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NASDAQ: VVOS

Vivos Therapeutics, Inc.

CIK 0001716166 · Surgical & Medical Instruments

We are a revenue stage medical technology and healthcare services company that features a comprehensive suite of proprietary oral appliances and therapeutic treatments. Our products non-surgically treat certain maxillofacial and developmental abnormalities of the mouth and jaws that are closely… About this business →

10-Q Filed May 20, 2026 · Period ending Mar 31, 2026 Red flag

Vivos posts 70% revenue growth from sleep services acquisition but losses double to $7.8M

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8-K Filed Apr 22, 2026 · Period ending Apr 22, 2026

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10-K Filed Apr 15, 2026 · Period ending Dec 31, 2025

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8-K Filed Apr 15, 2026 · Period ending Apr 15, 2026

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8-K Filed Apr 3, 2026 · Period ending Apr 3, 2026

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10-Q Filed Nov 19, 2025 · Period ending Sep 30, 2025

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10-Q Filed May 15, 2025 · Period ending Mar 31, 2025

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10-K Filed Mar 31, 2025 · Period ending Dec 31, 2024

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About Vivos Therapeutics, Inc.

Source: Item 1 (Business) from the 10-K filed April 15, 2026. Description as filed by the company with the SEC.

Item
1. Business.

Overview and Mission

We
are a revenue stage medical technology and healthcare services company that features a comprehensive suite of proprietary
oral appliances and therapeutic treatments. Our products non-surgically treat certain maxillofacial and developmental
abnormalities of the mouth and jaws that are closely associated with breathing and sleep disorders such as mild to severe
obstructive sleep apnea (known as OSA) and snoring in adults. We call the use of our appliances coupled with specific therapeutic treatment protocols The Vivos Method.

The
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 C.A.R.E. oral appliances have been utilized in approximately
60,000 patients treated worldwide by more than 2,000 trained dentists. We estimate our other lines of oral appliances have treated an
additional 15,000 or more patients worldwide.

Since 2024, we have been evolving
our business model towards one that focuses on deriving revenue from appliance sales but also the provision of healthcare services in
compliance with the laws relating to the corporate practice of medicine through (i) the acquisition and management of sleep medical practices
who diagnose and treat OSA and (ii) the establishment of Vivos supported and managed Dental and Medical Service Organizations (“DSOs”
and “MSOs”). We have begun to brand our OSA treatment business as Sleep and Airway Medicine Centers (or SAMC).

Read full description ↓

Our
mission is to rid the world of OSA by being a leading technology platform and go-to services resource for the latest and most effective
diagnostic tools, treatment modalities, products, and clinical education available to healthcare providers of all specialties who treat
patients suffering from breathing and sleep disorders and their comorbidities. We recognize that breathing and sleep disorders, including
OSA, are often complex conditions with multiple contributing factors that require more than a single solution. To that end, we have broadened
our product and services lines that comprise The Vivos Method to go beyond the proprietary technologies featured in our C.A.R.E. oral
appliances and now offer sleep health 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.

We
believe this evolution of our mission (which was originally focused almost exclusively on the dental community) will appeal to a much
broader array of healthcare professionals, including chiropractors, nutritionists, primary care physicians, cardiologists, physical therapists,
dentists and others, all of whom have a strong vested interest in the overall health and wellbeing of their patients, and each of whom
has something meaningful to contribute when properly educated and trained. As word spreads among a broader array of professionals and
their patients, we expect more people to come to know and understand the compelling advantages of The Vivos Method. We believe this will
allow us to scale our business and grow our company, offering our OSA solutions to a large and growing number of patients.

Historically, we
have offered independent dentists three separate clinical pathways
or programs to become Vivos product providers: (i) Guided Growth and Development, (ii) Lifeline and (iii) Complete Airway Repositioning
and Expansion (“C.A.R.E.”). Each program features specific proprietary and non-proprietary oral appliances, coupled
with specific therapeutic protocols and adjunctive treatments, and each clinical pathway is intended to address the specific needs of
a diverse patient population with different patient journeys.

Our
Guided Growth and Development program features the Vivos Guide and PEx appliances along with CO2 laser treatments and other
adjunctive therapies designed for treating palatal growth and expansion in pediatric patients as they grow. The mid-range priced Lifeline
program features a selection of mandibular advancement devices (“MADs”) such as the Versa and Vida Sleep which are
U.S. Food and Drug Administration (“FDA”) 510(k) cleared for mild-to-moderate OSA in adults, along with the patented
Vida appliance, which is FDA 510(k) cleared for the alleviation of Temporomandibular Joint Dysfunction (“TMD”) symptoms,
bruxism, migraine headaches, and nasal dilation.

As of April
2026, as part of the continuing evolution in our business model, we are no longer offering the Guided Growth and Development course
to unaffiliated independent dentists who are not employed by or contracted with a Vivos-supported DSO group. Lifeline and C.A.R.E.
training programs will continue to be offered to unaffiliated independent dentists and all three programs will be offered to any or
all existing dentists who became part of our historic Vivos Integrated Provider program (“VIP”) prior to April 2026, and also to all new or existing dentists who become employed by
or contracted with any Vivos-supported DSO.

Our
flagship C.A.R.E. program features our patented DNA, mRNA and mmRNA appliances, which are FDA 510(k) cleared for mild-to-severe OSA and
snoring in adults. The Vivos Method may also include adjunctive myofunctional, chiropractic/physical therapy, and laser treatments that,
when properly used with the C.A.R.E. appliances, constitute a powerful non-invasive and cost-effective means of reducing or eliminating
OSA symptoms. In a small subset of a study, The Vivos Method was shown to reduce OSA symptoms in a statistically significant portion
of patients. According to a retrospective analysis by a leading sleep doctor of real world data derived from users of our mRNA
and DNA devices “all patients treated with mRNA
showed an increase in transpalatal width while 97% of patients treated with DNA showed an increase. Apnea Hypopnea Index (AHI) scores improved or stayed the same in
91% of DNA patients in 88% of mRNA patients. AHI improved by at least one classification for 63% of DNA patients as compared to 61% of
mRNA patients.”

The primary competitive advantage of The Vivos Method over other OSA therapies is that The Vivos Method’s
typical course of treatment is limited in most cases to 9 to 12 months, and it is possible not to need lifetime intervention, unlike
continuous positive airway pressure (“CPAP”) (the so-called “gold standard” for OSA
treatment) and neuro-stimulation implants. Additionally, out of approximately 75,000 patients treated to date worldwide with our entire current
suite of products, there have been very few reported instances of relapse.

Although
not our current focus due to a strategic pivot in our business model, we have also historically offered a suite of
diagnostic and support products and services primarily to dentists as well as medical providers and distributors who service
patients with OSA or related conditions. Such products and services include (i) VivoScore home sleep screenings and tests (powered
by SleepImage® technology), (ii) Treatment Navigator (a concierge service to assist providers in educating and
supporting patients as they navigate insurance coverage, diagnostic indications and treatment options), (iii) Billing Intelligence
Services (which optimizes medical and dental reimbursement), (v) advanced training and continuing education courses at our Vivos
Institute in Denver, Colorado, and (iv) MyoSync (formerly MyoCorrect), a service through which Vivos-trained providers can provide
orofacial myofunctional therapy (“OMT”) to patients via a telemedicine and mobile application-based platform.
Some of these services including home sleep screenings, treatment navigator services and MyoSync, are being provided to patients
directly under our medical-provider focused sales, marketing and distribution model described below. With this shift in focus, we
shifted our Medical Integration Division to pursue strategic alliances and acquisitions of sleep centers to provide better options
using Vivos products for patients who have been diagnosed with OSA.

In
this Annual Report on Form 10-K, we sometimes refer to medical doctors, dentists and other medical professionals (including our independent Vivos-trained dentists) who treat OSA as “providers”.

Also,
in this Report, and unless the context requires otherwise and except as provided for in the footnotes to our audited financial statements
included herein, the term “common stock” refers to shares of our common stock, par value $0.0001 per share.

Legacy
Business Model

Our
historical business model was to teach, train, and support primarily dentists but also medical doctors and distributors in the use
of our products and services. Dentists who use our products and services, referred to as Vivos Integrated Providers, enrolled in a
variety of live or online training and educational programs offered through our Vivos Institute, an 18,000 sq. ft. facility located
near the Denver International Airport. Even currently, VIP dentists are able to select and purchase the specific program or clinical pathway they would like
to focus on, such as “Introduction to Sleep and Airway Medicine”, “Advanced Sleep and Airway
Medicine/C.A.R.E.”, “Frenectomy and Tongue Tie”, “Myofunctional Therapy”, and many more. Such
VIPs also have the option of purchasing practice support services and clinical support services. This approach differs from
our historical business model, referred to as our “legacy model”, where dentists were charged an upfront fee and all
training and support packages were included in that fee.

-1-

New
Medical-Provider Focused Sales, Marketing and Distribution Model

Over
the course of 2024 and 2025, we worked to pivot our business strategy and began to steadily decrease our prior dependence on
enrolling and training VIP dentists to sell our products. This new business strategy is focused on (i) contractual alliances with
and outright acquisitions of sleep specialty medical providers, sleep testing centers and other similar entities (such as we
accomplished in 2025 through the acquisition of SCN, as described below), and (ii) through the use of a MSO/DSO support model where
we provide administrative and comprehensive non-clinical services to professional entities that employ Vivos-trained and other
specialty providers (such as we accomplished in the Detroit-area during 2025, as described below).

In June 2024, we entered into our first contractual alliance with Rebis Health, a sleep center operator in
Colorado. Revenues from this arrangement did not develop as we had expected due to circumstances beyond our control and as of the
date of this Report we have ended the contractual alliance with Rebis. Nevertheless, we have gained important experience and
insights from our relationship with Rebis which we are using to improve our new business model.

In
June 2025, our new business model was set in motion when we acquired all assets, including operating assets such as sleep testing,
diagnostics, and treatment centers, of R.D. Prabhu-Lata K. Shete MDs, LTD., a Nevada professional corporation d/b/a The Sleep Center
of Nevada (“SCN”). This acquisition was accompanied by the establishment of our initial MSO and marked a
milestone in the pivot in our sales, marketing distribution model. Applying this new model, SCN will provide diagnosed sleep
disorder patients with the opportunity to be candidates for our advanced, proprietary and FDA-cleared C.A.R.E oral medical devices,
other oral appliances, and additional adjunctive therapies, as well as CPAP. Under customary agreements designed to comply with
applicable corporate practice of medicine law, our operation of SCN allows us to manage and capture both diagnostic and consulting
revenues through MSO service and support fees, representing new high margin revenue streams for us, as well as potential additional revenue
from new product and service offerings from SCN. This model ensures the dentists and medical doctors retain the autonomy and
independence to make the most appropriate treatment decisions for their patients. For further information on the integration of
SCN’s practice into our business, please see the section below titled “SCN Integration Update.”

We
are also exploring and seeking to implement additional acquisitions of, or collaborations with, medical sleep and similar healthcare
practices to expand our business model in an effort to grow our revenues. We refer to this new model herein alternatively as our new
medical-provider focused sales, marketing and distribution model or our strategic alliance and/or acquisition model.

SCN
Integration Update

Our
operational planning for the integration of SCN began in April 2025, when we signed the definitive agreement to purchase the assets of
SCN. We believe these two months of advance planning has benefited the process of integrating SCN into our business, as our operations
team has been able to execute our plan on schedule and under budget with respect to two of SCN’s seven locations in the greater
Las Vegas area. Also, because of this effort, we recognized a small amount of SCN revenue during our fiscal second quarter (for the period
beginning with the June 10, 2025, as the closing date of the SCN Acquisition, through June 30, 2025). During 2025, we recognized SCN
diagnostic revenue of $4.8 million and treatment revenue of $2.0 million. Our goal is to continue to increase this diagnostic and treatment
revenue in upcoming quarters.

As
we had anticipated during the initial stage of SCN integration, patient demand is exceeding our capacity to process and treat patients
under our model which includes offering SCN patients Vivos treatment options. Our goal is to ramp up our systems and operations by strategically
deploying additional personnel and resources to meet this demand. We currently expect that some of SCN’s locations, including the
two already integrated, to be primary treatment hubs with larger patient capacities, with the remaining being referral centers (which
could be relocated facilities) requiring less time and effort to integrate.

Our
operational plan is driven by our deployment of our Sleep Optimization (“SO”) teams, each consisting of one nurse
practitioner (or physician’s assistant) and two specially trained dentists, employed by a medical or dental professional
corporation, six dental assistants, six administrative support personnel, and one treatment navigator. These SO teams can be
dedicated to high demand locations or spread across multiple locations as circumstances dictate. We currently have approximately 1.5
SO teams deployed across two SCN locations and expect to have additional (partial or whole) SO teams deployed during 2026. We anticipate an initial ramp of up to 60 days for SO teams to become fully functional, and up to six months or longer
before net revenue collections match revenue generating activity (such as OSA diagnostic services or OSA treatment case starts).

Based
on the current volume of OSA patient demand, we believe the current addressable market served by SCN could support several
additional SO teams, especially if certain planned growth initiatives and patient referrals meet expectations. Such
initiatives include, but are not limited to, the expansion of diagnostic and treatment services, the establishment and rollout of a
pediatric OSA program, and the collaboration with certain specialty medical groups who treat patients with comorbid OSA but who lack
the ability to test, evaluate and treat such patients within their existing practice environments.

-2-

Based on our experience to date, we believe our limiting constraints for
near-term revenue growth at SCN are (1) physical space to see an optimal number of patients; (2) provider and staff recruiting, training,
and onboarding; and (3) customary issues with third party provider credentialing. At the end of 2025, our operations at the two SCN locations
we have onboarded were fully booked for appointments through April 2026, and we were processing what we believe were less than 40% of
patients attempting to get appointments for treatment. Our two greatest barriers to servicing more OSA patients at that time were a lack
of Vivos-trained dentists and delays in obtaining full access to most major insurance carriers. As of the date of this Report, we believe we had made
progress in both areas, although further work remains, and we do not believe we will be able to fully meet current demand until additional
SO teams are fully deployed, further insurance participation access is granted, and additional facility space is made ready.

Our initial average case revenue and acceptance rate for Vivos treatment
at SCN to date, based upon a limited period of operations at two of SCN’s seven locations, suggest that each SO team could potentially
generate collections in excess of $500,000 per month, net of adjustments, with contribution margins above 50%. In addition to current
Vivos diagnostic and treatment options, we expect to be able to offer SCN patients additional diagnostic and treatment services that could
generate additional revenue. We continue to gather additional data that will allow us to refine our model and optimize operations, and
results of operations, in future periods. See “Risk Factors” for a discussion of the risks associated with our new business
model.

Importantly,
we expect to apply the lessons learned from our SCN integration activities to future sleep center or medical practice acquisitions
or management collaborations we are currently exploring and hope to consummate in the future as described below. We expect to fund
costs associated with our SCN integration activities with net proceeds from our June 2025 debt and equity financings, our January
2026 warrant inducement and March 2026 private placements, potential future financings and our At The Market
(“ATM”) offering program, and ultimately revenue from operations.

Revised
OSA Provider Management Model

In
addition to growth through acquisitions of medical sleep providers like SCN, we are continuing to evolve our revised MSO/DSO
management model for situations where the sleep center or medical practice owners are not interested in being purchased by us but
are interested in making the full range of our OSA treatment options available to their patients. Our plan is to accomplish this
type of collaboration through the creation and pro-rata funding of a new management services entity that is jointly owned by the
sleep center owners and our company, but where our company retains an 80/20 supermajority controlling interest. The revised
management model incorporates, among other things, our experience with Rebis as described above. Under the revised model, through
the co-owned management company, we will have more operational control to help ensure that our business model is being properly
implemented.

We
believe this revised management model can provide financial upside for our company with limited capital expenditures, and with what we
believe are manageable risks. At the same time, this revised management model creates the potential for economic upside for sleep center
or medical practice collaborators who are currently not interested in an outright sale to our company. Moreover, we believe the overall
quality of care and service to the OSA patients of our medical provider collaborators can improve by having more treatment options available.
The revised management model, as in the previous model, is designed to be compliant with current state and federal healthcare, anti-kickback,
and corporate practice of medicine and dentistry regulations.

We
are also exploring and seeking to implement additional acquisitions of, or collaborations with, medical sleep and similar healthcare
practices to expand our business model in an effort to grow our revenues. We refer to this new model herein alternatively as our new
sales, marketing and distribution model or our strategic alliance and/or acquisition model.

On
July 14, 2025, we entered into a management agreement, AIM – Detroit, under this revised approach with MISleep Solution LLC to
provide our full suite of Vivos treatments and services to OSA patients at a joint location in Auburn Hills, Michigan, near Detroit.
Consistent with our new model, our company owns a supermajority equity stake in the management services company, with the sleep doctors
having minority ownership interests.

Based
on our internal analysis and experience, we expect the economics of our Detroit SO team to be similar to the economics described above
for our SO teams at SCN, except that net profit distributions from the management services entity will be paid out on a pro-rata basis
(with our company receiving the supermajority share). As of this time, we have minimal operating history in the Detroit, Michigan market
or with this new model. However, we believe that the overall benefit to our company of this model derives from the limited risks (as
opposed to outright acquisitions) and generally low equipment and facility capital expenditures relative to the potential revenue opportunity.
This model also obviates the need for us to finance the purchase and other costs associated with our acquisition model.

-3-

Additionally,
as of mid-December 2025, we constructed and opened a new physical facility for sleep testing and treatment in Auburn Hills, Michigan.
The Auburn Hills center is currently open and operational. We have hired one SO team in Auburn Hills and are currently in the process
of onboarding and training that SO team.

We
believe the advantages of our medical-provider focused strategic marketing and distribution model are compelling:


First,
it provides 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. In the absence of being informed about the benefits and advantages of treatment under The Vivos Method, the vast
majority of these patients would likely elect CPAP devices, which approximately 50% or more of OSA patients eventually abandon. By providing
patients with a full-spectrum of available FDA-cleared treatment modalities, Vivos patients can make better and more informed decisions
about their care.


Second,
when provided with complete information regarding their treatment options, including The Vivos Method, our experience has been that
a strong majority of patients will choose Vivos appliance treatment. In our pilot testing, which we conducted at over 45 separate locations around the
United States during 2023 and 2024, our Vivos-trained personnel consistently experienced over 70% of patients choosing 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 OSA patient treated are expected
to rise. Through the efficiencies of our MSO/DSO support services model, we expect to operate our treatment centers with contribution
margins of up to 50% and possibly more. This significantly improves the economics to our company, when compared to our prior VIP dental distribution
model.

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.

Potential
Provider Acquisition or Management Pipeline

We
are currently in active discussions with a number of potential acquisition targets to follow our SCN acquisition and Detroit-area management
agreement. Every prospect must meet a rigorous set of criteria and standards in order to be considered by our mergers and acquisitions
team for acquisition or management. One such acquisition target is currently under an exclusive letter of intent with us. Our pipeline
of additional potential acquisition and management opportunities with sleep centers and medical sleep specialists continues to expand.
This is happening largely through word of mouth and very little expenditure in terms of marketing efforts to the more than 2,600 American
Academy of Sleep Medicine accredited sleep testing centers nationwide. We believe this pipeline of potential acquisition and management
activity, together with the experience gained from previous endeavors, will be a key driver of future accretive growth for us.

Our
Products and Services

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


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


Daytime
Nighttime Appliance (or DNA appliance®) was granted 510(k) clearance from the FDA as a Class II medical device in December 2022 for the treatment of snoring and mild to moderate OSA, jaw repositioning and
snoring in adults. It is the only oral appliance ever to receive FDA clearance to treat OSA without mandibular advancement as its
primary mechanism of action. In November 2023, our DNA appliance was cleared by the FDA to treat moderate and severe OSA in adults,
18 years of age and older, along with positive airway pressure (PAP) and/or myofunctional therapy, as needed. 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.

-4-


Mandibular
Repositioning Nighttime Appliance (or mRNA appliance®) has 510(k) clearance from the FDA as a Class II medical
device for the treatment of snoring and mild to moderate OSA in adults. In November 2023, our mRNA appliance was cleared by the FDA
to treat moderate and severe OSA in adults, 18 years of age and older along with PAP and/or myofunctional therapy, as needed.


Modified
Mandibular Repositioning Nighttime Appliance (or mmRNA appliance), for which we were granted FDA Class II market clearance
in August 2021 for treating mild to moderate OSA, jaw reposition and snoring in adults. In November 2023, our mmRNA appliance was
cleared by the FDA to treat moderate and severe OSA in adults, 18 years of age and older along with PAP and/or myofunctional therapy,
as needed.


Adjunctive
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.

The
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. 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. For example, in April 2024 we received the required regulatory approvals to enable
Medicare reimbursement for our C.A.R.E. oral medical devices. We expect such approval could potentially lead to greater reimbursement
levels from Medicare and medical health insurance payors that follow Medicare guidelines.


Vivos
oral appliances and therapies outside of C.A.R.E. system include:


Vivos
Tooth Positioners are Class I pre-formed orthodontic appliances that are flexible, BPA-free, base polymer, monoblock intraoral
positioners and rescue appliances. The Tooth Positioners are FDA Class I registered product for orthodontic tooth positioning typically
used by dentists in children to address malocclusions and promote proper guided growth and development of the mouth and jaws.


Vivos
VersaTM is an FDA 510(k) cleared Class II device for treating mild to moderate OSA in adults. It is a comfortable,
easy-to-wear, medical grade nylon, 3D printed oral appliance featuring mandibular advancement as its mechanism of action. It is priced
to be very cost effective and offers Vivos providers and patients a comfortable and effective product at a much lower price point
for treatment. As with all other non-C.A.R.E. oral appliances, the Vivos Versa must be worn nightly for life in order to remain clinically
effective. We believe many Vivos Versa patients will eventually migrate up to our proprietary Vivos C.A.R.E. products. While we do
not own this product, we are a reseller of this product.


Vivos
MyoSync (formerly MyoCorrect) oral myofunctional therapy (OMT) services. Studies have shown OMT to be a clinically valuable
adjunctive treatment for patients with breathing and sleep disorders. When combined with Vivos’ C.A.R.E. products and
treatments, OMT can deliver an enhanced effect in many patients using our appliances. MyoSync treatment services are
cost-effective for providers and convenient for patients. MyoSync is billable to medical insurance in certain cases and constitutes
an additional profit center for both Vivos and providers.


Vivos
Vida™ is our proprietary FDA-cleared appliance (unspecified classification) that incorporates our patented Unilateral Biteblock technology for the alleviation of TMD symptoms, and aids in treating
bruxism and temporomandibular joint (“TMJ”) dysfunction.
The Vivos Vida helps alleviate symptoms such as TMJ/TMD pain, headaches, and facial muscle pain. The Vivos
Vida is worn during sleep and serves to protect the teeth and restorations from destructive forces of bruxism. It is a custom fabricated
appliance, designed for patient comfort.


Vivos
Vida Sleep ™ is an FDA 510(k) cleared Class II for treating mild to moderate OSA in adults. It uses the Vivos Unilateral
BiteBlock Technology and is designed to advance the mandible incrementally to stabilize the patient’s oropharyngeal airway.
It is highly efficient and has a sleep design which promotes space for the tongue to sit in the roof of the palate.

-5-


VivoScore
(from SleepImage), Rhinomanometry (from GM Instruments), Cone Beam Computerized Tomography or CBCT (from multiple vendors), Joint
Vibration Analysis (from BioResearch) and other key diagnostic technologies play an essential role as part of The Vivos Method
in patient assessment, proper clinical diagnosis, treatment planning, progress measurement, and optimal outcome facilitation. We
believe the combination and integration of such diagnostic tools and equipment as particularly taught to and practiced by Vivos-trained
providers constitutes a key trade secret of our company.


Vivos
AireO2 is an Electronic Health Record (EHR) software program specifically designed for use as a full practice
management software program in a medical or dental practice environment where treating breathing and sleep disorders is performed.
The program is built to handle both medical and dental billing and is integral in our Treatment Navigator program. As of the date of this Report, we are scaling back the deployment of this software program in our new business model.


Adjunctive
Diagnostic and Treatment modalities delivered by specialty MDs, 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 C.A.R.E. and
other Vivos devices.


Treatment
Navigators assist a clinician’s patients who may have a breathing or sleep disorder to get screened, diagnosed by a
board-certified sleep specialist, obtain insurance verification of benefits and preauthorization (where required), have their
questions answered, and receive assistance with scheduling, financing, medical billing or any other concerns regarding treatment
options best suited to their individual situation. Dentists typically pay set fees to us for this service. We utilize Treatment Navigators extensively in our new business model.


Vivos
Billing Intelligence Service (BIS) is our medical and dental billing service. It is both a subscription and fee for service
program for healthcare practitioners who wish to optimize their insurance reimbursement by leveraging both medical and dental benefits.
We are unaware of any other software platform or service on the market that offers the same set of features or capabilities.


Vivos
Airway Intelligence Service (AIS) is our technical support and advisory service that supports clinicians in their patient
data analysis, case selection, treatment planning and treatment implementation. AIS reports and services are priced into the cost
of appliances to providers.


The
Vivos Institute® (TVI) is widely regarded as one of the top educational and learning centers for dentofacial related
breathing and sleep disorders in North America. Opened in 2021, TVI is housed in a state-of-the-art 18,000 square foot facility near
the Denver International Airport where doctors from around the world come to receive instruction and advanced clinical training in a
wide range of topics delivered by leading national and international medical sleep specialists, cardiologists, pediatric sleep
specialists, dentists, orthodontists, specially trained chiropractors, nutritionists, key industry business leaders, and
university-based clinical researchers. In our new business model, we have not utilized the TVI space to its full extent as we had
expected. As such, we are currently sub-leasing the facility third parties for corporate and community events until our lease
expires in 2027.

These
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.

-6-

During
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 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
U.S. and Canada pursuant to a licensing agreement with MyCardio LLC. Based on our direct experience with our Vivos-trained providers,
approximately 53,000 VivoScore HSTs were performed during 2024. 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.

As
noted above, since our landmark FDA clearances in 2023 and 2024, we have not yet seen a corresponding increase in numbers 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
protocols. 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.

Treatment
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. We also utilize Treatment Navigators in our SCN operations.

Background
on OSA

OSA
is a serious and chronic disease that negatively impacts a patient’s sleep, health, and quality of life. According to a 2019 article
published in Chest Physician, it is estimated that OSA afflicts 54 million adults in the U.S. alone. 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. According to the study “Global Prevalence of Obstructive Sleep Apnea (OSA)”
conducted by an international panel of leading researchers, nearly 1 billion people worldwide have sleep apnea, and as many as 80% remain
undiagnosed. Research has shown that when left untreated, OSA can increase the risk of comorbidities, such as high blood pressure, heart
failure, stroke, diabetes, dementia, chronic pain and other debilitating, life-threatening diseases.

Unfortunately
for OSA patients, the medical profession has not been able to provide them with solutions that are both effective and desirable. CPAP
is the “gold standard” treatment for over 90% of OSA patients, but no one wants to wear those devices to bed every night
for life, rendering long-term compliance rates low. Traditional oral appliances can be effective over limited time frames but often create
other problems with 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 by a factor of about 2 to 1.

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We
believe our proprietary products comprising the Vivos C.A.R.E. oral appliances represent the first non-surgical, minimally invasive treatment
option for patients diagnosed with mild to severe OSA that offers cost-effective treatment featuring (i) limited treatment times; with
(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 C.A.R.E. represents
a completely new treatment modality in the treatment of dentofacial abnormalities that often lead to OSA and many other health conditions.

Our
Target Customers

Because
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 medical-provider focused 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.

During
2024 and 2025, we expanded our mission and product line positioning to extend the reach and scope of The Vivos Method beyond the dental
profession and to allow for greater collaboration and mutual referrals from other healthcare practitioners, including primary care physicians,
medical specialists, chiropractors, nutritionists, physical therapists, and others who see and treat patients with breathing and sleep
disorders. We believe this extension of our approach will broaden the knowledge among various professions as to what our technology and
products can do for their patients, ultimately leading more patients into treatment with Vivos products and services. We also incorporate
courses and curricula at 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.

As
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.

Our
Market Opportunity

The global
sleep apnea devices market size is generally estimated at between $6.9 and $10.3 billion in 2025, and is projected to rise to between
$11.6 billion and $18.30 billion by 2032, with a CAGR of 8.6% during the forecast period. According to an American Sleep Association study
published in 2020, an estimated 50 million to 70 million people in the U.S. are suffering from some form of sleep disorders. In 2023,
Eli Lilly analyses expanded that estimate to over 80 million. 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.

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Based
on our direct experience with our Vivos-trained providers performing nearly 60,000 VivoScore home sleep testes administered during
2025, 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 approximately 2,000 middle-aged to older adults from the Multi-Ethnic Study of Atherosclerosis
(MESA), where 44% had moderate to severe OSA and 75% had mild, moderate or severe OSA from the study “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.

There
are an estimated 3.5 million sleep tests conducted in the United States each year. An estimated 75% to 90% of those patients test
positive for some sort of sleep disorder, of which obstructive sleep apnea is the most predominant. Our Vivos supported dentists and
providers in Las Vegas generate approximately $5,000 on average per clinical case with an estimated 50% of patients accepting some
form of Vivos product or service. Using our treatment data to extrapolate with an assumption that 75% of 3.5 million patients are
positive for OSA, we believe there are 2.6 million new OSA patients that remain to be diagnosed. Approximately half of all OSA
patients are classed as moderate to severe, as such we believe a conservative number of 1.3 million new patients to be diagnosed and
treated from OSA each year. As we pivot to our medical-provider focused alliance marketing and distribution model, we see our
average sales price to patients to increasing to approximately $5,000. This would give us an estimated total addressable annual U.S.
market (TAM) of $6.5 billion just from new adult patients with OSA. The estimated 10 million American children with OSA could add
another estimated $4 billion to the TAM.

Our
Treatment Alternative for OSA - The Vivos Method

The
Vivos Method is a non-invasive, non-surgical, non-pharmaceutical, multi-disciplinary treatment modality for the treatment of dentofacial
abnormalities and/or mild, moderate and severe OSA and snoring in adults. Proprietary and virtually painless, The Vivos Method has been
shown to typically expand the upper airway and offers patients what we believe to be an effective treatment alternative based on published
peer-reviewed retrospective clinical data. Based on feedback from independent VIPs and their patients, we believe initial therapeutic
benefits from using the treatment guidance’s and devices are often achieved relatively quickly (in days or weeks) and final clinical
results are typically achieved in 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.

The
Vivos Method alters the size, shape and position of the tissues that surround and define the functional space known as the upper
airway. Our treatment also improves nasal breathing, reduces mouth breathing, reduces AHI scores, and
generally facilitates better breathing and sleep. These statements are based on retrospective raw data with validated before and
after sleep studies, rhinomanometry testing before and after treatment, Cone Beam Computerized Tomography (CBCT) scans from treating
clinicians and patient testimony. As The Vivos Method treatment process progresses, the airway typically expands, with many patients
reporting a significant reduction of their OSA and snoring symptoms. The primary products used in The Vivos Method are our 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 typical
treatment times range from 9 to 12 months. Our appliances may require periodic adjustments,
some of which can be performed by the patient and others that are typically rendered at the dental office where treatment was
initiated.

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Our
Growth Strategy

Our
goal is to be the global leader in providing a clinically effective non-surgical, non-invasive, non-pharmaceutical, and low-cost
alternative for patients with dentofacial abnormalities and/or mild to severe OSA and snoring in adults. As we continue our pivot to
a medical-provider focused alliance marketing and distribution model and generate revenue from MSO/DSO support services, we expect our products to be available to greater pool of
OSA patients. We believe the following strategies will play a critical role in achieving this goal and in establishing more
predictable and growing revenue leading, ultimately, to cash flow positive and profitable operations:


Expand
public awareness of the life-threatening and debilitating nature of OSA and its prevalence throughout the world, while letting the
world know of our proprietary and highly effective treatment as an alternative to CPAP. We actively identify and develop strategic
relationships and selective acquisitions of sleep clinics throughout the country.


Expand
the number of medical provider focused strategic marketing and sales alliances we have and cultivate active referral sources among
physicians, sleep specialists, dentists and other healthcare providers. We have seven individuals within our company dedicated to
cultivating referral sources for our appliances. We also have an internal 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.


Hire and expand our employee and contract dentists and other healthcare providers in connection with our affiliation and acquisition activities
throughout the United States.


Achieve
full payment by in network major insurance carriers for Vivos Method treatment. Our BIS medical and dental billing service helps
providers secure medical and dental insurance benefits, and in March 2026 we announced that SCN physician-owned professional
entities, supported by our wholly-owned management services subsidiary in Nevada, have received notices of ‘in-network’
status with a number of commercial health insurance payers, along with ‘participating’ status with Medicare.


Lever
technology and streamline service offerings to make it easier for both dental and medical professionals to interact and do business
with Vivos.


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


Invest
in research and development to drive innovation and expand indications.


Pursue
strategically adjacent markets and international opportunities.

Our
Revenue Model

Our
revenue is currently derived from the following primary sources:

Diagnostic and Treatment Revenue from SCN and
MSOs/DSOs. Under our new model, we generate revenue through (i) sleep testing services and (ii) via our SAMC facilities, patient
customized OSA treatments (which can include, but are not limited to, treatment with The Vivos Method). Our ability to generate these
revenue may be impacted by the extent to which reimbursement of OSA testing and treatment offered by our supported providers is available.
All of these revenue sources have been designed to comply with applicable federal and state laws and regulations regarding the corporate
practice of medicine.


Recurring
Vivos appliance sales. 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 tooth positioners.
Under our medical-provider focused 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.


SleepImage
HST revenue. 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.


The
Vivos Institute. Our TVI provides product-specific training for the use of our products and services. Revenue from such courses
is not material at the present time, but our expectation is that increased training awareness of OSA and the promotion of our products
and services will be enhanced by our TVI. In our new business model, we have not utilized our TVI space to its
full extent as we expected. As such, we are currently sub-leasing the facility third parties for corporate and community events until
our lease expires in 2027.

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The
Airway Intelligence Service (AIS). This service provides a complete resource for VIPs to help simplify the diagnostic and
appliance design matrix and expedite the treatment planning process. AIS is provided as part of the price of each appliance and is
not a separate revenue stream.


Billing
Intelligence Services (BIS). This complete third-party billing solution includes a comprehensive integrated revenue cycle
management software system that allows dentists to focus on running their practice and delivering the best care for their patients.
This medical billing service generates recurring subscription fees from participating VIPs and independent dentists in the United
States.


AireO2
Patient Management Software. This management software enables healthcare professionals to diagnose, treat and monitor
patients with OSA and its related conditions more effectively. Developed in collaboration with Lyon Dental, AireO2 contains features
that enhance a VIP’s billing services and practice management systems. AireO2 is a complement to our BIS software system. We
have discontinued deploying this software in our owned and managed sleep centers.


M&A
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 medical-provider 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.


MyoSync
(formerly MyoCorrect) (Orofacial Myofunctional Therapy) Program. In March 2021, we introduced orofacial myofunctional therapy
(or OMT) as a service that is part of The Vivos Method, under the name MyoCorrect. Through MyoCorrect, dentists enrolled in the VIP
program and sleep clinics aligned with Vivos will have access to trained therapists who provide OMT via telemedicine technology. Our
C.A.R.E. 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.

Our
Competitive Strengths

We
believe that our medical-provider focused strategic business model has numerous advantages over our legacy dentist-focused model that,
taken together, set us apart from the competition and position us for success in the marketplace:


New
Medical Provider-Focused Sales, 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 other
healthcare 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 mild, moderate and severe OSA.

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Superior
Economics of New Marketing and Distribution Business Model. Our medical-provider focused strategic alliance and acquisition
business model allows us to expand and grow our revenues through acquisitions of, or collaborations with, medical sleep and similar
healthcare practices. The vertically integrated nature of our 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 net margins.


Significant
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, provide 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.


Vivos
Method Insurance Reimbursement. Most major commercial insurance (and also Medicare for our mmRNA and Vida Sleep 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 our mmRNA and Vida Sleep appliance
will vary by the Centers for Medicare and Medicaid Services (CMS) jurisdiction in the U.S.


Body
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 75,000 patients treated with our proprietary and non-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.


First
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 durable medical equipment 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.


Novel
and Differentiated products. 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 in both adults and children. 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.


Intellectual
Property Portfolio and Research and Development Capabilities. We have a comprehensive patent portfolio to protect our intellectual
property and technology, three design patents that expire between 2028 and 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. Our U.S. trademark portfolio consists of 14 registered
marks and one pending published application. Extensive online and in-person training, multiple touch point support systems, specific
fabrication materials, customized appliance designs, and multi-disciplinary treatment modalities are all considered proprietary trade
secrets and competitive advantages with no known counterparts. 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 completely. 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.


Targeted
Approach to Market Development. We have established a systematic and scalable approach to actively and consistently engage
with U.S. sleep centers as well as U.S. and Canadian dentists.

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Sales
and Marketing

Prior
to 2024, we directed our prospecting and marketing efforts to the dental community. Starting in 2024 and accelerating in 2025, we
repositioned personnel and resources to support our medical-provider focused strategic marketing distribution and acquisition model.
As part of this model, we acquired the assets of SCN 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. 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. This
significantly alters the economics 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 OSA Vivos treatment options to more patients, refer a higher
percentage of cases into Vivos treatment, and generate more revenue and profit per case. Accordingly, we have ceased 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, Inc. 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 beyond the MENA region and will continue to focus and deploy resources
primarily in the United States.

Insurance
Reimbursement

Insurance
reimbursement is generally available across the full spectrum of Vivos appliances. However, medical coverage and benefits are subject
to medical necessity, provider credentialing, and payer guidelines. We have experienced challenges with these insurance processes
in connection with establishing our SCN-related operations, causing delays in revenue generation and cash flow, and we expect to face
these challenges with other sleep practices we may acquire or affiliate with.

Although medical insurance is never a guarantee of
payment, the average reimbursement seen for out of network patients is approximately 50% (ranging from 5% to 70%). In-network benefits and coverage can vary widely, and are typically at a lower price when compared to out-of-network
reimbursements. Benefits payable
are subject to deductibles and policy limitations that may vary. A verification of benefits (VOB) is generally required for all
medical policies to check for validity of billable coding for oral appliance therapy (OAT) and need for pre-authorization that may
be required for reimbursement. 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. 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 and
patients of sleep clinics through our emerging DSO and MSO business model.

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Our
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 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.

To
meet the billing requirements of CMS for custom mandibular advancement oral appliances, the mmRNA 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 PAP and/or myofunctional therapy, as needed.
In December 2021, the mmRNA was accepted by the CMS Pricing, Data Analysis and Coding (PDAC). This acceptance places the mmRNA device
on the PDAC list of oral appliances covered by and billable to Medicare, making the benefits of the mmRNA device available to millions
of Medicare beneficiaries. Notwithstanding this important achievement, in general we have found the lack of inclusion on the current
CMS Medicare PDAC list does not hinder market distribution or acceptance of Vivos appliances. This is due to the fact that most dentists
who work with The Vivos Method are out-of-network with commercial payers and do not typically file for reimbursement under Medicare.
When Medicare reimbursement is desired by Vivos providers they are typically registered with Medicare DME as a non-participating DME
supplier, allowing the provider to balance bill patients like they would when billing as an out-of- network provider to commercial policies
and are not limited to accepting Medicare reimbursement rates as payment in full.

We
have seen an increase in the ability for reimbursement for our other FDA registered oral appliances such as the Vivos Tooth Positioners
for children and the DNA appliance for adults. 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 Tooth Positioners 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.

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 PAP and/or myofunctional therapy, as needed. While the DNA appliance
can still be pre-authorized and billed using an undefined CPT code, the newly issued 510(k) clearance for the DNA appliance allows for
additional code types to be utilized when OSA is present and diagnosed by a Medical Doctor. The DNA appliance can be pre-authorized and
billed using a HCPCS Code designated for use by reducing upper airway collapsibility, 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.

In
September 2024, the American Medical Association (AMA) issued new CPT Codes for billing medical insurance which apply only to Vivos C.A.R.E.
appliances. 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. devices
to be more consistently covered by medical insurance payers.

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Importantly,
in March 2026 we announced that the SCN physician-owned professional entities supported by our wholly-owned management services
subsidiary in Nevada have received notices of ‘in-network’ status with a number of commercial health insurance payers,
along with ‘participating’ status with Medicare. We believe this major development has the potential to positively and
significantly impact patient access to OSA treatments and resulting top-line revenue and overall profitability from operations in
our key treatment market of Las Vegas, NV.

Dental
Insurance Coverage

Dental
insurance coverage for Vivos appliances also exists. Codes for sleep apnea appliances were added to the CDT code set in 2022. Vivos appliances
with indications for treatment of OSA are billable with these codes, however dental benefits for these codes are nascent at present and
secondary to medical coverage. Orthodontic coverage and benefits are also available for Vivos appliances registered with indication of
jaw expansion and tooth movement.

Published
Research

There
are several studies in the medical literature on upper airway remodeling in pathologic conditions such as asthma, chronic obstructive
pulmonary disease and similar conditions. This includes a landmark study published in October 2025 in the Journal of
Clinical Medicine, titled ‘Correlation Between Severity of Obstructive Sleep Apnea and Dental Arch Form in Adults,’
demonstrated a direct and statistically significant relationship between key oral cavity dimensions, particularly intermolar width, palatal
height and OSA severity.

In contrast, there is a dearth of studies that have documented pneumatization and physiologic upper airway remodeling. Advances in
3D digital imaging, adjunctive treatments from chiropractic and other specialists, and applied diagnostic technologies such as
rhinomanometry, combined with real-world experience in many thousands of cases, has allowed us to make further advances in the
understanding of dentofacial phenomena and how to activate and optimize dentofacial development for improved airway form and
function. 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
2009, our technology has been the subject of over 60 peer-reviewed articles in the medical, dental and orthodontic literature. While
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.

Intellectual
Property

To
establish and protect our proprietary rights, we rely on a combination of patents, trademarks, copyrights and trade secrets, including
know-how, license agreements, confidentiality procedures, non-disclosure agreements with third parties, employee disclosure and invention
assignment agreements, and other contractual rights. Our intellectual property is important in achieving and maintaining our position
in the market. We currently own three design patents that expire between 2028 through 2029 and two utility patents expiring in 2029 and
2030. We also own two Canadian patents and a 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. Our U.S. trademark portfolio consists of 14
registered marks and one pending published application. Extensive online and in-person training, multiple touch point support systems,
specific fabrication materials, customized appliance designs, and multi-disciplinary treatment modalities are all considered proprietary
trade secrets and competitive advantages with no known counterparts.

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FDA
Regulatory Status

The
Vivos Method offers treatment modalities that uses nonsurgical, noninvasive, and cost-effective oral appliance technology prescribed
by trained dentists and medical professionals to treat dentofacial abnormalities and/or mild to severe OSA and snoring. The Vivos
Method includes a customized treatment plan that may begin with a simple and easy at-home sleep apnea screening using proprietary
HST technology from SleepImage. We offer three Class II devices cleared by the FDA (DNA, mRNA and mmRNA) 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 with malocclusions. In addition, we offer our own specially
designed pre-formed Vivos Tooth Positioners, 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:


A
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.


Prior
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.


In
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, as needed.
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 children with
OSA.


Vivos Tooth Positioners are an FDA-registered Class I product for orthodontic tooth positioning. In October 2021, we announced that
results from a peer-reviewed, published study by an independent dentist found a significant reduction of tooth decay in pediatric
patients after undergoing treatment using our Vivos Tooth Positioners. A second study was peer reviewed and published in 2022 showing
a 97.4% resolution of nocturnal enuresis (bedwetting) in children within 60 days of starting treatment with Vivos Tooth Positioners.
Other papers and studies on the use of Vivos Tooth Positioners have been submitted to various journals and are awaiting acceptance
and publication.


Vivos Vida™ is an FDA cleared appliance as an unspecified classification
to treat symptoms such as migraine headache and facial muscle pain symptoms associated with TMD, and nasal dilation in children, 12 and
up.


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


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

All
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.

Manufacturing
and Supply

We
rely on third-party suppliers and manufacturers on a per order, or per item basis. Outsourcing manufacturing reduces our need for capital
investment and reduces operational expenses. Additionally, outsourcing provides expertise and capacity necessary to scale up or down
based on demand for our appliances. We select our manufacturing labs so we can ensure that our appliances are safe and effective, adhere
to all applicable regulations, are of the highest quality, and meet our supply needs. We also rely on third-party carriers and freight
forwarders for product shipments, including shipments to and from our manufactures’ distribution facilities and customer distribution
facilities.

During
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, 2025,
approximately 20-30% of total appliance orders are being fulfilled by our new Orem facility.

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Our
Ongoing Clinical Research

We
are committed to ongoing research and development, and we have and intend in the future to invest in our clinical trial work to further
improve our products and clinical outcomes, increase patient acceptance and comfort and broaden the patient population that can benefit
from Vivos products and technology. Currently, Vivos is sponsoring a large independent prospective pediatric trial on the clinical effects
of Vivos Tooth Positioners 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.


Daytime
Nighttime Appliance (DNA) therapy for the treatment of OSA clinical trial agreement dated May 2023. The aim of
this randomized clinical trial conducted with Stanford University is to investigate structural and functional effects of using the
DNA appliance® in the treatment of mild to moderate OSA in adults. This study will test the hypothesis that treatment
of the upper airway associated with functional improvements of sleep parameters in adults with mild, moderate and severe OSA.


Treatment
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 Tooth Positioners (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 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. Findings 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 Tooth Positioners 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.


Treatment
of ADHD and other child behavioral issues. We also began a separate trial in March 2023 relating to our Vivos Tooth Positioners.
The 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 Tooth Positioners 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. 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.

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.

Once
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 Tooth Positioners.

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Government
Regulation

Our
products and our operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States,
as well as comparable authorities in the European Economic Area (“EEA”). Our products are subject to regulation as
medical devices under the Federal Food, Drug, and Cosmetic Act, or FDCA, as implemented and enforced by the FDA. The FDA regulates the
development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation,
servicing, recordkeeping, premarket clearance or approval, import, export, adverse event reporting, advertising, promotion, marketing
and distribution, and import and export of medical devices to ensure that medical devices distributed domestically are safe and effective
for their intended uses and otherwise meet the requirements of the FDCA.

In
addition to U.S. regulations, we are subject to a variety of regulations in the EEA governing clinical trials and the commercial sales
and distribution of our products. Whether or not we have or are required to obtain FDA clearance or approval for a product, we will be
required to obtain authorization before commencing clinical trials and to obtain marketing authorization or approval of our products
under the comparable regulatory authorities of countries outside of the United States before we can commence clinical trials or commercialize
our products in those countries. The approval process varies from country to country and the time may be longer or shorter than that
required for FDA clearance or approval.

FDA
Premarket Clearance and Approval Requirements

Unless
an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket
notification or pre-market approval (PMA). Under the FDCA, medical devices are classified into one of three classes-Class I, Class II
or Class III-depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control
needed to ensure its safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety
and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with
the applicable portions of the QSR, facility registration and product listing, reporting of adverse medical events, and truthful and
non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the FDA’s General Controls, and
special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include
performance standards, post-market surveillance, patient registries and FDA guidance documents. While most Class I devices are exempt
from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket
notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s permission
to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Under the 510(k)
process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially equivalent”
to either a device that was legally marketed (for which the FDA has not required a PMA submission) prior to May 28, 1976, the date upon
which the Medical Device Amendments of 1976 were enacted, or another commercially available device that was cleared to through the 510(k)
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.

The
Vivos Tooth Positioners are registered with the FDA as Class I devices for orthodontic tooth positioning. On December 30, 2022 the FDA
granted 510k clearance for the DNA appliance® to treat mild to moderate obstructive sleep apnea and snoring in adults.
This approval was the first time the FDA has granted such a clearance on an oral appliance with a mechanism of action other than mandibular
advancement. The mRNA appliance® has 510(k) clearance from the FDA as a Class II medical device for the treatment of snoring, and
mild-to-moderate OSA in adults. The mmRNA appliance® has 510(k) clearance from the FDA as a Class II medical device for
jaw repositioning, and for the treatment of snoring, and mild-to-moderate OSA in adults. 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.

Devices
deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting or some implantable devices, or devices that have
a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed
in Class III, requiring approval of a PMA. Some pre-amendment devices are unclassified but are subject to the FDA’s premarket notification
and clearance process in order to be commercially distributed. We do not have any Class III devices.

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PMA
Pathway

Class
III devices require PMA approval before they can be marketed although some pre-amendment Class III devices for which the FDA has not
yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process.
In a PMA application, the manufacturer must demonstrate that the device is safe and effective, and the PMA application must be supported
by extensive data, including data from preclinical studies and human clinical trials. The PMA must also contain a full description of
the device and its components, a full description of the methods, facilities and controls used for manufacturing, and proposed labeling.
Following receipt of a PMA application, the FDA determines whether the application is sufficiently complete to permit a substantive review.
If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA application, although in
practice, the FDA’s review often takes significantly longer and can take up to several years. An advisory panel of experts from
outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability
of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally conduct a preapproval
inspection of the applicant or its third-party manufacturers.

The
FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA application constitute
valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s). The FDA
may approve a PMA application with post-approval conditions intended to ensure the safety and effectiveness of the device, including,
among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients
in the clinical study that supported a PMA approval or requirements to conduct additional clinical studies post-approval. The FDA may
condition a PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional
safety and efficacy data for the device in a larger population or for a longer period of use. In such cases, the manufacturer might be
required to follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those
patients. Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of
the approval.

Certain
changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the
design performance specifications, which affect the safety or effectiveness of the device, require submission of a new PMA application
or a PMA supplement. PMA supplements often require submission of the same type of information as a PMA application, except that the supplement
is limited to information needed to support any changes from the device covered by the original PMA application and may not require as
extensive clinical data or the convening of an advisory panel. Certain other changes to an approved device require the submission of
a new PMA application, such as when the design change causes a different intended use, mode of operation, and technical basis of operation,
or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with
the original PMA application are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.

Clinical
Trials

Clinical
trials are typically required to support a Premarket Approval (PMA) application and in some cases, a 510(k) submission. All clinical
investigations of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s
investigational devices to determine safety and effectiveness must comply with the FDA’s Investigational Device Exemption (IDE)
regulations. 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
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 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.

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In
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.

During
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
and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them. The clinical investigators
in the clinical study are also subject to FDA regulations and must obtain patient informed consent, rigorously follow the investigational
plan and study protocol, control the disposition of the investigational device, and comply with all reporting and recordkeeping requirements.
Additionally, after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial at any time for various reasons,
including a belief that the risks to study subjects outweigh the anticipated benefits.

We
are conducting an institutional review board (“IRB”)-approved clinical study, overseen by WIRB-Copernicus Group, Inc.,
titled “Treatment of Upper Airway Resistance Syndrome with an Intraoral Device in an Adult Population: A Time Series Study.”
The study is designed to evaluate the safety and performance of a custom intraoral orthotic in adult patients exhibiting symptoms associated
with upper airway resistance syndrome (“UARS”). The investigational device is designed to support oral positioning
during use, including anterior and superior positioning of the tongue. The study is intended to assess whether use of the device is associated
with changes in sleep-related parameters, airway function, and autonomic nervous system activity. Study endpoints include objective and
subjective measures such as respiratory disturbance index (“RDI”), respiratory effort-related arousals (“RERAs”),
inspiratory flow limitation, nasal airflow, sleep quality, and patient-reported outcomes. Additional assessments include rhinomanometry,
home sleep testing, heart rate variability, and biomarkers associated with autonomic nervous system activity.

The
study includes baseline, mid-intervention, and post-treatment evaluations, including certain measurements obtained both with and without
the device in place. This study is exploratory in nature, and there can be no assurance that the results will demonstrate clinical benefit
or support future regulatory submissions or product claims.

Post-market
Regulation

After
a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These include:


establishment
registration and device listing with the FDA;


Quality
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
process;


labeling
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 promotion
is prohibited, and all claims must be substantiated; FDA guidance on off-label dissemination of information and responding to unsolicited
requests for information;


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


state
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
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;


the
federal False Claims Act (and similar state laws) prohibiting, among other things, knowingly presenting, or causing to be presented,
claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material
to an obligation to pay or transmit money or property to the federal government or knowingly concealing, or knowingly and improperly
avoiding or decreasing, an obligation to pay or transmit money to the federal government. The government may assert that claim includes
items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes
of the false claims statute;

-20-


clearance
or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would
constitute a major change in intended use of one of our cleared devices, or approval of a supplement for certain modifications to
PMA devices;


medical
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;


correction,
removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls
or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a
risk to health;


complying
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”);


the
FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation
of governing laws and regulations; and


post-market
surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide
additional safety and effectiveness data for the device.

We
may be subject to similar foreign laws that may include applicable post-marketing requirements such as safety surveillance. Our manufacturing
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
use. See “Risk Factors- The misuse or off-label use of The Vivos Method may harm our reputation in the marketplace, result in
injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed
to have engaged in the promotion of these uses, any of which could be costly to our business.”

The
FDA has broad regulatory compliance and enforcement powers. If the FDA determines that we failed to comply with applicable regulatory
requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:


warning
letters, untitled letters, fines, injunctions, consent decrees and civil penalties;


recalls,
withdrawals, or administrative detention or seizure of our products;


operating
restrictions or partial suspension or total shutdown of production;


refusing
or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;


withdrawing
510(k) clearances or PMAs that have already been granted;


refusal
to grant export or import approvals for our products; or


criminal
prosecution.

We are in the process of transitioning our FDA designation from “Spec
Developer” to “Manufacturer.” We believe this transition is a significant regulatory development that will subject
us to materially higher levels of FDA oversight and compliance obligations, including full compliance with the Quality System Regulation
(QSR) / 21 CFR Part 820, mandatory facility registration, device listing requirements, MDR obligations, and
readiness for periodic FDA inspections of our manufacturing facility in Orem, Utah. We are currently undergoing preparations for a third-party
inspection and compliance readiness evaluation as a prerequisite to completing this transition. While we have implemented workflow processes,
documentation procedures, and quality management systems in anticipation of this change, there can be no assurance that we will complete
the transition on the timeline we currently expect, or that we will be found to be in full compliance upon inspection. Any failure to
achieve or maintain manufacturer compliance could result in the FDA restricting or suspending our manufacturing operations, issuing warning
letters, or requiring recalls or other corrective actions, any of which could have a material adverse effect on our business, financial
condition, and results of operations. See “Risk Factors — Our failure to obtain government approvals, or to comply with
ongoing governmental regulations, could delay or limit introduction of our products.”

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Regulation
of Medical Devices in Canada

Canada
regulates the import and sale of medical devices through Health Canada (or HC). HC reviews medical devices to assess their safety, effectiveness,
and quality before being authorized for sale in Canada. HC classifies medical devices into four classifications, with Class I being the
lowest risk and Class IV being the highest. Class I and II devices are often cleared for sale after they are CE marked or listed on 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)
process. Higher classification risk devices (Class III and IV) require filing dossiers that resemble FDA 510(k) applications. These applications
can range in cost and typically take longer for approval.

Regulation
of Medical Devices in Australia

Australia
regulates the import and sale of medical devices through the Therapeutic Goods Administration (TGA) of Australia, a Tier 1 regulatory
body. Registering a medical device with the TGA entails risk-based classification; compliance with quality, safety and performance principles;
compliance with regulatory controls for manufacturing processes; listing in the Australian Register of Therapeutic Goods; and post-market
vigilance programs. Australia follows the standards applied by the International Organization for Standardization (ISO) which is currently
made up of 165 members/countries. Equivalent to the FDA in the United States, the TGA regulates the manufacturing and distribution of
therapeutic goods in Australia.

Federal,
State and Foreign Fraud and Abuse and Physician Payment Transparency Laws

In
addition to FDA restrictions on marketing and promotion of drugs and devices, other federal and state laws restrict our business practices.
These laws include, without limitation, foreign, federal, and state anti-kickback and false claims laws, as well as transparency laws
regarding payments or other items of value provided to healthcare providers.

The
federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving any remuneration
(including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind to induce or in return for
purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any good, facility, item or service reimbursable,
in whole or in part, under Medicare, Medicaid or other federal healthcare programs. The term “remuneration” has been broadly
interpreted to include anything of value, including stock, stock options, and the compensation derived through ownership interests.

Recognizing
that the federal Anti-Kickback Statute is broad and may prohibit many innocuous or beneficial arrangements within the healthcare industry,
the United State Department of Health and Human Services (“DHHS”) issued regulations in July 1991, which DHHS has
referred to as “safe harbors.” These safe harbor regulations set forth certain provisions which, if met in form and substance,
will assure medical device manufacturers, healthcare providers and other parties that they will not be prosecuted under the federal Anti-Kickback
Statute. Additional safe harbor provisions providing similar protections have been published intermittently since 1991. Although there
are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and
safe harbors are drawn narrowly. Our arrangements with physicians, hospitals and other persons or entities who are in a position to refer
may not fully meet the stringent criteria specified in the various safe harbors. Practices that involve remuneration that may be alleged
to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not fall within an exception
or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does
not make the conduct per se illegal under the federal Anti-Kickback Statute. Instead, the legality of the arrangement will be
evaluated on a case-by-case basis based on a cumulative review of all its facts and circumstances. Several courts have interpreted the
statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of
federal healthcare covered business, the federal Anti-Kickback Statute has been violated. In addition, a person or entity does not need
to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Moreover, a claim including
items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes
of the federal civil False Claims Act (described below).

-22-

Violations
of the federal Anti-Kickback Statute may result in civil monetary penalties up to $100,000 for each violation, plus up to three times
the remuneration involved. Civil penalties for such conduct can further be assessed under the federal False Claims Act. Violations can
also result in criminal penalties, including criminal fines of up to $100,000 and imprisonment of up to 10 years. Similarly, violations
can result in exclusion from participation in government healthcare programs, including Medicare and Medicaid. Liability under the federal
Anti-Kickback Statute may also arise because of the intentions or actions of the parties with whom we do business. While we are not aware
of any such intentions or actions, we have only limited knowledge regarding the intentions or actions underlying those arrangements.
Conduct and business arrangements that do not fully satisfy one of these safe harbor provisions may result in increased scrutiny by government
enforcement authorities. The majority of states also have anti-kickback laws which establish similar prohibitions and, in some cases,
may apply more broadly to items or services covered by any third-party payor, including commercial insurers and self-pay patients.

The
federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented,
a false or fraudulent claim for payment or approval to the federal government or knowingly making, using or causing to be made or used
a false record or statement material to a false or fraudulent claim to the federal government. A claim includes “any request or
demand” for money or property presented to the U.S. government. The federal civil False Claims Act also applies to false submissions
that cause the government to be paid less than the amount to which it is entitled, such as a rebate. Intent to deceive is not required
to establish liability under the civil federal civil False Claims Act.

In
addition, private parties may initiate “qui tam” whistleblower lawsuits against any person or entity under the federal civil
False Claims Act in the name of the government and share in the proceeds of the lawsuit. Penalties for federal civil False Claim Act
violations include fines for each false claim, plus up to three times the amount of damages sustained by the federal government and,
most critically, may provide the basis for exclusion from government healthcare programs, including Medicare and Medicaid. On May 20,
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. In part, the FERA amends the federal civil False Claims Act such that penalties may now apply to any person,
including an organization that does not contract directly with the government, who knowingly makes, uses or causes to be made or used,
a false record or statement material to a false or fraudulent claim paid in part by the federal government. The government may further
prosecute conduct constituting a false claim under the federal criminal False Claims Act. The criminal False Claims Act prohibits the
making or presenting of a claim to the government knowing such claim to be false, fictitious or fraudulent and, unlike the federal civil
False Claims Act, requires proof of intent to submit a false claim. When an entity is determined to have violated the federal civil False
Claims Act, the government may impose civil fines and penalties ranging from $11,181 to $22,363 for each false claim, plus treble damages,
and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs.

The
Civil Monetary Penalty Act of 1981 imposes penalties against any person or entity that, among other things, is determined to have presented
or caused to be presented a claim to a federal healthcare program that the person knows or should know is for an item or service that
was not provided as claimed or is false or fraudulent, or offering or transferring remuneration to a federal healthcare beneficiary that
a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable
by the government from a particular provider or supplier.

HIPAA
also created additional federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting
to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling
or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly
and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement
in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute,
a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed
a violation.

Many
foreign countries have similar laws relating to healthcare fraud and abuse. Foreign laws and regulations may vary greatly from country
to country. For example, the advertising and promotion of our products is subject to EU Directives concerning misleading and comparative
advertising and unfair commercial practices, as well as other EEA Member State legislation governing the advertising and promotion of
medical devices. These laws may limit or restrict the advertising and promotion of our products to the general public and may impose
limitations on our promotional activities with healthcare professionals. Also, many U.S. states have similar fraud and abuse statutes
or regulations that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid
and other state programs.

-23-

Additionally,
there has been a recent trend of increased foreign, federal, and state regulation of payments and transfers of value provided to healthcare
professionals or entities. The federal Physician Payments Sunshine Act imposes annual reporting requirements on certain drug, biologics,
medical supplies and device manufacturers for which payment is available under Medicare, Medicaid or Children’s Health Insurance
Program (“CHIP”), for payments and other transfers of value provided by them, directly or indirectly, to physicians
(including physician family members), certain other healthcare providers, and teaching hospitals, as well as ownership and investment
interests held by physicians and their immediate family members. A manufacturer’s failure to submit timely, accurately and completely
the required information for all payments, transfers of value or ownership or investment interests may result in civil monetary penalties
ranging from $1,000 to $10,000 for each payment or other transfer of value that Is not reported (up to a maximum per annual report of
$150,000) and from $10,000 to $100,000 for each knowing failure to report (up to a maximum per annual report of $1,150,000). Manufacturers
must submit reports by the 90th day of each calendar year. Certain foreign countries and U.S. states also mandate implementation
of commercial compliance programs, impose restrictions on device manufacturer marketing practices and require tracking and reporting
of gifts, compensation and other remuneration to healthcare professionals and entities. Additionally, there are criminal penalties if
an entity intentionally makes false statement in such reports. With some exceptions, the information that manufacturers report is made
publicly available.

Data
Privacy and Security Laws

We
are also subject to various federal, state and foreign laws that protect the confidentiality of certain patient health information, including
patient medical records, and restrict the use and disclosure of patient health information by healthcare providers, such as HIPAA, as
amended by HITECH, in the United States.

HIPAA
established uniform standards governing the conduct of certain electronic healthcare transactions and requires certain entities, called
covered entities, to comply with standards that include the privacy and security of protected health information, or PHI. HIPAA also
requires business associates, such as independent contractors or agents of covered entities that have access to PHI in connection with
providing a service to or on behalf of a covered entity, of covered entities to enter into business associate agreements with the covered
entity and to safeguard the covered entity’s PHI against improper use and disclosure.

The
HIPAA privacy regulations cover the use and disclosure of protected health information by covered entities as well as business associates,
which are defined to include subcontractors that create, receive, maintain, or transmit protected health information on behalf of a business
associate. They also set forth certain rights that an individual has with respect to his or her protected health information maintained
by a covered entity, including the right to access or amend certain records containing protected health information, or to request restrictions
on the use or disclosure of protected health information. The security regulations establish requirements for safeguarding the confidentiality,
integrity, and availability of protected health information that is electronically transmitted or electronically stored. HITECH, among
other things, established certain health information security breach notification requirements. A covered entity must notify any individual
whose protected health information is breached according to the specifications set forth in the breach notification rule. The HIPAA privacy
and security regulations establish a uniform federal “floor” and do not supersede state laws that are more stringent or provide
individuals with greater rights with respect to the privacy or security of, and access to, their records containing protected health
information or insofar as such state laws apply to personal information that is broader in scope than protected health information as
defined under HIPAA.

HIPAA
requires the notification of patients, and other compliance actions, in the event of a breach of unsecured protected health information,
or PHI. If notification to patients of a breach is required, such notification must be provided without unreasonable delay and in no
event later than 60 calendar days after discovery of the breach. In addition, if the PHI of 500 or more individuals is improperly used
or disclosed, we would be required to report the improper use or disclosure to DHHS, Office of Civil Rights, which would post the violation
on its website, and to the media. Failure to comply with the HIPAA privacy and security standards can result in civil monetary penalties
up to $59,522 per violation, not to exceed $1,785,651 per calendar year for non-compliance of an identical provision, and, in certain
circumstances, criminal penalties with fines up to $250,000 per violation and/or imprisonment.

-24-

HIPAA
authorizes state attorneys general to file suit on behalf of their residents for violations. Courts are able to award damages, costs
and attorneys’ fees related to violations of HIPAA in such cases. While HIPAA does not create a private right of action allowing
individuals to file suit against us in civil court for violations of HIPAA, its standards have been used as the basis for duty of care
cases in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI. In addition, HIPAA mandates that
the Secretary of DHHS conduct periodic compliance audits of HIPAA covered entities, such as us, and their business associates for compliance
with the HIPAA privacy and security standards. It also tasks DHHS with establishing a methodology whereby harmed individuals who were
the victims of breaches of unsecured PHI may receive a percentage of the civil monetary penalty paid by the violator.

Healthcare
Reform

Economic,
political and regulatory influences are continuously causing fundamental changes in the healthcare industry in the United States. In
2010, the U.S. Congress enacted, and President Obama signed into law, significant reforms to the U.S. healthcare system. These reforms,
contained primarily in the Patient Protection and Affordable Care Act of 2010 (the “PPACA”) and its companion act, the Health
Care Education and Reconciliation Act of 2010 (collectively, the “Health Reform Laws”), significantly altered the U.S. healthcare
system by authorizing, among many other things: (i) increased access to health insurance benefits for the uninsured and underinsured
populations; (ii) new facilitators and providers of health insurance, as well as new health insurance purchasing access points (i.e.,
exchanges); (iii) incentives for certain employer groups to purchase health insurance for their employees; (iv) opportunities for subsidies
to certain qualifying individuals to help defray the cost of premiums and other out-of-pocket costs associated with the purchase of health
insurance, and over the longer term; and (v) mechanisms to foster alternative payment and reimbursement methodologies focused on outcomes,
quality and care coordination. In addition, certain states in which we operate are periodically considering various healthcare reform
proposals.

Since
their passage in 2010, the Health Reform Laws have triggered many changes to the U.S. healthcare system, some of which took effect (e.g.,
the subsequently eliminated individual mandate penalty) while others have continued to be delayed and subsequently repealed (e.g., the
medical device tax). The Health Reform Laws also have faced several challenges and remain subject to ongoing efforts to repeal or modify
the laws. For example, President Trump issued an Executive Order 13765 (Minimizing the Economic Burden of the Patient Protection and
Affordable Care Act Pending Repeal) on January 20, 2017 granting authority to certain executive departments and agencies to minimize
the economic burden of the PPACA. However, President Biden revoked this Executive Order on January 28, 2021 (as part of President Biden’s
Executive Order on Strengthening Medicaid and the Affordable Care Act) and directed heads of departments to “consider whether to
suspend, revise, or rescind - and, as applicable, publish for notice and comment proposed rules suspending, revising, or rescinding”
actions taken by the Trump Administration which may hinder the operation of the Health Reform Laws.

Nevertheless,
the core tenets of the Health Reform Laws remain in effect with several exceptions. The individual mandate penalty was eliminated beginning
in 2019 through the Tax Cuts and Jobs Act of 2017. In addition, on December 20, 2019, the Further Consolidated Appropriations Act, 2020
was signed into law which repealed several provisions that were included in the Health Reform Laws to pay for the increased federal spending
associated with the Health Reform Laws. Specifically, Congress: (i) repealed the Medical Device Excise Tax, which imposed a 2.3% excise
tax on manufacturers, producers and importers of certain medical devices; (ii) repealed the health insurance tax, which applies to most
fully insured plans, beginning in 2021; and (iii) repealed the so-called Cadillac Tax, which imposed an excise tax of 40% on premiums
for employer-sponsored individuals and families that exceeded a certain minimum threshold. Prior to these changes Congress had passed
a short-term spending bill as part of the Continuing Appropriations Act of 2018 that delayed the implementation of these provisions and
eliminated the Independent Payment Advisory Board, which was a 15- member panel of healthcare experts created by the Health Reform Laws
and tasked with making annual cost-cutting recommendations for Medicare if Medicare spending exceeded a specified growth rate.

The
Health Reform Laws have also been the subject of litigation. In particular, in 2019, a collection of 20 state governors and state attorneys
general (subsequently two states have dropped out) filed a lawsuit against the federal government in the Northern District of Texas seeking
to enjoin the entire Health Reform Laws following the elimination of the individual mandate penalty. The District Court ruled that without
the penalty the individual mandate was unconstitutional and further held that all other provisions of the Health Reform Laws should be
overturned as well. The U.S. Court of Appeals for the 5th Circuit affirmed the trial court’s decision; however, instead of deciding
whether the rest of the PPACA must be struck down, the 5th Circuit sent the case back to the trial court for additional analysis. In
March of 2020 the United States Supreme Court agreed to review the case and heard oral arguments on November 10, 2020. On June 17, 2021,
the Supreme Court held that the plaintiffs lacked standing and reversed the Fifth Circuit’s judgment in respect to standing, vacated
the Fifth Circuit’s judgment, and remanded the case with instructions to dismiss the case. Subsequently the Fifth Circuit vacated
the judgement of the District Court in its entirety and remanded the case to the District Court with instructions to dismiss. The District
Court finally dismissed the case on July 27, 2021.

-25-

In
2021 President Biden issued an Executive Order on Strengthening Medicaid and the Affordable Care Act, directing heads of departments
to review and potentially revoke or revise these Trump-era actions. In light of the ongoing efforts to alter the Health Reform Laws,
we are unable at this time to predict the full impact that potential changes will have on our business, including provisions in the Health
Reform Laws related to Medicare payments, mechanisms to foster alternative payment and reimbursement methodologies focused on outcomes,
quality and care coordination, Medicare enrollment and claims submission requirements and revisions to other federal healthcare laws
such as the federal Anti-Kickback Statute, the Stark Law and the federal False Claims Act.

On
February 13, 2025, Robert F. Kennedy, Jr. was sworn in as the 26th Secretary of the Department of Health and Human Services. Secretary Kennedy oversees the National Institutes of Health, the Centers for Disease Control and Prevention, the FDA, and the Centers
for Medicare and Medicaid Services. The current administration has indicated a focus on investigating the root causes of chronic disease and exploring
alternative healthcare delivery approaches. We are monitoring any regulatory or policy developments under the current DHHS leadership
that may affect the regulatory environment for medical devices, including our products. We are also monitoring new laws and programs passed
or adopted under the Trump administration, such as elements of The One Big Beautiful Bill Act of 2025, for their impact on our business.
There can be no assurance that any such developments will be favorable to our business.

We
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. Any repeal or modification of the Health Reform
Laws may materially adversely impact our business, financial condition, results of operations, cash flow, capital resources and liquidity.
In addition, the potential proposals for alternative legislation to replace the Health Reform Laws may have an adverse impact on our
business.

Anti-Bribery
and Corruption Laws

We
are subject to the Foreign Corrupt Practices Act (“FCPA”). We are required to comply with the FCPA, which generally
prohibits covered entities and their intermediaries from engaging in bribery or making other prohibited payments to foreign officials
for the purpose of obtaining or retaining business or other benefits. In addition, the FCPA imposes accounting standards and requirements
on publicly traded U.S. corporations and their foreign affiliates, which are intended to prevent the diversion of corporate funds to
the payment of bribes and other improper payments, and to prevent the establishment of “off books” slush funds from which
such improper payments can be made. We also are subject to similar anticorruption legislation implemented in Europe under the Organization
for Economic Co-operation and Development’s Convention on Combating Bribery of Foreign Public Officials in International Business
Transactions.

Human
Capital Resources

As
of December 31, 2025, we had 268 full-time employees. None of our employees are represented by a union. We consider our relations with
our employees to be good, but we do have a Whistleblower Hotline setup for employees to confidentially report concerns. As of December
31, 2025, no employees had used our Whistleblower Hotline. Of our current employees, approximately four are part of finance and accounting,
eight are involved in senior management, three in research, development and regulatory and 253 in operations.

We
value the importance of retention, growth and development of our employees and we believe we offer competitive compensation (including
salary, incentive bonus, and equity) and benefits packages. We traditionally will benchmark compensation with external sources to verify
positions are paid in-line with the market. Our corporate culture is built on passion - we believe in 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. 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.

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Corporate
History

Formation

We
were originally organized on July 7, 2016 in Wyoming as Corrective BioTechnologies, Inc. On September 6, 2016, we changed our name from
Corrective BioTechnologies, Inc. to Vivos BioTechnologies, Inc. On March 2, 2018, we changed our name from Vivos BioTechnologies, Inc.
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. Madden
(4,000 shares) at a purchase price of $0.01 per share (for an aggregate of $280 of proceeds).

Acquisition
of BioModeling Solutions, Inc. and First Vivos, Inc.

In
August and September 2016, we completed, by way of a share exchange, an agreement to acquire the business and operations of (1) BMS (now
a wholly-owned subsidiary), which was engaged in the manufacture and sale of our patented DNA appliance® and FDA cleared
mRNA appliance® (collectively with special proprietary treatment modalities that comprises The Vivos Method), and (2)
First Vivos, Inc., a Texas corporation (“First Vivos”), which proposed to develop and operate a retail chain of Vivos
Centers with specially trained dentists that offer The Vivos Method and corroborating physicians. In connection with the share exchange
with BMS, we issued 3,333,334 shares of common stock to the shareholders of BMS (including, but not limited to, Dr. G. Dave Singh, our
founder and former Chief Medical Officer and director, who received 3,219,705 shares) in exchange for 12,423,500 shares of BMS, which
constitutes 100% ownership interest in BMS. In connection with the share exchange with First Vivos, we issued 3,333,334 shares of common stock to the shareholders of First Vivos (including, but not limited to, R. Kirk Huntsman, our co-founder, Chairman of the Board and
Chief Executive Officer, who received 1,833,334 shares) in exchange for 5,000 shares of First Vivos, which constitutes 100% ownership
interest in First Vivos.

The
transaction was accounted for as a reverse acquisition and recapitalization, with BMS as the acquirer for financial reporting and accounting
purposes. Upon the consummation of the acquisition, the historical financial statements of BMS became our historical financial statements
and continued to be recorded at their historical carrying amounts.

Replacement
of the 2019 Stock and Option Award Plan and Adoption of the 2024 Omnibus Plan

On
April 18, 2019, our stockholders approved the adoption of a stock and option award plan (the “2019 Plan”), under which 13,334
shares were reserved for future issuance for options, restricted stock awards and other equity awards. On June 18, 2020, our stockholders
approved an amendment and restatement of the 2019 Plan to increase the number shares or our common stock available for issuance thereunder
by 33,334 shares of common stock such that, after amendment and restatement of the 2019 Plan, for a total of 46,667 shares of common stock available for issuance under the 2019 Plan. On September 22, 2023, our stockholders approved an amendment and restatement of the
2019 Plan to increase the number shares or our common stock available for issuance thereunder by 80,000 shares of common stock such that,
after amendment and restatement of the 2019 Plan, 126,667 shares of common stock are available for issuance under the 2019 Plan.

On
November 26, 2024, our shareholders approved and adopted 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. For a discussion of the 2024 Omnibus
Plan, please refer to “Corporate History - Adoption of 2024 Omnibus Equity Incentive Plan” below.

Approval
of Transfer of Corporate Domicile and Reverse Stock Split

On
April 18, 2019, our stockholders voted to authorize our board of directors to recapitalize our common stock by way of reverse stock split
at a ratio of up to one for three. In addition, on such date, our shareholders also authorized our board of directors to transfer our
corporate domicile from Wyoming to another U.S. state. Our board of directors elected not to implement the reverse stock split transfer
of corporate domicile at that time.

-27-

Effective
August 12, 2020, we transferred our corporate domicile and became a Delaware corporation pursuant to Section 17-16-1720 of the Wyoming
Business Corporation Act and Section 265 of the Delaware General Corporation Law. As a result of the transfer of corporate domicile,
each share of capital stock of Vivos Wyoming became a share of capital stock of Vivos Delaware on a one-to-one basis, and such shares
shall carry the same terms in all material respects as the shares of Vivos Wyoming. The transfer of corporate domicile has heretofore
been approved by the board of directors and majority shareholders of Vivos Wyoming.

On
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 our 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.

On
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 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
25, 2023. 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.

New
Medical Provider-Focused Marketing and Distribution Alliance Strategy

We
believe our sales, marketing and distribution pivot, which began in 2024, will be critical to our ability to drive our future revenue
growth. In June 2024, as our initial entry into our new sales, marketing and distribution model, we entered into our first contractual
alliance with Rebis, a sleep center operator in Colorado. Revenues from this arrangement have not developed as we had expected for many
reasons beyond our control, but we learned important lessons which have led to changes to this model.

In
an important milestone in our business model pivot we undertook during 2024 and 2025, on June 10, 2025, we acquired the net operating
assets of SCN pursuant to the SCN Purchase Agreement whereby we agreed to purchase the net operating assets and liabilities related to
SCN’s sleep testing, diagnostics, and treatment centers from SCN’s shareholders Dr. Prabhu and Lata K. Shete, M.D.

Our
operational plan is driven by our deployment of our Sleep Optimization (“SO”) teams, each consisting of one nurse
practitioner (or physician’s assistant) and two specially trained dentists, employed by a medical or dental professional corporation,
six dental assistants, six administrative support personnel, and one treatment navigator. These SO teams can be dedicated to high demand
locations or spread across multiple locations as circumstances dictate.

Based
on our internal analysis and experience, we expect the economics of our Detroit SO team to be similar to the economics described above
for our SO teams at SCN, except that net profit distributions from the management services entity will be paid out on a pro-rata basis
(with our company receiving the supermajority share). As of this time, we do not have much operating history in the Detroit, Michigan
market or with this new model. However, we believe that the overall benefit to our company of this model derives from the limited risks
(as opposed to outright acquisitions) and generally low equipment and facility capital expenditures relative to the potential revenue
opportunity. This model also obviates the need for us to finance the purchase and other costs associated with our acquisition model.

We
believe the advantages of this new strategic marketing and distribution model are compelling. First, it provides 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 and employed
personnel, although our company cannot and will not exert any direct influence over the
independent clinical judgment of any licensed provider. 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 $5,000 on average to top line revenue, with contribution margins of approximately 50%. This MSO/DSO management services model
significantly alters the economics to our company. 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.

-28-

January
2023 Private Placement

On
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 our securities in a private placement consisting of 80,000 shares
of our common stock, a pre-funded warrant to purchase up to an aggregate of 186,667 (the “January 2023 PFW”) shares
of our common stock and a common stock purchase warrant to purchase up to an aggregate of 266,667 shares of our common stock (the “January
2023 Warrant”).

The
January 2023 PFW entitled the holder for a period until the entirety of the pre-funded warrant was exercised, to purchase up to 186,667
shares of our common stock at an exercise price of $0.0001 per share. The January 2023 Warrant entitles the holder, for a period of five
years and 6 months, to purchase one share of common stock at an initial exercise price of $30.00 per share. The January 2023 PFW was
exercisable and the January 2023 continues to be exercisable on a “cashless” basis if the shares of common stock underlying
such warrants are not registered for resale pursuant to an effective registration statement.

The
January 2023 Warrant which remains outstanding was amended in connection with our November 2023 private placement discussed below to
reduce the exercise price of the January 2023 Warrant to $3.83 per share and extended the expiration date of such warrant to November
2, 2028. The amendment also restates 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.

As
of the date of this Report, the January 2023 PFW was exercised in full and the January 2023 Warrant was exercised, in full, in connection
with the January 2026 Inducement Transaction described below.

November
2023 Private Placement

On
November 2, 2023, we closed a private placement with an institutional investor (the “November 2023 Private Placement”)
pursuant to which we sold an aggregate of approximately $4,000,000 of our securities in a private placement consisting of (i) 130,000
shares of our common stock, (ii) a pre-funded warrant to purchase 850,393 shares of our common stock (the “November 2023 PFW”),
(iii) a five-year Series A 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 “November 2023 Series A Warrant”) 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 “November 2023 Series B
Warrant”).

The
November 2023 PFW entitled the holder, for a period until the entirety of the pre-funded warrant is exercised, to purchase up to 850,393
shares of our common stock at an exercise price of $0.0001 per share. The November 2023 PFW, the November 2023 Series A Warrant and the
November 2023 Series B Warrant were all exercisable on a “cashless” basis if the shares of common stock underlying such warrants
are not registered for resale pursuant to an effective registration statement.

As
of the date of this Report, the November 2023 PFW has been exercised in full and the November 2023 Series A Warrant was exercised, in
full, in connection with the January 2026 Inducement Transaction described below. The November 2023 Series B Warrant was amended and
exercised in full in connection with our February 2024 inducement transaction discussed below.

February
2024 Warrant Exercise Transaction

On
February 14, 2024, we entered into a warrant inducement letter agreement (the “February 2024 Inducement Agreement”)
with an institutional investor pursuant to which the investor agreed to exercise for cash the entirety of the November 2023 Series B
Warrant at an 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 the Company of approximately $4.0 million. The February 2024 Inducement
Transaction closed on February 20, 2024.

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Pursuant
to the February 2024 Inducement Agreement, in consideration for the immediate exercise of the November 2023 Series B Warrant in full,
the Company agreed to issue to the investor, in a new private placement transaction (the “February 2024 Inducement Transaction”):
(i) a 5-year, Series B-1 Common Stock Purchase Warrant to purchase 735,296 shares of our common stock at an exercise price of $5.05 per
share (the “February 2024 B-1 Warrant”), and (ii) an 18-month, Series B-2 Common Stock Purchase Warrant to purchase
735,296 shares of our common stock at an exercise price of $5.05 per share (the “February 2024 B-2 Warrant”, and collectively,
the “February 2024 Inducement Warrants” and such aggregate 1,470,592 shares of common stock underlying the Inducement
Warrants, the “February 2024 Inducement Warrant Shares”). The February 2024 Inducement Warrants are identical to each
other, other than their dates of expiration, and are substantially identical to the November 2023 Series B Warrant.

As
of the date of this Report, the February 2024 B-2 Warrant expired and the February 2024 B-1 Warrant was exercised, in full, in connection
with the January 2026 Inducement Transaction described below.

June
2024 Private Placement and Management Services Agreement with New Seneca Partners, Inc. (“Seneca”)

On
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.

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

The
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.

The
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.

The
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.

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Management
Services Agreement with V-CO

Also
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.

The
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.

During
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.

As
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). Effective October 1, 2025, the quarterly management fee payable
to Seneca was increased to $62,500.

In
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.

The
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.

September
2024 Registered Direct Offering

On
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.

H.C.
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, 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.

In
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.

-31-

The
shares of the September 2024 Offering were issued pursuant to a 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.

The
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.

Adoption
of 2024 Omnibus Equity Incentive Plan

Our
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. On November 4, 2025, the Company conducted its 2025 annual meeting of stockholders (the
“Annual Meeting”). At the Annual Meeting, the Company’s stockholders approved and adopted an amendment to the
2024 Omnibus Plan to increase the number of shares of our common stock authorized to be issued pursuant to the 2024 Omnibus Plan from
1,600,000 shares to 4,100,000 shares in the aggregate. We anticipate that the 4,100,000 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 Plan. As of December 31, 2025, we had five non-employee directors, two officers, 268 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”). As of December 31, 2025, awards (in the form of options) for an aggregate of 1,110,487 shares of common stock have been issued under our 2024 Omnibus Plan.

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

On
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.

The
shares from the December 2024 Offering were issued pursuant to an effective resale registration statement on Form S-1 that was filed
with the SEC (File No. 333-284399) on January 22, 2025 and declared effective on January 30, 2025.

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Pursuant
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.

We
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 date.

The
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.

June
2025 Private Placement

On
June 9, 2025, we entered into a Securities Purchase Agreement (the “June 2025 PIPE SPA”) with V-Co 2. V-Co 2 is an
affiliate of Seneca. Pursuant to the June 2025 PIPE SPA, the Company sold to V-Co 2 in a private placement offering (the “June
2025 PIPE Offering”): (i) 828,000 shares (the “June 2025 PIPE Shares”) of common stock, (ii) a pre-funded
warrant to purchase 725,258 shares of common stock (the “June 2025 Pre-Funded Warrant”, with the shares of common
stock underlying the Pre-Funded Warrant being referred to as the “June 2025 PFW Shares”), and (iii) a Common Stock
Purchase Warrant to purchase up to 2,329,886 shares of common stock (the June 2025 Common Stock Purchase Warrant, and together with the
Pre-Funded Warrant, the “June 2025 Warrants”, and with the shares of common stock underlying the Common Stock Purchase
Warrant being referred to as the “June 2025 Warrant Shares”).

V-Co
2 paid a purchase price of $2.42 for each June 2025 PIPE Share and June 2025 Pre-Funded Warrant Share and associated June 2025 Common
Stock Purchase Warrant, with such price being established for purposes of compliance with the listing rules of Nasdaq. The June 2025
PIPE Offering closed on June 9, 2025.

The
June 2025 Common Stock Purchase Warrant has a term ending on or before June 9, 2029, an exercise price of $2.23 per share and became
exercisable immediately as of the date of issuance. The June 2025 Pre-Funded Warrant has a term ending on the complete exercise of the
June 2025 Pre-Funded Warrant, an exercise price of $0.0001 per share and became exercisable immediately as of the date of issuance. The
June 2025 Warrants also contain customary stock-based (but not price-based) anti-dilution protection as well as beneficial ownership
limitations preventing Seneca or its affiliates from exercising the June 2025 Warrants if such exercise would result in Seneca or its
affiliates from owning in excess of 19.99% of the then outstanding common stock.

We
agreed to file a registration statement under the Securities Act covering the resale of the June 2025 Warrants with 45 calendar days
following the closing of the June 2025 SPA and to use commercially reasonable effort to cause the registration statement to be declared
effective by the SEC within 90 days of the closing of the June 2025 SPA. Subsequently, pursuant to an amendment to the June 2025 PIPE
SPA, dated July 24, 2025, we and V-Co 2 agreed to extend the respective date for which we must file the registration statement and cause
such registration statement to be declared effective by 30 days.

SCN
Acquisition

On
June 10, 2025, we acquired all of the operating assets of the SCN in consideration for a (i) cash payment equal to $6.0 million, (ii)
607,287 shares of restricted common stock, equal to $1.3 million based on the VWAP of the common stock for the 30 days immediately preceding
the Acquisition and (iii) the assumption of certain specific trade accounts payable and liabilities related to specific SCN contracts
assigned to us as part of the acquisition of SCN. Pending the achievement of an agreed to financial milestone, we will pay to Prabhu
Rachakonda, M.D., SCN’s principal owner (“Dr. Prabhu”) a contingent “earn out” consideration in
the form of restricted common stock equal to $1.5 million based on the VWAP of the common stock for the 30 days following the date on
which such financial milestone is achieved, as determined in accordance with U.S. generally accepted accounting principles. See Note
3 for further information.

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June
2025 Streeterville Note

On
June 9, 2025, concurrently with the SCN Acquisition, the Company entered into a Note Purchase Agreement (the “Streeterville
Note Purchase Agreement”) with Streeterville Capital, LLC, a Utah limited liability company (“Streeterville”),
pursuant to which the Company issued and sold to Streeterville a Secured Promissory Note (the “Streeterville Note”)
in the original principal amount of $8,250,000 (the financing as described herein, the “Streeterville Note Financing”).
The principal amount of the Streeterville Note includes an original issue discount of $675,000. The Company also agreed to pay $50,000
to Streeterville to cover its legal fees, accounting costs, due diligence, monitoring, and other transaction costs, each of which was
added to the Principal Amount, resulting in a purchase price of for the Streeterville Note and gross proceeds to the Company of $7,500,000
received by the Company. The Streeterville Note is not convertible into shares of common stock or otherwise.

The
Streeterville Note accrues interest at a rate of nine percent (9%) per annum and has a maturity date of eighteen (18) months from the
issuance of the Streeterville Note, unless earlier prepaid, redeemed or accelerated in accordance with its terms prior to such date.
The Company used net proceeds from the Streeterville Note Financing for funding the cash portion of the SCN Acquisition purchase price
and to support the Company in connection with the SCN Acquisition. No placement agent was used in connection with the Streeterville Note
Financing.

The
Streeterville Note is secured by all of the tangible and intangible assets of AIM pursuant to that certain Security Agreement, dated
June 9, 2025, between AIM and Streeterville The Company has also pledged the entirety of AIM’s membership interests to Streeterville
as collateral for the Loan pursuant to that certain Pledge Agreement dated June 9, 2025, between the Company and Streeterville and caused
AIM to enter into the Guaranty Agreement, dated June 9, 2025, in favor of Streeterville to respectively secure the performance of the
Company and provide a guarantee of the Company’s obligations to Streeterville under the Streeterville Note and the other transaction
documents.

Commencing
six (6) months after the date of issuance of the Streeterville Note and at any time thereafter until the Streeterville Note is paid in
full, Streeterville will have the right to redeem up to $550,000 of the principal amount of the Streeterville Note per calendar month.
The Company must pay the redeemed amount in cash within three (3) trading days of receiving a redemption notice. The Company may prepay
all or any portion of the outstanding balance of the Streeterville Note. If the Company elects to prepay the Streeterville Note in part
within one hundred twenty (120) days from the issuance of Streeterville Note, the Company will be required to pay to Streeterville an
amount in cash equal to one hundred and seven percent (107%) of the portion, or a prepayment premium, of the outstanding balance the
Company elects to prepay. Notwithstanding the foregoing, the prepayment premium shall not apply to any outstanding balance of the Streeterville
Note that the Company elects to prepay on or after the one hundred twenty (120) days after the issuance of the Streeterville Note. Additionally,
if the Streeterville Note remains outstanding on the one hundred twenty (120) days from the anniversary of the issuance, the Company
will incur a one-time monitoring fee equal to the difference between (i) the outstanding balance of the Streeterville Note divided by
0.85 (as minuend), and (ii) the outstanding balance of the Streeterville Note (as subtrahend), which fee will be added to the principal
amount of the Streeterville Note if incurred.

The
Streeterville Note provides for customary events of default, including, among other things, the event of nonpayment of principal, interest,
fees or other amounts, a representation or warranty proving to have been incorrect when made, failure to perform or observe covenants
as specified in the Streeterville Note, failure to obtain prior written consent from Streeterville on a fundamental transaction (including
consolidations, mergers, and certain changes in control of the Company) undertaken by the Company, and the occurrence of a bankruptcy,
insolvency or similar event affecting the Company. Upon the occurrence of certain events of default related to the occurrence of a bankruptcy,
insolvency or similar event affecting the Company, the outstanding principal amount of the Streeterville Note will become automatically
due and payable. Additionally, upon the occurrence of any events of default, interest shall begin accruing on the outstanding balance
of the Streeterville Note from the date of the event of default equal to the lesser of twenty-two percent (22%) per annum and the maximum
rate allowable under law.

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December
2025 Avondale Note

On
December 5, 2025, we entered into a Note Purchase Agreement (the “Avondale Note Purchase Agreement”) with from Avondale
Capital, LLC, a Utah limited liability company (“Avondale”), pursuant to which the Company issued and sold to Avondale
a Promissory Note (the “Avondale Note”) in the original principal amount of $2,093,340 (the financing as described
herein, the “Avondale Note Financing”). The principal amount of the Avondale Note includes an original issue discount
of $587,340. The Company also agreed to pay $6,000 to Avondale to cover its legal fees, accounting costs, due diligence, monitoring,
and other transaction costs, each of which was added to the principal amount of the Avondale Note, resulting in a purchase price of for
the Avondale Note and gross proceeds to the Company of approximately $1,500,000 received by the Company. The Avondale Note is not convertible
into shares of common stock or otherwise. Avondale is an affiliate of Streeterville.

The
Avondale Note does not bear interest and no interest will accrue on the Avondale Note unless an event of default occurs as further described
below. The Company will make weekly payments of $69,778 beginning from December 12, 2025 until the Avondale Note is paid in full. The
Company may prepay the outstanding amount due under the Avondale Note at any time without penalty. If the Company prepays the Avondale
Note in full by January 4, 2026, the outstanding balance of the Avondale Note will be automatically reduced by $286,140. The Company
intends used the net proceeds from the Avondale Note Financing for working capital and other general corporate purposes. No placement
agent was used in connection with the Avondale Note Financing.

The
Avondale Note is unsecured. In connection with the Avondale Note Financing, the Company has caused Company’s wholly-owned subsidiary,
AIM to enter into the Guaranty Agreement, dated December 5, 2025, in favor of Avondale to provide a guarantee of the Company’s
obligations to Avondale under the Avondale Note and the other transaction documents.

The
Avondale Note provides for customary events of default, including, among other things, the event of nonpayment of principal, interest,
fees or other amounts, a representation or warranty proving to have been incorrect when made, failure to perform or observe covenants
as specified in the Avondale Note, failure to obtain prior written consent from Avondale on a fundamental transaction (including consolidations,
mergers, and certain changes in control of the Company) undertaken by the Company, a material breach of covenants or other terms in any
financial or material agreements between the Company and Avondale or its affiliate (which includes Streeterville), and the occurrence
of a bankruptcy, insolvency or similar event affecting the Company. Upon the occurrence of any events of default, interest shall begin
accruing on the outstanding balance of the Avondale Note from the date of the event of default equal to the lesser of eighteen percent
(18%) per annum and the maximum rate allowable under law. Additionally, upon the occurrence of certain events of default related to the
occurrence of a bankruptcy, insolvency or similar event affecting the Company, the outstanding principal amount of the Avondale Note
will become automatically due and payable.

“At-the-Market”
Equity Offering

As
previously reported on a Current Report on From 8-K filed on February 14, 2025 (the “February 8-K”), on February 14,
2025, pursuant to a prospectus supplement to the Company’s previously filed shelf registration statement on Form S-3 (File No.
333-262554) (the “Prior Shelf Registration”), the Company entered into an At The Market Offering Agreement (the “ATM
Sales Agreement”) with HCW, pursuant to which the Company may offer and sell shares of common stock from time to time through
HCW. The Company did not sell any shares of common stock under the Prior Shelf Registration pursuant to the ATM Sales Agreement.

On
September 12, 2025, we filed a prospectus supplement (the “ATM Pro Supp”) with the SEC pursuant to which we
may continue, under the ATM Sales Agreement, to sell, from time to time, up to an aggregate sales price of $5,830,572 of common stock
(the “ATM Shares”), through HCW as sales agent. HCW will be entitled to compensation at a fixed commission rate of
3.0% of the gross proceeds of each sale of Shares. In connection with the sale of our ATM Shares on our behalf, HCW will be deemed to
be an “underwriter” within the meaning of the Securities Act and the compensation of HCW will be deemed to be underwriting
commissions or discounts. We have also agreed to provide indemnification and contribution to HCW with respect to certain liabilities,
including liabilities under the Securities Act.

The
offer and sale of the ATM Shares have been made pursuant to a shelf registration statement on Form S-3 (File No. 333-284834), as amended
(the “New Shelf Registration”), initially filed by the Company with the SEC on February 11, 2025 and declared effective
by the SEC on September 10, 2025, as supplemented by the ATM Pro Supp filed with the SEC pursuant to Rule 424(b) under the Securities
Act.

-35-

During
the twelve month period ended December 31, 2025, the Company sold an aggregate of 1,770,021 ATM Shares at an average price of $3.05 per
share through the ATM Sales Agreement, resulting in proceeds of $2.4 million net of commissions. Under the ATM Offering, $2,782,265 million
shares of common stock remain available for future sales as of December 31, 2025; however, the Company is not obligated to make any sales
under this program.

January
2026 V-Co Investors 3 LLC Note

On
January 15, 2026, we entered into an unsecured convertible promissory note in favor of V-Co Investors 3 LLC (“V-Co
3”) in the maximum principal amount of up to $5,500,000 (the “V-Co 3 Note” and the maximum principal
amount, inclusive of the original issuance discount described below, the “Maximum Principal”). V-Co 3 is an
affiliate of Seneca.

The
purpose of the V-Co 3 Note is to provide advanced funding and support to the Company in connection with a proposed equity financing of
the Company in the aggregate amount of up to $5,500,000 (the “Subsequent Financing”).

On
January 15, 2026, V-Co funded an initial $900,000 to the Company under the V-Co 3 Note. At any time until the close of business day on
February 16, 2026, or the “Outside Date”, V-Co shall advance funds and confirm such amount in advance to the Company,
up to the Maximum Principal. The Maximum Principal shall include a ten percent (10%) original issuance discount of the aggregate Maximum
Principal as a financing fee to V-Co 3.

The V-Co 3 Note does not bear any interest, except in the case of an event
of default, which is defined as (i) the Company fails to pay the principal or any accrued interest under the V-Co 3 Note on demand, (ii)
the Company fails to observe or perform any other material covenant, obligation, condition or agreement in any material respect contained
in the V-Co 3 Note, (iii) the Company’s voluntary bankruptcy or (iv) an involuntary bankruptcy is commenced against the Company.
Upon the occurrence of any event of default, interest shall accrue on the V-Co 3 Note at a rate equal to fifteen percent (15%) per annum
and shall be computed on the basis of a 365-day year.

In
the event of a Subsequent Financing prior to the Outside Date, all principal under the V-Co 3 Note shall automatically convert
dollar-to-dollar, without any further action required on the part of V-Co or the Company, into such equity instruments of the
Company as are issued in the Subsequent Financing. The Subsequent Financing may, but is not required to be, led by V-Co. Following
the Outside Date, the Company may repay all or any portion of the outstanding principal amount and any accrued interest of the V-Co
3 Note in whole or in part without penalty.

On March 31, 2026, we entered into an equity financing with V-Co 3 and
accordingly, $1,400,000 of the V-Co 3 automatically converted into such equity financing. For more information, please refer to “March
2026 PIPE Offering” below.

January
2026 Warrant Inducement

On
January 15, 2026, we entered into a warrant inducement letter agreement with the Holder (the “Inducement Agreement”)
pursuant to which the Holder agreed to exercise for cash the entirety of the Warrants at a reduced exercise price of $2.34 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 $4.6 million. The resale of the shares of common stock underlying the Warrants have been registered
pursuant to a Post-Effective Amendment to Form S-1 on a Registration Statement on Form S-3 (File No. 333-278564), which became effective
with the Securities and Exchange Commission (“SEC”) on January 7, 2026.

Pursuant
to the Inducement Agreement, in consideration for the immediate exercise of the Warrants in full for cash, we agreed to issue to the
Holder, in a private placement transaction: (i) a five-year, Series A Common Stock Purchase Warrant to purchase up to 1,982,356 shares
of common stock at an exercise price of $2.09 per share, and (ii) a 24-month, Series B Common Stock Purchase Warrant to purchase up to
1,982,356 shares of common stock at an exercise price of $2.09 per share (collectively, the “Inducement Warrants”
and such aggregate 3,964,712 shares of common stock underlying the Inducement Warrants, the “Inducement Warrant Shares”).
The Inducement Warrants are identical to each other, other than their dates of expiration and the absence of a “Black-Scholes put
right” in the Series B Inducement Warrant.

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The
transactions contemplated by the Inducement Agreement (the “Inducement Transaction”) closed on January 20, 2026. We
intend to use these net proceeds received from the Inducement Transaction for general working capital and general corporate purposes.

H.C.
Wainwright & Co., LLC (“Wainwright”) acted the Company’s exclusive placement agent in connection with the
Inducement Transaction. Pursuant to the Engagement Agreement dated May 2, 2024, as amended on August 2, 2024, December 22, 2024, February
7, 2025, April 5, 2025 and May 23, 2025 between Wainwright and the Company, the Company paid Wainwright (i) a cash fee equal to 7.0%
of the gross proceeds received by the Company in the Inducement Transaction, (ii) issued to Wainwright or its designees warrants to purchase
138,765 shares of common stock representing 7.0% of the shares of common stock underlying the Inducement Warrants (the “Placement
Agent Warrants”), (iii) paid Wainwright a management fee of 1.0% of the aggregate gross proceeds of the Inducement Transaction,
and (iv) reimbursed Wainwright for certain expenses. The terms of the Placement Agent Warrants are substantially identical to the Series
A Common Stock Purchase Warrant, except that the exercise price of the Placement Agent Warrants is $2.925 per share of common stock.

March 2026 PIPE Offering

On
March 31, 2026, the Company entered into a Securities Purchase Agreement (the “March 2026 PIPE SPA”) with V-Co 3.

Pursuant to the March 2026
PIPE SPA, the Company sold to V-Co 3 in a private placement offering (the “March 2026 PIPE Offering”): (i) 1,353,625
shares (the “March 2026 PIPE Shares”) of common stock, (ii) a pre-funded warrant to purchase 429,957 shares of common stock (the “March 2026 Pre-Funded Warrant”, with the shares of common stock underlying the Pre-Funded Warrant being
referred to as the “March 2026 PFW Shares”), (iii) a Series A Common Stock Purchase Warrant (the “March 2026
Series A Warrant”) to purchase up to 1,783,582 shares of common stock and (iv) a Series B Common Stock Purchase Warrant to
purchase up to 1,783,582 shares of common stock (the “March 2026 Series B Warrant”, and together with the Series A
Warrant, the “March 2026 Common Stock Purchase Warrants”, and together with the Pre-Funded Warrant, the “March
2026 Warrants”, and with the shares of common stock underlying the Common Stock Purchase Warrants being referred to as the
“March 2026 Warrant Shares”).

V-Co
3 paid a purchase price of $1.34 for each March 2026 PIPE Share and March 2026 Pre-Funded Warrant Share and associated March 2026 Common
Stock Purchase Warrants, with such price being established for purposes of compliance with the listing rules of the Nasdaq Stock Market
LLC. The March 2026 PIPE Offering closed on March 31, 2026. The Company received $850,000 in cash proceeds upon the closing of the March
2026 PIPE Offering. Additionally, $1,400,000 previously funded by V-Co 3 under the V-Co 3 Note automatically converted into the PIPE
Offering. The gross proceeds funded under the V-Co 3 Note exclude an original issue discount of $140,000 paid by the Company in connection
with previous funding under the V-Co 3 Note. The Company expected to use the net proceeds from the March 2026 PIPE Offering for general
working capital purposes. No placement agent was used in connection with the March 2026 PIPE Offering.

Both March 2026 Common Stock
Purchase Warrants have an exercise price of $1.09 per share and became exercisable immediately as of the date of issuance. The March
2026 Common Stock Purchase Warrants are identical to each other, other than their dates of expiration (the March 2026 Series A Warrant
has a term of two years and the March 2026 Series B Warrant has a term of five years). The March 2026 Pre-Funded Warrant has a term ending
on the complete exercise of the March 2026 Pre-Funded Warrant, an exercise price of $0.0001 per share and became exercisable immediately
as of the date of issuance. The March 2026 Warrants also contain customary stock-based (but not price-based) anti-dilution protection
as well as beneficial ownership limitations preventing Seneca or its affiliates from exercising March 2026 Warrants if such exercise
would result in Seneca or its affiliates from owning in excess of 19.99% of the then outstanding common stock.

The terms of the March 2026
PIPE SPA require the Company to file a registration statement on Form S-3 or other appropriate form registering the March 2026 PIPE Shares,
the March 2026 PFW Shares and the March 2026 Warrant Shares (collectively, the “March 2026 Registerable Securities”)
for resale no later than 45 days of the closing of the March 2026 PIPE Offering and to use commercially reasonable best efforts to cause
such resale registration statement to be effective within 90 days of the closing of the March 2026 PIPE Offering. The Company must also
use its commercially reasonable efforts to keep such resale registration statement continuously effective (including by filing a post-effective
amendment to such resale registration statement or a new registration statement if such resale registration statement expires) for a
period of three (3) years after the date of effectiveness of such resale registration statement or for such shorter period as such securities
no longer constitute March 2026 Registrable Securities, subject to certain limitations specified in the March 2026 PIPE SPA.

The March 2026 PIPE SPA further
provides that the Company shall pay V-Co 3 in the amount equal to $50,000 for the fees and expenses of V-Co 3’s counsel incurred
in connection with the March 2026 PIPE Offering. The March 2026 PIPE SPA also includes standard representations, warranties, indemnifications,
and covenants of the Company and V-Co 3.

Segment
Information

We
manage our business within one reportable segment. Segment information is consistent with how management reviews our business, makes
investing and resource allocation decisions, and assesses our operating performance.

Corporate
Information

Our
principal offices are located at 7921 Southpark Plaza, Suite 210, Littleton, Colorado 80120, and our telephone number is (866) 908-4867.
Our website is www.vivos.com. Our website and the information on or that can be accessed through such website are not part of
this Annual Report on Form 10-K.

Available
Information

We
maintain a website at www.vivos.com. You may access our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports
on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act with the SEC free
of charge at our website as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC.
The reference to our website address does not constitute incorporation by reference of the information contained on our website, and
you should not consider the contents of our website in making an investment decision with respect to our common stock.