionality in selecting a diagnostic or treatment solution that is best for their patients.

approach recognizes that there is no “one size fits all” solution for patients, and that both providers and patients are

best served by offering a variety of solutions at various price points that can meet the needs of a larger segment of the population.

believe this evolution of our mission (which was originally focused almost exclusively on the dental community) will appeal to a much

broader array of healthcare professionals, including chiropractors, nutritionists, primary care physicians, cardiologists, physical therapists,

dentists and others, all of whom have a strong vested interest in the overall health and wellbeing of their patients, and each of whom

has something meaningful to contribute when properly educated and trained.

In addition, we see tremendous opportunity with Durable Medical

Equipment (DME) companies, who also have relationships with OSA patients.

As word spreads among a broader array of professionals, equipment

suppliers and their patients, we expect more people to come to know and understand the compelling advantages of The Vivos Method.

believe this will allow us to scale our business and grow our company more rapidly.

Market Opportunity

According to an August 2019 article published in the Lancet, a n

estimated 936 million adults globally aged 30-69 years (men and women) have mild to severe obstructive sleep apnea, which includes 425

million adults aged 30-69 years who have moderate to severe obstructive sleep apnea.

The number of affected individuals with OSA was highest

in China, followed by the U.S., Brazil, and India.

The article indicated that 1 billion people (inclusive of children) are affected with

OSA, with prevalence exceeding 50% in some countries.

We therefore believe that effective diagnostic and treatment strategies are needed

to minimize the negative health impacts of OSA and to maximize cost-effectiveness.

from publicly available information vary as to the extent of obstructive sleep apnea in the United States, but we believe the market

is significant.

According to a 2010 publicly available analysis from researchers at the Harvard Medical School Division of Sleep Medicine,

mild obstructive sleep apnea is defined by an apnea-hypopnea index (or AHI) of between 5 and 15 and has a prevalence of 8-11% of the

adult population in the United States.

A 2004 study published in the Journal of the American Medical Association stated the prevalence

of mild obstructive sleep apnea is one in five adults.

Based on our analysis of the available public information, we estimate that approximately

15% of the adult population in the United States and Canada suffers from OSA.

Based on the estimated total adult population

of 284 million in the United States and Canada, we believe the total addressable United States and Canadian market is approximately 43

million adults.

Our estimates set forth below relating to the intended uses of The Vivos Method are also based in part upon data found

in the study Oral Appliance Treatment for Obstructive Sleep Apnea:

An Update, published publicly by the National Institutes of

Health in 2014.

Targeted treatment projections identified by this method of sleep titration were found to result in effective treatment

in 87% of patients predicted to be successfully treated of OSA in an initial study.

To be conservative and based on available data and

our internal market analysis, we estimate that over 80% of individuals diagnosed with OSA in the North American addressable market may

be candidates for The Vivos Method, leaving us with a total addressable consumer market of over 43.2 million adults.

currently charge clinicians an average sales price of approximately $1,600 per adult case for The Vivos Method.

There are approximately

200,000 general dentists and dental specialists in the United States and another 30,000 in Canada who could potentially offer the Vivos

Method to their patients.

Based on the addressable U.S.

and Canadian consumer market described above and average sales price, we believe

the addressable consumer market for adults in the United States and Canada is approximately $69 billion.

According to a March 2021 Sleep

Apnea Devices Market Size & Share Report, “Sleep Apnea Devices Market Size, Share & Trends Analysis Report By Product

Type (Diagnostic Devices, Therapeutic Devices, Sleep Apnea Masks), By Region (North America, Europe, APAC, Latin America, MEA), And Segment

Forecasts, 2021 – 2028” , the global sleep apnea devices market size was valued at $3.7 billion in 2020 and is

expected to expand at a compound annual growth rate (CAGR) of 6.2% from 2021 to 2028.

According to an American Sleep Association study

published in 2020, an estimated 50 million to 70 million people in the U.S.

to a March 2021 Sleep Apnea Devices Market Size & Share Report, the global sleep apnea devices market size was valued at $3.7 billion

in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 6.2% from 2021 to 2028.

According to an American Sleep Association

study published in 2020, an estimated 50 million to 70 million people in the U.S.

are suffering from some form of sleep disorders.

2 unchanged sentences

According to a study conducted by ResMed in 2018, around 175 million people in Europe were suffering from sleep

We therefore believe that effective diagnostic and treatment strategies are needed to minimize the negative health impacts of

OSA and to maximize cost-effectiveness.

on our direct experience with our Vivos-trained providers performing nearly 60,000 VivoScore HSTs during 2022, we strongly believe the

published estimates from available public information, which range from 12% to 20% of the population, seriously underestimate the extent

of the condition and scope of the problem in the United States and Canada.

Our VivoScore testing routinely results in approximately 50%

of patients testing positive OSA, a number consistent with a recent study published in the Journal of the American Heart Association

on a sample consisting of ~2000 middle-aged to older adults from the Multi-Ethnic Study of Atherosclerosis, where 47% had

moderate-to-severe sleep apnea (OSA).

We therefore believe our prior estimate that approximately 15% of the adult population in the United

States and Canada suffers from OSA to be extremely conservative.

Based on the estimated total adult population of 284 million in the

United States and Canada, we believe the total addressable United States and Canadian market could be as high as 80 million adults.

be conservative and based on available data and our internal market analysis, we estimate that over 80% of individuals diagnosed with

OSA in the North American addressable market may be candidates for The Vivos Method, leaving us with a total addressable consumer market

of approximately 64 million adults.

currently charge clinicians an average sales price of approximately $1,500 per adult case for The Vivos Method.

There are approximately

200,000 general dentists and dental specialists in the United States and another 30,000 in Canada who could potentially offer the Vivos

Method to their patients.

Add to that the nearly 80,000 licensed chiropractors and over 1.1 million medical doctors across all specialties

who routinely see and treat patients with OSA.

Each of them see and treat patients with OSA for many related conditions on a regular

basis even though the vast majority remain undiagnosed with respect to their OSA.

As we raise awareness, and now that new technologies

such as SleepImage ® have driven the cost of diagnosis down dramatically, more providers will be able to integrate evaluations

of breathing and sleep into their basic clinical treatments, and more patients will get diagnosed and seek treatment.

Therefore, based

on the addressable U.S.

and Canadian consumer market described above and average sales price, we believe the addressable consumer market

for adults in the United States and Canada is approximately $96 billion.

Treatment Alternative for OSA - The Vivos Method

The Vivos Method is a non-invasive,

non-surgical, non-pharmaceutical, multi-disciplinary treatment modality for the treatment of dentofacial abnormalities and/or mild to

moderate OSA and snoring.

Proprietary and virtually painless, The Vivos Method may enhance and increase the upper airway and offers patients

what we believe to be an effective treatment alternative based on clinical retrospective data showing that some patients diagnosed with

mild to moderate OSA and snoring symptoms.

are improving.

Based on feedback from independent VIP and their patient we have received, we

believe initial therapeutic benefits from using the protocols and devices are often achieved relatively quickly (in days or weeks) and

final clinical results are typically achieved in 12 to 24 months), all at a relatively low cost to consumers ranging between $7,000 and

$10,000 for adults and $3,500 to $6,000 for children (costs vary by provider) when compared to other options such as surgery.

We believe that The Vivos Method

alters the size, shape and position of the tissues that surround and comprise the functional space known as the upper airway.

is based on retrospective raw data with validated before and after sleep studies and Cone Beam Computerized Tomography (CBCT) scans from

treating clinicians and patient testimony.

As The Vivos Method treatment process progresses, the airway expands, with many patients reporting

a significant reduction of their mild to moderate OSA and snoring symptoms.

Our primary products used in The Vivos Method is our

mRNA appliance ® , and our mmRNA appliance ® which are specifically designed, custom oral appliance that

are worn primarily in the evening hours and overnight and are available for adults.

The treatment time may range from 12 to 24 months.

Our appliances may require periodic adjustments some of which can be performed by the patient and others that are typically rendered

at the dental office where treatment was initiated.

Through the course of treatment with The Vivos Method, patients have reported a variety

of outcomes, including:

in AHI level and/or other indicators of mild to moderate OSA;

of mild to moderate OSA symptoms;

Vivos Method is a non-invasive, non-surgical, non-pharmaceutical, multi-disciplinary treatment modality for the treatment of

dentofacial abnormalities in adults and children and/or mild to moderate OSA and snoring in adults.

Proprietary and virtually painless, The

Vivos Method has been shown to typically expand the upper airway and offers patients what we believe to be an effective treatment

alternative based on published peer-reviewed retrospective clinical data.

Based on feedback from independent VIPs and their

patients, we believe initial therapeutic benefits from using the treatment guidance’s and devices are often achieved

relatively quickly (in days or weeks) and final clinical results are typically achieved in 12 to 18 months), all at a relatively low

cost to consumers ranging between $7,000 and $10,000 for adults (costs vary by provider) when compared to other options such as

lifetime CPAP or surgery.

With our recently announced product line expansion, Vivos now has less expensive treatment options

available for patients down to around $3,500.

These lower cost options include mandibular advancement devices (MAD) that are not

considered a permanent solution, but may offer certain patients an affordable interim solution until they can upgrade to our CARE

Vivos Method’s CARE devices alter the size, shape and position of the tissues that surround and define the functional space known

as the upper airway.

Our treatment also improves nasal breathing, reduces mouth breathing, reduces Apnea Hypopnea Index (AHI) scores,

and generally facilitates better breathing and sleep.

These statements are based on retrospective raw data with validated before and

after sleep studies, rhinomanometry testing before and after treatment, Cone Beam Computerized Tomography (CBCT) scans from treating

clinicians and patient testimony.

As The Vivos Method CARE treatment process progresses, the airway typically expands, with many patients

reporting a significant reduction of their mild to moderate OSA and snoring symptoms.

The primary products used in The Vivos Method CARE

treatment are the DNA appliance ® , the mRNA appliance ® , and the mmRNA appliance ® , each of

which is a specifically designed, customized oral appliance that is worn primarily in the evening hours and overnight.

The treatment

time may range from 10 to 24 months, with 12 to 18 months being typical.

Our appliances may require periodic adjustments some of which

can be performed by the patient and others that are typically rendered at the dental office where treatment was initiated.

course of treatment with The Vivos Method CARE devices, patients have reported a variety of outcomes, including:

in AHI level and/or other measures of OSA;

of OSA symptoms;

and improvement of normal (nasal) breathing;

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of TMJ pain, clicking, and locking;

aesthetic improvement, including a broader smile and reduced ‘gummy smile’.

Facial aesthetic improvement, including a broader smile and reduced “gummy smile”;

posture with better balance and facial symmetry.

Growth Strategy

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for patients with dentofacial abnormalities and/or mild to moderate OSA and snoring in adults.

We believe the following

strategies will play a critical role in achieve this goal and our future growth:

our North American (U.S.

and Canada) sales and marketing organization to drive adoption of The Vivos Method.

to continue the growth our sales and marketing organization and related strategic programs in order to target and expand our network

of Vivos Integrated Practices.

medical and dental community awareness of The Vivos Method.

We intend to continue to promote awareness of the value proposition

of The Vivos Method through training and educating dentists, physicians, and other healthcare providers, including at our Vivos Institute

in Denver, Colorado.

to establish indirect marketing channels .

We have entered, and plan to expand, strategic alliances within the medical and

dental communities to increase awareness of our products.

For example, in August 2021, we announced a new cooperative relationship

with Empower Sleep, a San Bernardino, California-based company empowering patients with affordable, accessible and personalized telemedicine

sleep care, to provide critical diagnostic and medical consultation services to people across North America who suffer from OSA.

We plan to leverage Empower Sleep’s core technologies to provide a user-friendly platform with personalized insights for our

products for patients who are being screened for OSA by North American dentists and other healthcare providers.

consumer awareness of The Vivos Method.

We also plan to continue building consumer awareness through our direct-to-patient

marketing initiatives which we anticipate will include celebrity endorsements, paid search, radio, television, social media, influencers,

company sponsored events, corporate wellness programs, and online video.

We believe the following strategies will

play a critical role in achieve this goal and in establishing more predictable and growing revenue leading, ultimately, to cash flow

positive and profitable operations:

public awareness of the life-threatening and debilitating nature of OSA and its prevalence throughout the world, while letting the

world know of our proprietary and highly effective treatment as an alternative to CPAP.

We plan to continue to create public

demand for Vivos treatments to drive adoption by healthcare providers and coverage by insurance payers.

We also plan to continue

building consumer awareness through our direct-to-patient marketing initiatives which we anticipate will include celebrity endorsements,

paid search, radio, television, social media, influencers, company sponsored events, corporate wellness programs, and online video.

more qualified new patients to our VIP practices.

Leveraging social media and online assets, non-dental professional referral

sources such as MD’s, chiropractors, physical therapists, and others, as well as DME companies, Vivos is driving more case

starts and recurring revenue volume throughout our VIP network.

We also believe that by making our Vivos-trained providers more productive

and profitable, more new dentists will be encouraged to enroll and get trained.

full payment by in network major insurance carriers for The Vivos Method treatment.

We are working to broaden and extend

the insurance coverage available to patients for The Vivos Method beyond what it is today.

Most insurance payers will reimburse at

about 50% of the cost of treatment.

We need to drive that percentage up so patients do not have to pay as much out of pocket.

To this end, in December 2022, we announced a collaboration with Nexus Dental Systems (“Nexus”), which effectively combines our

proprietary out-of-network Billing Intelligence Service with the Nexus’ in-network medical billing platform.

The goal is to

provide both companies’ medical professional networks with greater access to both in or out-of-network billing with all major

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

it easy for both patients and professionals to interact and do business with Vivos.

We are simplifying our training, our

software, and our products in order to make working with us smooth and easy and a great customer experience.

to drive medical and dental community awareness of The Vivos Method and build bridges between medical doctors and dentists through

DSO marketing and our Medical Integration Division.

In late 2021, we began to market The Vivos Method to the large and rapidly

growing segment of private equity and corporate sponsored dental groups known as dental service organizations (known as DSOs).

an estimated 2,600 DSO groups in the U.S.

and Canada covering total office locations in excess of 40,000, we believe makes the integration

of sleep medicine as part of the DSO offering an ideal fit for Vivos to help drive awareness of OSA, new VIP subscriptions and sales

of our products and services.

Our MID and our collaborations with Pneusomnia sleep centers, which are owned jointly by both doctors

and dentists and managed by Vivos, are also a part of our marketing strategy.

We are also continuing to promote awareness of the

value proposition of The Vivos Method through training and educating dentists, physicians, and other healthcare providers, including

at our TVI in Denver, Colorado.

in research and development to drive innovation and expand indications.

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outside of North America, and we plan to conduct further strategic evaluation of such markets as we expand our market penetration

throughout the United States and Canada.

throughout the United States, Canada, the Middle East, Australia, and most recently India.

Revenue Model

revenue is currently derived from the following primary sources:

VIP office training and enrollment fees .

These fees are comprised of one-time, up-front fees, as well as optional renewal fees after 12 months.

Recurring Vivos appliance sales .

Once we train the VIP on how dentists can help treat OSA, the goal is to have them initiate “new case starts” with patients, which leads to sales of our appliances and guides.

Recurring VIP subscription fees.

These are recurring fees that a portion of our VIPs pay us to receive additional value-added services and training.

SleepImage HST revenue .

As described above, we recently

modified our agreement with MyCardio LLC relating to our SleepImage HST for sleep apnea, which creates the potential

for revenue from our leasing of SleepImage HST ring recorders to our VIPs as part of the VivoScore Program.

The Vivos Institute.

Opened in August 2021, our 15,000

square foot Vivos Institute provides advanced post-graduate education and certification to dentists, dental teams, and other healthcare

professionals in a live and hands-on setting in the emerging science of what we call Vivos Care (Complete Airway Repositioning

and Expansion) and product-specific training for the use of our products and services.

Revenue from such courses is

not material at the present time, but our expectation is that increased training awareness of OSA and the promotion of our products

and services will be enhanced by the Vivos Institute.

The Airway Intelligence Service (AIS).

This service provides a complete resource for VIPs to help simplify the diagnostic and appliance design matrix and expedite the treatment planning process.

AIS is provided as part of the price of each appliance and is not a separate revenue stream.

Billing Intelligence Services (BIS).

This complete third-party billing solution includes a comprehensive integrated revenue cycle management software system that allows dentists to focus on running their practice and delivering the best care for their patients.

This medical billing service generates recurring subscription fees from participating VIPs and independent dentists in the United States.

AireO 2 Patient Management Software.

This management software enables healthcare professionals to diagnose, treat and monitor patients with OSA and its related conditions more effectively.

Developed in collaboration with Lyon Dental, AireO 2 contains features that enhance a VIP’s billing services and practice management systems.

office training and enrollment fees .

These fees are comprised of one-time, up-front fees, as well as optional renewal fees

after 12 months.

Vivos appliance sales .

Once we train the VIP on how dentists can help treat OSA, the goal is to have them initiate “new

case starts” with patients, which leads to sales of our appliances and guides.

VIP subscription fees.

These are recurring fees that a portion of our VIPs pay us to receive additional value-added services

and training.

HST revenue .

In 2022, we modified our agreement with MyCardio LLC relating to our SleepImage ® HST for

sleep apnea, which creates the potential for revenue from our leasing of SleepImage ® HST ring recorders to our VIPs

as part of the VivoScore Program.

Vivos Institute (TVI).

Our TVI provides product-specific training for the use of our products and services.

such courses is not material at the present time, but our expectation is that increased training awareness of OSA and the promotion

of our products and services will be enhanced by our TVI.

Airway Intelligence Service (AIS).

This service provides a complete resource for VIPs to help simplify the diagnostic and

appliance design matrix and expedite the treatment planning process.

AIS is provided as part of the price of each appliance and is

not a separate revenue stream.

Intelligence Services (BIS).

This complete third-party billing solution includes a comprehensive integrated revenue cycle

management software system that allows dentists to focus on running their practice and delivering the best care for their patients.

This medical billing service generates recurring subscription fees from participating VIPs and independent dentists in the United

Patient Management Software .

This management software enables healthcare professionals to diagnose, treat and monitor patients

with OSA and its related conditions more effectively.

Developed in collaboration with Lyon Dental, AireO2 contains features that

enhance a VIP’s billing services and practice management systems.

AireO2 is a complement to our BIS software system.

In April 2021, we entered into an asset purchase agreement with Lyon Management and Consulting, LLC and its affiliates to acquire certain medical billing and practice management software, licenses and contracts, including the software underlying AireO2.

The asset acquisition allows us to expand and enhance our current medical billing practice through our BIS division.

The terms of the purchase include $0.2 million of cash and the issuance of a warrant to purchase 25,000 shares of our common stock at a price of $8.90 per share for three years.

The vesting of the warrant is as follows:

5,000 shares vested immediately upon issuance of the warrant, 10,000 shares vest and become exercisable on April 14, 2022 and 10,000 shares vest and become exercisable on April 14, 2023.

Medical Integration Division (MID).

In late 2020, we

launched our MID to assist VIP practices to establish clinical collaboration ties to local primary care physicians, sleep

specialists, ear, nose a throat doctors (ENTs), cardiologists, pediatricians, pulmonologists and other healthcare providers who

routinely see or treat patients with sleep and breathing disorders.

The primary objective of our MID is to promote The Vivos Method

to medical providers and thus facilitate the potential for more mild to moderate OSA patients gaining access to The Vivos Method

while offering continuum of care.

The MID seeks to fulfill that objective by meeting with VIP dentists and medical providers in

their local areas to establish physician practices using the trademarked name “Pneusomnia Sleep Reimagined Center” (which

we refer to as Pneusomnia Centers that are part of the Vivos MID).

These independent medical practices will be managed by our

company under a management and development agreement which pays us six (6%) percent of all net revenue from sleep-related services.

We also collect a development fee for each clinic prior to opening establishing all operational protocols.

We have built into our

core MID business model a great degree of flexibility, such that elements of each Pneusomnia Center as described above may change

and be adapted to local state laws and regulations, and entity formation laws as any such alterations do not violate any state or

federal statutes or regulations.

We believe our early market response from MID activities has been promising, and in March 2021 we

announced the opening of the first Pneusomnia Center in Del Mar, California, and in May 2021, the second in Modesto, California,

with plans to open additional Pneusomnia Centers in several other cities in the U.S.

However, it remains too early to predict the

eventual impact on our overall revenue.

If successful, the MID is expected to enhance the overall practice level economics for

independent VIP offices and generate additional lines of recurring revenue for us.

MyoCorrect (Orofacial Myofunctional Therapy) Program.

In March 2021, we introduced orofacial myofunctional therapy (or OMT) as a service that is part of The Vivos Method, under the name MyoCorrect.

Through MyoCorrect, dentists enrolled in the VIP program will have access to trained therapists who provide OMT via telemedicine technology.

This OMT therapy can be a component of obstructive sleep apnea treatment in conjunction with The Vivos Method which includes our Class II oral appliances and protocols.

OMT, which is given by a certified OMT therapist, involves exercises and other techniques aimed at strengthening the tongue and orofacial muscles by teaching individuals how to engage the muscles to the appropriate position.

Integration Division (MID).

In late 2020, we launched our MID to assist VIP practices to establish clinical collaboration

ties to local primary care physicians, sleep specialists, ear, nose a throat doctors (ENTs), cardiologists, pediatricians,

pulmonologists and other healthcare providers who routinely see or treat patients with sleep and breathing disorders.

objective of our MID is to promote The Vivos Method to medical providers and thus facilitate the potential for additional mild to

moderate OSA patients gaining access to The Vivos Method while offering continuum of care.

The MID seeks to fulfill that objective

by meeting with VIP dentists and medical providers in their local areas who will establish airway centric clinics using the

trademarked name “Pneusomnia “ (which are referred to as Pneusomnia and Pneusomnia Plus Centers).

These independent

clinics that are owned jointly with medical doctors and dentists or just medical doctors depending on local state regulations will

be managed by our company under a management and development agreement which pays us six to eight (6% to 8%) percent of all net

revenue from sleep-related services.

We also collect a development fee for each clinic prior to opening thus establishing all

operational protocols.

We have built into our core MID business model a great degree of flexibility, such that elements of each

Pneusomnia Center as described above may change and be adapted to local state laws and regulations, and entity formation laws as any

such alterations do not violate any state or federal statutes or regulations.

We believe our market response from MID activities has

been promising, and in March 2021 we announced the opening of the first Pneusomnia Center in Del Mar, California, and in May 2021,

the second in Modesto.

2022 was a good year for the MID with the addition of two new locations located in Toluca Lake California,

and Newport Beach California.

These two new locations are branded under the name Pneusomnia Plus as

these are dental offices jointly owned by independent dentists and physicians.

The MID has plans to assist in the opening of

additional Pneusomnia Centers in several other cities in the U.S.

including two locations in Las Vegas, Nevada and one in

Scottsdale, AZ.

The MID is expected to enhance the overall practice level economics for independent VIP offices and generate

additional lines of recurring revenue for us.

(Orofacial Myofunctional Therapy) Program .

In March 2021, we introduced orofacial myofunctional therapy (or OMT) as a service

that is part of The Vivos Method, under the name MyoCorrect.

Through MyoCorrect, dentists enrolled in the VIP program will have access

to trained therapists who provide OMT via telemedicine technology.

OMT can be a component of obstructive sleep apnea treatment in

conjunction with The Vivos Method which includes our Class II oral appliances and treatment guidelines.

OMT, which is given by a

certified OMT therapist, involves exercises and other techniques aimed at strengthening the tongue and orofacial muscles by teaching

individuals how to engage the muscles to the appropriate position.

As of December, 31, 2022, 1,206 patients have enrolled in MyoCorrect.

Competitive Strengths

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then develop and promulgate the systems and best practices required to successfully

integrate the treatment of dentofacial abnormalities and/or mild to moderate OSA and snoring using this novel treatment

modality in a dental practice;

then establish and provide, by recruitment and otherwise, ongoing clinical mentoring and support to

independent dentists engaged in treating their patients for dentofacial abnormalities and/or mild to moderate OSA and

snoring and related conditions (clinical mentors are limited and may be hard to find);

and finally, assisting the dentists with

case selection, case acceptance, patient financing, and medical insurance reimbursement.

We believe we have strategically and effectively

addressed each and every one of the aforementioned barriers to entry, and thus have created a novel and compelling single-source

value proposition for dentists seeking to deliver OSA treatment to their patients.

integrate the treatment of dentofacial abnormalities and/or mild to moderate OSA and snoring using this novel treatment modality

in a dental practice;

then establish and provide, by recruitment and otherwise, ongoing clinical mentoring and support to independent

dentists engaged in treating their patients for dentofacial abnormalities and/or mild to moderate OSA and snoring and related conditions

(clinical mentors are limited and may be hard to find);

and finally, assisting the dentists with case selection, case acceptance,

patient financing, and medical insurance reimbursement.

We believe we have strategically and effectively addressed each and every

one of the aforementioned barriers to entry, and thus have created a novel and compelling single-source value proposition for dentists

seeking to deliver OSA treatment to their patients.

Method insurance reimbursement:

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Services (CMS) jurisdiction in the U.S.

We continue to pursue our own billing code(s) for Vivos CARE treatment along with pilot programs

at major US payers.

of published research and strong patient outcomes:

Together with our network of trained dentists, we have developed a body

of clinical and patient data over approximately ten years and an estimated 25,000 patients treated with our proprietary clinical

protocols that demonstrates the safety, effectiveness, therapy adherence (patient compliance), and benefits of The Vivos Method for

its registered and 510(k) cleared uses.

Together with our network of trained dentists, we have developed a database

of clinical and patient data over approximately ten years that includes an estimated 25,000 patients treated with our proprietary

clinical treatments that demonstrates the safety, effectiveness, therapy adherence (patient compliance), and benefits of The Vivos

Method for its registered and 510(k) cleared uses.

The documented and reported benefits of treatment with The Vivos Method have been

consistent across reports from independent dentists and have been highlighted in approximately 55 published studies, case

reports, and articles, many of which have been peer reviewed.

We believe this favorable data provides us with a significant

competitive advantage and will continue to support increased adoption.

consistent across reports from independent dentists and have been highlighted in approximately 60 published studies, case reports,

and articles, many of which have been peer reviewed.

We believe this favorable data provides us with a significant competitive advantage

and will continue to support increased adoption.

mover advantage:

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Differentiated

To our knowledge, we believe only The Vivos Method offers a truly differentiated, non-invasive treatment

option that actually works on a common root cause of OSA.

We also believe that older oral appliances are typically less expensive,

but do not reshape the upper airway like our appliances, and therefore require nightly use over a lifetime, and have a number

of other disadvantages.

To our knowledge, we believe only The Vivos Method offers a truly differentiated, non-invasive treatment option

that actually works on a common root cause of OSA.

We also believe that older oral appliances are typically less expensive, but do

not reshape the upper airway like our appliances, and therefore require nightly use over a lifetime, and have a number of other disadvantages.

property portfolio and research and development capabilities We have a comprehensive patent portfolio to protect our intellectual

property and technology, five design patents that expire between 2023 through 2029 and two utility patents expiring

in 2029 and 2030.

We own two Canadian patents and one European patent that has been validated in Belgium, Switzerland, Germany,

Denmark, Spain, France, United Kingdom, Hungary, Italy and the Netherlands, all of which expire in 2029.

We also have three pending

utility patents.

property and technology, five design patents that expire between 2023 through 2029 and two utility patents expiring in 2029 and 2030.

We own two Canadian patents and one European patent that has been validated in Belgium, Switzerland, Germany, Denmark, Spain, France,

United Kingdom, Hungary, Italy and the Netherlands, all of which expire in 2029.

We also have three pending utility patents.

trademark portfolio consists of 10 registered marks and one pending trademark applications.

Extensive online and in-person training, multiple touch point support systems, specific fabrication materials, customized appliance

designs, and multi-disciplinary treatment protocols are all considered proprietary trade secrets and competitive advantages with

no known counterparts.

Extensive online and in-person training,

multiple touch point support systems, specific fabrication materials, customized appliance designs, and multi-disciplinary treatment

modalities are all considered proprietary trade secrets and competitive advantages with no known counterparts.

Training and Support Systems:

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approach to market development :

We have established a systematic and scalable approach to actively and consistently engage

with our primary target audience of U.S.

and Canadian dentists.

In addition, our MID is actively targeting physicians and other relevant

healthcare providers in order to build awareness and collaborative patient options for independent VIP practices.

We have established a systematic and scalable approach to engage with our primary target

audience of U.S.

and Canadian dentists actively and consistently.

In addition, our MID is actively targeting physicians and other

relevant healthcare providers in order to build awareness and collaborative patient options for independent VIP practices.

Patient access to The Vivos Method at a VIP practice is becoming more readily available, and active VIP providers

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have established a methodical approach to market development which centers on active engagement directly with members of the medical

community, including general dentists and medical doctors who treat dentofacial abnormalities and/or mild to moderate OSA and

snoring, to educate them on The Vivos Method and its benefits.

The goals of our sales and marketing efforts are (i) to secure new

VIP dentists and provide them with the tools to treat patients with our products and (ii) more broadly educate the medical community

regarding our products with a view towards expanding our number of VIPs as well as medical professionals who could refer patients to

our VIPs for treatment.

community, including general dentists and medical doctors who treat dentofacial abnormalities and/or mild to moderate OSA and snoring,

to educate them on The Vivos Method and its benefits.

The goals of our sales and marketing efforts are (i) to secure new VIP dentists

and provide them with the tools to treat patients with our products and (ii) more broadly educate the medical community regarding our

products with a view towards expanding our number of VIPs as well as medical professionals who could refer patients to our VIPs for treatment.

sell the VIP Program to dentists through a direct sales force that primarily targets general dentists in the United States and Canada.

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350 new content creation projects.

Our VIP program was developed to train independent dentists to identify and treat dental

conditions that may be associated with mild to moderate sleep apnea.

Our sales program to target medical doctors is our MID

program, which was developed to assist VIP practices to establish clinical collaboration ties to local primary care physicians, sleep

specialists, ENTs, pediatricians, pulmonologists and other healthcare professionals who routinely see or treat patients with sleep and

breathing disorders.

Our VIP program was developed to train independent dentists to identify and treat dental conditions

that may be associated with mild to moderate sleep apnea.

Our sales program to target medical doctors is our MID program, which was developed

to assist VIP practices to establish clinical collaboration ties to local primary care physicians, sleep specialists, ENTs, pediatricians,

pulmonologists and other healthcare professionals who routinely see or treat patients with sleep and breathing disorders.

countries outside of North America we typically offer a modified training and support program at a lower cost.

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current VIP sales organization is comprised of three teams consisting of:

Enrollment Specialist , who is the primary salesperson responsible for enrolling new

Enrollment Support Staff members, who are responsible for organizing potential VIP

appointments for the Enrollment Specialist;

Business Development Associates , who are responsible for cultivating new business

leads which are referred to the Enrollment Support Staff;

Outreach and Engagement Associate , who is responsible for engaging with potential

VIPs in our sales process with surveys and offers of online courses with the purpose of leads

to be referred to the Enrollment Support Staff members;

Practice Advisory Onboarding Specialist , who is responsible for onboarding new VIPs

to our training programs.

MID sales organization is comprised of a Senior Vice President that leads the MID sales efforts and one Senior Director of Business Development.

We plan on growing our MID sales organization by recruiting candidates that have extensive healthcare backgrounds, strong business development

experience setting up physician owned medical facilities/practices and significant healthcare regulatory knowledge.

Enrollment Specialist , who is the primary salesperson responsible for enrolling new VIPs;

Enrollment Support Staff members, who are responsible for organizing potential VIP appointments for the Enrollment Specialist;

Area Business Managers , who are responsible for cultivating new business leads which are referred to the Enrollment Support

Area Business Managers are responsible for cultivating new leads, sales of new products, coordinating local Clinical Education

Outreach and Engagement Associate , who is responsible for engaging with potential VIPs in our sales process with surveys and

offers of online courses with the purpose of leads to be referred to the Enrollment Support Staff members;

Practice Advisory Onboarding Specialist , who is responsible for onboarding new VIPs to our training programs.

MID is comprised of a Senior Vice President that leads the MID sales, marketing, operations and finance efforts with one Senior Director

of Business Development, one Director of Operations and one Senior Market Manager.

We plan to grow our MID organization by recruiting

candidates that have extensive healthcare backgrounds, strong business development experience setting up physician owned medical facilities/practices

and significant healthcare regulatory knowledge.

the late fourth quarter of 2021, we launched our sales initiative targeting the large and rapidly growing segment of private equity and

corporate sponsored dental groups known as Dental Service Organizations (or DSOs).

With an estimated 2,600 DSO groups in the U.S.

Canada covering total office locations in excess of 40,000, DSOs provide business management and support to dental practices, including

non-clinical operations.

In many ways, DSO’s represent the most patient centric and profit motivated model to scale in dentistry,

which we believe makes the integration of sleep medicine as part of the DSO offering an ideal fit for Vivos to help drive awareness of

OSA, new VIP subscriptions and sales of our products and services.

Our early experience in working with DSOs has been that while some

DSO-participating dentists have become VIPs and direct customers of ours, in some cases, the DSO would prefer to be the customer or have

primary (or shared) responsibility for paying VIP subscription fees to us.

utilize indirect and direct marketing channels to inform and educate dentists, medical doctors and healthcare professionals about The

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advisor network.

In 2021, we made strides by establishing the following strategic partnerships aimed and broadening awareness

of and selling efforts for The Vivos Method:

In October 2021, we announced a new collaboration with Candid Care

Co., a digital platform for oral healthcare, which that will seek to provide patients with a comprehensive, whole-mouth solution

to diagnose and treat OSA in adult patients and provide orthodontic treatment from the same provider network.

At the core of this

collaboration, Vivos and Candid will market each company’s products and areas of expertise to deliver a comprehensive sleep

and oral health solution to patients in the United States and Canada.

The focus of the collaboration will be Candid’s CandidPro

clear aligner for straightening teeth and the Vivos Method for treating OSA.

The two companies will also share educational resources,

training, and key opinion leaders to bridge the gap between airway health and orthodontic therapy.

Our ongoing collaboration with Candid is still in the early and

formative stages, primarily due to a major strategy change by Candid where they completely shut down their direct-to-consumer initiatives

in order to focus entirely on their CandidPro model emphasizing active dentist participation and patient interaction.

Now that Candid

has made that transition, we fully expect to see an increase in alignment and close collaboration between our two companies.

The emphasis will be on sharing provider lists, dentist prospects, DSO affiliations, and jointly developing future clinical products.

We currently have bi-weekly conference calls between respective company senior management and expect that to continue.

In August 2021, we announced a cooperative relationship with Empower Sleep, a San Bernardino, California-based company empowering patients with affordable, accessible and personalized telemedicine sleep care, to provide critical diagnostic and medical consultation services to people across North America who suffer from OSA.

Together, Vivos and Empower Sleep plan to leverage each company’s core technologies to provide a user-friendly platform with personalized insights for patients who are being screened for OSA by North American dentists and other healthcare providers.

Empower Sleep spent most of 2021 organizing and obtaining medical licensure

throughout the U.S.

Currently, Empower Sleep is fully licensed to practice medicine in approximately 40 states and expect to be in all

50 states by the end of the second quarter of 2022.

Sahil Chopra is the primary sleep specialist and owner of Empower Sleep.

speaks at Vivos events and has largely organized his company in a manner that best serves our VIPs and their patients.

While much progress

has been made to fully operationalize the Vivos/Empower Sleep dentist and patient interactions, we believe some work remains to smooth

out the inefficiencies and normal start-up risks.

We believe our two companies work very well together and share a mutual purpose and

direct marketing channels include outreach to prospective VIPs using digital advertising platforms including Facebook and Google ad placements.

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further believe our dentist and medical doctor marketing efforts have been effective in facilitating contact via our Vivos introduction

and online training webinars, despite significant headwinds throughout our core customer base, mostly driven by COVID-19 Delta and

Omicron variant resurgences in the middle and latter part of the year.

and online training webinars, despite significant headwinds throughout our core customer base, mostly driven by COVID-19 Delta and Omicron

variant resurgences in the early and middle part of the year.

Economics for Trained VIP Clinicians

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from assigned mentors.

As a result, we are able to complete the initial training workshops, both online and in person, typically

within just 15 days spread out over several weeks.

Our success in training approximately 1,450 dentists confirms our belief that

training represents a minimal barrier to adoption for most dentists.

As a result, we are able to complete the initial training workshops, both online and in person, typically within

just 6-7 days spread out over a couple of weeks.

Our success in training approximately 1,650 dentists confirms our belief that training

represents a minimal barrier to adoption for most dentists.

is an illustrative model depicting the total additional revenue a dentist might receive by treating patients with The Vivos Method.

potential patients with dentofacial abnormalities and/or mild to moderate OSA is determined by using a calculation that results

in a conservative estimate that 30% of patients of a dental practice patient may suffer from OSA (according to a 2019 article published

in Chest Physician ).

potential patients with dentofacial abnormalities and/or mild to moderate OSA is determined by using a calculation that results in a

conservative estimate that 30% of patients of a dental practice patient may suffer from OSA (according to a 2019 article published in

Chest Physician ).

The revenue treatment fee is estimated at $9,000 per patient.

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might want to become a trained VIP and use The Vivos Method.

Number of Active

Patients in Typical

Dental Practice

Patients with

Number of Active Patients

in Typical Dental

Potential Patients

facilitate the adoption of The Vivos Method, we market the VIP Program, and as part of that offering, we often partner with equipment

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Reimbursement

mRNA appliance ® and mmRNA appliance ® are custom fabricated appliances to treat mild to moderate

reimbursement is available across the full spectrum of Vivos appliances.

Medical coverage and benefits are subject to medical necessity

and payer guidelines.

Although medical insurance is never a guarantee of payment, the average reimbursement seen is approximately 50%

(ranging from 5% to 70%).

Benefits payable are subject to deductibles and policy limitations that may vary.

A verification of benefits

(VOB) is generally required for all medical policies to check for validity of billable coding for oral appliance therapy (OAT) and need

for pre-authorization that may be required for reimbursement.

Vivos Integrated Practices (VIPs) typically remain out-of-network with

commercial health insurance, but this depends on the individual practice and the commercial payer guidelines in each state.

As out-of-network

providers, dentists can set their own fees and balance bill the patient for the cost of care not covered by the patient’s health

Although many patients pay for treatment out of pocket on a fee for service basis, the availability of health insurance coverage

is an important consideration for many patients who desire treatment so that billing guidance is an important component of support provided

by Vivos to VIPs.

mRNA appliance® and mmRNA appliance® are custom fabricated mandibular advancement appliances indicated to treat mild to moderate

OSA and snoring in adults.

The mRNA and mmRNA can be billed in and out of network to most commercial payers under the E0486 CPT

The E0486 is reimbursable by many major commercial medical payers following a medical diagnosis of OSA.

Level of reimbursement

is approximately 50% (ranging from 5% to 70%), although medical insurance is never a guarantee of payment, and patient deductibles and

policy limitations may vary.

A verification of benefits is required for all medical policies to check for validity of CPT code E0486

and oral appliance therapy (OAT).

Pre-authorization may be required for reimbursement.

Pre-Authorization requirements may vary based

on the payer policies and patient’s insurance coverage.

Although many patients pay for treatment out of pocket on a fee for service

basis, the availability of health insurance coverage is an important consideration for many patients who desire treatment in The Vivos

All medical policies have different reimbursement policies which may affect availability of reimbursement.

typically remain out of network with commercial health insurance payers, but this depends on the individual practice and the commercial

payer guidelines in each state.

As out of network providers, dentists can set their own fees and balance bill the patient for the cost

of care not covered by the patient’s health insurance.

The American Medical Association will provide fee ranges for all billable

A dentist must set their own fees for the CPT codes billed in their office that are within their scope of practice.

mRNA appliance ® and our DNA appliance are not covered by Medicare or Medicaid as they do not meet the approved design

criteria by CMS.

We made modifications to the mRNA appliance ® to meet CMS criteria for the billing code E0486 to

These slight modifications of the mRNA appliance ® led to the creation of a new FDA cleared device,

the mmRNA appliance ® ( Modified Mandibular Repositioning Nighttime Appliance ).

In February 2021, we submitted a

510(k) for Class II clearance to the FDA for the mmRNA appliance with indications to treat mild to moderate OSA and snoring in

adults, which was approved by FDA in August 2021.

In December 2021, we received acceptance from a Centers for Medicare &

Medicaid Services Pricing, Data Analysis and Coding (“PDAC”) contractor for our mmRNA applicable for treating mild to

moderate OSA and snoring in adults.

This acceptance places the mmRNA device on the PDAC list of oral appliances covered by and

billable to Medicare, making the benefits of the mmRNA device available to millions of Medicare beneficiaries.

Notwithstanding this

important achievement, in general we have not found the lack of inclusion on the current CMS Medicare list of approved sleep

appliances to hinder market distribution or acceptance due to the fact that most dentists who work with The Vivos Method are out of

network with commercial payers and do not typically file for reimbursement under Medicare.

have seen an increase in the ability for reimbursement for our other FDA registered oral appliances such as the DNA appliance and the

Vivos Guides.

These oral appliances are being pre-authorized and billed under an undefined CPT code only when medical necessity is present

and documented properly.

Pre-authorization with medical director review is required with a “letter of medical necessity”

(LMN) to gain possible medical reimbursement.

A dentist billing an undefined CPT code for a Class I or Class II oral appliance must proceed

with caution.

Billing an undefined CPT code for OAT must be supported with documented medical necessity and is reviewed by the medical

director at the payor before being submitted for possible reimbursement.

Typically, the dentist writes an LMN to explain the medical

necessity and the patient’s request for oral appliance therapy and submits the LMN for review to the medical directors at the payor.

The plan medical directors will then review the LMN, including any dentofacial abnormalities, CT images, comorbidities, and any medical

conditions the patient has be diagnosed with by a medical doctor.

This documentation is how the dentist establishes medical necessity.

Once pre-authorization is gained, then OAT can be billed for a possible reimbursement from the medical payor.

A dentist typically can

gain reimbursement for OAT by the medical insurance if the undefined code is valid and billable under their policy and there is

medical necessity present, supported, and documented.

The mRNA and mmRNA can be billed in- and out-of-network to most commercial payers under the E0486 CPT code.

The E0486 code is reimbursable by many major commercial medical payers following a medical diagnosis of OSA and adherence to payer guidelines

for alternative OSA therapy.

Pre-authorization may also be required for reimbursement of these appliances and the pre-authorization requirements

may vary based on the payer policies and patient’s insurance coverage.

As described above, the same VOB and pre-authorization/LMN

process is employed in the billing practices for these appliances to navigate the pathway to payment of medical benefits.

mRNA appliance® and our DNA appliance are not currently covered by Medicare or Medicaid as they do not feature the specific

design criteria required by the Centers for Medicaid and Medicare (CMS) for payment for oral appliances billed with code E0486.

meet the billing requirements of CMS for custom mandibular advancement oral appliances, the mmRNA appliance® (Modified

Mandibular Repositioning Nighttime Appliance) was developed based on the original design of the mRNA appliance.

In August 2021

510(k) for Class II clearance from the FDA for the mmRNA appliance with indications to treat jaw repositioning and mild to moderate

OSA and snoring in adults was approved.

In December 2021, the mmRNA was accepted by the CMS Pricing, Data Analysis and Coding

This acceptance places the mmRNA device on the PDAC list of oral appliances covered by and billable to

Medicare, making the benefits of the mmRNA device available to millions of Medicare beneficiaries.

Notwithstanding this important

achievement, in general we have found the lack of inclusion on the current CMS Medicare PDAC list does not hinder market

distribution or acceptance of Vivos appliances.

This is due to the fact that most dentists who work with The Vivos Method are

out-of-network with commercial payers and do not typically file for reimbursement under Medicare.

When Medicare reimbursement is

desired by Vivos providers they are typically registered with Medicare DME as a non-participating DME supplier, allowing the

provider to balance bill patients like they would when billing as an out-of- network provider to commercial policies and are not

limited to accepting Medicare reimbursement rates as payment in full.

have seen an increase in the ability for Reimbursement for our other FDA registered oral appliances such as the Vivos Guides for children

and the DNA appliance for adults.

When preauthorizing and billing the Vivos Guides and DNA appliance an undefined CPT code can be utilized

only when medical necessity is present and documented properly.

A dentist billing an undefined CPT code for a Class I or Class II oral

appliance must proceed with caution.

These preauthorization and billing requirements pertain to all valid and billable codes and must

be supported with documented medical necessity reviewed by the medical director at the payor before being submitted for possible reimbursement.

Pre-authorization with medical review is accomplished via a “letter of medical necessity” (LMN) used to summarize and communicate

the existing medical necessity.

The plan’s medical director will then review the LMN, supporting clinical documentation of dentofacial

abnormalities present, CT images, co-morbidities, and any other related medical conditions diagnosed by a medical doctor.

Once authorized

the OAT can be billed for benefit calculation and payment.

In December 2022 the DNA appliance received 510(k) clearance with indications

to treat mild to moderate OSA and snoring in adults.

While the DNA appliance can still be pre-authorized and billed using an undefined

CPT code, the newly issued 510(k) clearance for the DNA appliance allows for additional code types to be utilized when OSA is present

and diagnosed by a Medical Doctor.

The DNA appliance can be pre-authorized and billed using a HCPCS Code designated for use by reducing

upper airway collapsibility, that is custom fabricated, without a fixed mechanical hinge.

While the use of this designated HCPCS code

is new there is a potential pathway for additional registrations with Vivos appliances on the PDAC list of oral appliances covered by

and billable to Medicare.

Insurance Coverage

insurance coverage for Vivos appliances also exists.

Codes for sleep apnea appliances were added to the CDT code set in 2022.

Vivos appliances

with indications for treatment of OSA are billable with these code, however dental benefits for these codes are nascent at present and

secondary to medical coverage.

Orthodontic coverage and benefits are also available for Vivos appliances registered with indication of

jaw expansion and tooth movement.

are several studies in the medical literature on upper airway remodeling in pathologic conditions such as asthma, chronic obstructive

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upper airway remodeling.

Advances in 3D digital technology, as well as an increased understanding of the human genome and epigenetics,

has allowed us to make further advances in the understanding of dentofacial phenomena.

For example, while it was believed that sutures

undergo closure in early adulthood, according to published research, it is now thought that populations of stem cells may persist to

permit continued growth and development.

Using this premise, the midfacial bone volume can be increased surgically or non-surgically.

Since the roof of the mouth is the floor of the nose, the volume of the nasal airway can also be increased surgically or non-surgically.

Therefore, using our patented, non-surgical protocols we targeted oral conditions and upper airways to address dentofacial

abnormalities and/or mild to moderate OSA and snoring.

Using various assessment techniques, we found surface area, volumetric and

functional changes of the upper airway.

2009, our technology has been the subject of approximately 55 peer-reviewed articles in the medical, dental and orthodontic literature.

Of the 55 articles, 27 of these are journal papers, with Dr.

Dave Singh, our founder and former Chief Medical Officer, as first author

on 22 of these papers.

Of the 27 journal papers, 17 of these articles describe the studies that examine the impact of our technology

and protocols on the AHI scores of patients with varying degrees of OSA as described in “Overview” above.

In addition, over

25 conference papers have been published as abstracts, with Dr.

Singh as first author on 20 of these conference papers.

Additionally,

there were 19 independent dentists and five different sleep physicians are co-authors on these publications as well.

published in these case reports and articles, together with patient-reported outcomes, have illustrated that The Vivos Method

therapy can provide a significant change in the severity of patients’ with dentofacial abnormalities and/or mild

to moderate OSA and snoring (as measured by industry standard indices such as the AHI, among others), improvement in oral conditions,

sleep-related quality of life, reduction in snoring, high patient compliance rates and a strong safety profile.

Advances in 3D digital imaging, adjunctive treatments from chiropractic and other specialists, and applied diagnostic

technologies such as rhinomanometry, combined with real-world experience in many thousands of cases, has allowed us to make further advances

in the understanding of dentofacial phenomena and how to activate and optimize dentofacial development for improved airway form and function.

For example, while it was believed that cranial sutures undergo closure in early adulthood, it is now thought that populations of stem

cells may persist to permit continued growth and development.

Using this premise, the midfacial bone volume may be increased surgically

or non-surgically.

Since the roof of the mouth is the floor of the nose, the volume of the nasal airway can also be increased surgically

or non-surgically.

There are certain aspects of the underlying biological and bio-mechanical processes that we currently do not fully

understand, and are continually exploring.

Nevertheless, our experience continues to be that using our patented, non-surgical treatment

we are able to target and evoke a resizing of the oral cavity and upper airways to address dentofacial abnormalities and/or mild to moderate

OSA and snoring.

Using various assessment techniques, we have previously reported surface area, volumetric and functional changes of

the upper airway.

2009, our technology has been the subject of over 60 peer-reviewed articles in the medical, dental and orthodontic literature.

most of these papers have been small uncontrolled case series, their results were reflected in our retrospective database review of 220

patients undergoing CARE treatment for Obstructive Sleep Apnea published in July 2022 in Sleep Medicine .

The results of that review

showed 63.6% of Vivos patients had achieved improvement in their AHI scores by at least one severity class, while 25.9% saw a complete

resolution of their OSA symptoms.

Again, these results were measured pre- and post-treatment, with no appliance in the mouth.

more retrospective data sets have been presented at scientific meetings in the past year that further corroborate clinical efficacy of

Vivos CARE treatment in adult OSA, pediatric OSA, and also in adult headache severity.

The results of these presentations are in various

stages of medical journal submission.

The results published have illustrated that CARE therapy when provided as part of the Vivos Method

can provide a significant change in the severity of patients’ dentofacial abnormalities and/or OSA and snoring (as measured by

industry standard indices such as the AHI, among others), improvement in oral conditions, sleep-related quality of life, reduction in

snoring, high patient compliance rates and a strong safety profile.

establish and protect our proprietary rights, we rely on a combination of patents, trademarks, copyrights and trade secrets, including

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Extensive online and in-person training, multiple touch point support systems,

specific fabrication materials, customized appliance designs, and multi-disciplinary treatment protocols are all considered proprietary

specific fabrication materials, customized appliance designs, and multi-disciplinary treatment modalities are all considered proprietary

trade secrets and competitive advantages with no known counterparts.

Regulatory Status

The Vivos Method offers treatment

protocol that uses nonsurgical, noninvasive, and cost-effective oral appliance technology prescribed by trained dentists and medical

professionals to treat dentofacial abnormalities and/or mild to moderate OSA and snoring.

The Vivos Method includes a customized treatment

plan that may begin with a simple and easy at-home sleep apnea screening using proprietary HST technology from SleepImage.

offer two Class II devices cleared by the FDA ( mRNA and mmRNA ) and one Class I device registered with the FDA (DNA).

our own pre-formed Vivos Guides.

Vivos Method offers treatment modalities that uses nonsurgical, noninvasive, and cost-effective oral appliance technology prescribed

by trained dentists and medical professionals to treat dentofacial abnormalities and/or mild to moderate OSA and snoring.

The Vivos Method

includes a customized treatment plan that may begin with a simple and easy at-home sleep apnea screening using proprietary HST technology

from SleepImage ® .

We offer three Class II devices cleared by the FDA ( DNA , mRNA and mmRNA ).

own specially designed pre-formed Vivos Guides.

The regulatory status of our products is as follows:

mmRNA (Pat.Pend.) appliance has a 510(k) clearance from the FDA as a Class II medical device

for the treatment of jaw repositioning, snoring and mild to moderate OSA in adults.

mRNA appliance ® has 510(k) clearance from the FDA as a Class II medical device

for the treatment of snoring and mild to moderate OSA in adults.

DNA appliance ® is an FDA-registered product for expansion and

is currently used by Vivos-trained clinicians.

We instruct all dentists prescribing the DNA

appliance about the device’s approved indications of use and of the fact that the DNA

appliance is a Class I FDA registered oral appliance.

Dentists, as licensed clinicians within

the scope of their practice, are free to diagnose, treat and prescribe the appropriate oral

appliance therapy as they see fit, including uses which might be “off label”,

based on their professional judgement.

Given the fact that our dentists regularly prescribe

the DNA appliance to treat conditions closely associated with OSA, we do not believe a failure

to receive FDA Class II clearance would materially impact our results or financial condition.

Any potential consequences of off-label use of the DNA appliance are the responsibility of

the treating dentist;

however, we may face consequences related to such off-label use.

“ Risk Factors— The misuse or off-label use of The Vivos Method may harm our

reputation in the marketplace, result in injuries that lead to product liability suits or

result in costly investigations, fines or sanctions by regulatory bodies if we are deemed

to have engaged in the promotion of these uses, any of which could be costly to our business.”

Vivos Guides are an FDA-registered product for orthodontic tooth positioning.

2021, we announced that results from a peer-reviewed, published study by an independent dentist

found a significant reduction of tooth decay in pediatric patients after undergoing treatment

using our Vivos Guides.

are conducting two separate Western Copernicus Group Institutional Review Board (WCG IRB) approved pediatric clinical trials

with eight private dental sites around the country.

The purpose of the first study is to evaluate the safety and efficacy of an intraoral

device (the DNA) to reduce sleep-disordered breathing (SDB) in children, including:

snoring, mild to moderate obstructive sleep apnea

(OSA), and Upper Airway Resistance Syndrome (UARS).

The child subjects enrolled in this study will be using the DNA appliance to correct

orthodontic issues.

They will also present with midfacial hypoplasia suitable for palatal expansion.

During orthodontic treatment and

palatal expansion, the device will be studied to determine whether it can also reduce symptoms of sleep disordered breathing in children.

The study will recruit pediatric subjects who have already elected to utilize the study device for their orthodontic treatment.

meet the inclusion and exclusion criteria, then they will be included in the study.

The purpose of the second study is to evaluate the

safety and efficacy of an intraoral device (the Vivos Grow and/or Vivos Way appliances) to reduce sleep-disordered breathing (SDB) in

children, including:

snoring, mild to moderate obstructive sleep apnea (OSA), and Upper Airway Resistance Syndrome (UARS).

mmRNA (Pat.Pend.) appliance has a 510(k) clearance from the FDA as a Class II medical device for the treatment of jaw repositioning,

snoring and mild to moderate OSA in adults.

mRNA appliance ® has a 510(k) clearance from the FDA as a Class II medical device for the treatment of snoring and mild to moderate OSA in adults.

DNA appliance ® has a 510(k) clearance from the FDA as a Class II medical device for the treatment of jaw

repositioning, snoring and mild to moderate OSA in adults.

Vivos Guides are an FDA-registered Class I product for orthodontic tooth positioning.

In October 2021, we announced that results

from a peer-reviewed, published study by an independent dentist found a significant reduction of tooth decay in pediatric patients

after undergoing treatment using our Vivos Guides.

A second study was peer reviewed and published in 2022 showing a 97.4% resolution

of nocturnal enuresis (bedwetting) in children within 60 days of starting treatment with Vivos Guides.

Other papers and studies on

the use of Vivos Guides have been submitted to various journals and are awaiting acceptance and publication.

are conducting two separate Western Copernicus Group Institutional Review Board (“WCG IRB”) approved pediatric clinical trials with eight

private dental sites around the country.

The purpose of the first study is to evaluate the safety and efficacy of an intraoral device

(the DNA) to reduce sleep related breathing disorders in children, including:

snoring, mild to moderate obstructive sleep apnea (OSA),

and Upper Airway Resistance Syndrome (“UARS”).

The child subjects enrolled in this study will be using the DNA appliance to correct orthodontic

They will also present with midfacial hypoplasia suitable for arch development.

During orthodontic treatment and arch development,

the device will be studied to determine whether it can also reduce symptoms of sleep-related breathing disorders in children.

will recruit pediatric subjects who have already elected to utilize the study device for their orthodontic treatment.

If they meet the

inclusion and exclusion criteria, then they will be included in the study.

The purpose of the second study is to evaluate the safety and efficacy of an intraoral device (the Vivos Grow and/or Vivos Way

appliances) to reduce sleep-related breathing disorders in children, including:

snoring, mild to moderate OSA, and UARS.

subjects enrolled in this study will be using the Vivos Grow/Vivos Way appliance to correct orthodontic issues.

They will also present

with midfacial hypoplasia suitable for palatal expansion.

During orthodontic treatment and palatal expansion, the devices will be studied

to determine whether they can also reduce symptoms of sleep disordered breathing in children.

The study will recruit pediatric subjects

who have already elected to utilize the study device for their orthodontic treatment.

If they meet the inclusion and exclusion criteria

they can be included in the study.

Upon completion of these WIRB pediatric clinical trials (expected to be completed in the next 6

to 12 months), we plan to submit two separate 510(k) applications to the FDA requesting pediatric clearances and indications of use

for the DNA appliance ® as well as the Vivos Guides.

Our mRNA appliance ®

and mmRNA appliance ® are cleared by the FDA as Class II sleep appliances to treat mild to moderate OSA and snoring

Patients undergoing treatment are seeing improvement in the said cleared indications of use, but clinicians have also reported

that they are seeing other comorbidities and medical conditions improve due to treatment.

These appliances (which are central to The

Vivos Method) and other Vivos appliances are made available to trained clinicians who exercise their independent clinical judgment with

respect to their use and suitability as a part of an overall treatment protocol created for each individual patient.

September 2017 our subsidiary, BMS, was the subject of its first routine FDA audit.

That audit resulted in findings that required BMS

to remediate certain deficiencies such as:

(i) inadequate documentation of certain FDA-required procedures (i) not keeping certain records

and materials in paper format and in triplicate, and (iii) the use of certain descriptive words and phrases on its website and in marketing

materials that were not approved in advance by FDA.

We immediately hired a highly qualified FDA consultant and legal counsel with FDA

expertise to assist BMS in preparing both a written response and a plan for regaining and maintaining compliance with FDA regulations

and guidelines.

In good faith, and based on documents provided by BMS, we believed BMS had filed its response to the original audit in

a timely manner with FDA which was due on [ ].

However, in January 2018 BMS received a request for a response to an FDA Warning Letter

(the “Warning Letter”) that had been posted online at the FDA website.

The Warning Letter stated that BMS failed to reply

in a timely manner and address the findings of the September audit.

We believed that we had filed out response to the FDA on September

The local BMS office in Portland, Oregon was closed down as of September 30, 2017 pursuant to a share exchange agreement which

made BMS a subsidiary of our company (and which transaction was accounted for as a merger as disclosed in the consolidated financial

This transaction was disclosed to the FDA, and neither we nor BMS ever received any further notices from FDA after September

upon becoming aware of the miscommunication and deficiency, we notified the FDA of the error and provided the FDA with full documentation

of our substantial efforts to fully comply with FDA rules and regulations.

The FDA completed a second audit in April 2018, which examined

our responses to the initial deficiencies and our compliance plan.

We believe that this matter has been satisfactorily resolved, although

no definitive statement to that effect has been made by FDA, nor has the Warning Letter been taken down from the FDA website.

also audited our company (then known as Vivos BioTechnologies, Inc.) and issued one minor observation, to which we have responded and

August of 2020, we underwent our 2-year FDA regulatory inspection.

This inspection resulted in our receipt of an FDA Form 483 with two

observations.

These observations were corrected and responded to according the Code of Federal Regulations.

Upon the review of the 483

responses, the FDA delivered a letter to us requesting additional information.

We responded to the letter, and thereafter learned that

the FDA was satisfied with our responses.

They will also

present with midfacial hypoplasia suitable for arch development.

During orthodontic treatment and arch development, the devices will

be studied to determine whether they can also reduce symptoms of sleep related breathing disorders in children.

The study will

recruit pediatric subjects who have already elected to utilize the study device for their orthodontic treatment.

If they meet the

inclusion and exclusion criteria they can be included in the study.

Upon completion of the two pediatric clinical trials described

below which are expected to be completed in the next 6 to 12 months we plan to submit two separate 510(k) applications to the FDA

requesting pediatric clearances and indications of use for the DNA appliance ® as well as the Vivos Guides.

of the oral appliances that comprise our Vivos Complete Airway Repositioning and/or Expansion (CARE) system (our DNA

appliance ® , mRNA appliance and mmRNA appliance ® ) are cleared by the FDA as Class II sleep appliances

to treat mild to moderate OSA and snoring in adults.

Patients undergoing treatment are seeing improvement in the said cleared

indications of use, but clinicians have also reported that they are seeing other comorbidities and medical conditions improve due to

These appliances (which are central to The Vivos Method) and other Vivos appliances are made available to trained

clinicians who exercise their independent clinical judgment with respect to their use and suitability as a part of an overall

treatment created for each individual patient.

October of 2022, we underwent our 2-year FDA regulatory inspection.

This inspection resulted in our receipt of an FDA Form 483 with three

observations, none of which was a repeat offense from previous inspections.

These observations were corrected and responded to according

to the Code of Federal Regulations.

The FDA delivered a final report of the October 2022 inspection to us in January 2023.

Manufacturing

We rely on third-party suppliers

and manufacturers on a per order, or per item basis.

Outsourcing manufacturing reduces our need for capital investment and reduces operational

Additionally, outsourcing provides expertise and capacity necessary to scale up or down based on demand for our appliances.

We select our manufacturing labs so we can ensure that our appliances are safe and effective, adhere to all applicable regulations, are

of the highest quality, and meet our supply needs.

We also rely on third-party carriers and freight forwarders for product shipments,

including shipments to and from our manufactures’ distribution facilities and customer distribution facilities.

rely on third-party suppliers and manufacturers on a per order, or per item basis.

Outsourcing manufacturing reduces our need for capital

investment and reduces operational expenses.

Additionally, outsourcing provides expertise and capacity necessary to scale up or down

based on demand for our appliances.

We select our manufacturing labs so we can ensure that our appliances are safe and effective, adhere

to all applicable regulations, are of the highest quality, and meet our supply needs.

We also rely on third-party carriers and freight

forwarders for product shipments, including shipments to and from our manufactures’ distribution facilities and customer distribution

Ongoing Clinical Research

are committed to ongoing research and development, and we intend to invest in our business to further improve our products and

clinical outcomes, increase patient acceptance and comfort and broaden the patient population that can benefit from The Vivos Method.

approved February 2021 –

Biomimetic oral appliance therapy (BOAT) for the treatment of mild to moderate OSA in adults (March 2022 renamed “ Daytime

Nighttime Appliance (DNA) therapy for the treatment of Obstructive Sleep Apnea (OSA)”) .

The aim of this study

is to investigate structural and functional effects of the treatment protocol using the DNA appliance ® in

the treatment of mild to moderate OSA in adults.

This study will test the hypothesis that treatment of the upper airway associated

with functional improvements of sleep parameters in adults with mild to moderate OSA.

January 2019 – Treatment of SDB with an intraoral device in a pediatric population.

are committed to ongoing research and development, and we intend to invest in our business to further improve our products and clinical

outcomes, increase patient acceptance and comfort and broaden the patient population that can benefit from The Vivos Method.

to the following two currently active clinical trials we are aggressively pursuing head-to-head comparisons of the DNA vs.

CPAP in moderate

to severe OSA, DNA vs.

tonsillectomy in pediatric OSA, and DNA vs.

routine management in Veterans with OSA and post-traumatic stress

disorder with potential sites identified and preliminary work underway.

approved February 2021 -Daytime Nighttime Appliance (DNA) therapy for the treatment of Obstructive Sleep Apnea (OSA).

aim of this study is to investigate structural and functional effects of using the DNA appliance ® in the treatment

of mild to moderate OSA in adults.

This study will test the hypothesis that treatment of the upper airway associated with functional

improvements of sleep parameters in adults with mild to moderate OSA.

January 2019 - Treatment of OSA with an intraoral device in a pediatric population.

Approved by WCG IRB as non-significant

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mild to moderate OSA, and UARS.

The WCG IRB is an independent Institutional Review Board located in Olympia, Washington that

provides services for academic and non-academic institutions.

WCG IRB is accredited by the Association for the Accreditation

of Human Research Protection Programs.

(AAHRPP) Clinical outcomes:

Pediatric Sleep Questionnaire, reduction in sleep apnea and UARS

using the AHI, Epworth Sleepiness Scale for Children and Adolescents, and changes in upper airway volume.

Clinical outcomes:

Pediatric Sleep Questionnaire, reduction in sleep apnea and UARS using the AHI,

Epworth Sleepiness Scale for Children and Adolescents, and changes in upper airway volume.

products and our operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States,

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notification or pre-market approval (PMA).

Under the FDCA, medical devices are classified into one of three classes—Class I, Class

II or Class III—depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory

control needed to ensure its safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for

which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance

with the applicable portions of the QSR, facility registration and product listing, reporting of adverse medical events, and truthful

and non-misleading labeling, advertising, and promotional materials.

Class II devices are subject to the FDA’s General Controls,

and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.

These special controls can

include performance standards, post-market surveillance, patient registries and FDA guidance documents.

While most Class I devices are

exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a

premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.

permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.

the 510(k) process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially

equivalent” to either a device that was legally marketed (for which the FDA has not required a PMA submission) prior to May 28,

1976, the date upon which the Medical Device Amendments of 1976 were enacted, or another commercially available device that was cleared

to through the 510(k) process.

The FDA has 90 days from the date of the pre-market equivalence acceptance to authorize or decline commercial

distribution of the device.

However, similar to the PMA process, clearance may take longer than this three-month window, as the FDA can

request additional data.

If the FDA resolves that the product is not substantially equivalent to a predicate device, then the device

acquires a Class III designation, and a PMA must be approved before the device can be commercialized.

Under the FDCA, medical devices are classified into one of three classes-Class I, Class II

or Class III-depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control

needed to ensure its safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for which safety

and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with

the applicable portions of the QSR, facility registration and product listing, reporting of adverse medical events, and truthful and

non-misleading labeling, advertising, and promotional materials.

Class II devices are subject to the FDA’s General Controls, and

special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.

These special controls can include

performance standards, post-market surveillance, patient registries and FDA guidance documents.

While most Class I devices are exempt

from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket

notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.

The FDA’s permission

to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.

Under the 510(k)

process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially equivalent”

to either a device that was legally marketed (for which the FDA has not required a PMA submission) prior to May 28, 1976, the date upon

which the Medical Device Amendments of 1976 were enacted, or another commercially available device that was cleared to through the 510(k)

The FDA has 90 days from the date of the pre-market equivalence acceptance to authorize or decline commercial distribution of

However, similar to the PMA process, clearance may take longer than this three-month window, as the FDA can request additional

If the FDA resolves that the product is not substantially equivalent to a predicate device, then the device acquires a Class III

designation, and a PMA must be approved before the device can be commercialized.

Vivos Guides are registered with the FDA as Class I devices for orthodontic tooth positioning.

The DNA appliance ® is registered

with the FDA as a Class I device for expansion and is currently used by Vivos-trained clinicians accordingly.

On December 30, 2022, the FDA granted

510k clearance for the DNA appliance ® as a Class II medical device for jaw repositioning, and for the treatment

of mild to moderate obstructive sleep apnea and snoring in adults.

This approval

was the first time the FDA has granted such a clearance on an oral appliance with a mechanism of action other than mandibular advancement.

The mRNA appliance® has 510(k) clearance from the FDA as a Class II medical device for the treatment of snoring, and mild-to-moderate

OSA in adults.

The mmRNA appliance® has 510(k) clearance from the FDA as a Class II medical device for jaw repositioning, and for

the treatment of snoring, and mild-to-moderate OSA in adults.

deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting or some implantable devices, or devices that have

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in Class III, requiring approval of a PMA.

Some pre-amendment devices are unclassified but are subject to the FDA’s premarket

notification and clearance process in order to be commercially distributed.

Some pre-amendment devices are unclassified but are subject to the FDA’s premarket notification

and clearance process in order to be commercially distributed.

We do not have any Class III devices.

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registration and device listing with the FDA;

requirements, which require manufacturers, including third-party manufacturers, to follow

stringent design, testing, control, documentation, and other quality assurance procedures

during all aspects of the design and manufacturing process;

and marketing regulations, which require that promotion is truthful, not misleading, fairly

balanced and provide adequate directions for use and that all claims are substantiated, and

also prohibit the promotion of products for unapproved or off-label uses and impose other

restrictions on labeling;

FDA guidance on off-label dissemination of information and responding

to unsolicited requests for information;

federal Physician Sunshine Act and various state and foreign laws on reporting remunerative

relationships with health care customers;

federal Anti-Kickback Statute (and similar state laws) prohibiting, among other things, soliciting,

receiving, offering or providing remuneration intended to induce the purchase or recommendation

of an item or service reimbursable under a federal healthcare program, such as Medicare or

A person or entity does not have to have actual knowledge of this statute or specific

intent to violate it to have committed a violation;

federal False Claims Act (and similar state laws) prohibiting, among other things, knowingly

presenting, or causing to be presented, claims for payment or approval to the federal government

that are false or fraudulent, knowingly making a false statement material to an obligation

to pay or transmit money or property to the federal government or knowingly concealing, or

knowingly and improperly avoiding or decreasing, an obligation to pay or transmit money to

the federal government.

The government may assert that claim includes items or services resulting

from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim

for purposes of the false claims statute;

or approval of product modifications to 510(k)-cleared devices that could significantly affect

safety or effectiveness or that would constitute a major change in intended use of one of

our cleared devices, or approval of a supplement for certain modifications to PMA devices;

device reporting regulations, which require that a manufacturer report to the FDA if a device

it markets may have caused or contributed to a death or serious injury, or has malfunctioned

and the device or a similar device that it markets would be likely to cause or contribute

to a death or serious injury, if the malfunction were to recur;

● correction,

removal and recall reporting regulations, which require that manufacturers report to the

FDA field corrections and product recalls or removals if undertaken to reduce a risk to health

posed by the device or to remedy a violation of the FDCA that may present a risk to health;

with the new federal law and regulations requiring Unique Device Identifiers (UDI) on devices

and also requiring the submission of certain information about each device to the FDA’s

Global Unique Device Identification Database (GUDID);

FDA’s recall authority, whereby the agency can order device manufacturers to recall

from the market a product that is in violation of governing laws and regulations;

● post-market

surveillance activities and regulations, which apply when deemed by the FDA to be necessary

to protect the public health or to provide additional safety and effectiveness data for the

requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation,

and other quality assurance procedures during all aspects of the design and manufacturing process;

and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions

for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or off-label uses and impose

other restrictions on labeling;

FDA guidance on off-label dissemination of information and responding to unsolicited requests for

federal Physician Sunshine Act and various state and foreign laws on reporting remunerative relationships with health care customers;

federal Anti-Kickback Statute (and similar state laws) prohibiting, among other things, soliciting, receiving, offering or providing

remuneration intended to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program,

such as Medicare or Medicaid.

A person or entity does not have to have actual knowledge of this statute or specific intent to violate

it to have committed a violation;

federal False Claims Act (and similar state laws) prohibiting, among other things, knowingly presenting, or causing to be presented,

claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material

to an obligation to pay or transmit money or property to the federal government or knowingly concealing, or knowingly and improperly

avoiding or decreasing, an obligation to pay or transmit money to the federal government.

The government may assert that claim includes

items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes

of the false claims statute;

or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would

constitute a major change in intended use of one of our cleared devices, or approval of a supplement for certain modifications to

device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed

to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or

contribute to a death or serious injury, if the malfunction were to recur;

removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls

or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a

risk to health;

with the new federal law and regulations requiring Unique Device Identifiers (UDI) on devices and also requiring the submission of

certain information about each device to the FDA’s Global Unique Device Identification Database (GUDID);

FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation

of governing laws and regulations;

surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide

additional safety and effectiveness data for the device.

may be subject to similar foreign laws that may include applicable post-marketing requirements such as safety surveillance.

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distribution, installation, and servicing of finished devices intended for human use.

The QSR also requires, among other things,

maintenance of a device master file, device history file, and complaint files.

As a manufacturer, our facilities, records, and

manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA.

Our failure to maintain compliance with

the QSR or other applicable regulatory requirements could result in the shut-down of, or restrictions on, our manufacturing operations

and the recall or seizure of our products.

The discovery of previously unknown problems with any of our products, including unanticipated

adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of

its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal

of the product from the market or voluntary or mandatory device recalls or a public warning letter that could harm both our reputation

Any potential consequences of off-label use of the DNA appliance are the responsibility of the treating independent

however, we may face consequences related to such off-label use.

See “ Risk Factors— The misuse or off-label use

of The Vivos Method may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in

costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of

which could be costly to our business.”

The QSR also requires, among other things, maintenance

of a device master file, device history file, and complaint files.

As a manufacturer, our facilities, records, and manufacturing processes

are subject to periodic scheduled or unscheduled inspections by the FDA.

Our failure to maintain compliance with the QSR or other applicable

regulatory requirements could result in the shut-down of, or restrictions on, our manufacturing operations and the recall or seizure

of our products.

The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse

events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label

by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the

market or voluntary or mandatory device recalls or a public warning letter that could harm both our reputation and sales.

Any potential

consequences of off-label use of the DNA appliance are the responsibility of the treating independent dentist;

however, we may face consequences

related to such off-label use.

See “ Risk Factors- The misuse or off-label use of The Vivos Method may harm our reputation in

the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory

bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.”

FDA has broad regulatory compliance and enforcement powers.

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restrictions or partial suspension or total shutdown of production;

or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified

● withdrawing

or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;

510(k) clearances or PMAs that have already been granted;

to grant export or import approvals for our products;

of Medical Devices in the EEA

is currently no premarket government review of medical devices in the EEA (which is comprised of the 28 Member States of the EU plus

Norway, Liechtenstein and Iceland).

However, all medical devices placed on the market in the EEA must meet the relevant essential requirements

laid down in Annex I of Directive 93/42/EEC concerning medical devices, or the Medical Devices Directive.

There is also a directive specifically

addressing Active Implantable Medical Devices (Directive 90/385/EEC).

The most fundamental essential requirement is that a medical device

must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety

and health of users and others.

In addition, the device must achieve the performances intended by the manufacturer and be designed, manufactured

and packaged in a suitable manner.

The European Commission has adopted various standards applicable to medical devices.

These include

standards governing common requirements, such as sterilization and safety of medical electrical equipment, and product standards for

certain types of medical devices.

There are also harmonized standards relating to design and manufacture.

While not mandatory, compliance

with these standards is viewed as the easiest way to satisfy the essential requirements as a practical matter.

Compliance with a standard

developed to implement an essential requirement also creates a rebuttable presumption that the device satisfies that essential requirement.

demonstrate compliance with the essential requirements laid down in Annex I to the Medical Devices Directive, medical device manufacturers

must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.

assessment procedures require an assessment of available clinical evidence, literature data for the product and post-market experience

in respect of similar products already marketed.

Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where

the manufacturer can self-declare the conformity of its products with the essential requirements (except for any parts which relate to

sterility or metrology), a conformity assessment procedure requires the intervention of a “Notified Body”.

Notified Bodies

are often separate entities and are authorized or licensed to perform such assessments by government authorities.

The Notified Body would

typically audit and examine a product’s technical dossiers and the manufacturers’ quality system.

If satisfied that the relevant

product conforms to the relevant essential requirements, the Notified Body issues a certificate of conformity, which the manufacturer

uses as a basis for its own declaration of conformity.

The manufacturer may then apply the CE Mark to the device, which allows the device

to be placed on the market throughout the EEA.

Once the product has been placed on the market in the EEA, the manufacturer must comply

with requirements for reporting incidents and field safety corrective actions associated with the medical device.

order to demonstrate safety and efficacy for their medical devices, manufacturers must conduct clinical investigations in accordance

with the requirements of Annex X to the Medical Devices Directive, Annex 7 of the Active Implantable Medical Devices Directive, and applicable

European and International Organization for Standardization standards, as implemented or adopted in the EEA member states.

Clinical trials

for medical devices usually require the approval of an ethics review board and approval by or notification to the national regulatory

Both regulators and ethics committees also require the submission of serious adverse event reports during a study and may

request a copy of the final study report.

April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the EU

Medical Devices Directive and the Active Implantable Medical Devices Directive.

Unlike directives, which must be implemented into the

national laws of the EEA member States, the regulations would be directly applicable, i.e., without the need for adoption of EEA member

State laws implementing them, in all EEA member States and are intended to eliminate current differences in the regulation of medical

devices among EEA member States.

The Medical Devices Regulation, among other things, is intended to establish a uniform, transparent,

predictable and sustainable regulatory framework across the EEA for medical devices and ensure a high level of safety and health while

supporting innovation.

The Medical Devices Regulation will however only become applicable three years after publication (in 2020).

applicable, the new regulations will among other things:

the rules on placing devices on the market and reinforce surveillance once they are available;

explicit provisions on manufacturers’ responsibilities for the follow-up of the quality,

performance and safety of devices placed on the market;

the traceability of medical devices throughout the supply chain to the end-user or patient

through a unique identification number;

up a central database to provide patients, healthcare professionals and the public with comprehensive

information on products available in the EU;

● strengthened

rules for the assessment of certain high-risk devices, such as implants, which may have to

undergo an additional check by experts before they are placed on the market.

are subject to regulations and product registration requirements in many foreign countries in which we may sell our products, including

in the areas of:

development, manufacturing and testing;

safety reporting;

sales and distribution;

and storage requirements;

requirements;

and language of instructions for use;

keeping procedures;

● advertising

and promotion;

and field corrective actions;

● post-market

surveillance, including reporting of deaths or serious injuries and malfunctions that, if

they were to recur, could lead to death or serious injury;

and export restrictions;

regulations, duties and tax requirements;

● registration

for reimbursement;

of testing performed in country by distributors for licensees;

time required to obtain clearance required by foreign countries may be longer or shorter

than that required for FDA clearance, and requirements for licensing a product in a foreign

country may differ significantly from FDA requirements.

EU Medical Devices Regulation became effective in May 2020.

The revised regulation includes further controls and requirements on the

following activities:

level of request for premarket clinical evidence for high-risk devices;

scrutiny of technical files for implantable devices;

of notified bodies, by independent auditors;

requirements regarding vigilance and product traceability (specifically related to labeling

requirements);

regulation for non-traditional roles such as importer and distributor.

of Medical Devices in Canada

regulates the import and sale of medical devices through Health Canada (or HC).

HC reviews medical devices to assess their safety, effectiveness,

and quality before being authorized for sale in Canada.

HC classifies medical devices into four classifications, with Class I being the

lowest risk and Class IV being the highest.

Class I and II devices are often cleared for sale after they are CE marked or listed on the

company’s ISO certification and filed via fax-back applications for a Medical Device License (“MDL”).

Obtaining an MDL is comparable

to the FDA 510(k) process.

Higher classification risk devices (Class III and IV) require filing dossiers that resemble FDA 510(k) applications.

These applications can range in cost and typically take longer for approval.

of Medical Devices in Australia

regulates the import and sale of medical devices through the Therapeutic Goods Administration (TGA) of Australia, a Tier 1 regulatory

Registering a medical device with the TGA entails risk-based classification;

compliance with quality, safety and performance principles;

compliance with regulatory controls for manufacturing processes;

listing in the Australian Register of Therapeutic Goods;

and post-market

vigilance programs.

Australia follows the standards applied by the International Organization for Standardization (ISO) which is currently

made up of 165 members/countries.

Equivalent to the FDA in the United States, the TGA regulates the manufacturing and distribution of

therapeutic goods in Australia.

During 2022, we received clearance from TGA to sell our full line of products in Australia, with no restrictions

as to the severity of OSA or other constraints.

State and Foreign Fraud and Abuse and Physician Payment Transparency Laws

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most critically, may provide the basis for exclusion from government healthcare programs, including Medicare and Medicaid.

2009, the Fraud Enforcement Recovery Act of 2009, or FERA, was enacted, which modifies and clarifies certain provisions of the federal

2009, the Fraud Enforcement Recovery Act of 2009 (“FERA”), was enacted, which modifies and clarifies certain provisions of the federal

civil False Claims Act.

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the victims of breaches of unsecured PHI may receive a percentage of the civil monetary penalty paid by the violator.

the European Union, we may be subject to laws relating to our collection, control, processing and other use of personal data (i.e.,

data relating to an identifiable living individual).

We process personal data in relation to our operations.

We process data of both

our employees and our customers, including health and medical information.

The data privacy regime in the EU includes the EU Data Protection

Directive (95/46/EC) regarding the processing of personal data and the free movement of such data, the E-Privacy Directive 2002/58/EC

and national laws implementing each of them.

Each EU Member State has transposed the requirements laid down by the Data Protection Directive

and E-Privacy Directive into its own national data privacy regime and therefore the laws may differ by jurisdiction, sometimes significantly.

We need to ensure compliance with the rules in each jurisdiction where we are established or are otherwise subject to local privacy laws.

requirements include that personal data may only be collected for specified, explicit and legitimate purposes based on legal grounds

set out in the local laws and may only be processed in a manner consistent with those purposes.

Personal data must also be adequate,

relevant, not excessive in relation to the purposes for which it is collected, be secure, not be transferred outside of the EEA unless

certain steps are taken to ensure an adequate level of protection and must not be kept for longer than necessary for the purposes of

To the extent that we process, control or otherwise use sensitive data relating to living individuals (for example, patients’

health or medical information), more stringent rules apply, limiting the circumstances and the manner in which we are legally permitted

to process that data and transfer that data outside of the EEA.

In particular, in order to process such data, explicit consent to the

processing (including any transfer) is usually required from the data subject (being the person to whom the personal data relates).

new EU-wide General Data Protection Regulation, or GDPR, became applicable on May 25, 2018, replacing the current data protection laws

issued by each EU member state based on the Directive 95/46/EC.

Unlike the Directive (which needed to be transposed at national level),

the GDPR text is directly applicable in each EU member state, resulting in a more uniform application of data privacy laws across the

The GDPR imposes onerous accountability obligations requiring data controllers and processors to maintain a record of their data

processing and policies.

It requires data controllers to be transparent and disclose to data subjects (in a concise, intelligible and

easily accessible form) how their personal information is to be used, imposes limitations on retention of information, increases requirements

pertaining to pseudonymized (i.e., key-coded) data, introduces mandatory data breach notification requirements and sets higher standards

for data controllers to demonstrate that they have obtained valid consent for certain data processing activities.

Fines for non-compliance

with the GDPR are significant—the greater of EUR 20 million or 4% of global turnover.

The GDPR provides that EU member states may

introduce further conditions, including limitations, to the processing of genetic, biometric or health data, which could limit our ability

to collect, use and share personal data, or could cause our compliance costs to increase, ultimately having an adverse impact on our

are subject to the supervision of local data protection authorities in those jurisdictions where we are established or otherwise subject

to applicable law.

depend on a number of third parties in relation to our provision of our services, a number of which process personal data on our behalf.

With each such provider we enter into contractual arrangements to ensure that they only process personal data according to our instructions,

and that they have sufficient technical and organizational security measures in place.

Where we transfer personal data outside the EEA,

we do so in compliance with the relevant data export requirements.

We take our data protection obligations seriously, as any improper

disclosure, particularly with regard to our customers’ sensitive personal data, could negatively impact our business and/or our

political and regulatory influences are continuously causing fundamental changes in the healthcare industry in the United States.

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Health Reform Laws have also been the subject of litigation.

In particular, in 2019, a collection of 20 state governors

and state attorneys general (subsequently two states have dropped out) filed a lawsuit against the federal government in the Northern

District of Texas seeking to enjoin the entire Health Reform Laws following the elimination of the individual mandate penalty.

Court ruled that without the penalty the individual mandate was unconstitutional and further held that all other provisions of the Health

Reform Laws should be overturned as well.

In particular, in 2019, a collection of 20 state governors and state attorneys

general (subsequently two states have dropped out) filed a lawsuit against the federal government in the Northern District of Texas seeking

to enjoin the entire Health Reform Laws following the elimination of the individual mandate penalty.

The District Court ruled that without

the penalty the individual mandate was unconstitutional and further held that all other provisions of the Health Reform Laws should be

overturned as well.

Court of Appeals for the 5th Circuit affirmed the trial court’s decision;

instead of deciding whether the rest of the PPACA must be struck down, the 5th Circuit sent the case back to the trial court for additional

In March of 2020 the United States Supreme Court agreed to review the case and heard oral arguments on November 10, 2020.

June 17, 2021, the Supreme Court held that the plaintiffs lacked standing and reversed the Fifth Circuit’s judgment in respect

to standing, vacated the Fifth Circuit’s judgment, and remanded the case with instructions to dismiss the case.

Subsequently the

Fifth Circuit vacated the judgement of the District Court in its entirety and remanded the case to the District Court with instructions

The District Court finally dismissed the case on July 27, 2021.

Trump Administration made a number of changes that have affected the individual and small group exchange markets, including modifications

to the open enrollment periods, funding cuts to patient support resources, including the patient navigator program, and failing to issue

cost-sharing reduction payments to insurers participating in the exchanges.

In June 2018, the Trump Administration published a final

rule that allows small businesses and self-employed individuals to band together to create associations that are considered “employers”

under the Employee Retirement Income Security Act (“ERISA”) such that these associations are eligible to access large

group health plans, which are typically less expensive and are not subject to as many of the consumer protections imposed by the PPACA

on small group and individual health plans.

In addition, the Trump Administration published a final rule which makes short term, limited

duration plans more accessible, providing individuals with another product offering that is generally less expensive but has fewer protections

than under the PPACA plans.

This final rule combined with the association health plan final rule, may increase instability in the healthcare

exchanges by siphoning off potentially healthier people from the risk pool.

However, in 2021 President Biden issued an Executive Order

on Strengthening Medicaid and the Affordable Care Act, directing heads of departments to review and potentially revoke or revise these

Trump-era actions.

In light of the ongoing efforts to alter the Health Reform Laws, we are unable at this time to predict the full impact

that potential changes will have on our business, including provisions in the Health Reform Laws related to Medicare payments, mechanisms

to foster alternative payment and reimbursement methodologies focused on outcomes, quality and care coordination, Medicare enrollment

and claims submission requirements and revisions to other federal healthcare laws such as the federal Anti-Kickback Statute, the Stark

Law and the federal False Claims Act.

however, instead of deciding

whether the rest of the PPACA must be struck down, the 5th Circuit sent the case back to the trial court for additional analysis.

March of 2020 the United States Supreme Court agreed to review the case and heard oral arguments on November 10, 2020.

On June 17, 2021,

the Supreme Court held that the plaintiffs lacked standing and reversed the Fifth Circuit’s judgment in respect to standing, vacated

the Fifth Circuit’s judgment, and remanded the case with instructions to dismiss the case.

Subsequently the Fifth Circuit vacated

the judgement of the District Court in its entirety and remanded the case to the District Court with instructions to dismiss.

Court finally dismissed the case on July 27, 2021.

2021 President Biden issued an Executive Order on Strengthening Medicaid and the Affordable Care Act, directing heads of departments

to review and potentially revoke or revise these Trump-era actions.

In light of the ongoing efforts to alter the Health Reform Laws,

we are unable at this time to predict the full impact that potential changes will have on our business, including provisions in the Health

Reform Laws related to Medicare payments, mechanisms to foster alternative payment and reimbursement methodologies focused on outcomes,

quality and care coordination, Medicare enrollment and claims submission requirements and revisions to other federal healthcare laws

such as the federal Anti-Kickback Statute, the Stark Law and the federal False Claims Act.

anticipate, however, that federal and state governments will continue to review and assess alternative healthcare delivery systems and

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consider our relations with our employees to be good but we do have a Whistleblower Hotline setup for employees to confidentially report

Of our current employees, approximately, nine are part of finance and accounting, 11 are involved in senior management, 19

Of our current employees, approximately, seven are part of finance and accounting, seven are involved in senior management,

20 in sales and marketing, one in research, development and regulatory and 128 in operations.

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positions are paid in-line with the market.

Our corporate culture is built on passion – we believe in the company’s vision

of ridding the world of sleep apnea and hire employees who want to share that same passion.

We hold annual company-wide trainings and

host regularly scheduled management meetings where management communicates notable corporate developments to be disseminated to employees,

as well as a periodic corporate all hands meetings.

We are always looking for additional ways to diversify our workforce.

Our corporate culture is built on passion - we believe in the company’s vision of ridding

the world of sleep apnea and hire employees who want to share that same passion.

We hold annual company-wide trainings and host regularly

scheduled management meetings where management communicates notable corporate developments to be disseminated to employees, as well as

a periodic corporate all hands meetings.

We hire new employees based on merit and qualifications for the job, regardless of ethnicity,

race, gender, religion, sexual preference, or any other non-job related criteria.

We thus have created both a diverse and highly skilled

We will continue to promote a work environment that is based on the fundamental principles of human dignity, equality and

mutual respect.

In addition, we are committed to providing a safe and healthy work environment for all of our employees.

to the COVID-19 pandemic, we encouraged employees to work closely with their personal physicians to determine whether or not to receive

the vaccine, and we have followed the most current science with respect to the use of personal protective equipment such as masks, social

distancing, etc.

Many employees work remotely and when appropriate, we have limited travel as a result of the pandemic.

We will continue

to promote a work environment that is based on the fundamental principles of human dignity, equality and mutual respect.

we are committed to providing a safe and healthy work environment for all of our employees.

In response to the COVID-19 pandemic, we

have required personal protective equipment for patient-facing employees in addition to requiring daily health questionnaires and temperature

Many employees work remotely and we have limited travel as a result of the pandemic.

We will continue to support our workforce

during these unprecedented circumstances to ensure their safety and well-being.

to support our workforce during these unprecedented circumstances to ensure their safety and well-being.

were originally organized on July 7, 2016 in Wyoming as Corrective BioTechnologies, Inc.

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a wholly-owned subsidiary), which was engaged in the manufacture and sale of our patented DNA appliance ® and FDA cleared

mRNA appliance ® (collectively with special proprietary treatment protocols comprises The Vivos Method), and (2) First

Vivos, Inc., a Texas corporation (“First Vivos”), which proposed to develop and operate a retail chain of Vivos Centers

mRNA appliance ® (collectively with special proprietary treatment modalities that comprises The Vivos Method), and (2)

First Vivos, Inc., a Texas corporation (“First Vivos”), which proposed to develop and operate a retail chain of Vivos Centers

with specially trained dentists that offer The Vivos Method and corroborating physicians.

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investing and resource allocation decisions, and assesses our operating performance.

principal offices are located at 9137 Ridgeline Boulevard, Suite 135, Highlands Ranch, Colorado 80129, and our telephone number is (866)

Our website is www.vivos.com and the information that can be accessed through our website is not part of this Annual

Report on Form 10-K.

principal offices are located at 7921 Southpark Plaza, Suite 210, Littleton, Colorado 80120, and our telephone number is (866) 908-4867.

Our website is www.vivos.com .

Our website and the information on or that can be accessed through such website are not part of

this Annual Report on Form 10-K.

maintain a website at www.vivos.com .

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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 1. Business