What changed in this filing

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Item 1. Business

2024-03-28 compared with 2023-03-30 · 480 added, 618 removed, 798 unchanged (58% of the section changed)

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).

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 dentofacial abnormalities and the wide array of medical conditions that may

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

We believe our proprietary oral

appliances, diagnostic tools, 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 and sleep disorders and their comorbidities.

to this point, our primary focus has been on expanding awareness of, and providing treatment options for OSA for and through the dental

industry, which we believe represents a large and relatively untapped market for OSA treatment.

As our business has evolved, we have

expanded our marketing, provider outreach, and treatment programs to encompass a broader more multidisciplinary approach, with a greater

emphasis on working with medical doctors and other healthcare providers beyond dentists.

Now that we have established a national network

of Vivos-trained dentists, it is time to focus our resources and efforts on the source of where the vast majority of OSA patients are

first diagnosed and treated—the medical profession and durable medical equipment (DME) companies.

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

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

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

myofunctional therapy.

We call our solution The Vivos Method .

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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.

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

snoring in adults.

It is the only oral appliance ever to receive FDA clearance to treat OSA without mandibular advancement as its

primary mechanism of action.

In November 2023, our DNA appliance was cleared by the FDA to treat moderate and severe OSA in adults,

18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

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.

In November 2023, our mRNA appliance was cleared by the FDA

to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional

therapy, as needed.

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.

In November 2023, our mmRNA appliance was

cleared by the FDA to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP)

and/or myofunctional therapy, as needed.

November 2023 clearance of our CARE appliances for the indication described above represents the first time the FDA has ever granted

an oral appliance a clearance to treat severe OSA.

We believe this unprecedented decision by the FDA will generate broader acceptance

throughout the medical community for our treatment options, leading to the potential for higher patient referrals and case starts as

well as collaboration with medical professionals.

We also believe it will enhance our value proposition to third-party distribution partners

such as DME companies.

This approval could also clear the way for greater reimbursement levels from medical insurance payors and Medicare.

oral appliances and therapies outside of CARE system include:

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

FDA Class I 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.

Versa TM is an FDA 510(k) cleared Class II device for treating mild to moderate OSA in adults.

It is a comfortable,

easy-to-wear, medical grade nylon, 3D printed oral appliance featuring mandibular advancement as its mechanism of action.

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

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.

While we do not

own this product, we are a reseller of this product.

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.

for patients with breathing and 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

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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.

Vida ™ is an FDA cleared appliance as unspecified classification for the alleviation of TMD symptoms, and aids in treating

bruxism and TMJ Dysfunction.

The Vivos Vida help to alleviate symptoms such as TMJ/TMD, headaches and facial muscle pain.

Vida is worn during sleep, and serves to protect the teeth and restorations from destructive forces of bruxism.

It is a custom fabricated

appliance, designed for patient comfort.

Vida Sleep ™ is an FDA 510(k) cleared Class II for treating mild to moderate OSA in adults.

It uses the Vivos Unilateral

BiteBlock Technology and is designed to advance the mandible incrementally to stabilize the patient’s oropharyngeal airway.

It is highly efficient and has a sleep design which promotes space for the tongue to sit in the roof of the palate.

design decreases contact points between the maxillary and mandibular teeth that may help reduce clenching and overall bite forces

that occur during sleep.

(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.

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.

management software program in a medical or dental practice environment where treating breathing and 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.

Treatment from specialty chiropractors and other healthcare providers according to a very specific set of particular integrated

protocols has also proven to enhance and improve clinical outcomes using CARE and other Vivos devices.

Navigator is our most recent program to assist a clinician’s patients who may have a breathing or 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.

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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.

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 researchers.

products and services are used in a collaborative multidisciplinary treatment model comprising 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.

2023, we expanded our product portfolio by acquiring certain devices (now known as Vivos Vida , Vivos Versa

and Vivos Vida Sleep ) from Advanced Facialdontics, LLC.

During 2022, we continued to expand and grow our screening and

home sleep test (or 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

and Canada pursuant to a licensing agreement with MyCardio LLC.

Based on our direct experience with our Vivos-trained providers,

approximately 61,000 VivoScore HSTs were performed during 2023.

Due to 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

We believe the rapid growth of our VivoScore program confirms our belief that the SleepImage ® HST offers

significant commercial advantages over existing home sleep apnea products and technologies in the market and allows healthcare providers

to more efficiently screen, diagnose and initiate treatment for OSA in their patients.

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

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

Throughout 2023, we continued to address this by conducting additional regional dental team training sessions on integrating

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As of December 31, 2023, 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.

were 57 Vivos-trained (VIP) dental offices who are at some stage of onboarding with our Treatment Navigator program.

our evaluation of the program, we will restructure the Treatment Navigator program into a monthly subscription-based model.

that this will grow into a material and important revenue stream as we move forward.

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

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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

is the “gold standard” treatment for over 90% of OSA patients, but no one wants to wear those devices to bed every night

for life, rendering long-term compliance rates low.

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.

As 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 treatment option

for patients diagnosed with mild to severe OSA that offers cost-effective treatment featuring (i) limited treatment times;

lasting or durable effects;

and (iii) the prospect of seeing a complete reversal of symptoms.

Combining treatment technologies that impact

the upper airway by altering the size, shape, patency and position of corresponding hard and soft 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

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

the second half of 2021, we increased our efforts to market The Vivos Method and related products and services to larger dental support

organizations (or DSOs).

Marketing to DSOs creates an opportunity to enroll and onboard multiple dental practices as VIPs under one common

ownership structure.

This would allow us to leverage training and support across multiple VIP practices and gain economies of scale with

the goal of faster growth, both in VIP enrollments and in Vivos case starts.

As of December 31, 2023, we believe we have made important

progress in penetrating this market, but as we cautioned previously, DSOs tend to move slowly when adopting new technologies or programs.

2023, we further extended our market reach by executing a U.S.

nationwide distribution agreement with Lincare, a leading supplier of

in-home respiratory therapy products and services for approximately 1.8 million patients.

The agreement follows the conclusion of a distribution

pilot with Lincare, and marks an important milestone in our strategy to engage with leading durable medical equipment (DME) companies

in the United States.

Under the agreement, Lincare will have a six-month exclusivity period to distribute certain designated devices

in our portfolio.

We also executed distribution and other strategic collaborations during 2023 to help drive sales of our expanding portfolio

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.

from breathing and sleep disorders and their comorbidities.

We fully recognize that breathing and 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

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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.

As word spreads among a broader array of professionals and

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

We believe this will

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

Market Opportunity

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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.

on our direct experience with our Vivos-trained providers, approximately 61,000 VivoScore HSTs were performed during 2023.

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.

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

moderate-to-severe 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.

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 approximately

64 million adults.

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

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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.

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

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

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;

in overall sleep quality;

in the need for other lifetime treatment options such as CPAP;

and maintenance of proper facial symmetry and alignment;

and orthodontic improvement and/or correction;

of TMJ pain, clicking, and locking;

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

posture with better balance and facial symmetry.

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

abnormalities and/or mild, moderate and severe 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.

Vivos Method alters 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.

The Vivos Method treatment process progresses, the airway typically expands, with many patients reporting a significant reduction of

their OSA and snoring symptoms.

The primary products used in The Vivos Method are our CARE devices – 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 9 to 18 months, with 12 to

15 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.

Growth Strategy

goal is to be the global leader in providing a clinically effective non-surgical, non-invasive, non-pharmaceutical, and low-cost alternative

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

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

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

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

positive and profitable operations:

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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.

Active Referral Sources Among Physicians, Sleep Specialists, Dentists and Other Healthcare Providers.

more qualified new patients to our VIP practices and teach VIPs how to better present and close Vivos treatment via the “Boost”

and “Kick-Off” programs.

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

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

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.

our market penetration with DME distribution agreements.

in research and development to drive innovation and expand indications.

We are committed to ongoing research and development,

and we intend to invest in our business to further improve our products and validate our value proposition.

strategically adjacent markets and international opportunities.

We believe there is a significant opportunity for our products

outside the United States.

We have begun an initial assessment of the development and commercialization of The Vivos Method for markets

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, Canada, the Middle East, Australia, and most recently India.

Revenue Model

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

We are also seeking to drive appliance sales

through our distribution arrangements with DMEs.

VIP subscription fees.

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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).

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.

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.

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 our TVI.

Airway Intelligence Service (AIS).

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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.

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 additional mild to severe 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 are referred to as Pneusomnia Centers).

These independent medical practices will be managed

by our company under a management and development agreement which pays us six (6% to 8%) percent of all net revenue from sleep-related

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

(Orofacial Myofunctional Therapy) Program .

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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.

Our CARE appliances are cleared by the FDA to treat moderate and

severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

Competitive Strengths

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barriers to entry.

We believe that third parties seeking to compete directly with us have significant barriers to entry for

the following reasons:

competitors must offer a treatment modality with similar features, capabilities, research support, FDA regulatory

clearances, and successful clinical outcomes in the market;

then establish a comprehensive educational training program featuring

other clinical professionals with actual experience and success using that particular treatment modality to properly educate dentists

on all clinical aspects of use with patients;

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.

Method insurance reimbursement.

Most major commercial insurance (and also Medicare for the mmRNA appliance, which we achieved

during 2021), reimburse for our adult treatment in the United States.

The average level of commercial payer reimbursement is approximately

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

policy restrictions will vary.

Medicare reimbursement for the mmRNA appliance will vary by the Centers for Medicare and Medicaid

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 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 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.

Our business model is the first to focus on dentists screening patients for mild to moderate OSA, referring

patients to physicians for diagnosis, with the dentists then serving as the primary source of treatment using The Vivos Method for

such patients.

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.

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.

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

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

property portfolio and research and development capabilities.

Training and Support Systems.

We believe our extensive online and in-person clinical and business systems training program

offered through The Vivos Institute is unmatched anywhere in dentistry and is a clear competitive strength that would be difficult

to replicate.

approach to market development.

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

can now be found in almost all major U.S.

cities and in many cities in Canada.

and Marketing

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,

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

Our sales effort is developed through social media initiatives, and our new website with over 150 videos, and the production of over

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.

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

for our VIP dentists from medical doctors and other healthcare professionals;

(ii) provide them with the tools to treat patients

with our products;

and (iii) 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.

have recently restructured the VIP Program to include a Kick-Off program as an essential part of the value proposition.

With a properly

executed Kick-Off, led by specially trained Vivos corporate staff, a newly enrolled VIP could easily recoup 100% or more of his or her

initial enrollment fees, thus making the decision to enroll much easier and attractive.

We continue to sell the VIP Program to dentists

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

Our sales effort is developed through

social media initiatives, and our new website with over 150 videos, and the production of over 350 new content creation projects.

VIP program was developed to train independent dentists to identify and treat dental conditions that may be associated with OSA.

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.

We currently have approximately

25 direct sales representatives in the United States and Canada.

Our direct sales force engages in sales efforts and promotional activities

focused on referring physicians, as well as directly to the over 200,000 professionally active general dentists in the United States

and 20,000 general dentists in Canada.

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

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

15 direct sales and support representatives in the United States and Canada.

Our direct sales force engages in sales efforts and promotional

activities focused on referring physicians, as well as directly to the over 200,000 professionally active general dentists in the United

States and 20,000 general dentists in Canada.

current sales organization is comprised of individuals performing various roles consisting of:

Enrollment Specialists , who are the primary salespeople responsible for enrolling new VIPs;

Enrollment Support Staff member, who is responsible for organizing potential VIP appointments for the Enrollment

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

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).

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

Operations and one Senior Market Manager.

We plan on growing 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.

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.

and Canada covering total office

locations in excess of 40,000, DSOs provide business management and support to dental practices, including non-clinical operations.

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, most DSOs are slow and deliberate in their approach to introducing sleep dentistry programs.

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

Vivos Method.

Our indirect marketing channels include strategic partners, industry key opinion leaders, trade shows and our own clinical

Our indirect marketing channels include strategic partners, key industry opinion leaders, trade shows and our own clinical

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:

October 2021, we announced a new collaboration with Candid Care Co., a digital platform for oral healthcare, which 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.

Over the course of time, the Candid collaboration proved to be unsustainable and unprofitable to

the point where it was cancelled by Vivos in the early part of 2023.

October, 2023, we announced two key strategic agreements to expand our current product line, and thus create exciting new revenue

opportunities.

The first was with Ormco, a division of publicly traded Envista Holdings Corporation, purveyors of Spark Clear Aligners.

Spark Aligners are rapidly becoming the “go to” clear aligners of choice for orthodontic specialists.

The majority of

our VIPs use clear aligners as a key component of their Vivos treatment.

This agreement will provide pricing discounts to the VIPs

and profit margin for Vivos.

The second key agreement announced in early October was with On Demand Orthodontist (ODO) and represents

an exciting new service to our VIPs, featuring direct access and case collaboration with airway-focused orthodontic specialists who

are available to help optimize clinical outcomes for Vivos cases.

ODO orthodontists strongly prefer Spark aligners due to their many

proven clinical capabilities and advantages over other aligner brands such as Candid.

Vivos-trained dentists will now benefit from

better overall pricing, while Vivos benefits from a distribution margin associated with each case.

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

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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

that enroll in our VIP program have the potential for compelling economics.

The actual incidence of dental patients with OSA will vary,

but our conservative estimate would suggest that the average dental practice sees 400-500 adult patients a year with a high risk of suffering

from obstructive sleep apnea.

Using these demographic figures, the economic potential per dentist may be calculated, based on a retail

adult case fee of approximately $9,000, fully burdened VIP provider costs of approximately $3,000, and net profit of approximately $6,000,

to be over $3.3 million in annual gross revenue potential annually with over $2.4 million in potential net profit.

We believe, based

on our experience, that dentists have seen accretive economic additions to their practices by utilizing The Vivos Method, and thus participation

in the VIP program can likely add to the dentist’s take-home income.

terms of continuing training, our sales and clinical advisory dentists conduct training primarily in a highly personalized, deep immersion

workshop format at our Vivos Institute.

The key topics covered in training include case selection, clinical diagnosis, treatment planning,

appliance design, adjunctive therapies, information on our productions and services, guidance on pricing, case acceptance, instruction

on insurance reimbursement protocols and interacting with our proprietary software system and the many other features of our website.

We present our training material in a manner we believe to be superior to most other dental training and experience, including preparatory

online courses, didactic lectures, hands-on training, specialized small group breakout sessions, and post training technical support

from assigned mentors.

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 ).

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

This illustration helps to explain why a dentist

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

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

manufacturers to bundle training and equipment into a turn-key program financed by third party lenders for those dental practices who

need to purchase additional equipment.

The VIP Program fees are also often financed by third party lenders separate from any equipment

Loan terms and payments will vary depending on the doctor’s credit, the interest rate, the amount financed, and the

term of the loan.

Generally, payments on such financing range from about $600 to $2,500 per month.

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

Reimbursement

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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.

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

OSA and snoring in adults (and in the case of severe OSA, along with positive airway pressure (PAP) and/or myofunctional therapy, as

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.

The E0486 code is

reimbursable by many major commercial medical payers following a medical diagnosis of OSA and adherence to payer guidelines for alternative

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.

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 mild to moderate OSA and snoring in adults was approved.

In November 2023, the mmRNA appliance was cleared by the FDA to treat moderate and severe OSA in adults, 18 years of age and older along

with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

In December 2021, the mmRNA was accepted by the CMS Pricing,

Data Analysis and Coding (“PDAC”).

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

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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.

In November 2023, the DNA appliance was cleared by the FDA to treat moderate and

severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

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

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Vivos appliances

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

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

secondary to medical coverage.

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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.

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 severe 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.

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 recently published in Sleep Medicine .

Several more retrospective

data sets have been presented at scientific meetings in the past year that further corroborate clinical efficacy in adult OSA, pediatric

OSA, and also in adult headache severity.

The results of these presentations are in various stages of medical journal submission.

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 mild to severe 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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France, United Kingdom, Hungary, Italy and the Netherlands, all of which expire in 2029.

trademark portfolio consists of ten

registered marks and one pending trademark application.

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.

trademark portfolio consists of 13

registered marks.

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.

Regulatory Status

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.

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

The Vivos Method

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

own specially designed pre-formed Vivos Guides.

We offer our own specially designed

pre-formed Vivos Guides.

We also offer the Vivos Versa , and two devices that use a unilateral bite block technique, the Vivos

Vida and the Vivos Vida Sleep .

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,

mmRNA 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.

In November 2023, our mmRNA appliance was cleared by the FDA to treat moderate and severe OSA

in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

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.

In November 2023, our mRNA appliance was cleared by the FDA to treat moderate and severe OSA in adults,

18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

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.

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.

In November 2023, our DNA appliance was cleared by the FDA to treat moderate and severe

OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

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

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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 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.

Vida™ is an FDA cleared appliance as an unspecified classification to treat symptoms such as TMJ/TMD, headaches and facial

Vida Sleep™ is an FDA 510(k) cleared Class II for treating mild to moderate OSA in adults.

Versa™ is an FDA 510(k) cleared Class II device for treating mild to moderate OSA in adults.

of the oral appliances that comprise our CARE system (our DNA appliance ® , mRNA appliance and mmRNA appliance ® )

are cleared by the FDA as Class II sleep appliances to treat mild to severe OSA and snoring in adults.

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.

observations, none of which were repeat offenses from previous inspections.

These observations were corrected and responded to according

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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.

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

controlled clinical trials, we are conducting 2 separate clinical trials to evaluate the safety and efficacy of the DNA appliance ®

and the Vivos Guides (which we call the Vivos Grow and Vivos Way appliances) to reduce SDB in children, including snoring,

mild to moderate OSA, and UARS.

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.

are committed to ongoing research and development, and we have and intend in the future to invest in our clinical trial work 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.

The following is summary of our currently active clinical trials:.

approved February 2021 – Daytime Nighttime Appliance (DNA) therapy for the treatment of OSA .

The aim of this

randomized clinical trial conducted with Stanford University 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.

of SDB with an intraoral device in a pediatric population.

Approved by the Western Copernicus Group Institutional Review

Board (WCG IRB) as non-significant controlled clinical trials, we are conducting a clinical trial to evaluate the safety and efficacy

of the Vivos Guides (which in this context we call the Vivos Grow and Vivos Way appliances) to reduce sleep disordered breathing

(SDB) in children, including snoring, mild to moderate OSA, and Airway Resistance Syndrome (UARS).

The children 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 SDB 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.

Specially, this study will be examining the potential for reduction in sleep apnea and UARS using the AHI, Epworth Sleepiness Scale

for Children and Adolescents, and changes in upper airway volume.

of ADHD and other child behavioral issues.

We also began a separate trial in March 2023 relating to our Vivos Guides.

purpose of the third trial is to establish a connection and treatment between children and behavior issues such as attention-deficit/hyperactivity

disorder (known as ADHD), bed wetting, problems at school, crowded teeth that may be associated with lack of sleep and or teeth grinding

with underdeveloped growth of the jaw and teeth positioning.

completion of the second and third pediatric clinical trial described above, which is expected to be completed in the during 2024, we

plan to submit a 510(k) application to the FDA requesting pediatric clearances and indications of use for the Vivos Guides.

addition, we are aggressively pursuing head-to-head comparisons of (i) our DNA device versus tonsillectomy in pediatric OSA, and (ii)

our DNA device vs.

routine management of veterans with OSA and post-traumatic stress disorder with potential sites identified and preliminary

work underway.

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.

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.

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.

Vivos Guides are registered with the FDA as Class I devices for orthodontic tooth positioning.

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.

On December 30, 2022 the FDA granted 510(k)

clearance for the DNA appliance ® to treat mild to moderate obstructive sleep apnea and snoring in adults.

This approval

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

In November 2023, our DNA, mRNA and mmRNA appliances were cleared by the

FDA to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional

therapy, as needed.

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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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.”

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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to grant export or import approvals for our products;

addition to all of the above, the FDA regulates and monitors manufacturers engaged in the fabrication of FDA regulated medical devices

such as those offered by Vivos.

Vivos intends to convert its FDA status from an FDA designated “Spec Developer” to a “Manufacturer,”

and as such will become subject to a new level of regulatory compliance and oversight.

The company has spent many months in preparation

for this transition, including the adoption of the requisite workflow processes, documentation procedures, and other current good manufacturing

The company expects to be subject to a third-party inspection and readiness evaluation to gain a certification to proceed

forward as a duly approved and compliant manufacturer sometime prior to the end of the first quarter of 2024.

of Medical Devices in Canada

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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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Capital Resources

of December 31, 2022, we had 154 full-time employees and 9 part-time employees.

of December 31, 2023, we had 114 full-time employees.

None of our employees are represented by a union.

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, 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.

We consider our relations with

our employees to be good but we do have a Whistleblower Hotline setup for employees to confidentially report concerns.

Of our current

employees, approximately three are part of finance and accounting, nine are involved in senior management, 10 in sales and marketing,

one in research, development and regulatory and 91 in operations.

Our headcount has been significantly reduced in the past year as part of our cost cutting initiatives, and restructuring

of our operations.

value the importance of retention, growth and development of our employees and we believe we offer competitive compensation (including

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We traditionally will benchmark compensation with external sources to verify

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 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.

that 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 training

courses and host regularly scheduled management meetings where management communicates notable corporate developments to be disseminated

to employees, as well as periodic corporate all hands meetings.

We are always looking for additional ways to diversify our workforce.

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 support our workforce during these unprecedented circumstances to ensure their safety and well-being.

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 checks.

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.

were originally organized on July 7, 2016 in Wyoming as Corrective BioTechnologies, Inc.

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to Vivos Therapeutics, Inc.

During our formation in 2016, we issued an aggregate of 933,334 shares of common stock to a group of our

founders, including Summit Capital USA (now Upeva, Inc., 666,667 shares), Regal Capital Venture Partners LLC (166,667 shares) and Thomas

Madden (100,000 shares) at a purchase price of $0.0003 per share (for an aggregate of $280 of proceeds).

During our formation in 2016, we issued an aggregate of 37,334 shares of common stock to a group of our founders,

including Summit Capital USA (now Upeva, Inc., 26,667 shares), Regal Capital Venture Partners LLC (6,667 shares) and Thomas P.

(4,000 shares) at a purchase price of $0.01 per share (for an aggregate of $280 of proceeds).

of BioModeling Solutions, Inc.

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approved an amendment and restatement of the 2019 Plan to increase the number shares or our common stock available for issuance thereunder

by 833,333 share of common stock such that, after amendment and restatement of the 2019 Plan, 1,166,667 shares of common stock will be

by 33,334 share of common stock such that, after amendment and restatement of the 2019 Plan, for a total of 46,667 shares of common stock

available for issuance under the 2019 Plan.

The 2019 Plan permits grants of equity awards to employees, directors, consultants and other

independent contractors.

On September 22, 2023, our stockholders approved an amendment and restatement of the 2019

Plan to increase the number shares or our common stock available for issuance thereunder by 80,000 shares of common stock such that,

after amendment and restatement of the 2019 Plan, 126,667 shares of common stock are available for issuance under the 2019 Plan.

December 31, 2023, awards (in the form of options) for an aggregate of 73,917 shares of common stock have been issued under our 2019

of Transfer of Corporate Domicile and Reverse Stock Split

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been approved by the board of directors and majority shareholders of Vivos Wyoming.

July 30, 2020, prior to the transfer of our corporate domicile from Wyoming to Delaware, Vivos Wyoming we implemented a one-for-three

reverse stock split of our outstanding common stock pursuant to which holders of Vivos Wyoming’s outstanding common stock received

one share of common stock for every three shares of common stock held.

Unless the context expressly dictates otherwise, all references

to share and per share amounts referred to in this Annual Report reflect the reverse stock split.

July 30, 2020, prior to the transfer of our corporate domicile from Wyoming to Delaware, we implemented a one-for-three reverse stock

split of our outstanding common stock pursuant to which holders of Vivos Wyoming’s outstanding common stock received one share

of common stock for every three shares of common stock held.

Unless the context expressly dictates otherwise, all references to share

and per share amounts referred to in the Annual Report reflect the reverse stock split.

October 25, 2023, we effected a reverse stock split of outstanding shares of common stock at a ratio of 1-for-25.

The reverse stock split,

which was approved by the Company’s Board of Directors under authority granted by the Company’s stockholders at the Company’s

2023 Annual Meeting of Stockholders held on September 22, 2023, was consummated pursuant to a Certificate of Amendment filed with the

Secretary of State of Delaware on October 25, 2023.

Unless the context expressly dictates otherwise, all references to share and per

share amounts referred to in the Annual Report reflect the reverse stock split.

manage our business within one reportable segment.

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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