What changed in this filing

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Item 1. Business

2026-04-15 compared with 2025-03-31 · 1208 added, 758 removed, 968 unchanged (67% of the section changed)

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

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

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

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

Food and Drug Administration (or FDA)

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

We believe our C.A.R.E.

and other proprietary oral appliances, diagnostic tools, myofunctional therapy, clinical treatments, continuing education, and practice

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

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

Studies and direct experience have

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

comparison to or when combined with other largely palliative treatments such as the current standard of care for OSA, continuous positive

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

We call our overall solution The Vivos Method .

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

training and marketing through dentists to their patients with OSA.

Through a variety of sales efforts, including a direct sales

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

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

In addition, to build product credibility

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

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

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

In November 2023, we obtained a

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

oral medical devices to treat severe OSA.

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

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

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

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

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

distribution channel for our products and services.

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

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

This new business strategy is focused on contractual alliances

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

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

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

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

Rebis rolled out this alliance,

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

By the end of 2024, Rebis patients

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

Subsequently, we

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

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

testing and treatment centers nationwide.

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

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

These testing labs are typically

affiliated with or owned by independent sleep specialists.

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

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

Once patients receive a diagnosis and in

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

As noted above, through extensive interactions with

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

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

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

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

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

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

We believe this makes our Vivos treatment much more

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

Importantly, the data which we submitted to the

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

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

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

driving much higher insurance payer reimbursements.

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

(including our independent Vivos-trained dentists).

Marketing and Distribution Alliance Strategy

We believe our sales, marketing

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

Our Rebis alliance, which we hope will

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

and distribution model for our cutting-edge OSA appliances.

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

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

oral medical devices, oral

appliances and additional adjunctive therapies and methods including CPAP machines.

The program commenced in August of 2024 in the Longmont

office of Rebis.

We believe the advantages of this

new strategic marketing and distribution model are compelling:

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

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

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

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

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

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

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

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

In summary, under our new model,

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

more revenue and profit per case.

The Rebis strategic alliance was announced alongside

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

(who we refer herein as Seneca).

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

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

Overview and Mission

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.

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).

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.

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.

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.

Guided Growth and Development program features the Vivos Guide and PE x 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

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.

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 .

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

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.

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.

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 ”.

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.

Business Model

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.

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.

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.

Medical-Provider Focused Sales, Marketing and Distribution Model

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

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.

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.”

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.

Integration Update

operational planning for the integration of SCN began in April 2025, when we signed the definitive agreement to purchase the assets of

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.

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.

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).

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.

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.

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

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.

OSA Provider Management Model

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.

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

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.

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.

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.

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.

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.

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

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

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.

patients with a full-spectrum of available FDA-cleared treatment modalities, Vivos patients can make better and more informed decisions

about their care.

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

Third, top line revenue and profit per OSA patient treated are expected

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

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.

Provider Acquisition or Management Pipeline

are currently in active discussions with a number of potential acquisition targets to follow our SCN acquisition and Detroit-area management

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.

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.

Products and Services

1 unchanged sentence

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

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

Food & Drug Administration

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

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.

11 unchanged sentences

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.

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

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

1 unchanged sentence

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.

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,

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

6 unchanged sentences

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.

We also believe it will enhance our value proposition to third-party distribution partners such as DME companies.

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

For example, in April

2024 we received the required regulatory approvals to enable Medicare reimbursement for 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.

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

system include:

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

The Guides 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.

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.

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

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

MyoCorrect oral myofunctional therapy (OMT) services.

Studies have shown OMT to be a clinically valuable adjunctive treatment

for patients with breathing and sleep disorders.

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.

MyoCorrect treatment services are cost-effective for providers and convenient

for patients.

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

and providers.

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

bruxism and TMJ Dysfunction.

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

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.

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.

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

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

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

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

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

and other Vivos devices.

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

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.

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.

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.

other Vivos devices.

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.

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

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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.

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

As such, we are currently sub-leasing the facility third parties for corporate and community events until our lease

expires in 2027.

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

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

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

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.

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

We also utilize Treatment Navigators in our SCN operations.

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

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According to a 2016 report by Frost & Sullivan, OSA

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

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

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

Research has shown that

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

chronic pain and other debilitating, life-threatening diseases.

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

Research has shown that when left untreated, OSA can increase the risk of comorbidities, such as high blood pressure, heart

failure, stroke, diabetes, dementia, chronic pain and other debilitating, life-threatening diseases.

Unfortunately

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Traditional oral appliances can be effective over limited time frames but often create

other problems with temporomandibular joint (or TMJ) dysfunction, open bites, infections, and more.

other problems with TMJ dysfunction, open bites, infections, and more.

As with CPAP, they too must be worn

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When The Vivos Method is presented as a viable treatment option against

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

the alternatives discussed above, we believe it will be the preferred choice of most patients by a factor of about 2 to 1.

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

oral appliances represent the first non-surgical, non-invasive treatment

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;

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

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

cases of OSA where patients are compliant with clinical treatments.

Our patented oral appliances have been utilized in approximately

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

Target Customers

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

Our alliance marketing and distribution model provides

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

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

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.

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.

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

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.

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

the medical profession, including sleep centers and medical doctors and dentists

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

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

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 fully recognize that breathing and sleep disorders, including OSA,

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

To that end, we have broadened

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

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

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

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

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

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 more rapidly.

Market Opportunity

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

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

According to the March

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

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

According to an American Sleep Association

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

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.

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

were at higher risk of developing OSA.

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

suffering from sleep apnea.

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

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

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

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

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

Our VivoScore testing routinely results in approximately

Sleep Irregularity and Subclinical Markers of Cardiovascular Disease:

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.

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.

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

There are approximately

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

Method to their patients.

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

who routinely see and treat patients with OSA.

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

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

As we pivot to the alliance marketing and distribution

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

As we raise awareness, and now that new

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

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

Therefore, based

on the addressable U.S.

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

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

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.

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.

Treatment Alternative for OSA - The Vivos Method

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(costs vary by provider) when compared to other options such as lifetime CPAP or surgery.

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

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

better breathing and sleep.

These statements are based on retrospective raw data with validated before and after sleep studies, rhinomanometry

testing before and after treatment, Cone Beam Computerized Tomography (CBCT) scans from treating clinicians and patient testimony.

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

their OSA and snoring symptoms.

Vivos Method alters the size, shape and position of the tissues that surround and define the functional space known as the upper

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 treatment time may range from 9 to 12 months, with 10 to 12

months being typical.

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

are typically rendered at the dental office where treatment was initiated.

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.

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

Growth Strategy

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

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

As we pivot to the alliance marketing and

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

We believe the following strategies will

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:

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:

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

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relationships and selective acquisitions of sleep clinics throughout the country.

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

dentists and other healthcare providers.

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

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

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

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

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

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

Our BIS m edical

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

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

interact and do business with Vivos.

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.

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.

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

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

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revenue is currently derived from the following primary sources:

Diagnostic and Treatment Revenue from SCN and

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.

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 guides.

Under our new

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

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

office training and enrollment fees .

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

While we have shifted

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

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.

HST revenue .

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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.

Airway Intelligence Service (AIS).

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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.

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.

have discontinued deploying this software in our owned and managed sleep centers.

Group (formerly our Medical Integration Division) .

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continuum of care.

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

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

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.

(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.

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.

(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.

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

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

Competitive Strengths

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

and position us for success in the marketplace:

Marketing and Distribution Business Model.

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

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

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

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

who seek to avoid or get off their CPAP machines.

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

help educate patients.

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

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

Finally, with our new marketing and distribution model, our

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

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

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:

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.

Economics of New Marketing and Distribution Business Model.

The vertically integrated nature of our new strategic alliance

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

and therapeutic care.

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

high and fixed costs low.

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

therapeutic services.

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

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.

Barriers to Entry .

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OSA diagnosis and treatment;

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

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.

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Method Insurance Reimbursement .

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

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

The average level of commercial payer reimbursement

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

deductibles and policy restrictions will vary.

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

and Medicaid Services (CMS) jurisdiction in the U.S.

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.

of Published Research and Strong Patient Outcomes .

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

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

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

therapy adherence (patient compliance).

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

across reports from independent dentists and have been highlighted in over 60 published studies, case reports, and articles, many

of which have been peer reviewed.

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

to support increased adoption of the Vivos Method.

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.

Mover Advantage .

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We believe we are also the first

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

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

Differentiated

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

that actually works on a common root cause of OSA.

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

not reshape the upper airway like our C.A.R.E.

appliances and therefore require nightly use over a lifetime and have a number of

other disadvantages.

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.

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.

Property Portfolio and Research and Development Capabilities .

We have a comprehensive patent portfolio to protect our intellectual

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

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,

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trademark portfolio consists of 14 registered

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

appliance designs, and multi-disciplinary treatment modalities are all considered proprietary trade secrets and competitive advantages

with no known counterparts.

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

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

We believe the myriads of highly nuanced

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

to replicate or reverse engineering.

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

to untrained providers at minimal cost.

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

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

also the use of uniquely designed customized oral appliances.

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

will be less than acceptable to patients.

Training and Support Systems .

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

offered through The Vivos Institute is unmatched anywhere and is a clear competitive strength that would be difficult to replicate.

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.

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.

Approach to Market Development .

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and Marketing

Domestically,

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

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

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

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

oral medical devices, oral appliances and

additional adjunctive therapies and methods including CPAP machines.

The program commenced in August of 2024 in the Longmont office

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.

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

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

we expect to close more cases using Vivos-trained personnel.

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

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

approximately 4-6 times.

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

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

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 scaled back our VIP

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

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Internationally,

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

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

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

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

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

At this time, we do not have plans to continue

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

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.

Reimbursement

reimbursement is available across the full spectrum of Vivos appliances.

Medical coverage and benefits are subject to medical necessity

and payer guidelines.

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

(ranging from 5% to 70%).

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

A verification of benefits

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

for pre-authorization that may be required for reimbursement.

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

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

As out-of-network providers, dentists

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

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

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

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

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.

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).

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.

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

for alternative OSA therapy.

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

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

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

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

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

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

In August 2021 510(k)

for Class II clearance from the FDA for the mmRNA appliance with indications to treat mild to moderate OSA and snoring in adults was

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

older along with PAP and/or myofunctional therapy, as needed.

In December 2021, the mmRNA was accepted by

the CMS Pricing, Data Analysis and Coding (PDAC).

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

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

Notwithstanding

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

distribution or acceptance of Vivos appliances.

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

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

When Medicare reimbursement is desired by Vivos providers

they are typically registered with Medicare DME as a non-participating DME supplier, allowing the provider to balance bill patients like

they would when billing as an out-of- network provider to commercial policies and are not limited to accepting Medicare reimbursement

rates as payment in full.

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

and the DNA appliance for adults.

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

severe OSA in children with malocclusions.

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

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

A dentist billing an undefined CPT code for a Class I

or Class II oral appliance must proceed with caution.

These preauthorization and billing requirements pertain to all valid and billable

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

possible reimbursement.

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

to summarize and communicate the existing medical necessity.

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

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

a medical doctor.

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.

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.

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.

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

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

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

While the DNA appliance can still be pre-authorized and billed using an undefined CPT code, the newly issued 510(k) clearance

for the DNA appliance allows for additional code types to be utilized when OSA is present and diagnosed by a Medical Doctor.

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

fabricated, without a fixed mechanical hinge.

While the use of this designated HCPCS code is new there is a potential pathway for additional

registrations with Vivos appliances on the PDAC list of oral appliances covered by and billable to Medicare.

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

While the use of this designated HCPCS code is new there is a potential pathway for additional registrations with Vivos appliances

on the PDAC list of oral appliances covered by and billable to Medicare.

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

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to be more consistently covered by medical insurance payers.

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.

Insurance Coverage

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pulmonary disease and similar conditions.

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.

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.

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

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.

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

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

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in the market.

We currently own five design patents that expire between 2023 through 2029 and two utility patents expiring in 2029 and

We currently own three design patents that expire between 2028 through 2029 and two utility patents expiring in 2029 and

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

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trademark portfolio consists of 14

registered marks.

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

appliance designs, and multi-disciplinary treatment modalities are all considered proprietary trade secrets and competitive advantages

with no known counterparts.

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.

Regulatory Status

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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.

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.

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

Class I orthodontic devices for tooth positioning.

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

technique, the Vivos Vida and the Vivos Vida Sleep .

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.

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

The regulatory status of our products is as follows:

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In November 2023, our mmRNA appliance was cleared by the FDA to

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

therapy, as needed.

treat moderate and severe OSA in adults, 18 years of age and older along with PAP and/or myofunctional therapy, as needed.

to November 2023, our mRNA appliance ® had a 510(k) clearance from the FDA as a Class II medical device for the treatment

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

December 2022, our DNA appliance ® received a 510(k) clearance from the FDA as a Class II medical device for the treatment

of jaw repositioning snoring and mild to moderate OSA in adults.

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

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

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

with malocclusions.

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

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

In October 2021, we announced that results

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

after undergoing treatment using our Vivos Guides.

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

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

Other papers and studies on

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

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

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

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

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

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

of Vivos Guides with over 150 children currently enrolled.

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

potential cohort of 500 children.

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.

We expect to submit and

publish the results of this trial by the end of 2026.

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

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This study will test the hypothesis that treatment

of the upper airway associated with functional improvements of sleep parameters in adults with mild to moderate OSA.

of the upper airway associated with functional improvements of sleep parameters in adults with mild, moderate and severe OSA.

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

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Group Institutional Review Board (WCG IRB) as non-significant controlled clinical trials, we conducted a clinical trial to evaluate

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

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

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

The retrospective study recruited

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

The study analyzed eleven

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

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

We found immediate improvement

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

We also found a plateau of resolving or improvement

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

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

The most commonly

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

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

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

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.

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

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

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

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

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

of ADHD and other child behavioral issues.

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

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

with Vivos Guides for SDB and establish a connection and treatment between children and behavior issues such as attention-deficit/hyperactivity

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

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

indications of use for the Vivos Guides.

indications of use for the Vivos Tooth Positioners.

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.

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.

addition to U.S.

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

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

On December 30, 2022 the FDA granted 510k

clearance for the DNA appliance ® 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.

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

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,

deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting or some implantable devices, or devices that have

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under a conditional approval.

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

each clinical site.

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

the conduct of the study.

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

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

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

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including a belief that the risks to study subjects outweigh the anticipated benefits.

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.

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.

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

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registration and device listing with the FDA;

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

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

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

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

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

device reporting (“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

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;

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risk to health;

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

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

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

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

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

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to grant export or import approvals for our products;

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

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

in the development and production of our devices.

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

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

practices (cGMP).

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

to become a compliant manufacturer.

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

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

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 .”

of Medical Devices in Canada

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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

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

Additional safe harbor provisions providing similar protections have been published intermittently since 1991.

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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

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

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February 13, 2025, Robert F.

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

President Trump, along with Secretary Kennedy,

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

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

As Secretary, Mr.

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

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.

Over his 40-year career, Mr.

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

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

Kennedy has been a resolute leader in alternative

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

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.

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

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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

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.

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.

Capital Resources

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

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

eight are involved in senior management, three in research, development and regulatory and 253 in operations.

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

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to Vivos Therapeutics, Inc.

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

per share, (“Common Stock”) to a group of our founders, including Summit Capital USA (now Upeva, Inc., 26,667 shares), Regal

Capital Venture Partners LLC (6,667 shares) and Thomas P.

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

of $280 of proceeds).

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

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

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

of BioModeling Solutions, Inc.

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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.

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

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.

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.

transaction was accounted for as a reverse acquisition and recapitalization, with BMS as the acquirer for financial reporting and accounting

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and continued to be recorded at their historical carrying amounts.

of Stock and Option Award Plan

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

April 18, 2019, our stockholders approved the adoption of a stock and option award plan (the “2019 Plan”), under which 13,334

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

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

available for issuance under the 2019 Plan.

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

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

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

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

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.

of Transfer of Corporate Domicile and Reverse Stock Split

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

split of our outstanding Common Stock pursuant to which holders of Vivos’ outstanding Common Stock received one share of Common

Stock for every three shares of Common Stock held.

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

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on Form 10-K reflect the reverse stock split.

Marketing and Distribution Alliance Strategy

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

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

This alliance, which we hope will be the first

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

model for our cutting-edge OSA appliances.

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

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

oral medical devices, oral appliances and

additional adjunctive therapies and methods including CPAP machines.

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

Medical Provider-Focused Marketing and Distribution Alliance Strategy

believe our sales, marketing and distribution pivot, which began in 2024, will be critical to our ability to drive our future revenue

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.

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.

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.

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

This model also obviates the need for us to finance the purchase and other costs associated with our acquisition model.

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

First, it provides Vivos-trained providers

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

As we roll out this new model going forward, potentially

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

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

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

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

These figures held relatively

consistent across diverse demographic and economic patient profiles and geographies.

Third, top line revenue and profit per case are

expected to rise.

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

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

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

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

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

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

profit per case.

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

(who we refer herein as Seneca).

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

us and Rebis.

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

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

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.

2023 Private Placement

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

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

Each unit consists of one share of our

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

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

In connection with the January 2023

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

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

in November 2023 as described below).

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

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

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 ”).

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.

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

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.

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.

2023 Private Placement

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

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

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

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

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

private placement closed on November 2, 2023.

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

proceeds of approximately $3.5 million.

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

were exercised.

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

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

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

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

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

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.

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.

2024 Warrant Exercise Transaction

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

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

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

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

The resale of the shares of Common Stock

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

333-275726), which became

effective with the SEC on December 1, 2023.

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

the two Inducement Warrants in a new private placement transaction.

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

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

The Inducement Transaction closed on February 20, 2024.

2024 Private Placement and Management Services Agreement with Seneca

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

liability company (“V-CO”).

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.

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.

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.

2024 Private Placement and Management Services Agreement with New Seneca Partners, Inc.

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.

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

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

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

and distribution alliance with Rebis.

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

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.

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

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

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

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

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

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

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

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

using industry standard valuation metrics).

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.

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

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(“ 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;

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.

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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.

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

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

No common stock purchase

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

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

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

for the September 2024 Offering.

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

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

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

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

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

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

Offering) at an exercise price of $3.9375 per share of common stock, exercisable beginning upon issuance until five years from the commencement

of sales in the September 2024 Offering.

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

and other offering expenses payable by us.

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

and general corporate purposes.

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

the SEC (File No.

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

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.

A prospectus supplement relating to the September

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

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

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

Under the 2024

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

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

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

left in the 2019 Plan are to be retired.

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

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

The purpose of

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

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

Any non-employee director,

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

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

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

and three consultants.

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

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

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

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

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

2024 Omnibus Plan.

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.

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.

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.

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

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

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

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

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

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

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

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

Nasdaq Stock Market rules, to purchase 709,220 shares of common stock and, in a concurrent private placement (collectively, with the

registered direct offering, the “December 2024 Offering”), warrants (the “ December 2024 Warrants ”) to

purchase up to 709,220 shares of common stock (the shares of common stock issuable upon exercise of the December 2024 Warrants, the “ December

2024 Warrant Shares ”).

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

The December 2024 Warrants are immediately exercisable

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

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

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

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

the closing of the December 2024 Offering.

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

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

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.

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.

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

8 unchanged sentences

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

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

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

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

and other offering expenses payable by us.

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

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

the SEC (File No.

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

A prospectus supplement relating to the

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

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.

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

3 unchanged sentences

subject to certain exceptions.

2025 Private Placement

June 9, 2025, we entered into a Securities Purchase Agreement (the “ June 2025 PIPE SPA”) with V-Co 2.

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 ”).

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.

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.

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.

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.

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.

3 for further information.

2025 Streeterville Note

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.

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

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

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.

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.

2025 Avondale Note

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 (“ Avondal e”), 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

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.

Avondale Note does not bear interest and no interest will accrue on the Avondale Note unless an event of default occurs as further described

The Company will make weekly payments of $69,778 beginning from December 12, 2025 until the Avondale Note is paid in full.

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.

intends used the net proceeds from the Avondale Note Financing for working capital and other general corporate purposes.

agent was used in connection with the Avondale Note Financing.

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.

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

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

The Company did not sell any shares of common stock under the Prior Shelf Registration pursuant to the ATM Sales Agreement.

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.

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

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.

2026 V-Co Investors 3 LLC Note

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” ).

affiliate of Seneca.

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 ”).

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.

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.

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.

2026 Warrant Inducement

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.

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.

transactions contemplated by the Inducement Agreement (the “ Inducement Transaction ”) closed on January 20, 2026.

intend to use these net proceeds received from the Inducement Transaction for general working capital and general corporate purposes.

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

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 ”).

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

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

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.

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.

manage our business within one reportable segment.

12 unchanged sentences

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What changed 10-K

Item 1. Business