What changed in this filing

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Item 1. Business

2026-03-31 compared with 2025-03-24 · 629 added, 270 removed, 275 unchanged (77% of the section changed)

(the “ Company ,” “ we ,” “ us ,” “ our ”) is a radiation oncology

medical device company engaged in the development of its yttrium-90 (“ Y-90 ”) based precision radionuclide therapy

device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide Therapy TM .

A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories,

universities, and private corporations, lead the Company’s development efforts.

The Company’s overall vision is to globally

empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments

2013, the United States Food and Drug Administration (“ FDA ”) issued the determination that RadioGel™ is a device

for human therapy for non-resectable cancers in humans.

(the “Company,” “we,” “us,” “our”) is a radiation oncology medical device company

engaged in the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy devices.

This includes RadioGel®

Precision Radionuclide Therapy™ (Human Division) for treating solid tumors and positive surgical margins in humans and IsoPet®

(Animal Division) for treating solid tumors in animals.

The Company also sells PLGA-g-PEG polymers and PrecisionGel™, a hydrogel

polymer platform for delivering active pharmaceutical ingredients and therapeutic agents.

A prominent team of radiochemists, scientists,

and engineers, collaborating with strategic partners, including national laboratories, universities, and private corporations, lead the

Company’s development efforts.

The Company’s overall vision is to globally empower physicians, medical researchers, veterinarians,

and patients by providing them with new isotope technologies and advanced polymer solutions that offer safe and effective treatments

for cancer in both humans and animals.

2013, the United States Food and Drug Administration (“ FDA ”) issued the determination that RadioGel ®

is a device for human therapy for non-resectable cancers in humans.

This should result in a faster path than a drug for final approval.

January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel TM should be classified as

a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.

Additionally, after a legal review, the Company believes

that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but

rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals.

We expect the

result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet ®

for the treatment of solid tumors in animals.

The FDA does not have premarket authority over devices with a veterinary classification,

and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance

with all applicable laws and regulations.

on the FDA’s recommendation, RadioGel TM is being marketed as “IsoPet ® ” for use by veterinarians

January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel® (now marketed as IsoPet® for

veterinary use) should be classified as a medical device for animal therapy, initially specified for feline sarcomas and canine soft

tissue sarcomas.

Additionally, after legal review, the Company believes that this device classification from the FDA Center for Veterinary

Medicine is not strictly limited to canine and feline sarcomas but may extend to a broader population of veterinary cancers, including

all or most solid tumors in animals.

As veterinary medical devices do not require premarket approval or notification (such as 510(k)

or PMA) for commercial distribution in the United States, IsoPet® is authorized for marketing and commercial distribution following

this classification, provided the product is safe, effective, properly labeled, and compliant with applicable laws and regulations.

FDA does not exercise premarket authority over veterinary devices, and manufacturers bear responsibility for ensuring ongoing compliance.

This classification enables the commercial distribution of IsoPet® for treating solid tumors in animals.

on the FDA’s recommendation, RadioGel ® is being marketed as “IsoPet ® ” for use by veterinarians

to avoid any confusion between animal and human therapy.

The Company already has trademark protection for the “IsoPet ® ”

IsoPet ® and RadioGel TM are used synonymously throughout this document.

The only distinction between IsoPet ®

and RadioGel TM is the FDA’s recommendation that we use “IsoPet ® ” for veterinarian usage,

and reserve “RadioGel TM” for human therapy.

Historically, the Company’s primary focus was on the development

and marketing of Isopet ® for animal therapy, through the Company’s IsoPet ® Solutions division.

the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device

Exemption and to obtain approval for clinical trials in India.

IsoPet ® and RadioGel ® are used synonymously throughout this document.

The only distinction between

IsoPet ® and RadioGel ® is the FDA’s recommendation that we use “IsoPet ® ”

for veterinarian usage, and reserve “RadioGel ® ” for human therapy.

Historically, the Company’s primary

focus was on the development and marketing of Isopet ® for animal therapy, through the Company’s IsoPet ®

Solutions division.

Over the last four years much effort has been directed to completing the testing require to obtain FDA approval for

an Investigational Device Exemption and to obtain approval for clinical trials in India.

Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement of

university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the technology

in private clinics.

In January 2025 the Company restructured and aligned its internal resources and focused effort to align with animal

university veterinarian hospital to develop detailed therapy procedures to treat animal tumors and ultimately use of the technology in

private clinics.

In January 2025 the Company restructured and aligned its internal resources and focused efforts to align with animal

therapy, human therapy, and recently other applications of its patented technologies.

Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet ® /RadioGel TM

Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet ® /RadioGel™

testing and therapy.

Washington State University treated five cats for feline sarcoma and served to develop the procedures which

are incorporated in our label.

Washington State University treated five cats for feline sarcoma and served to develop the procedures which are

incorporated in our label.

They concluded that the product was safe and effective in killing cancer cells.

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He was given a high dose of 400Gy with heavy therapy at the margins.

Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet ® )

and related services, and from certifying veterinary clinics to administer IsoPet Therapy.

Until recently the Company certified clinics

at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification

Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel ® (under the name

IsoPet ® ) and related services, and from certifying veterinary clinics to administer IsoPet Therapy.

Until recently the

Company certified clinics at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its

first clinic for the certification process.

The Company has transitioned to “Volume Pricing” to stimulate broader interest

and adoption.

With significant growth achieved in 2025—including a reported 1,200% year-over-year increase in administered therapies

and expansion of the certified clinic network—the Animal Therapy Division (IsoPet®) is positioned to reach breakeven status

in 2026, supported by ongoing profitability-focused initiatives, continued clinic expansion, and improved operational efficiency.

plan is to incorporate the data assembled from our work with Isopet ® in animal therapy to support the Company’s

1 unchanged sentence

as a Class II medical device.

RadioGel™ is an injectable particle-gel for Precision Radionuclide Therapy radiation treatment of

cancerous tumors in people and animals.

RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature

and then gels when reaching body temperature after injection into a tumor.

In the gel are small, less than two microns, Y-90 phosphate

Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation

RadioGel ® is an injectable particle-gel for Precision Radionuclide Therapy radiation treatment

of cancerous tumors in people and animals.

RadioGel ® is comprised of a hydrogel, or a substance that is liquid at room

temperature and then gels when reaching body temperature after injection into a tumor.

In the gel are small, less than two microns, Y-90

phosphate particles.

Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local

radiation dose.

The radiation is beta, consisting of high-speed electrons.

These electrons only travel a short distance so the device can deliver

high radiation to the tumor with minimal dose to the surrounding tissue.

Optimally, patients can go home immediately following treatment

without the risk of radiation exposure to family members.

Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its

original value after ten days.

These electrons only travel a short distance so the device

can deliver high radiation to the tumor with minimal dose to the surrounding tissue.

Optimally, patients can go home immediately following

treatment without the risk of radiation exposure to family members.

Since Y-90 has a half-life of 2.7 days, the radioactivity drops to

5% of its original value after ten days.

2021 the Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with

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Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance.

December 2023, the Food and Drug Administration granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device

pursuant to the FDA’s Breakthrough Devices Program.

This gave the company access to the “sprint” rapid review process

for IDE comments.

For the last several months the company has been taking advantage of that program to resoled detailed FDA questions

on a variety of topics.

early 2025 the Company began actively pursuing human clinical trials in India.

This involved successful step-by-step implementation of

several requirements, including location of a respected lead investigator at a respected hospital;

regulatory approvals (securing clearances

from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health

& Family Welfare, and the Company was issued the Clinical Trial Registry-India (CTRI) number required for publishing results);

coordination (acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel ® ,

and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product);

protocol development (finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission

discussions);

operational readiness (re-validated RadioGel ® manufacturing at IsoTherapeutics to ensure compliance with

Quality Management System standards and FDA sterility and validation recommendations);

administrative preparations (signed agreements

with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region);

and training and

certification (conducted comprehensive certification training for the treatment team).

Failure on any step would have terminated the effort.

December 2024 the Company conducted an important offset strategic meeting to ensure that its entire key internal and external team was

alighted to its strategic plans.

Attendees included all our current internal team members, our senior health physics volunteer, the members

of the Medical Advisory Board and the Veterinary Medicine Advisory Board, lead Investigator for the proposed Mayo Clinic clinical trial,

lead investigator for the clinical trial in India, and our patent attorney.

The primary objective was to re-assess our business direction,

to select the next target series of indications for Use, to ensure that we have developed the optimum precision Radionuclide Therapy TM

approach for each cancer type, including the isotope, the delivery technique, and the dose, and to ensure that our current and

future patents protect these directions.

It also discussed the domestic and internation plans.

Company decided to explore the viability of harvesting its technology for other business opportunities as a separate “division.”

The Company is working with Akina, on these initiatives.

The current efforts are on the Peltier Chiller technology and the hydrogel.

To prevent the Company from being distracted from its primary focus of treating cancer, if viable, Akina would probably also be the principal

Alternatively, each business sector can be spun off as separate business activities to an interested party.

Laboratory Chilling - As Akina explained, it is easy to purchase many laboratory devices to control heating, but there are limited or

no options for controlled cooling, which is a common laboratory requirement usually involving ice baths.

The Company is now testing a

prototype universal laboratory cooling device.

– the Company spent years on refining the development of its hydrogel, in which gelation initiates just above room temperature

and is completed as it warms to body temperature.

It is currently investing in quantifying and controlling the hydrogel resorption characteristics.

There has been sufficient spontaneous interest in this component to warrant a serious business case assessment.

The Company just trademarked

the name Precision Gel TM and, in addition to its current hydrogel patent, has filed a new provisional patent in January 2025

to cover retention, transport, and release of a broad range of agents.

These agents include radioactive and non-radioactive materials,

solid particles, including nano-particles, large molecules, small molecules, including liquids, cells, and viruses.

A MOU has been drafted

to interface with potential clients including licensing and exclusive material contracting.

Initial meetings are scheduled in the first

quarter of 2025 with potential clients to assess the business viability.

original license agreement with Battelle National Laboratory (the “ Battelle License ”) reached its end of life in 2022.

We have expanded our proprietary knowledge, as well as our trademark and patent protection, in anticipation of the Battelle License reaching

the end of its term during the past several years.

trademark protection, which usually is extended to 17 countries, has been expanding continuously as summarized below:

own applications/registrations for the following and should mark as noted below:

RADIONUCLIDE THERAPY TM

PRECISIONGEL TM

we have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate

particles, and our injection system in the US office and more than ten others covering approximately 63 counties.

January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.

Regional Clinics

Veterinary Hospital (“ Vista ”) was selected as the pilot private clinic to initiate commercial sales of IsoPet ® .

It is good management practice to implement and learn from a pilot program before spreading to regional clinics across the country.

is in the Tri-Cities Washington area was convenient for interactions with key personnel of the Company.

has done well in several audits by the Washington State Department of Health.

The Company worked closely with the Washington State Department

of Health to refine and improve the radioactive material license by adding several detailed procedures, which will benefit future regional

In addition, a second veterinarian has been certified.

testing at the universities and at Vista have demonstrated that IsoPet ® is effective on killing cancer tissue near the

It is most effective in early cases before the cancer has begun to spread.

Later stage cancers are more difficult to treat

since the tendrils from the primary cancer site are not well defined or imaged and therefore can lead to recurrence.

Hopkins University Veterinary Clinical Trials Network (“ Johns Hopkins ”), is now an Isopet ® regional

They have the required radioactive material license and have completed their training certification for Isopet ® .

This important relationship will also help meet our objective of obtaining high quality data on a range of cancers that can be published

in leading journals.

These publications are the optimal way to increase awareness of Isopet ® , and to gain broader acceptance

from the veterinarian/oncology community.

Johns Hopkins just completed the VX2 Tumor therapy animal study in rabbits and is writing a

report for publication.

The study further demonstrated the safety of RadioGel ® , generating the activity decay curves that

show that the hydrogel remains at the injection site.

This study also:

(1) demonstrated the validity of the Instructions for Use;

the validity of the Injection Guidance Table;

and (3) provided a basis for refining the techniques for treating small human cancerous

classification as a breakthrough device was positively influenced by the safety and effectiveness of many animal therapies.

expanded the number of IsoPet Certified clinic from 4 in 2023 to 13 by the end of 2024:

Veterinary Hospital – Kennewick, WA

of Missouri – Columbia, MO

Hopkins University – Baltimore, MD

England Equine Practice – Patterson, NY

Equine Clinic, Rochester, NH

of Wisconsin School of Veterinary Medicine, Madison, W

Valley Equine Hospital, Navasota, TX

Creek Veterinary Hospital, Fort Wayne, IN

Animal Hospital - Hopkinton, N

VETS Veterinary Emergency Trauma & Specialty Center, Robbinsville, NJ

Emergency & Specialty Center of Knoxville, Knoxville, TN

Veterinary Hospital, Sumner, WA

University of Illinois College of Veterinary Medicine, Urbana, IL

now treat feline, canine, equine, and exotic animals.

are targeting to open approximately ten more clinics in 2025.

Company worked closely with FX Masse to assist the clinics with licensing.

They developed nine certification training modules for use

in potential regional clinics.

These modules are necessary to satisfy the radioactive material handling licenses.

2024, the Company saw the development of three new websites to elevate the online presence and brand identity.

These included a corporate

website and dedicated sites for its two divisions, RadioGel ® and IsoPet ® , tailored to their unique audiences.

Each site featured user-friendly designs, informative content, and engaging blogs to educate visitors and build industry authority.

Materials were created that effectively communicated our innovative cancer treatment Precision Radionuclide Therapy™.

team managed a booth at six conferences.

LeeAnna Binder toured the country discussing IsoPet therapy with several clinics in a specially modified IsoPet van.

To amplify visibility, our marketing team managed and maintained an

active presence on social media platforms, including Facebook, Instagram, X, and LinkedIn, with consistent, engaging posts to

connect with our target audience.

This comprehensive approach enhanced brand recognition, drove traffic to our websites, and

supported business growth.

2024, IsoPet Division transitioned from data collection to commercialization, utilizing our extensive data to refine our offerings.

collaborating closely with certified clinics, we have recalibrated our pricing to make our services more affordable for pet patients.

As we enter 2025, with plans to expand our clinic network across strategic US regions, we are excited about enhancing pet care nationwide.

With increasing patient volumes, we are also aligning with our production team to establish a more defined ordering schedule.

This strategy

will help synchronize patient bookings with product availability, ultimately reducing production costs and making IsoPet’s solutions

even more accessible.

objectives are to open several more regional clinics over the next three years, and to participate in a minimum of four conferences annually

to spread the word about IsoPet ® in the veterinarian community for treating tumors in small animals and horses.

Our Veterinary

Medicine Steering Board provides advice on obtaining new pet patients.

September 17, 2025, the Board of Directors of the Company approved the creation of Vivos Scientific India LLP (“VSIL”), a

wholly owned separate legal entity in India.

Vivos India was formally established in September 2025 (with incorporation completed and

government approvals finalized shortly thereafter), expanding the Company’s strategic initiatives in the region.

The primary objectives

include establishing the Company’s first international manufacturing center for RadioGel® and IsoPet®, advancing expanded

human therapy demonstrations and clinical trials (including ongoing patient treatments initiated in December 2024 and progress toward

DCGI regulatory clearance for larger-scale trials), pursuing commercialization of therapies for both humans and animals in India, and

generating additional human trial data to support the Company’s regulatory processes with the U.S.

Food and Drug Administration

(FDA), such as the planned Investigational Device Exemption (IDE) submission in early 2026.

As of February 2026, discussions continue

with experienced radiopharmaceutical contract manufacturers in India to support the establishment of this international production facility,

with a target for operational status by the end of 2026 to reduce shipping costs, enhance logistical efficiency, and facilitate broader

global access to the Company’s precision radionuclide therapies.

the third quarter ended September 30, 2025, the Company strengthened its leadership team to support accelerating growth in both the U.S.

and international markets by appointing Brad Allan Weeks as President (effective September 1, 2025) and David J.

Swanberg as Chief Operating

Officer (effective September 15, 2025).

These appointments reflect the Company’s strategic response to rapid expansion, particularly

in the IsoPet® Animal Therapy Division—which achieved a reported 1,200% year-over-year increase in administered therapies from

2024 to 2025—and ongoing advancements in RadioGel® human therapy development, including progress toward FDA Investigational

Device Exemption (IDE) submission and the establishment of Vivos Scientific India LLP in September 2025.

The new executive roles are

designed to enhance operational efficiency, scale commercial activities, drive clinic certifications and therapy adoption, and position

the Company for sustained growth and potential profitability in the Animal Therapy Division by 2026.

- In December 2023, the FDA granted RadioGel® Precision Radionuclide Therapy™

designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program, thereby giving the Company access

to the “sprint” rapid review process for IDE comments.

For the first two quarters of 2025, the Company took advantage

of the process to resolve detailed FDA questions on a variety of topics.

On August 13, 2025, the FDA rejected the Company’s

IDE based on cited deficiencies.

Based on the FDA recommendations, the Company used the pre-submission process to respond to the

FDA’s comments.

On October 14, 2025, the Company submitted the pre-submission document dedicated to sterility.

This document

incorporated the new E-Beam sterilization process.

the past several years, the Company has engaged extensively with the FDA, successfully addressing feedback from more than 40 individual

reviewers—many comments stemming from frequent review team changes within the Agency.

Vivos has provided comprehensive data

and finalized the key technical parameters related to demonstrating precision delivery of RadioGel ® to the treatment

area and ensuring minimal exposure to non-target tissues.

a key strategic move, Vivos has engaged one of the top regulatory experts in the field of brachytherapy and combination radiotherapy

devices, with deep experience guiding such products through the FDA’s Center for Devices and Radiological Health (CDRH).

expert’s prior role at the FDA and proven track record of successful IDE approvals for Class III implantable radiation device,

several reviewed by the same branch overseeing RadioGel ® , have provided invaluable guidance.

this expert’s analysis of FDA feedback patterns, the Company is bolstering its IDE submission by:

addressing all outstanding FDA concerns and adopting a submission format and structure proven effective by regulatory experts for similar

Incorporating

additional information from clinical human data that has become available since the Company’s last IDE submission, further

strengthening the evidence package.

and summarizing pre-clinical data in a manner that more directly and effectively addresses the remaining FDA concerns.

extensive veterinary clinical data from IsoPet ® commercial use:

Integrating comprehensive treatment outcomes from

over 100 safely administered therapies across diverse tumor types and species, with zero reportable serious adverse events attributable

to the product, to provide additional real-world safety and efficacy evidence supporting the Precision Radionuclide Therapy™

specialized equine ocular applications:

Including detailed case data on successful treatments of ocular squamous cell carcinoma in

horses (with injections near or into the cornea), showing no major side effects in adjacent critical structures, to further demonstrate

the therapy’s precision, minimal invasiveness, and favorable risk profile in challenging anatomical locations.

enhancements maintain the intended use while maximizing the submission’s clarity, completeness, and alignment with Agency expectations.

These recommendations required substantial effort to incorporate into our next submission.

Commercialization

of Human Therapy in India - The Company is actively pursuing an expanded permit from

the Drugs Controller General of India (DCGI) to continue treating the initial cohort of up

to 30 patients focused on head and neck cancers (including cancerous lymph nodes) and to

initiate larger-scale clinical trials supporting potential commercial applications in India.

This next phase would involve a second hospital site with a new principal investigator, incorporating

an enhanced protocol that aligns with prior FDA feedback—such as post-treatment whole-body

PET examinations for broader safety validation and efficacy assessment across additional

tumor locations.

September 2025, the Company established Vivos Scientific India LLP (VSIL), a wholly owned subsidiary in India, to accelerate developmental

testing, support regulatory processes (including DCGI clearances), expand human and animal therapy demonstrations, and lay the groundwork

for the Company’s first international manufacturing center for RadioGel® and IsoPet®.

The entity has secured its Certificate

of Incorporation and completed key foundational steps (e.g., name reservation, digital signatures, and LLP Agreement filing), with

headquarters in Mumbai, supported by an Indian Advisory Board.

As of February 2026, VSIL is operational and advancing these initiatives,

though full business activation and manufacturing setup remain in progress pending additional regulatory and logistical milestones.

This subsidiary strengthens the Company’s long-term commitment to India as a key hub for clinical advancement, data generation

to bolster the U.S.

FDA pathway (e.g., IDE support), and eventual commercialization in both human oncology and veterinary applications.

Therapy in India – In the second quarter of 2025, the Company sponsored a highly

successful “Pets in the Park” event in Mumbai, featuring a renowned speaker to

raise awareness about pet cancer and introduce IsoPet® therapy.

The event generated overwhelming

positive response and demonstrated strong interest in initiating animal therapy in India.

Building on this momentum, the Company has established solid contacts with interested veterinary

clinics and key stakeholders in the region.

establishment of Vivos Scientific India LLP (VSIL) in September 2025 further supports these efforts by providing a dedicated local

entity to advance developmental testing, pursue regulatory pathways for veterinary applications (complementing ongoing human therapy

progress with the DCGI), and explore commercialization opportunities for IsoPet® in India.

A local production site in India—targeted

as part of the Company’s international manufacturing expansion, with one facility anticipated to become operational by the

end of 2026—would significantly enhance cost-effectiveness by reducing shipping expenses, improving supply chain logistics,

and enabling broader, more affordable access to IsoPet® Precision Radionuclide Therapy™ for veterinary use in the Indian

market and beyond.

This aligns with the Company’s global strategy to expand the IsoPet® division, which has already seen

substantial growth in the U.S.

(including a reported 1,200% year-over-year increase in administered therapies from 2024 to 2025),

and positions India as a promising hub for both animal and human applications of the platform.

Production Facilities – Previous corporate filings have highlighted risk factors

associated with the Company’s reliance on a single production site.

For the past two

years, the Company has actively assessed alternate facilities to mitigate this risk and support

scalable growth.

a significant step announced on February 17, 2026, Vivos Inc.

is advancing plans to diversify its manufacturing base.

The Company’s

strategic target is to establish one domestic production facility—where Vivos will serve as the manufacturer of record—and

one international production facility, both operational in 2026.

These facilities will produce the yttrium-90 (Y-90) phosphate particles

and mix them with sterile hydrogel to create individual patient doses for RadioGel® (human applications) and IsoPet® (veterinary

applications).

the domestic site, Vivos has signed a contract for production space at the Applied Process Engineering Laboratory (APEL) in Richland,

Equipment has been ordered, installation is underway, and licensing applications have been submitted to support operational

The international facility is being pursued through ongoing discussions with experienced radiopharmaceutical contract

manufacturers in India, aligned with the establishment and activities of Vivos Scientific India LLP (VSIL), to reduce shipping costs,

enhance logistical efficiency, and expand access to global markets.

Company will continue production with its existing contract manufacturer through Q2 2026, ensuring continuity during the transition

to these new facilities.

This multi-site approach is expected to address previous single-source vulnerabilities, improve supply chain

resilience, accommodate higher production volumes as demand grows (particularly in the IsoPet® division, which reported substantial

therapy increases in 2025), and support the Company’s broader commercialization and regulatory goals for both human and animal

Indications for Use and Alternate Isotopes – In December 2024, the Company conducted an offsite strategic meeting with

our key technical staff, both our Medical and Veterinary Advisory Boards, our principal investigators from Mayo Clinic and India,

and the Chairman of our Board.

The objective was to determine our next target indications for use and to ensure that Y-90 was the

best therapeutic isotope to treat these cancers.

time we intend to expand the indications for use to include all lymph nodes, lung cancer,

childhood brain cancer, eyelid cancer, and finally all solid tumors.

Our health physics experts

reviewed the benefits of every available isotope, with respect to the target range of potential

indication for use.

strategic group confirmed that our current isotope, Y-90 was effective for all the targeted indications for use.

However, we also decided

to explore P-32, Lu-177, and Ac-225.

is not as energetic as Y-90;

however, we could modify the concentration, as it has a longer half-life, which could prove to be an

advantage for international shipments.

Lu-177 is relatively low-energy, we could adjust the concentration, as it has a lower penetration distance, which might be an advantage

in therapies near critical structures since that would result in a higher therapeutic ratio.

has a very low penetration distance, but it would be distributed homogeneously in our hydrogel.

This could be an advantage in treating

brain tumors and bone cancer due to its extremely low alpha penetration.

Recent successful therapies of equine ocular tumors without damaging the eye and human therapy on cancerous nodes directly on the trachea without damaging that organ, confirm the use of Y-90 and may impact the business case of development of alternate isotopes.

Our trademarks include BetaGel and AlphaGel and our provisional patents cover the isotopes P-32, Lu-177, and Ac-225.

Depending on the business case conclusions, over the next three years we intend to conduct laboratory testing and then animal and finally human studies in India.

Company is exploring the viability of leveraging its technology to develop other businesses

unrelated to the Company’s principal business of cancer treatment.

Each business opportunity

could generate income to support our primary objectives or potentially be spun off as a separate

business activity to an interested party.

To date the focus has been on:

– The Company spent years refining the development of its hydrogel, in which gelation initiates at room temperature and is

completed as it warms to body temperature.

The Company is currently investing in quantifying and controlling the hydrogel resorption

and agent dispersal characteristics.

There has been enough interest in this component to warrant a serious business case assessment.

Company has trademarked the name Precision Gel™ and, in addition to its current hydrogel patent, filed a new provisional patent

in January 2025.

In 2026 Akina and Vivos will release a publication to summarize years of development on our hydrogel, including

rheology, resorption characteristics, concentration and composition control, and agent release data, including retention, transport,

and release of a broad range of agents.

It is anticipated that this publication will be beneficial to marketing Precision Gel.

the second quarter of 2025, we signed a contract with Akina, Inc to sell this polymer.

is now in their catalog.

The Company has had recent sales to universities and pharmaceutical

we anticipate this will be a slow growing but solid market.

The priority remains

IDE approval.

Chiller – Akina encouraged Vivos to leverage our Peltier Chiller technology to develop a general laboratory equipment

device for non-water localized chilling.

An elementary device demonstrated proof of concept.

A prototype will be produced at APEL

for testing at and eventual distribution by Akina.

Company’s original license agreement with Battelle National Laboratory (the “Battelle License”) reached its end of

life in 2022.

In anticipation of this expiration, Vivos has significantly expanded its proprietary knowledge base, along with robust

trademark and patent protections, over the past several years.

The Company no longer relies on the Battelle license for any core intellectual

or proprietary technology, having developed and secured independent advancements in its Precision Radionuclide Therapy™ (PRnT™)

Protection continues to expand globally, now covering registrations and applications in 17 countries (with ongoing efforts to broaden

this footprint):

Company owns applications/registrations for the following key marks:

RADIONUCLIDE THERAPY™

PRECISIONGEL™

Portfolio has been systematically strengthened through provisional and utility patent filings covering critical components of the platform,

including the hydrogel formulation, yttrium-90 phosphate particles, injection/delivery systems, and related methods.

These protections

are pursued in the United States and in more than ten additional patent offices, encompassing approximately 63 countries.

recent milestones include:

January 2025, the Company filed an additional provisional patent related to PrecisionGel™.

September 3, 2025, a provisional patent (No.

63/873,014) was filed for sterile thermogels

using electron beam sterilization, enhancing manufacturing processes for the hydrogel component.

January 13, 2026, the United States Patent and Trademark Office (USPTO) issued U.S.

12,521,452 B2, titled “Radiotherapy Gel and Method of Preparing the Same.”

This patent protects critical advancements in the proprietary PRnT™ platform, including

the integration of biodegradable, thermosensitive PLGA-g-PEG hydrogel with yttrium-90 particles

for targeted beta radiation delivery into solid tumors while minimizing exposure to surrounding

healthy tissue.

It underpins the flagship products RadioGel® (human applications) and

IsoPet® (veterinary use).

● Concurrently,

PRECISIONGEL™ trademark approvals advanced, with publication in the U.S.

and New Zealand.

● Additionally,

the Company filed a new patent application in early 2026 to further protect and expand the

PrecisionGel™ hydrogel technology, including its use for timed-release delivery of

various therapeutic agents (e.g., anti-cancer drugs and gene therapies) beyond radionuclide

applications.

developments—highlighted in the Company’s January 28, 2026, press release—materially enhance Vivos’ intellectual

property position, support ongoing clinical and regulatory progress (including FDA IDE efforts and international expansion via Vivos

Scientific India LLP (VSIL)), enable broader global commercialization, and position the Company for potential strategic partnerships

and licensing opportunities.

The comprehensive IP portfolio, including four years of developmental data, validated Quality Management

System documentation, and worldwide protections, provides a strong foundation for the Precision Radionuclide Therapy™ platform

in both human and veterinary oncology.

March 2026, the Company filed with the SEC an offering statement on Form 1-A (including a preliminary offering circular dated

February 13, 2026, amended March 4, 2026) under Regulation A for the offering of up to $75.0 million of shares of its Common Stock,

which offering was qualified by the SEC as of March 5, 2026 (the “2026 Regulation A+

Offering” and, together with the 2019 Regulation A+ Offering, 2021 Regulation A Offering, and July 2024 Regulation A+

Offering, the “Regulation A+ Offerings”).

the year ended December 31, 2023, $1,179,245 was raised through the sale of 16,132,000 shares of Common Stock through the Regulation

A+ Offerings and concurrent private placements of 18,797,000 warrants.

During the year ended December 31, 2024, $2,266,000 was raised

through the issuance of 24,950,000 shares of Common Stock through the Regulation A+ Offerings.

During the year ended December 31, 2025,

$1,500,000 was raised through the issuance of 12,500,000 shares of Common Stock through the Regulation A+ Offerings and $6,250 through

a concurrent private placement of 6,250,000 warrants.

In March 2026, the Company raised

$1,553,000 through the sale of 19,200,000 shares of Common Stock through the Regulation A+ Offering and concurrent private placement of

17,000,000 warrants.

proceeds from these offerings have supported critical advancements, including Breakthrough Device designation (December 2023), ongoing

IDE resubmission preparations (with strengthened submission planned by end of Q1 or April 2026), international human therapy data generation

in India, manufacturing diversification (new domestic facility at APEL in Richland, WA, and international site discussions aligned with

Vivos Scientific India LLP (VSIL)), leadership enhancements, intellectual property expansion (e.g., U.S.

12,521,452 B2 issued

January 13, 2026, and additional provisional filings), and substantial growth in the IsoPet® Animal Therapy Division (1,200% year-over-year

increase in administered therapies from 2024 to 2025).

successful qualification, the 2026 Regulation A+ Offering would provide expanded capacity for equity fundraising to further advance RadioGel®

human therapy development (including IDE submission and potential approval for clinical trials), scale IsoPet® commercialization

(targeting breakeven in the Animal Therapy Division in 2026), support VSIL initiatives for local manufacturing and clinical trials in

India, mitigate single-site production risks through multi-facility operations (targeted for 2026 readiness), and pursue broader global

access to the Precision Radionuclide Therapy™ platform in both human and veterinary oncology.

The Company continues to monitor

cash needs closely and explore additional financing avenues as it progresses toward regulatory milestones and operational profitability.

receipt of required regulatory approvals (including potential FDA IDE clearance for human trials) and necessary financing to support

working capital and expansion, the Company plans to transition to greater operational control over key aspects of its supply chain.

the U.S., Vivos is establishing Company-managed production facilities (with Vivos as the manufacturer of record) to produce Y-90 particles,

hydrogel mixtures, and patient doses, while continuing to leverage select contract manufacturing during the transition period through

This approach aims to enhance supply chain resilience, reduce dependencies, and accommodate growing demand in both RadioGel®

(human) and IsoPet® (veterinary) applications.

For international markets, the Company is pursuing direct commercialization pathways

through subsidiaries such as Vivos Scientific India LLP (VSIL), including local manufacturing and regulatory advancement in India, while

remaining open to strategic licensing arrangements, partnerships, or collaborations to accelerate global access and market penetration

for its Precision Radionuclide Therapy™ platform.

the Company intends to consider resuming research on additional products and technologies to improve cancer diagnosis and treatment (e.g.,

expanded PRnT™ indications or PrecisionGel™ applications for other therapeutics).

These goals depend on:

adequate funding (e.g., via the pending 2026 Regulation A+ Offering or other sources);

(ii) obtaining

regulatory approvals for RadioGel® and related brachytherapy products (e.g., FDA IDE

clearance, with submission planned by end of Q1/April 2026);

(iii) successfully

commercializing current products (RadioGel® for humans and IsoPet® for veterinary

use), including scaling adoption and operationalizing new manufacturing facilities in 2026.

on the Company’s financial history since inception, the independent registered public accounting firm has expressed substantial

doubt about the Company’s ability to continue as a going concern.

The Company has limited revenue, nominal cash, and accumulated

significant deficits.

Without sufficient additional capital, the Company may need to delay its business strategy or may be unable to

continue operations.

Management continues to pursue fundraising (including the 2026 Regulation A+ Offering), cost controls, and key milestones—such

as IsoPet® growth and potential breakeven in the Animal Therapy Division in 2026—to address liquidity challenges.

Company’s corporate headquarters are located in Kennewick, Washington (Suite N288, 1030 N.

Center Parkway, Kennewick, WA 99336),

in the Tri-Cities region of Southeast Washington.

The Company continues its marketing efforts in the IsoPet® animal therapy market,

with a focus on expanding nationwide adoption across the U.S.

Following substantial growth in 2025—including a reported 1,200%

year-over-year increase in administered therapies, expansion to 17 certified clinics, and a sharp rise in inbound inquiries from veterinarians

and pet owners—the Company is implementing profitability-focused initiatives starting in Q1 2026.

These include ongoing clinic

certifications (now billing clinics for the process), volume pricing to stimulate broader interest, and efforts to increase exposure,

generate revenue, and scale the network of certified veterinary treatment centers nationwide.

This national expansion builds on the therapy’s

proven safety and efficacy (over 100 treatments with zero reportable serious adverse events) and supports the goal of achieving breakeven

status in the Animal Therapy Division in 2026.

of December 31, 2025, the Company had $1,558,525 in cash on hand.

There are currently commitments to vendors for products and services

To continue the development of the Company’s products, the current level of cash will be insufficient to cover the fixed

and variable obligations of the Company.

Company anticipates allocating proceeds from the Regulation A+ Offerings (including the pending 2026 Regulation A+ Offering) primarily

to advance its core Precision Radionuclide Therapy™ (PRnT™) platform across both veterinary and human applications, while

supporting operational growth, regulatory progress, and manufacturing enhancements.

the Animal Therapy Market (IsoPet®):

marketing and outreach via the Company website, social media, conferences, and publications

to grow the number of certified veterinary clinics (for small animals and equine therapy)

and expand patient treatments.

controlled IsoPet® studies by providing complimentary products in exchange for data and

publications on specific cancers, ensuring broader treatment access for viable candidates.

new regional clinics with licensing, certification training, and therapy demonstrations (including

margin therapy applications).

to volume pricing to drive broader adoption and revenue growth.

the Human Market (RadioGel®):

and diversify production sites (including the new domestic facility in Richland, WA, and

international site discussions aligned with Vivos Scientific India LLP (VSIL)) to mitigate

single-source risks and scale capacity.

the Quality Management System pedigree for regulatory compliance.

automation in product manufacturing processes.

liability insurance for human clinical studies.

human clinical studies and trials in the U.S.

(post-IDE approval) and India (ongoing demonstrations

and expanded DCGI-permitted trials).

and operationalize Vivos Scientific India LLP (VSIL) to support local manufacturing, regulatory

advancement, and commercialization in India.

allocations align with the Company’s priorities of achieving breakeven in the Animal Therapy Division in 2026, securing FDA IDE

clearance (with resubmission targeted for end of Q1/April 2026), diversifying manufacturing (targeting operational facilities in 2026),

and generating additional clinical data to support global commercialization of RadioGel® and IsoPet®.

Actual use may vary based

on regulatory timelines, funding levels, and strategic opportunities.

and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity

and debt securities, including from the Regulation A+ Offerings.

The Company requires additional funding of approximately $3.0 million

annually to maintain operating activities.

Over the next 36 months, the Company believes it will require approximately $9.0 million in

additional capital to:

(i) fund the FDA approval process to conduct human clinical trials;

(ii) conduct Phase I, pilot, clinical trials;

(iii) activate several regional clinics to administer IsoPet ® across the U.S.;

(iv) create an independent production center

within the current production site to create a template for future international manufacturing;

and (v) initiate regulatory approval

processes outside of the United States.

The proceeds raised from the Regulation A+ Offerings were used to fund this development and will

be used to continue such development efforts.

continued deployment of precision radionuclide therapy products and a worldwide regulatory approval effort will require additional resources

and personnel.

The principal variables in the timing and amount of spending for the precision radionuclide therapy products in the next

12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as Class II or

Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies.

the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals

and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products

and the products’ success in the U.S.

and elsewhere.

The Company intends to fund its activities through strategic transactions

such as licensing and partnership agreements or from proceeds raised from the Regulation A+ Offerings.

Company has vendor commitments for products and services, and current cash levels are insufficient to cover fixed and variable obligations

or sustain ongoing product development.

To minimize overhead, the Company has operated with a virtual office for several years and retained

experienced industry consultants on an as-needed basis, allowing Regulation A+ Offering proceeds to focus on strategic objectives such

as regulatory advancement, manufacturing diversification, and therapy commercialization.

is no guarantee that the Company will secure additional funds or do so on favorable terms to stockholders.

financial statements do not include adjustments for the recoverability and classification of liabilities that might be necessary if the

Company cannot continue as a going concern.

Continuation as a going concern depends on generating sufficient cash flow to meet obligations

timely and ultimately achieving profitability.

The independent registered public accounting firm has expressed substantial doubt about

the Company’s ability to continue as a going concern due to limited revenue, nominal cash, and accumulated deficits since inception.

Management plans to pursue additional funding through debt and equity financing (including the pending 2026 Regulation A+ Offering),

enhance operating performance via strategic focus on core products, process efficiencies, and cost structure improvements.

be no assurance of success in raising working capital or achieving profitable operations, and the financial statements include no adjustments

for outcomes of this uncertainty.

Animal Division

Company selected Vista Veterinary Hospital in Kennewick, Washington (Tri-Cities area), as the pilot private clinic for initiating commercial

IsoPet® sales.

This location facilitated close collaboration with Company personnel to refine processes, serving as a model before

national expansion.

Vista has successfully passed multiple audits by the Washington State Department of Health, with the Company working

closely alongside the Department to enhance the radioactive material license by incorporating detailed procedures that benefit future

A second veterinarian at Vista has also been certified.

experience at universities and Vista demonstrates IsoPet®’s effectiveness in ablating cancer tissue near injection sites, performing

best in early-stage tumors before metastasis.

Later-stage cancers are more challenging due to poorly defined tendrils, increasing recurrence

Hopkins University Veterinary Clinical Trials Network (Baltimore, MD) is now a certified IsoPet® regional clinic, holding the required

radioactive material license and completing training.

This partnership supports high-quality data collection across cancer types for

publication in leading journals, boosting awareness and acceptance in the veterinary oncology community.

Johns Hopkins recently completed

a VX2 tumor study in rabbits, confirming IsoPet® (and by extension RadioGel®) safety, with hydrogel retention at the injection

site, activity decay curves, validation of Instructions for Use and Injection Guidance Table, and insights for refining human lymph node

therapy safety and efficacy data from IsoPet® contributed positively to RadioGel®’s Breakthrough Device designation.

of December 31, 2025, the Company has 17 certified regional clinics nationwide, treating feline, canine, equine, and exotic animals:

Veterinary Hospital – Kennewick WA – (Drs.

Michelle Meyer and Jeffrey Goebel)

of Missouri – Columbia MO – (Dr.

Charle Maitz)

Hopkins University – Baltimore MD – (Dr.

Rebecca Krimins)

Creek Veterinary Hospital - Fort Wayne IN – (Dr.

Kevin Cawood)

Animal Hospital - Weare NH – (Dr.

Michael Dutton retiring, Dr.

Jordan Gange)

VETS - Robbinsville, NJ - (Dr.

Diana Sanchez)

Emergency & Specialty Center of Knoxville, Knoxville, NJ (Dr.

Jeffrey Phillips)

Veterinary Hospital, Sumner, WA (Dr.

Vanessa Rizzo)

England Equine Practice – Patterson NY – (Dr.

Bill Bradley)

Equine Clinic – Rochester NH – (Dr.

Michael Myhre)

of Wisconsin School of Veterinary Medicine - (Dr.

of Illinois College of Veterinary Medicine, Urbana, IL (Dr, Kimberly Selting)

Equine Hospital, Navasota, TX (Dr.

Ben Buchanan)

of Florida Large Animal Hospital (Dr.

Diego De Gasperid)

Veterinary Specialists (Drs.

Kevin Drygas, Carl Jehn)

of Florida Small Animal Hospital (Dr.

City Veterinary Surgical Center, El Paso, TX (Dr.

2024, three new dedicated websites were launched:

the corporate site and separate ones for RadioGel® (human) and IsoPet® (veterinary),

featuring user-friendly designs, educational content, and blogs to build authority.

Marketing materials effectively highlight Precision

Radionuclide Therapy™.

2025, the IsoPet® division achieved a reported 1,200% year-over-year increase in administered therapies, with over 100 safe treatments

(zero serious adverse events).

The team staffed booths at six conferences, and LeeAnna Binder conducted nationwide outreach via a modified

Active social media management on Facebook, Instagram, X, and LinkedIn drove engagement and website traffic.

division shifted from data collection to commercialization in 2024–2025, refining pricing for affordability, aligning production

with patient bookings to reduce costs, and implementing volume pricing.

Starting Q1 2026, profitability initiatives include billing clinics

for certification and continued network expansion.

include adding several more regional clinics in 2026 (with interested parties in the pipeline) and participating in at least four conferences

annually to promote IsoPet® for small animal and equine tumors.

The Veterinary Medicine Steering Board advises patient acquisition

This nationwide growth supports the goal of breakeven in the Animal Therapy Division in 2026.

Regulatory Status- Recent Developments

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principal investigators to improve the clinical trial protocol for their Institutional Review Board.

July 2025 we applied for FDA IDE with an application approval containing new India human therapy data.

In FDA August 2025 the FDA declined

approval based on their detailed questions/concerns.

In November 2025 we participated in a Pre-Submission meeting focused on sterilization

to address their comments confirming completion of container closure integrity testing and to introduce the Agency to the Company’s

enhanced Electron Beam (E-Beam) sterilization process for the RadioGel hydrogel to determine their reaction and recommendations.

maximize the probability of IDE approval on the next submission, in October 2025 the Company engaged one of the leading regulatory experts

in the field of brachytherapy and combination radiotherapy devices.

This expert has over 25 years of direct experience guiding such products

through the FDA’s Center for Devices and Radiological Health (CDRH), including prior senior roles within the FDA’s Office

of Device Evaluation.

He has a proven track record of leading successful IDE approvals for multiple Class III implantable radiation devices,

several of which were reviewed by the same Interventional Radiology and Oncology branch currently assigned to RadioGel®.

knowledge of this review team’s expectations, historical precedents, and common deficiency patterns has been instrumental in shaping

the Company’s regulatory strategy.

the IDE is in preparation under this expert’s guidance.

The Company is positioned to incorporate final FDA input and submit the

complete IDE application in the near term (targeted by the end of the first quarter or in April 2026).

This expert’s proven ability

to present complex IDE data in a format that this specific review panel can easily digest and understand has strengthened the submission,

alongside integration of newly available human clinical data, reformatted pre-clinical information, and leveraging veterinary outcomes

from IsoPet® (over 100 therapies with zero reportable serious adverse events).

The Company remains encouraged by the constructive

ongoing dialogue with the FDA and is strongly positioned for IDE approval to advance human clinical trials.

Medical Advisory Board (“ MAB ”) selected 18 applications for RadioGel™, each of which meet the criteria described

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animal testing.

Company requires funding of approximately $3.5 million per year for Selling and General Administration costs and to fund its ongoing

Over the next 36 months, the Company believes it will cost approximately $10 million to:

(1) conduct human clinical trials;

(2) activate several regional clinics to administer IsoPet ® across the county;

(3) create an alternate manufacturing center

based on a template for future international manufacturing.

principal variables in the timing and amount of spending depends on the speed of FDA approval for clinical trials.

The currently approved

1-A Reg A provided a basis for obtaining most of the required investment, assuming there are willing investors.

The Company intends to

reduce its funding requirement via generating income from sales in the animal sector.

of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.

on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed

substantial doubt as to the Company’s ability to continue as a going concern.

The Company has limited revenue, nominal cash, and

has accumulated deficits since inception.

If the Company cannot obtain sufficient additional capital, the Company will be required to

delay the implementation of its business strategy and may not be able to continue operations.

of December 31, 2024, the Company has $2,212,548 cash on hand.

There are currently commitments to vendors for products and services purchased.

To continue the development of the Company’s products, the current level of cash may not be enough to cover the fixed and variable

obligations of the Company.

The company has been utilizing the previously authorized Reg A as the principal vehicle to obtain funding

and intends to continue to bring in the funding necessary to support the projected activities through 2027.

There is no guarantee that

the Company will be able to raise additional funds or to do so at an advantageous price.

Company’s RadioGel™ device has the following product features:

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from Production to Therapy

the next two years, the Company intends to continue to outsource material aspects of manufacturing and distribution.

As future product

volume increases, the Company will reassess its make-buy decision on manufacturing and will analyze the cost/benefit of a centrally located

2025 the Company decided to expand its manufacturing capabilities and to target for on domestic and one international production center.

Several candidates were assessed.

of the Hydrogel

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It is then passed through an ultra-fine filter to ensure sterility.

An alternate process

of E-Beam sterilization was developed and verified.

Limited GDA recommended testing will be conducted next year to obtain FDA approval

for human therapy.

of the Yttrium-90 Phosphate Particles

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The last remaining

animal test has been completed, and the Company is engaged in the detailed sprint revie process.

trials have just initiated in India.

It is anticipated that these data will help accelerate FDA approval in the USA.

are approximately 150 million pet dogs and cats in the United States.

Nearly one-half of dogs and one-third of cats are diagnosed with

cancer at some point in their lifetime.

The Veterinary Oncology & Hematology Center in Norwalk, Connecticut, reports that cancer

is the number one natural cause of death in older cats and dogs, accounting for nearly 50 percent of pet deaths each year.

Veterinary Medical Association reports that half of the dogs ten years or older will die because of cancer.

animal test has been completed, and the Company is engaged in the detailed sprint revie process, and the Company is engaged in the detailed

sprint revie process.

It has recently utilized the pre-submission process and the expertise of a well-respected advisor.

trials have initiated in India.

It is anticipated that these data, when it is restructured and expanded, will help accelerate FDA approval

We have applied for the regulatory approval to complete the remaining designated patients.

United States is home to approximately 163.6 million pet dogs and cats (with recent 2025 estimates from the American Veterinary Medical

Association (the “ AVMA ”) indicating about 87.3 million dogs and 76.3 million cats).

Cancer remains a leading health

concern for these pets:

roughly half of dogs over age 10 and a significant portion of older cats develop cancer, which is the number

one natural cause of death in senior dogs and cats, accounting for nearly 50% of pet deaths in many cases.

The National Cancer Institute

reports that about six million dogs are diagnosed with cancer each year, translating to more than 16,000 a day.

Company’s IsoPet ® operating division focuses on the veterinary oncology market Richard Weller DVM, DACVIM, is now

the Chairman of the Veterinary Medicine Advisory Board.

In addition, John E.

Hendrich, PhD, DVM is a new member.

of the product and application techniques and animal testing is allowed under FDA regulation.

Commercial sales of RadioGel TM for

animals requires confirmation by the FDA Center for Veterinary Medicine (“ CVM ”).

In January 2018, the Center for Veterinary

Medicine Product Classification Group, the entity within the CVM that is responsible for determining the classification of a product,

ruled that RadioGel TM should be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.

Additionally,

after a legal review, the Company believes that the device classification obtained from the FDA Center for Veterinary Medicine is not

limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers, including all or

most all solid tumors in animals.

We expect the result of such classification and label approval will be that no additional regulatory

approvals are necessary for the use of RadioGel TM for the treatment of solid tumors in animals.

The FDA does not have premarket

authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe,

effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.

Company currently intends to utilize university veterinary hospitals for therapy development, given that veterinary hospitals offer superior

and plentiful veterinarians and students, many animal patients, radioactive material handling licenses, and are respected by private

veterinary centers and hospitals.

and veterinary sources estimate that about 6 million dogs are diagnosed with cancer each year (more than 16,000 per day), with similar

high incidence in cats.

development, application techniques, and animal testing for IsoPet® (the veterinary branding of the yttrium-90 based therapy) are

permitted under FDA regulations.

For commercial sales in animals, the FDA’s Center for Veterinary Medicine (CVM) provides classification

In January 2018, the CVM Product Classification Group ruled that RadioGel® (now marketed as IsoPet® for veterinary

use) is classified as a medical device for animal therapy, initially for feline sarcomas and canine soft tissue sarcomas.

legal review, the Company believes this device classification is not strictly limited to those specific sarcomas but can extend to a

broader range of veterinary cancers, including most or all solid tumors in animals.

As veterinary medical devices do not require premarket

approval, notification (e.g., 510(k)), or other premarket authorization from the FDA for commercial distribution in the United States,

IsoPet® is authorized for marketing and use following this classification—provided the product is safe, effective, properly

labeled, and compliant with all applicable laws and regulations.

The FDA exercises no premarket authority over veterinary devices, placing

responsibility on manufacturers to ensure ongoing compliance.

This classification enables the commercial distribution of IsoPet®

for treating solid tumors in animals without additional regulatory approvals.

IsoPet® division reported a 1,200% year-over-year increase in administered therapies from 2024 to 2025, as stated in the Company’s

December 22, 2025, press release.

This growth reflects accelerating nationwide adoption among veterinarians and pet owners seeking a

precise, minimally invasive, and cost-effective alternative to conventional radiation or surgery for solid tumors.

recent months, the Company has observed a significant increase in inbound inquiries from veterinarians and pet owners regarding access

to IsoPet® therapy, indicating growing awareness and demand for this targeted Precision Radionuclide Therapy™ platform.

in Q1 2026, the division is implementing profitability-focused initiatives, including billing clinics for certification training, applying

volume pricing to encourage broader adoption, refining production scheduling for efficiency, and continuing to expand the network of

certified clinics.

date, over 100 IsoPet® treatments have been safely administered across dogs, cats, horses, and exotic animals, with zero reportable

serious adverse events attributable to the product.

This veterinary clinical data supports ongoing commercialization efforts in the Animal

Therapy Division and provides supporting safety and efficacy evidence for the shared yttrium-90 platform in the RadioGel® human program

(including contributions to the Breakthrough Device designation and the pending IDE resubmission).

17 certified clinics operational as of December 31, 2025, and additional interested sites in the pipeline, the Company is positioned

to continue building on this momentum through scaled adoption, operational efficiencies, and strategic outreach (such as conferences,

social media, and publications from case studies).

These efforts support the target of achieving breakeven in the Animal Therapy Division

Company competes in a market characterized by technological innovation, extensive research efforts, and significant competition.

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have been FDA approved including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK.

Company currently subcontracts the manufacturing of RadioGel TM at IsoTherapeutics.

Eckert and Ziegler is the sole supplier

of the Y-90 used by IsoTherapeutics to manufacture the Company’s RadioGel ™ .

The Company obtains supplies, hardware,

handling equipment and packaging from several different U.S.

Eckert and Ziegler previously provided Y-90 to the USA from Germany,

but we now receive the material from their Massachusetts operations.

2024 IsoTherapeutics was acquired by Telix.

That has stimulated Vivos to accelerate its efforts to develop an additional manufacturing

Our objective is to develop more than one alternative to manufacture our components by 2026.

2021, the Company engaged Akina, Inc.

as an alternate supplier of its hydrogel polymer component.

We have now expanded to include SciPoly

as another alternate polymer supplier.

We are completing the actions to expand Akina’s role to be the supplier of sterilized hydrogel,

PrecisionGel TM .

Company anticipates that potential customers for our potential precision radionuclide therapy products likely would include those

institutions and individuals that currently purchase brachytherapy products or other oncology treatment products.

We anticipate that

the veterinarian and medical communities will recognize the Precision Radionuclide Therapy TM as the best option for

treating many solid tumors.

Company currently subcontracts the manufacturing of RadioGel® (and IsoPet®) to its contract manufacturer in Texas (previously

IsoTherapeutics, acquired by Telix Pharmaceuticals in April 2024).

This acquisition prompted the Company to accelerate plans for manufacturing

diversification to reduce dependency on a single provider and enhance supply chain resilience.

& Ziegler serves as the sole supplier of yttrium-90 (Y-90), now sourced from their Massachusetts operations (previously from Germany).

The Company procures additional supplies, hardware, handling equipment, and packaging from various U.S.

address single-source risks, the Company is advancing toward multiple production alternatives targeted for 2026 operational status:

domestic facility where Vivos will act as the manufacturer of record (contract signed for

space at the Applied Process Engineering Laboratory (APEL) in Richland, Washington;

ordered, installation underway, and licensing applications submitted).

international facility (ongoing discussions with experienced radiopharmaceutical contract

manufacturers in India, aligned with Vivos Scientific India LLP (VSIL) activities to reduce

shipping costs and support global access).

Company will continue production with the existing Texas contract manufacturer through Q2 2026 to ensure continuity during the transition.

the hydrogel polymer component (PrecisionGel™), the Company engaged Akina, Inc.

as an alternate supplier in 2021.

Efforts are underway

to further expand Akina’s role to supply sterilized hydrogel (PrecisionGel™), supporting manufacturing scalability and compliance

needs for both RadioGel® (human) and IsoPet® (veterinary) applications.

initiatives—detailed in the February 17, 2026, press release on manufacturing diversification—align with the Company’s

strategy to mitigate supply chain vulnerabilities, accommodate growing demand (particularly in the IsoPet® division), and facilitate

broader commercialization following regulatory progress (e.g., pending IDE resubmission).

Company anticipates that potential customers for its Precision Radionuclide Therapy™ (PRnT™) products—RadioGel®

for human applications and IsoPet® for veterinary use—will primarily include institutions and individuals already utilizing

brachytherapy or other oncology treatments.

For the veterinary market (IsoPet®), this encompasses certified veterinary clinics, university

veterinary hospitals, specialty animal oncology centers, and private practices treating small animals (dogs and cats), equine patients

(horses), and exotic species.

Adoption has accelerated nationwide, with 17 certified regional clinics operational as of December 31,

2025, including academic institutions like the University of Florida (both small and large animal hospitals), Johns Hopkins University

Veterinary Clinical Trials Network, University of Missouri, University of Wisconsin, University of Illinois, and private facilities such

as Vista Veterinary Hospital, NorthStar VETS, and Sun City Veterinary Surgical Center.

These clinics serve pet owners seeking minimally

invasive, targeted alternatives to traditional surgery or external radiation for solid tumors.

human applications (RadioGel®), potential customers would include hospitals, oncology centers, interventional radiologists, and medical

professionals treating non-resectable solid tumors, particularly in challenging anatomical locations.

The therapy’s precision—delivering

localized beta radiation via direct injection while minimizing exposure to healthy tissue—positions it as a compelling option for

institutions focused on advanced radiotherapy.

veterinary and medical communities are expected to recognize Precision Radionuclide Therapy™ as an effective treatment for many

solid tumors, supported by real-world veterinary data (over 100 safe treatments with zero reportable serious adverse events) and ongoing

human demonstrations in India.

Growing inbound inquiries from veterinarians, pet owners, and medical professionals, along with clinic

expansions, publications from case studies, and marketing efforts (e.g., conferences, social media, and dedicated websites), are driving

broader awareness and demand across both markets.

The Company’s strategy emphasizes direct sales to certified clinics (veterinary)

and eventual partnerships or institutional adoption (human), with scalability enhanced by manufacturing diversification targeted for

Company’s present and future intended activities in the development, manufacturing, and sale of cancer therapy products, including

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this purpose.

Inc has applied to Washington state for the manufacturing license to produce IsoPet and RadioGel.

Environmental

4 unchanged sentences

shipping company during shipment and misuse by the treatment facility upon arrival.

operations in APEL have minimal environmental risk and are covered by liability insurance.

2017, the Company has followed the cost-effective model of having had one full-time employee, the CEO.

4 unchanged sentences

enables the Company to operate on very low overhead, for cost-effective utilization of its investment and to manage our work scope like

September 2025 the Company’s brought on a full-time President to assist the CEO in managing the Company which includes expansion

both domestically and internationally.

Company prepares and files annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and certain other

7 unchanged sentences

The content on any website referred to

in this Offering Circular is not incorporated by reference into this Offering Circular, unless (and only to the extent) expressly so

stated herein.

in this Annual Report is not incorporated by reference into this Annual Report, unless (and only to the extent) expressly so stated herein.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business