What changed in this filing

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Item 1. Business

2025-03-31 compared with 2024-03-28 · 993 added, 545 removed, 733 unchanged (68% 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 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 .

multi-disciplinary treatment modalities for patients with cranial, dentofacial and postural 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 and children

Our flagship oral appliances for treating OSA, which have received clearances from the U.S.

Food and Drug Administration (or FDA)

as described below, are our Complete Airway Repositioning and/or Expansion (C.A.R.E.) devices.

We believe our C.A.R.E.

and other 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.

Studies and direct experience 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 the current standard of care for OSA, continuous positive

airway pressure (known as CPAP), or oral myofunctional therapy.

We call our overall solution The Vivos Method .

our inception in 2016 through the latter part of 2023, our primary focus was to increase market share and sales of our appliances by

training and marketing through dentists to their patients with OSA.

Through a variety of sales efforts, including a direct sales

force, email campaigns, social media, print and online media, extensive clinical training and support, we established an

international network of approximately 2,000 dentists to sell our products and services.

In addition, to build product credibility

and broad public awareness, we sought to obtain additional regulatory approvals from the FDA.

In this model, our revenue was generated from both sales of appliances and related services to dentists as well as

having dentists enroll for a fee in our Vivos Integrated Practice (or VIP) program.

In November 2023, we obtained a

significant first-ever FDA 510(k) clearance for one of our Vivos C.A.R.E.

oral medical devices to treat severe OSA.

knowledge, no other oral appliance has ever received such a clearance.

While such FDA 501(k) clearance was initially met with great

enthusiasm, by early 2024 our expectation for an increase in appliance sales to our roughly 2,000 trained dentists did not

We thus determined that, in a post-COVID dental industry environment and despite technological advantages of Vivos

treatment over alternative treatments for OSA, it was no longer prudent to rely primarily on the dentistry market as the primary

distribution channel for our products and services.

Over the course of 2024, we worked to pivot our business strategy and began to steadily decrease our prior dependence

on dentists to sell our products and our dependence on VIP enrollment revenue.

This new business strategy is focused on contractual alliances

with (and, in the future, potential outright acquisitions by us of) OSA healthcare providers, including dentists, sleep centers and others

and is based on a profit-sharing model between us and the provider which aligns our revenue generation more directly to sales of our novel

In June of 2024, our business strategy pivot was realized through our entry into our first strategic alliance with Rebis Health

Holdings, LLC, an operator of multiple sleep treatment centers in Colorado (who we refer to herein as Rebis).

Rebis rolled out this alliance,

which promotes all forms of OSA treatments, including the Vivos Method, at a single Rebis location.

By the end of 2024, Rebis patients

were selecting Vivos treatment at a rate of approximately 2 to 1 over CPAP, or declining treatment options altogether.

Subsequently, we

and Rebis announced that two additional locations within the greater Denver metro area would adopt our new business model.

results of our affiliation with Rebis to date, we intend to seek additional strategic affiliations, acquisitions, or alliances with sleep

testing and treatment centers nationwide.

See “New Marketing and Distribution Alliance Strategy” below for more information.

are approximately 4,500 sleep testing centers or sleep treatment clinics throughout the United States.

These testing labs are typically

affiliated with or owned by independent sleep specialists.

Medical doctors of all kinds tend to refer to patients who suspect of having

OSA into these facilities for testing and consultation with sleep specialist medical doctors.

Once patients receive a diagnosis and in

many of these clinics, the default treatment recommendation is some form of CPAP.

As noted above, through extensive interactions with

patients, at Rebis and otherwise, we have seen patients prefer Vivos treatment about 2 to 1 over CPAP or declining treatment options

When patients are educated about their OSA condition and the harm it does to their overall health, most of them would like

to fix the problem and not have to wear a medical device such as CPAP for the rest of their lives.

connection with our business model pivot, we have refined and enhanced diagnostic services and clinical care for patients with OSA.

As a direct result of these efforts, our average treatment times for our multidisciplinary Vivos Method using Vivos C.A.R.E.

devices have been reduced from approximately 18 to 24 months to 9 to 12 months.

We believe this makes our Vivos treatment much more

appealing to patients with OSA as opposed to alternative treatments such as CPAP or surgical treatments.

Importantly, the data which we submitted to the

FDA pursuant to our clearance showed average treatment times of 9.7 months.

In addition, we have developed, and are currently in the

process of implementing, a more robust clinical diagnostic protocol that facilitates gathering greater clinical data, while also

driving much higher insurance payer reimbursements.

this Annual Report on Form 10-K, we sometimes refer to medical doctors, dentists and other medical professionals who treat OSA as “providers”

(including our independent Vivos-trained dentists).

Marketing and Distribution Alliance Strategy

We believe our sales, marketing

and distribution pivot in 2024 will be critical to our ability to drive our future revenue growth.

Our Rebis alliance, which we hope will

be the first of a series of similar alliances and potential acquisitions across the country, marks an important pivot in our marketing

and distribution model for our cutting-edge OSA appliances.

Under the new alliance, we are collaborating with Rebis to offer OSA patients

a full spectrum of evidence-based treatments such as our own advanced, proprietary and FDA-cleared C.A.R.E.

oral medical devices, oral

appliances and additional adjunctive therapies and methods including CPAP machines.

The program commenced in August of 2024 in the Longmont

office of Rebis.

We believe the advantages of this

new strategic marketing and distribution model are compelling:

First, it provides Vivos-trained providers direct access to far more OSA patients who are likely candidates for OSA treatment with The Vivos Method.

As we roll out this new model going forward, potentially thousands of patients each month could be introduced to Vivos treatment options.

Second, we expect to close (meaning convincing the patient to start) more OSA treatment cases using Vivos-trained personnel.

In our pilot testing, which we conducted at over 45 separate locations around the United States during 2023 and 2024, our Vivos-trained personnel were able to consistently close over 70% of patients into some form of Vivos treatment.

These figures were relatively consistent across diverse demographic and economic patient profiles and geographies.

Third, top line revenue and profit per case are expected to rise.

We project that each patient who signs up for Vivos treatment represents a potential increase to Vivos top line revenue with contribution margins of up to 50%.

This significantly alters the economics to Vivos, when compared to our prior model, increasing top-line revenues per case start by approximately 4-6 times.

In summary, under our new model,

we expect to present Vivos treatments to more patients, refer a higher percentage of cases into Vivos treatment, and potentially generate

more revenue and profit per case.

The Rebis strategic alliance was announced alongside

a $7.5 million equity private placement by us with an affiliate of New Seneca Partners, Inc.

(who we refer herein as Seneca).

to certain conditions, Seneca will participate in our net cash flow allocation from the alliance up to an agreed-upon amount as partial

consideration for the management advisory services Seneca is providing to us.

Products and Services

The Vivos Method comprises the following products and services:

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

The Vivos Method is comprised of the following products and services:

Complete Airway Repositioning and/or Expansion (C.A.R.E.) oral appliance therapy including our:

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

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

In September 2024,

the DNA appliance was granted another landmark FDA 510(k) clearance to treat moderate to severe OSA in children ages 6 to 17 who

also have malocclusions that may require orthodontics.

The DNA appliance remains the only oral appliance of any kind that has been

FDA cleared to treat children with OSA.

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

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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

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

therapy, as needed.

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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)

cleared by the FDA to treat moderate and severe OSA in adults, 18 years of age and older along with 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

Diagnostic and Therapeutic Products and Services constitute a key element of our overall clinical success.

Such key adjunctive

diagnostic evaluations and therapies include, but are not limited to, extensive and proprietary questionnaires that target certain

known areas of clinical concern, full body postural evaluations, cranial and facial bone and tissue evaluations, specialized kinds

of chiropractic care, certain targeted physical and exercise therapy, nutritional and toxicity consultations, specialized CO2 laser

therapy using DEKA patented technology from Italy, and the integrative use of Vivos’ patented Unilateral Bite Block technology

such as with the Vivos Vida appliance.

November 2023 clearance of our C.A.R.E.

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.

In our experience working closely with sleep specialists and other medical professionals

since that time, we believe this unprecedented decision by the FDA is generating broader acceptance throughout the medical community

for our treatment options, leading to the potential for higher patient referrals and case starts as well as closer 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:

For example, in April

2024 we received the required regulatory approvals to enable Medicare reimbursement for our C.A.R.E.

oral medical devices.

oral appliances and therapies outside of C.A.R.E.

system include:

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

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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.

While we do not

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

As with all other non-C.A.R.E.

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 C.A.R.E.

not own this product, we are a reseller of this product.

MyoCorrect oral myofunctional therapy (OMT) services.

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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.

When combined with Vivos’ C.A.R.E.

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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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

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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.

protocols has also proven to enhance and improve clinical outcomes using C.A.R.E.

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

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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.

products, services and resources are used to promote a collaborative multidisciplinary treatment model comprising dentists, general practice

physicians, sleep specialist physicians, myofunctional therapists, nutritionists, chiropractors, physical therapists, and healthcare

professionals.

As part of cost optimization, and consistent with our business model pivot, during 2024 we eliminated our legacy subscription-based

program to train dentists called the Vivos Integrated Practice (VIP) program.

Essentially, we unbundled the subscription-based VIP training

into several component parts.

Currently, dentists can take courses individually in a customized fashion, learning at their own pace,

and only learning the materials they need in order to serve their patients.

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

During 2024, we continued 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 in the

and Canada pursuant to a licensing agreement with MyCardio LLC.

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approximately 53,000 VivoScore HSTs were performed during 2024.

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 plague the dental

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

Vivos products and treatments.

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

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

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

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

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

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

an appointment with a VIP in their area.

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

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

As of December 31, 2023, there

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.

Due to the volume of home sleep test screening 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 growth of our VivoScore program confirms our belief that the SleepImage ®

HST offers significant technological and commercial advantages over alternative 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.

noted above, since our landmark FDA clearances in 2023 and 2024, we have not yet seen a corresponding increase in enrollment of patients

using our appliances.

Based on feedback from our Vivos-trained providers, we believe this to be a function of staffing turnover in their

practices and labor shortages that continue to plague the dental workplace in the aftermath of the COVID-19 pandemic.

Throughout 2024,

we continued to address this by conducting additional regional dental team training sessions on integrating Vivos products and treatment

In addition, we drastically reduced the number of individuals we call Practice Advisors who had previously been used as “boots

on the ground” to help facilitate case starts and provide Vivos-trained providers with support, and we replaced them with a new

service called Treatment Navigator which we piloted and began to rollout in the late summer and fall of 2022.

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

on our C.A.R.E.

appliances and other Vivos treatment options, aiding in education, screening, insurance verification of benefits and

preauthorization, coordination among various professional practitioners, recordkeeping, problem solving, as well as, delivering a home

sleep test and following up with scheduling an appointment with an affiliated sleep clinic or dentist (including dentists who are VIPs)

in their area.

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

thus adding an important new revenue line to our business.

Based on our evaluation of the Treatment Navigator program, we have restructured

the Treatment Navigator program into a monthly subscription-based model.

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

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

According to a 2016 report

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

According to the study “ Global Prevalence of

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

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

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

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

In June 2024, Eli Lilly recently

reported that over 80 million adults in the U.S.

are estimated to suffer from OSA.

Recent medical literature estimates the prevalence

of OSA in the U.S.

pediatric population at 20.4% or about 10 million children.

According to a 2016 report by Frost & Sullivan, OSA

has an annual societal cost of over $149.6 billion and a Harvard and McKinsey study from 2010 put the figure at over $165 billion annually.

According to the study “ Global Prevalence of Obstructive Sleep Apnea (OSA) ” conducted by an international panel of

leading researchers, nearly 1 billion people worldwide have sleep apnea, and as many as 80% remain undiagnosed.

Research has shown that

when left untreated, OSA can increase the risk of comorbidities, such as high blood pressure, heart failure, stroke, diabetes, dementia,

chronic pain and other debilitating, life-threatening diseases.

Unfortunately

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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;

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, our experience shows it will be the preferred choice of most patients by a factor of about 2 to 1.

believe our proprietary products comprising the Vivos C.A.R.E.

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;

(ii) 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.

Combining treatment technologies that

impact the upper airway by altering the size, shape, patency and position of corresponding hard and soft tissues, Vivos C.A.R.E.

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

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

cases of OSA where patients are compliant with clinical treatments.

Our patented oral appliances have been utilized in over 42,000 patients

treated worldwide by more than 1,900 trained dentists.

Our patented oral appliances have been utilized in approximately

58,000 patients treated worldwide by more than 2,000 trained dentists.

Target Customers

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

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

By virtue of the close connection and relationship

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

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

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

sleep disordered patients the best care possible.

of the close connection and relationship between the oral cavity and airway form and function, properly trained dentists, sleep specialists

and other medical providers can play a pivotal and even leading role in the treatment of dentofacial abnormalities which are known to

impact breathing and sleep, which in turn can lead to serious health conditions.

Our alliance marketing and distribution model provides

sleep centers with whom we collaborate better alternatives to CPAP and surgery for patients diagnosed with mild to severe OSA.

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

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We also incorporate courses

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

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

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

and curricula at our TVI into our Vivos Method training that provides information, tools, techniques, and systems that enable other healthcare

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

we have established a national network of Vivos-trained dentists, we are pivoting our focus to the source of where we believe the vast

majority of OSA patients are first diagnosed and treated:

the medical profession.

(including sleep centers and medical doctors and dentists

who offer OSA treatment, as well durable medical equipment (DME) companies who manufacture and distribute OSA therapies.

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

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To that end, we have broadened

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

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

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

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

our product and services lines that comprise The Vivos Method to go beyond the proprietary technologies featured in our C.A.R.E.

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

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

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

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

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Market Opportunity

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

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

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

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

According to the March

2025 edition of the same report, the global sleep apnea devices market size was $9.70 billion in 2024, and that the market is projected to grow from $10.30

billion in 2025 to $18.30 billion in 2032, a CAGR of 8.6% during the forecast period.

According to an American Sleep Association

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are suffering from some form of sleep disorders.

according to Canadian Respiratory Journal in 2014, around 5.4 million adults in Canada were diagnosed with sleep apnea or were at higher

risk of developing OSA.

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

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

OSA and to maximize cost-effectiveness.

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

Moreover, according to Canadian Respiratory Journal in 2014, around 5.4 million adults in Canada were diagnosed with sleep apnea or

were at higher risk of developing OSA.

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

suffering from sleep apnea.

We therefore believe that effective diagnostic and treatment strategies are needed to minimize the

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

on our direct experience with our Vivos-trained providers performing approximately 53,000 VivoScore HSTs during 2024, we strongly believe

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

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

Our VivoScore testing routinely results in approximately

50% of patients testing positive OSA, a number consistent with a recent study published in the Journal of the American Heart Association

on a sample consisting of ~2000 middle-aged to older adults from the Multi-Ethnic Study of Atherosclerosis (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.

Sleep Irregularity and Subclinical Markers of Cardiovascular Disease:

The Multi-Ethnic Study of Atherosclerosis.

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

As we raise awareness, and now that new technologies

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

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

Therefore, based on the addressable

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.

As we pivot to the alliance marketing and distribution

model, we anticipate our average sales price to patients to increase to approximately $4,500.

As we raise awareness, and now that new

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

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

Therefore, based

on the addressable U.S.

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

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

Treatment Alternative for OSA - The Vivos Method

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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.

results are typically achieved in 9 to 12 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.

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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 primary products used in The Vivos Method are our C.A.R.E.

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 12 months, with 10 to 12

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

As we pivot to the alliance marketing and

distribution model, we expect Vivos products to be available to greater pool of OSA patients.

We believe the following strategies will

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

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.

our market penetration with DME distribution agreements.

We actively identify and develop strategic

relationships and selective acquisitions of sleep clinics throughout the country.

the number of strategic marketing and sales alliances we have and cultivate active referral sources among physicians, sleep specialists,

dentists and other healthcare providers.

We have 12 individuals within our company dedicated to cultivating referral sources for our

We also have a group of individuals (who we refer to as our M&A Group) which is dedicated to identifying sleep centers

that will be suitable candidates for the new alliance marketing and distribution model or accretive acquisition.

Drive more qualified new patients to our existing VIP practices and teach those VIPs how to better present and close

Vivos treatment via the “Boost” and “Kick-Off” programs.

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

Our BIS m edical

and dental billing service helps providers secure medical and dental insurance benefits.

Lever technology and streamline service offerings to make it easier for both dental and medical professionals to

interact and do business with Vivos.

our market penetration with sleep center integration and DME distribution agreements.

in research and development to drive innovation and expand indications.

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revenue is currently derived from the following primary sources:

office training and enrollment fees .

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

after 12 months.

Vivos appliance sales .

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

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

We are also seeking to drive appliance sales

through our distribution arrangements with DMEs.

VIP subscription fees.

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

and training.

Under the legacy VIP model, once we trained the VIP on how dentists can help treat OSA, the goal is

to have them initiate “new case starts” with patients, which leads to sales of our appliances and guides.

Under our new

alliance marketing and distribution model, we are seeking to drive appliance sales through our distribution arrangements with sleep

clinics, where the appliance is delivered by our alliance partner.

office training and enrollment fees .

Under our legacy VIP subscription model, these fees are comprised of one-time, up-front fees.

While we have shifted

our business model away from VIP enrollment revenue, we nonetheless expect to recognize some revenue from existing VIP subscriptions over

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.

We modified our agreement with MyCardio LLC relating to our SleepImage HST for sleep apnea, which generates

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

Vivos Institute.

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AireO2 is a complement to our BIS software system.

Integration Division (MID) .

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

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

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

The primary objective of our

MID is to promote The Vivos Method to medical providers and thus facilitate the potential for 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.

Group (formerly our Medical Integration Division) .

In late 2020, we launched our formerly named Medical Integration Division

(or 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.

Historically, the primary objective of our MID was 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.

With the change in business model to focus on alliance marketing and distribution of Vivos products through sleep

centers, the MID has been renamed the M&A Group and their mission and focus has shifted to identifying and closing strategic

alliances and / or acquisitions of sleep clinics and Vivos.

(Orofacial Myofunctional Therapy) Program .

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

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

to trained therapists who provide OMT via telemedicine technology.

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.

Through MyoCorrect, dentists enrolled in the VIP program and sleep clinics

aligned with Vivos will have access to trained therapists who provide OMT via telemedicine technology.

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

believe that The Vivos Method has numerous advantages that, taken together, set us apart from the competition and position us for success

in the marketplace:

believe that Vivos’ new strategic business model has numerous advantages that, taken together, set us apart from the competition

and position us for success in the marketplace:

Marketing and Distribution Business Model.

Our new business model has the combination of Vivos’ advanced proprietary

diagnostic and evidence-based treatment technology, delivered by closely aligned medical and dental professionals using our state-of-the-art

customized practice management and proprietary billing software and working together in a single, compliant dental service organization

(DSO) and medical service organization (MSO) practice model to treat a large and growing volumes of new and existing OSA patients

who seek to avoid or get off their CPAP machines.

We also have an experienced group of specially trained Treatment Navigators to

help educate patients.

Our management team has extensive experience acquiring and operating professional practices and the proven

ability to recruit, train, and manage medical and dental professionals.

Finally, with our new marketing and distribution model, our

unique business model can appeal and adapt to the unique needs and demands of sleep testing clinics as well as patients seeking viable

non-surgical solution to their chronic moderate to severe OSA.

Economics of New Marketing and Distribution Business Model.

The vertically integrated nature of our new strategic alliance

and acquisition business model minimizes costs of products as well as the unit costs associated with delivering clinical diagnostic

and therapeutic care.

Moreover, the co-locating of various medical, dental and other healthcare professionals keeps efficiencies

high and fixed costs low.

At the same time, the model allows for the full realization of revenue potential from both diagnostic and

therapeutic services.

We believe gross revenues per case could exceed $5,000 once all products and services are included, with high

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 develop the systems and best practices required to successfully

integrate diagnosis and treatment into a single-site, high-volume medical / dental practice offering substantially all options for

OSA diagnosis and treatment;

and finally, providing sleep testing and treatment centers with an attractive and mutually beneficial

model that meets the needs of their business as well as their patients.

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 and sleep specialists seeking to deliver a full range of OSA treatment options to their patients.

Method insurance reimbursement .

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

clearance 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.

of published research and strong patient outcomes .

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

of clinical and patient data, and benefits of The Vivos Method for its registered and 510(k) cleared use, spanning over approximately

ten years from nearly 58,000 patients treated with our proprietary clinical treatments that demonstrates the safety, effectiveness,

therapy adherence (patient compliance).

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

across reports from independent dentists and have been highlighted in over 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 of the Vivos Method.

mover advantage .

Our business model is the first to focus on sleep centers screening patients for mild to severe OSA with

the dentists serving as the primary source of treatment using The Vivos Method for such patients.

We believe we are also the first

to bring forth a go-to-market strategy that incorporates collaborating with DME companies, medical professionals and other non-traditional

healthcare providers such as chiropractors and physical therapists to expand access by patients to our products and services.

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 C.A.R.E.

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.

trademark portfolio consists of 14 registered

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.

However, management believes that its core intellectual property goes far beyond its patent estate and

is deeply embedded in the multi-disciplinary clinical diagnostic and therapeutic protocols.

We believe the myriads of highly nuanced

complexities and diversity with which OSA patients present effectively renders the key aspects of our technology virtually impossible

to replicate or reverse engineering.

For example, we know of several unsuccessful attempts to replicate our products and offer them

to untrained providers at minimal cost.

In every instance of which we are aware, the clinical outcomes were unsatisfactory or failed

The secrets of what we do are woven into how we do it, the order in which we apply certain adjunctive therapies, and

also the use of uniquely designed customized oral appliances.

If any one or more of those elements is missing or misapplied, results

will be less than acceptable to patients.

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 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 actively and consistently engage

sleep centers as well as U.S.

and Canadian dentists.

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 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 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

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

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 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.

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, 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.

The objective of our indirect and direct marketing efforts are to bring dentists, medical doctors and healthcare professionals to our

educational and training websites to learn about OSA and its treatment alternatives.

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

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

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

Domestically,

during 2024, we continued our prospecting and marketing efforts to the dental community, albeit on a limited and dramatically scaled

back basis, as we reposition personnel and resources over to support our new strategic marketing distribution and acquisition model.

As part of our new strategic marketing distribution, we are collaborating with Rebis to offer OSA patients a full spectrum of

evidence-based treatments such as our own advanced, proprietary and FDA-cleared C.A.R.E.

oral medical devices, oral appliances and

additional adjunctive therapies and methods including CPAP machines.

The program commenced in August of 2024 in the Longmont office

We believe this new strategic marketing and distribution model provides several advantages.

First, it provides

Vivos-trained providers direct access to far more OSA patients who are likely candidates for Vivos treatment.

As we roll out this

new model going forward, potentially thousands of patients each month could be exposed to Vivos treatment options.

Second, we expect

to close more cases using Vivos-trained personnel.

Third, top line revenue and profit per case are expected to rise.

significantly alters the economics to Vivos, when compared to our prior model, increasing top-line revenues per case start by

approximately 4-6 times.

In summary, under our new model, we expect to present Vivos treatment to more patients, refer a higher

percentage of cases into Vivos treatment, and generate more revenue and profit per case.

Accordingly, we have scaled back our VIP

enrollments, and as a result, our in-house direct sales personnel and have asked our Practice Advisors to assume direct sales and

marketing activities.

Although we have seen some initial benefits from these changes, we do not yet have data to support any

conclusions as to the effects of these changes overall on our revenue and potential for profit.

However, we believe the potential

for revenue growth from our new direct marketing distribution and acquisition model may eventually replace revenue from our legacy

model of VIP enrollments and we expect higher revenue and margins.

Internationally,

our efforts are primarily focused on the MENA region of the Middle East, where we have a very active international distributor, Noum,

In November 2024, we conducted our first regional training in Dubai.

Since then, patient interest in the region is exceeding forecasts,

and we expect to continue to support our training and distribution efforts going forward.

At this time, we do not have plans to continue

further international expansion and will continue to focus and deploy resources primarily in the United States.

Reimbursement

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for pre-authorization that may be required for reimbursement.

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

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

As out-of-network

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

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

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

by Vivos to VIPs.

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

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

VIPs typically remain out-of-network with commercial health insurance,

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

As out-of-network providers, dentists

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

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

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

to VIPs and patients of sleep clinics through our merging DSO and MSO business model.

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 PAP and/or myofunctional

therapy, as needed).

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

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.

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.

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

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 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

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and the DNA appliance for adults.

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

only when medical necessity is present and documented properly.

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

appliance must proceed with caution.

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

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

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

the existing medical necessity.

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

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

Once authorized

the OAT can be billed for benefit calculation and payment.

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

to treat mild to moderate OSA and snoring in adults.

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.

During 2024, the FDA expanded the DNA’s clearance to treat children ages 6-17 for moderate to

severe OSA in children with malocclusions.

When preauthorizing and billing the Vivos Guides and DNA appliances, an undefined CPT code

can be utilized only when medical necessity is present and documented properly.

A dentist billing an undefined CPT code for a Class I

or Class II oral appliance must proceed with caution.

These preauthorization and billing requirements pertain to all valid and billable

codes and must be supported with documented medical necessity reviewed by the medical director at the payor before being submitted for

possible reimbursement.

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

to summarize and communicate the existing medical necessity.

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

documentation of dentofacial abnormalities present, CT images, co-morbidities, and any other related medical conditions diagnosed by

a medical doctor.

authorized, the OAT can be billed for benefit calculation and payment.

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

indications to treat mild to moderate OSA and snoring in adults.

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 PAP and/or myofunctional therapy,

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.

appliance can be pre-authorized and billed using a HCPCS Code designated for use by reducing upper airway collapsibility, which 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.

September 2024, the American Medical Association (AMA) issued new CPT Codes for billing medical insurance which apply only to Vivos C.A.R.E.

As previously mentioned, Vivos C.A.R.E.

devices were already approved for Medicare reimbursement.

The new CPT Codes went

into effect January 1, 2025.

We do not yet know the level of reimbursement, if any, that commercial medical insurance payers will pay

out on the new codes.

However, we now believe it has taken all the major requisite steps in order to position our flagship C.A.R.E.

to be more consistently covered by medical insurance payers.

Insurance Coverage

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

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

cells may persist to permit continued growth and development.

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

or non-surgically.

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

or non-surgically.

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.

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

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 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.

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

patients undergoing C.A.R.E.

treatment for Obstructive Sleep Apnea recently published in the top-tier medical journal, 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.

The results published have illustrated that C.A.R.E.

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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from SleepImage.

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

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 .

We offer three Class II devices cleared by the FDA ( DNA , mRNA and mmRNA ) to treat mild to severe OSA.

In addition, in September 2024 the FDA granted the Vivos C.A.R.E.

DNA appliance ® an unprecedented clearance to treat children

ages 6-17 for moderate to severe OSA.

In addition, we offer our own specially designed pre-formed Vivos Guides, which the FDA considers

Class I orthodontic devices for tooth positioning.

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 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.

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.

510(k) clearance was initially granted by the FDA for our mmRNA appliance ® 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 PAP and/or myofunctional

therapy, as needed.

to November 2023, our mRNA appliance ® had 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 PAP and/or myofunctional therapy, as needed.

December 2022, our DNA appliance ® received 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 PAP and/or myofunctional therapy,

During 2024, the FDA expanded the DNA’s clearance to treat children ages 6-17 for moderate to severe OSA in children

with malocclusions.

The DNA appliance is thus the only oral appliance in the world that has been FDA cleared to treat OSA.

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

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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 ® )

of the oral appliances that comprise our C.A.R.E.

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 were repeat offenses from previous inspections.

These observations were corrected and responded to according

to the Code of Federal Regulations.

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

Manufacturing

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forwarders for product shipments, including shipments to and from our manufactures’ distribution facilities and customer distribution

the fourth quarter of 2024, we opened our facility in Orem, Utah as an in-house manufacturer of Vivos products.

Our goal is to increase

profit margins and product quality with the new facility while also shortening fabrication and delivery times.

As of December 31, 2024,

approximately 20-30% of total appliance orders are being fulfilled by our new Orem facility.

Ongoing Clinical Research

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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.

from Vivos products and technology.

Currently, Vivos is sponsoring a large independent prospective pediatric trial on the clinical effects

of Vivos Guides with over 150 children currently enrolled.

We expect to continue to enroll children ages 3-12 in the trial up to a total

potential cohort of 500 children.

We currently enroll approximately 20 new children per month.

We expect to submit and publish the results

of this trial by the end of 2026.

Nighttime Appliance ( DNA ) therapy for the treatment of OSA clinical trial agreement dated May 2023 .

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 Sleep Disordered Breathing (SDB) with an intraoral device in a pediatric population.

Reviewed by the Western Copernicus

Group Institutional Review Board (WCG IRB) as non-significant controlled clinical trials, we conducted 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).

ages 5-12 enrolled in this study used the Vivos Grow/Vivos Way appliance to correct orthodontic issues.

The retrospective study recruited

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

The study analyzed eleven

symptoms of SDB from questionnaire scores of forty-four children ages from 5 to 12 in monobloc oral appliance (MOA) treatment.

included immediate improvement of SDB symptoms from initial visit to the endpoint at 2 to 3 months.

We found immediate improvement

of SDB symptoms occurred from initial visit to the endpoint at 2 to 3 months.

We also found a plateau of resolving or improvement

of symptoms between the 2 to 3 months endpoint and the 4-6 months endpoint, but most profoundly, there is a high probability that

90% of children in MOA therapy with Vivos Guides will have SDB symptoms resolved or improved at the 7+ month endpoint.

The most commonly

observed symptoms of SDB such as snoring, mouth breathing, and bedwetting were significantly improved at the 2-to-3-month endpoint.

In conclusion, with early intervention, a statistically significant impact on resolving and reducing sleep disordered breathing symptoms

was achieved, ultimately improving physiological and emotional health and development of children.

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

purpose of the third trial was to evaluate the improvement of ADHD related symptoms in school-aged children ages 5 to 12 in treatment

with Vivos Guides for SDB and 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.

Results of the study suggest that undiagnosed ADHD behaviors and symptoms

among school-aged children in MOA treatment for sleep and breathing disorders improved in 4.2 months and were reported as resolved

or rarely occurred (over 60%) within 15 months.

The results emphasize the need to assess sleeping patterns in children before a confirmed

diagnosis of ADHD, healthcare providers and insurers consider MOA as a treatment choice and creating the necessary collaborative

bridge between mental health providers and dentistry.

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

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

the current pediatric clinical trial is complete, we plan to submit a 510(k) application to the FDA requesting pediatric clearances and

indications of use for the Vivos Guides.

products and our operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States,

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notification or pre-market approval (PMA).

Under the FDCA, medical devices are classified into one of three classes—Class I, Class

II or Class III—depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory

control needed to ensure its safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for

which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance

with the applicable portions of the QSR, facility registration and product listing, reporting of adverse medical events, and truthful

and non-misleading labeling, advertising, and promotional materials.

Class II devices are subject to the FDA’s General Controls,

and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.

These special controls can

include performance standards, post-market surveillance, patient registries and FDA guidance documents.

While most Class I devices are

exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a

premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.

permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.

the 510(k) process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially

equivalent” to either a device that was legally marketed (for which the FDA has not required a PMA submission) prior to May 28,

1976, the date upon which the Medical Device Amendments of 1976 were enacted, or another commercially available device that was cleared

to through the 510(k) process.

The FDA has 90 days from the date of the pre-market equivalence acceptance to authorize or decline commercial

distribution of the device.

However, similar to the PMA process, clearance may take longer than this three-month window, as the FDA can

request additional data.

If the FDA resolves that the product is not substantially equivalent to a predicate device, then the device

acquires a Class III designation, and a PMA must be approved before the device can be commercialized.

Under the FDCA, medical devices are classified into one of three classes-Class I, Class II

or Class III-depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control

needed to ensure its safety and effectiveness.

Class I includes devices with the lowest risk to the patient and are those for which safety

and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with

the applicable portions of the QSR, facility registration and product listing, reporting of adverse medical events, and truthful and

non-misleading labeling, advertising, and promotional materials.

Class II devices are subject to the FDA’s General Controls, and

special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.

These special controls can include

performance standards, post-market surveillance, patient registries and FDA guidance documents.

While most Class I devices are exempt

from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket

notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.

The FDA’s permission

to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.

Under the 510(k)

process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially equivalent”

to either a device that was legally marketed (for which the FDA has not required a PMA submission) prior to May 28, 1976, the date upon

which the Medical Device Amendments of 1976 were enacted, or another commercially available device that was cleared to through the 510(k)

The FDA has 90 days from the date of the pre-market equivalence acceptance to authorize or decline commercial distribution of

However, similar to the PMA process, clearance may take longer than this three-month window, as the FDA can request additional

If the FDA resolves that the product is not substantially equivalent to a predicate device, then the device acquires a Class III

designation, and a PMA must be approved before the device can be commercialized.

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

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OSA in adults.

The mmRNA appliance® has 510(k) clearance from the FDA as a Class II medical device for jaw repositioning, and for

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

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

The mmRNA appliance ® has 510(k) clearance from the FDA as a Class II medical device for jaw repositioning,

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

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 PAP and/or myofunctional

therapy, as needed.

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the original PMA application are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.

trials are almost always required to support a PMA application and are sometimes required to support a 510(k) submission.

trials are typically required to support a Premarket Approval (PMA) application and in some cases, a 510(k) submission.

investigations of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s

investigational device exemption, or IDE, regulations which govern investigational device labeling, prohibit promotion of the investigational

device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

the device presents a “significant risk” to human health, as defined by the FDA, the FDA requires the device sponsor to submit

an IDE application to the FDA, which must become effective prior to commencing human clinical trials.

A significant risk device is one

that presents a potential for serious risk to the health, safety, or welfare of a patient and either is implanted, used in supporting

or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment

of human health, or otherwise presents a potential for serious risk to a subject.

An IDE application must be supported by appropriate

data, such as animal and laboratory test results, showing that it is safe to test the device in humans and that the testing protocol

is scientifically sound.

The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies us that

the investigation may not begin.

If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires

modification, the FDA may require a response on such deficiencies or permit a clinical trial to proceed under a conditional approval.

addition, the study must be approved by, and conducted under the oversight of, an Institutional Review Board, or IRB, for each clinical

The IRB is responsible for the initial and continuing review of the IDE, and may pose additional requirements for the conduct of

If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin at a specific number of

investigational sites with a specific number of patients, as approved by the FDA.

If the device presents a non-significant risk to the

patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval

from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators

obtain informed consent, and labeling and record-keeping requirements.

Acceptance of an IDE application for review does not guarantee

that the FDA will allow the IDE to become effective and, if it does become effective, the FDA may or may not determine that the data

derived from the trials support the safety and effectiveness of the device or warrant the continuation of clinical trials.

An IDE supplement

must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the investigational plan that may

affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.

a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting

investigational devices to determine safety and effectiveness must comply with the FDA’s Investigational Device Exemption (IDE)

These regulations which govern investigational device labeling prohibit promotion of investigational devices, and specify

an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

If the device presents

a “significant risk”- defined by the FDA as one that presents a potential for serious risk to patient health, safety, or

welfare - the device sponsor must submit an IDE application to the FDA, which must become effective prior to commencing human clinical

A significant risk device is one that presents a potential for serious risk to the health, safety, or welfare of a patient and

either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating

disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject.

An IDE application

must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test the device in humans

and that the testing protocol is scientifically sound.

The IDE will automatically become effective 30 days after receipt by the FDA unless

the FDA notifies us that the investigation may not proceed.

If the FDA determines that there are deficiencies or other concerns with

an IDE for which it requires modification, the FDA may require a response on such deficiencies or permit a clinical trial to proceed

under a conditional approval.

addition, the study must be approved by, and conducted under the oversight of, an Institutional Review Board, (“IRB”), for

each clinical site.

The IRB is responsible for the initial and continuing review of the IDE and may pose additional requirements for

the conduct of the study.

If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin at a specific

number of investigational sites with a specific number of patients, as approved by the FDA.

If the device presents a “non-significant

risk” to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without

separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that

the investigators obtain informed consent, and labeling and record-keeping requirements.

It is important to note that FDA acceptance

of an IDE application does not guarantee that the FDA will allow the IDE to become effective and, if it does become effective, the FDA

may or may not determine that the data derived from the trials support the safety and effectiveness of the device or warrant the continuation

of clinical trials.

An IDE supplement must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change

to the investigational plan that may affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.

a clinical trial, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting

clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping

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registration and device listing with the FDA;

requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation,

and other quality assurance procedures during all aspects of the design and manufacturing process;

system Regulation (“QSR”) requirements, which require manufacturers, including third-party manufacturers, to follow stringent

design, testing, control, documentation, and other quality assurance procedures during all aspects of the design and manufacturing

and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions

for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or off-label uses and impose

other restrictions on labeling;

FDA guidance on off-label dissemination of information and responding to unsolicited requests for

for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or off-label promotion

is prohibited, and all claims must be substantiated;

FDA guidance on off-label dissemination of information and responding to unsolicited

requests for information;

federal Physician Sunshine Act and various state and foreign laws on reporting remunerative relationships with health care customers;

federal Anti-Kickback Statute (and similar state laws) prohibiting, among other things, soliciting, receiving, offering or providing

remuneration intended to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program,

such as Medicare or Medicaid.

A person or entity does not have to have actual knowledge of this statute or specific intent to violate

it to have committed a violation;

and federal Anti-Kickback Statute prohibiting, among other things, soliciting, receiving, offering or providing remuneration intended

to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as Medicare

A person or entity does not have to have actual knowledge of this statute or specific intent to violate it to have committed

federal False Claims Act (and similar state laws) prohibiting, among other things, knowingly presenting, or causing to be presented,

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constitute a major change in intended use of one of our cleared devices, or approval of a supplement for certain modifications to

device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed

to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or

contribute to a death or serious injury, if the malfunction were to recur;

device reporting (“MDR”) regulations, which require that a manufacturer report to the FDA if a device it markets may

have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets

would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls

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risk to health;

with the new federal law and regulations requiring Unique Device Identifiers (UDI) on devices and also requiring the submission of

certain information about each device to the FDA’s Global Unique Device Identification Database (GUDID);

with the new federal law and regulations requiring Unique Device Identifiers (“UDI”) on devices and also requiring the

submission of certain information about each device to the FDA’s Global Unique Device Identification Database (“GUDID”);

FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation

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Our manufacturing

processes are required to comply with the applicable portions of the quality system regulation (“QSR”), which cover the methods

and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging,

distribution, installation, and servicing of finished devices intended for human use.

The QSR also requires, among other things, maintenance

of a device master file, device history file, and complaint files.

As a manufacturer, our facilities, records, and manufacturing processes

are subject to periodic scheduled or unscheduled inspections by the FDA.

Our failure to maintain compliance with the QSR or other applicable

regulatory requirements could result in the shut-down of, or restrictions on, our manufacturing operations and the recall or seizure

of our products.

The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse

events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label

by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the

market or voluntary or mandatory device recalls or a public warning letter that could harm both our reputation and sales.

Any potential

consequences of off-label use of the DNA appliance are the responsibility of the treating independent dentist;

however, we may face consequences

related to such off-label use.

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

in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by

regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.”

processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for

the design, spec development, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution,

installation, and servicing of finished devices intended for human use.

The QSR also requires, among other things, maintenance of a device

master file, device history file, and complaint files.

As a manufacturer, our facilities, records, and manufacturing processes are subject

to periodic scheduled or unscheduled inspections by the FDA.

Our failure to maintain compliance with the QSR or other applicable regulatory

requirements could result in the shut-down of, or restrictions on, our manufacturing operations and the recall or seizure of our products.

The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing

severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a healthcare provider

in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary

or mandatory device recalls or a public warning letter that could harm both our reputation and sales.

Any potential consequences of off-label

use of our devices are the responsibility of the treating independent dentist;

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

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.

is in the process of transitioning its FDA designation from “Spec Developer” to “Manufacturer .” This transition

will subject us to a higher level of regulatory compliance and oversight, reflecting our commitment to maintaining the highest standards

in the development and production of our devices.

Over the past several months, we have made progress in preparing for this transition,

including the implementation of robust workflow processes, comprehensive documentation procedures, and adherence to current good manufacturing

practices (cGMP).

We are currently undergoing preparations for a third-party inspection and readiness evaluation, which is a requirement

to become a compliant manufacturer.

While the exact timing of this certification depends on regulatory review processes, we expect to

complete this transition in the near future and believe it may further strengthen our position in the market.

of Medical Devices in Canada

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lowest risk and Class IV being the highest.

Class I and II devices are often cleared for sale after they are CE marked or listed on the

company’s ISO certification and filed via fax-back applications for a Medical Device License (MDL).

Obtaining an MDL is comparable

to the FDA 510(k) process.

Class I and II devices are often cleared for sale after they are CE marked or listed on our

ISO certification and filed via fax-back applications for a Medical Device License (MDL).

Obtaining an MDL is comparable to the FDA 510(k)

Higher classification risk devices (Class III and IV) require filing dossiers that resemble FDA 510(k) applications.

These applications can range in cost and typically take longer for approval.

These applications

can range in cost and typically take longer for approval.

of Medical Devices in Australia

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most critically, may provide the basis for exclusion from government healthcare programs, including Medicare and Medicaid.

2009, the Fraud Enforcement Recovery Act of 2009 (FERA), was enacted, which modifies and clarifies certain provisions of the federal

2009, the Fraud Enforcement Recovery Act of 2009, or FERA, was enacted, which modifies and clarifies certain provisions of the federal

civil False Claims Act.

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such as the federal Anti-Kickback Statute, the Stark Law and the federal False Claims Act.

anticipate, however, that federal and state governments will continue to review and assess alternative healthcare delivery systems and

payment methodologies, and that public debate regarding these issues will continue in the future.

Changes in the law or new interpretations

of existing laws can have a substantial effect on permissible activities, the relative costs associated with doing business in the healthcare

February 13, 2025, Robert F.

Kennedy, Jr., was sworn in as the 26th Secretary to DHHS.

President Trump, along with Secretary Kennedy,

signed the “Establishing the President’s Make America Healthy Again Commission” Executive Order to investigate and

address the root causes of America’s escalating health crisis, with a focus on childhood chronic disease.

As Secretary, Mr.

is administering and overseeing the National Institutes of Health, the Centers for Disease Control and Prevention, the FDA, and the Centers

for Medicare and Medicaid Services.

Over his 40-year career, Mr.

Kennedy founded Children’s Health Defense, a mass membership organization

where he served as chairman to address childhood chronic disease and toxic exposures.

Kennedy has been a resolute leader in alternative

healthcare delivery systems which we believe will create a positive environment for our Company.

anticipate that federal and state governments will continue to review and assess alternative healthcare delivery systems and payment

methodologies, and that public debate regarding these issues will continue in the future.

Changes in the law or new interpretations of

existing laws can have a substantial effect on permissible activities, the relative costs associated with doing business in the healthcare

industry, and the amount of reimbursement available from government and other payors.

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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.

As of December

31, 2024, no employees had used our Whistleblower Hotline.

Of our current employees, approximately four are part of finance and accounting,

seven are involved in senior management, 12 in sales and marketing, three in research, development and regulatory and 83 in 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

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.

positions are paid in-line with the market.

Our corporate culture is built on passion - we believe in our 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.

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.

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.

Many employees work remotely, and we have reduced travel as

a result of the pandemic as well as cost reductions.

We will continue to support our workforce to ensure 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 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).

During our formation in 2016, we issued an aggregate of 37,334 shares of common stock, par value $0.0001

per share, (“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.

Madden (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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December 31, 2024, awards (in the form of options) for an aggregate of 174,380 shares of Common Stock have been issued under our 2019

A total of 287 shares remaining for issuance were retired with the approval and adoption of the 2024 Omnibus Plan (as further described

of Transfer of Corporate Domicile and Reverse Stock Split

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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.

split of our outstanding Common Stock pursuant to which holders of Vivos’ 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 on Form 10-K 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.

which was approved by our Board of Directors under authority granted by our stockholders at our 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

Unless the context expressly dictates otherwise, all references to share and per share amounts referred to in this Annual Report

on Form 10-K reflect the reverse stock split.

Marketing and Distribution Alliance Strategy

June 2024, we announced the execution of a strategic marketing and distribution alliance with Rebis Health Holdings, LLC (who we refer

herein Rebis), an operator of multiple sleep testing and treatment centers in Colorado.

This alliance, which we hope will be the first

of a series of similar alliances and potential acquisitions across the country, marks an important pivot in our marketing and distribution

model for our cutting-edge OSA appliances.

Under the new alliance, we are collaborating with Rebis to offer OSA patients a full spectrum

of evidence-based treatments such as our own advanced, proprietary and FDA-cleared C.A.R.E.

oral medical devices, oral appliances and

additional adjunctive therapies and methods including CPAP machines.

The program commenced in August of 2024 in the Longmont office of

believe the advantages of this new strategic marketing and distribution model are compelling.

First, it provides Vivos-trained providers

direct access to far more OSA patients who are likely candidates for Vivos treatment.

As we roll out this new model going forward, potentially

thousands of patients each month could be exposed to Vivos treatment options.

Second, we expect to close more cases using Vivos-trained

In our pilot testing, which we conducted at over 45 separate locations around the United States during 2023 and 2024, our

Vivos-trained personnel were able to consistently close over 70% of patients into some form of Vivos treatment.

These figures held relatively

consistent across diverse demographic and economic patient profiles and geographies.

Third, top line revenue and profit per case are

expected to rise.

Vivos projects that each patient who signs up for Vivos treatment represents approximately $4,500 on average to Vivos

top line revenue, with contribution margins of approximately 50%.

This significantly alters the economics to Vivos, when compared to our prior

model, increasing top-line revenues per case start by approximately 4-6 times.

In summary, under our new model, we expect to present

Vivos treatment to more patients, close a higher percentage of cases into Vivos treatment, and potentially generate more revenue and

profit per case.

Rebis strategic alliance was announced alongside a $7.5 million equity private placement by us with an affiliate of New Seneca Partners,

(who we refer herein as Seneca).

The new marketing and distribution strategic alliance is based on a profit-sharing model between

us and Rebis.

Subject to certain conditions, Seneca will participate in our net cash flow allocation from the alliance up to an agreed-upon

amount as partial consideration for the management advisory services Seneca is providing to us.

2023 Private Placement

January 9, 2023, we closed a private placement (the “January 2023 Private Placement”) with an institutional investor pursuant

to which we agreed sell up to an aggregate of $8,000,000 of securities of the Company of units.

Each unit consists of one share of our

common stock (“Common Stock”), $0.0001 par value, and pre-funded warrant to purchase one share of our Common Stock, and common

stock purchase warrants to purchase our Common Stock (each, a “January 2023 Warrant”).

In connection with the January 2023

Private Placement, we issued 80,000 shares of Common Stock, pre-funded warrants to purchase up to an aggregate of 186,666 shares of Common

Stock and the January 2023 Warrant to purchase up to an aggregate of 266,667 shares of Common Stock (the January 2023 Warrant was amended

in November 2023 as described below).

The purchase price per share and associated January 2023 Warrant was $30.00, and the purchase price

per pre-funded warrant and associated January 2023 Warrant was $29.9998.

2023 Private Placement

October 30, 2023 we entered into a securities purchase agreement with the same institutional investor pursuant to which we sold an aggregate

of $4,000,003.44 of securities in a private placement consisting of (i) 130,000 shares of Common Stock, (ii) a pre-funded warrant to

purchase 850,393 shares of Common Stock, (iii) a five-year Series A Common Stock Purchase Warrant to purchase up to 980,393 shares of

Common Stock with an exercise price of $3.83 per share and (iii) an 18-month Series B Common Stock Purchase Warrant to purchase up to

980,393 shares of our Common Stock with an exercise price of $3.83 per share (the “Series B Warrant”).

private placement closed on November 2, 2023.

After deducting the placement agent fees and estimated offering expenses, we received net

proceeds of approximately $3.5 million.

As of January 31, 2024, all of the pre-funded warrants granted as part of the private placement

were exercised.

part of the November 2023 private placement, we agreed with the investor to amend the January 2023 Warrant to reduce the exercise price

of the January 2023 Warrant to $3.83 per share and extended the expiration date of the January 2023 Warrant to November 2, 2028.

amendment also restated in its entirety the definition of “Black Scholes Value” contained in the January 2023 Warrant with

the intention of eliminating an embedded derivative liability associated with such warrant.

2024 Warrant Exercise Transaction

February 14, 2024, we entered into a warrant inducement letter agreement (the “Inducement Agreement”) with the same institutional

investor pursuant to which the investor agreed to exercise for cash the entirety of the Series B Warrant issued in November 2023 at a

reduced exercise price of $4.02 per share (with such exercise price being established for purposes of compliance with the listing rules

of the Nasdaq Stock Market), resulting in gross proceeds to us of approximately $4.0 million.

The resale of the shares of Common Stock

underlying the Series B Warrant has been registered pursuant to a Registration Statement on Form S-1 (File No.

333-275726), which became

effective with the SEC on December 1, 2023.

to the Inducement Agreement, in consideration for the immediate exercise of the Series B Warrant in full, we agreed to issue to the investor

the two Inducement Warrants in a new private placement transaction.

The Inducement Warrants are identical to each other, other than their

dates of expiration, and are substantially identical to the Series B Warrant.

The Inducement Transaction closed on February 20, 2024.

2024 Private Placement and Management Services Agreement with Seneca

June 10, 2024, we entered into a securities purchase agreement (the “June 2024 SPA”) with V-CO Investors LLC, a Wyoming limited

liability company (“V-CO”).

V-CO is an affiliate of Seneca, a leading independent private equity firm.

to the June 2024 SPA, we sold to V-CO in a private placement offering:

(i) 169,498 shares of our Common Stock, (ii) a pre-funded warrant

(which we refer to herein as the Pre-Funded Warrant) to purchase 3,050,768 shares of Common Stock (which we refer to herein as the Pre-Funded

Warrant Shares), and (iii) a Common Stock Purchase Warrant (which we refer to as the June 2024 Warrant) to purchase up to 3,220,266 shares

of Common Stock (which we refer to herein as the June 2024 Warrant Shares).

V-CO paid a purchase price of $2.329 for each share and Pre-Funded

Warrant Share and associated June 2024 Warrant, with such price being established for purposes of compliance with the listing rules of

the Nasdaq Stock Market LLC.

The private placement closed on June 10, 2024.

We received gross proceeds of $7,500,000 from the private

No placement agent was used in connection with the private placement.

June 2024 Warrant has a five-year term, an exercise price of $2.204 per share and became exercisable immediately as of the date of issuance.

The Pre-Funded Warrant has a term ending on the complete exercise of the Pre-Funded Warrant, an exercise price of $0.0001 per share and

became exercisable immediately as of the date of issuance.

The June 2024 Warrant and the Pre-Funded Warrants also contain customary stock-based

(but not price-based) anti-dilution protection as well as beneficial ownership limitations that may be waived at the option of the holder

upon 61 days’ notice to us.

June 2024 SPA provides that for a period of three (3) years from the closing of the private placement, Seneca shall be entitled to (i)

receive notice of any regular or special meeting of our board of directors at the time such notice is provided to the members of our

Board of Directors, (ii) receive copies of any materials delivered to our directors in connection with such meetings and (iii) allow

one Seneca representative (who shall be an officer or employee of Seneca) to attend and participate (but not vote) in all such meetings

of our Board of Directors.

The June 2024 SPA also includes standard representations, warranties, indemnifications, and covenants of our

company and V-CO.

terms of the June 2024 SPA require us to file a registration statement on Form S-3 or other appropriate form registering the shares,

the Pre-Funded Warrant Shares and the June 2024 Warrant Shares for resale no later than July 25, 2024 and to use commercially reasonable

best efforts to cause such registration statement to be effective by September 8, 2024.

We must also use its commercially reasonable

efforts to keep such registration statement continuously effective (including by filing a post-effective amendment or a new registration

statement if such registration statement expires) for a period of three (3) years after the date of effectiveness of such registration

statement, subject to certain limitations specified in the SPA.

We have filed with the SEC such registration statement registering the

shares and warrants as described herein on Form S-3 (File No.

333-281090) on July 30, 2024 which was subsequently declared effective

on August 7, 2024.

Services Agreement with V-CO

on June 10, 2024, our company, Airway Integrated Management Company, LLC, a Colorado limited liability company and a wholly owned subsidiary

of the Company (or “AIM”), and V-CO entered into a management services agreement (which we refer to herein as the “MSA”).

Pursuant to the MSA, V-CO will provide certain management, consulting, and advisory services to us related to our new strategic marketing

and distribution alliance with Rebis.

term of the MSA commences on the effective date of the agreement and continues until the later of (i) June 10, 2027 or (ii) such time

as V-CO has received two (2) times its original investment in the private placement we closed with V-CO.

The MSA will automatically renew

for additional terms of one (1) year unless any party sooner terminates the agreement in accordance with the terms of the MSA.

the term of the MSA, V-CO will provide to us and AIM oversight, management consulting and advisory services, including, without limitation:

(i) management of general and administrative expenses of the strategic alliance, (ii) advice on strategy of the strategic alliance with

a view towards maximizing the revenue and profit generated by the strategic alliance, (iii) searches for additional potential sleep center

operators to form strategic alliances with, (iv) making introductions to industry contacts of V-CO and its affiliates (including Seneca)

for purposes of expanding the business and opportunities of our company and the strategic alliance, and (v) performing other services

as may be reasonably requested from time to time by us and agreed to by V-CO, taking into account the level of compensation for services

and other engagements that V-CO and its affiliates may have.

consideration for such management services, AIM has agreed to pay to V-CO for three (3) years a management fee equal to $37,500 per quarter,

payable quarterly in arrears, with a minimum of $25,000 per quarter paid in cash and the remaining up to $12,500 per quarter paid in

the form of cash or restricted shares of our Common Stock, as decided by V-CO.

The value of such restricted Common Stock, if any, paid

as part of the management fee will be calculated based upon the average 5-day closing price of the Common Stock ending as of the end

of each applicable quarter (or, if the Common Stock is not then publicly listed, as determined in good faith by our Board of Directors

using industry standard valuation metrics).

addition to the management fee, V-CO will also receive a quarterly cash participation payment from AIM equal to an agreed upon percentage

of the net positive cash flow (as determined in accordance with U.S.

generally accepted accounting principles) generated by the operations

of the strategic alliance and received by VSI pursuant to the strategic alliance.

Such participation payment shall accrue and not be

paid until our company on a consolidated basis is cash flow positive from operations, as reported in our Securities and Exchange Commission

(“SEC”) filings.

Such profit participation shall continue to be earned quarterly until the later of such time as (i) V-CO

receives an amount equal to two (2) times its investment in the June 2024 private placement;

or (ii) or June 10, 2027.

MSA contains customary covenants regarding confidentiality and indemnification.

Under the MSA, V-CO will also assign to AIM or its affiliates

V-CO’s entire right, title, and interest in any intellectual property it creates while working for or on behalf of AIM.

2024 Registered Direct Offering

September 18, 2024, we entered into a securities purchase agreement (the “September 2024 SPA”) with certain institutional

investors in connection with a registered direct offering (the “September 2024 Offering”), priced at-the-market under Nasdaq

Stock Market rules, to purchase 1,363,812 shares of Common Stock at a purchase price of $3.15 per share.

No common stock purchase warrants

were offered or issued to investors in the September 2024 Offering.

Wainwright & Co., LLC (“HCW”), pursuant an engagement agreement with us, dated May 2, 2024 and amended on August 2, 2024

(as amended, the “HCW Engagement Agreement”), acted as the exclusive placement agent (the “Placement Agent”)

for the September 2024 Offering.

Pursuant to the HCW Engagement Agreement, the we have (i) paid the Placement Agent a cash fee equal

to 7.0% of the aggregate gross proceeds of the September 2024 Offering, (ii) paid the Placement Agent a management fee of 1.0% of the

aggregate gross proceeds of the September 2024 Offering, and (iii) reimbursed the Placement Agent for certain expenses and legal fees.

addition, we issued to the Placement Agent or its designees (who are among the selling stockholders named herein) warrants (the “September

2024 PA Warrants”) to purchase up to 95,467 shares of Common Stock (or 7% of the number of shares sold in the September 2024 Offering)

at an exercise price of $3.9375 per share of Common Stock, exercisable beginning upon issuance until five years from the commencement

of sales in the September 2024 Offering.

gross proceeds to us from the September 2024 Offering were approximately $4.3 million, before deducting the Placement Agent’s fees

and other offering expenses payable by us.

We currently intend to use the net proceeds from the September 2024 Offering for working capital

and general corporate purposes.

shares of the September 2024 Offering were issued pursuant to an effective shelf registration statement on Form S-3 that was filed with

the SEC (File No.

333-262554) on February 7, 2022 and declared effective on February 14, 2022.

A prospectus supplement relating to the

September 2024 Offering has been filed with the SEC on September 20, 2024.

September 2024 SPA contains customary representations, warranties and agreements of the Company and the investors and customary indemnification

rights and obligations of the parties.

Pursuant to the terms of the September 2024 SPA, we agreed to certain restrictions on the issuance

and sale of its shares of Common Stock and securities convertible into shares of Common Stock for a period of 30 days following the closing

of the September 2024 Offering.

We have also agreed not to effect or agree to effect any Variable Rate Transaction (as defined in the

September 2024 SPA) until one year following the closing of the September 2024 Offering, subject to certain exceptions.

of 2024 Omnibus Equity Incentive Plan

board of directors and shareholders adopted and approved on November 26, 2024, the Vivos Therapeutics, Inc.

2024 Omnibus Equity Incentive

Plan (or the “2024 Omnibus Plan”).

The 2024 Omnibus Plan automatically replaced and superseded the 2019 Plan.

Under the 2024

Omnibus Plan, a total of 1,600,000 shares are available for future use.

No awards are to be granted under the 2019 Plan or any other

prior plan on or after the effective date of the 2024 Omnibus Plan and after the 2024 Omnibus Plan became effective any unused shares

left in the 2019 Plan are to be retired.

We anticipate that the 1,600,000 shares will allow the 2024 Omnibus Plan to operate for several

years, although this could change based on other factors, including but not limited to merger and acquisition activity.

The purpose of

the 2024 Omnibus Plan is to promote the success and enhance the value of the Company by linking the personal interest of the participants

to those of our stockholders by providing the participants with an incentive for outstanding performance.

Any non-employee director,

officer, employee or consultant of the Company or its subsidiaries or affiliates will be eligible to participate in the 2024 Omnibus

As of December 31, 2024, we had five non-employee directors, two officers, 110 employees and three consultants, although we expect

that, based on our current usage, awards will be generally limited to approximately five non-employee directors, two officers ten employees,

and three consultants.

The 2024 Omnibus Plan provides for the grant of options to purchase shares of our Common Stock, including stock

options intended to qualify as incentive stock options (“ISOs”) under Section 422 of the Code and nonqualified stock options

that are not intended to so qualify (“NQSOs”), stock appreciation rights (“SARs”), restricted stock awards, and

other equity-based or equity-related awards including restricted stock units and performance units (each, an “Award”).

of December 31, 2024, awards (in the form of options) for an aggregate of 1,020,487 shares of Common Stock have been issued under our

2024 Omnibus Plan.

2024 Registered Direct Offering and Private Placement of the December 2024 Warrants

December 22, 2024, we entered into a securities purchase agreement (the “December 2024 SPA”) with certain institutional investors

(who are the selling stockholders named herein) in connection with a registered direct offering, priced at-the-market under Nasdaq Stock

Market rules, to purchase 709,220 shares of Common Stock and, in a concurrent private placement (collectively, with the registered direct

offering, the “December 2024 Offering”), warrants (the “December 2024 Warrants”) to purchase up to 709,220 shares

of Common Stock (the shares of Common Stock issuable upon exercise of the December 2024 Warrants, the “December 2024 Warrant Shares”).

The combined purchase price per share and each of the December 2024 Warrants is $4.935.

The December 2024 Warrants are immediately exercisable

upon issuance, will expire two years following the issuance date and have an exercise price of $4.81 per share.

agreed to file a registration statement under the Securities Act of 1933, as amended (the “Securities Act”), with the

SEC, covering the resale of the December 2024 Warrants Shares within 30 calendar days following the date of the December 2024 SPA and

to use commercially reasonable efforts to cause the registration statement to be declared effective by the SEC within 90 days following

the closing of the December 2024 Offering.

We registered the December 2024 Warrant Shares underlying the December 2024 Warrants

for public resale pursuant to the registration statement filed on January 31, 2025.

to the HCW Engagement Agreement dated May 2, 2024, as amended on August 2, 2024 and December 22, 2024 with us, HCW acted as the Placement

Agent for the December 2024 Offering.

Pursuant to the HCW Engagement Agreement, we have (i) paid the Placement Agent a cash fee equal

to 7.0% of the aggregate gross proceeds of the December 2024 Offering, (ii) paid the Placement Agent a management fee of 1.0% of the

aggregate gross proceeds of the December 2024 Offering, and (iii) reimbursed the Placement Agent for certain expenses and legal fees.

In addition, upon the exercise of any December 2024 Warrants for cash, we have agreed to (i) pay the Placement Agent a cash fee equal

to 7.0% of the aggregate exercise price paid in cash, (ii) pay the Placement Agent a management fee of 1.0% of the aggregate exercise

price paid in cash and (iii) issue to the Placement Agent or its designees warrants to purchase shares of Common Stock representing 7%

of the shares of Common Stock underlying the December 2024 Purchase Warrants that have been exercised.

also issued to the Placement Agent or its designees (who are among the selling stockholders named herein) warrants (the “December

2024 PA Warrants”) to purchase up to 95,467 shares of Common Stock (or 7% of the number of shares sold in the December 2024 Offering)

at an exercise price of $6.1688 per share of Common Stock, exercisable beginning upon issuance until two years following the issuance

gross proceeds to us from the December 2024 Offering were approximately $3.5 million, before deducting the Placement Agent’s fees

and other offering expenses payable by us.

We are using the net proceeds from the offering for working capital and general corporate

shares from the December 2024 Offering were issued pursuant to an effective shelf registration statement on Form S-3 that was filed with

the SEC (File No.

333-262554) on February 7, 2022 and declared effective on February 14, 2022.

A prospectus supplement relating to the

Shares was filed on December 26, 2024 with the SEC.

December 2024 SPA contains customary representations, warranties and agreements of our company and the investors and customary indemnification

rights and obligations of the parties.

Pursuant to the terms of the December 2024 SPA, we agreed not to effect or agree to effect any

Variable Rate Transaction (as defined in the Purchase Agreement) until one year following the closing of the December 2024 Offering,

subject to certain exceptions.

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