Vivos Inc 10-K for FY2025
Vivos Inc (RDGL)
About this 10-K
Vivos Inc filed this 10-K on March 31, 2026, covering the fiscal year ended December 31, 2025 (FY2025).
Headline figures
Fiscal year ended December 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $68.38K
- up 144.3% from $28K a year earlier
- Net loss
- $3.07M
- compared with a net loss of $2.91M a year earlier
- Diluted EPS
- -$0.01
- compared with -$0.01 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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most recently completed second fiscal quarter was approximately $
As of March 30, 2026, there were shares of the registrant’s common stock outstanding, 2,071,007 shares of the registrant’s Series A Convertible Preferred Stock outstanding, 363 of the registrant’s Series B Convertible Preferred Stock outstanding and 385,302 of the registrant’s Series C Convertible Preferred Stock outstanding.
VIVOS INC
Report on Form 10-K
TABLE OF CONTENTS
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PART I
FORWARD LOOKING STATEMENTS
Except for statements of historical fact, certain information described in this Annual Report on Form 10-K (“Annual Report”) contains “forward-looking statements” that involve substantial risks and uncertainties. You can identify these statements by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” “will,” “would” or similar words. The statements that contain these or similar words should be read carefully because these statements discuss the Company’s future expectations, including its expectations of its future results of operations or financial position, or state other “forward-looking” information. Vivos Inc. believes that it is important to communicate its future expectations to its investors. However, there may be events in the future that the Company is not able to accurately predict or to control. Further, the Company urges you to be cautious of the forward-looking statements which are contained in this Annual Report because they involve risks, uncertainties and other factors affecting its operations, market growth, service, products, and licenses. The risk factors in the section captioned “Risk Factors” in Item 1A of the Company’s Annual Report, as well as other cautionary language in this Annual Report, describe such risks, uncertainties and events that may cause the Company’s actual results and achievements, whether expressed or implied, to differ materially from the expectations the Company describes in its forward-looking statements. The occurrence of any of the events described as risk factors could have a material adverse effect on the Company’s business, results of operations and financial position.
ITEM 1. BUSINESS.
Vivos Inc. (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.
In 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.
In 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. The 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.
Based 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®” name. 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.
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The 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 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.
The 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. They concluded that the product was safe and effective in killing cancer cells. Colorado State University demonstrated the CT and PET-CT imaging of IsoPet®. The University of Missouri conducted an animal study to treat canine sarcoma. Johns Hopkins University completed a study on VX2 Tumors in Rabbits. Every study confirmed that the Y-90 stayed at the injection site with insignificant distribution outside that boundary.
Commencing in July 2019, the Company recognized its first commercial sale of IsoPet®. A veterinarian from Alaska brought his cat with a re-occurrent spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy, but now the tumor was growing rapidly. He was given a high dose of 400Gy with heavy therapy at the margins.
The 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.
The plan is to incorporate the data assembled from our work with Isopet® in animal therapy to support the Company’s efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell RadioGel® 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 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.
In 2021 the Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical remnant ablation (for example, after prior incomplete radioiodine therapy). Papillary thyroid carcinoma belongs to the general class of head and neck tumors for which tumors are accessible by intraoperative direct needle injection. The Company’s Medical Advisory Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance.
On 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.
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In 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.
Strategic Initiatives
| ● | IDE - In December 2023, the FDA granted RadioGel® Precision Radionuclide Therapy™ the 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.
Over 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.
In 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). This 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.
With this expert’s analysis of FDA feedback patterns, the Company is bolstering its IDE submission by: |
| 1. | Fully addressing all outstanding FDA concerns and adopting a submission format and structure proven effective by regulatory experts for similar devices. | |
| 2. | Incorporating additional information from clinical human data that has become available since the Company’s last IDE submission, further strengthening the evidence package. | |
| 3. | Reformatting and summarizing pre-clinical data in a manner that more directly and effectively addresses the remaining FDA concerns. | |
| 4. | Leveraging 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™ platform. | |
| 5. | Highlighting 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. |
These 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.
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| ● | 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.
In 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. | |
| ● | Animal 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.
The 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. | |
| ● | Alternate 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.
In 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). For the domestic site, Vivos has signed a contract for production space at the Applied Process Engineering Laboratory (APEL) in Richland, Washington. Equipment has been ordered, installation is underway, and licensing applications have been submitted to support operational readiness. 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.
The 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 therapies. | |
| ● | Future 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. |
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Over 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.
This 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. |
| ○ | P-32 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. | |
| ○ | While 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. | |
| ○ | Ac-225 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.
| ● | The 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:
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| PrecisionGel – 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. | ||
| The 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. |
In the second quarter of 2025, we signed a contract with Akina, Inc to sell this polymer. It is now in their catalog. The Company has had recent sales to universities and pharmaceutical companies; we anticipate this will be a slow growing but solid market. The priority remains IDE approval.
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| Duncan 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. |
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Intellectual Property
The 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™) platform.
Trademark Protection continues to expand globally, now covering registrations and applications in 17 countries (with ongoing efforts to broaden this footprint):
The Company owns applications/registrations for the following key marks:
| ○ | ISOPET® | |
| ○ | RADIOGEL® | |
| ○ | ALPHA-GEL™ | |
| ○ | BETA-GEL™ | |
| ○ | GAMMA-GEL™ | |
| ○ | PRECISION RADIONUCLIDE THERAPY™ | |
| ○ | PRECISIONGEL™ | |
| ○ | Peltier Chlller© | |
| ○ | Duncan Chiller™ |
Patent 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.
Key recent milestones include:
| ● | In January 2025, the Company filed an additional provisional patent related to PrecisionGel™. | |
| ● | On 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. | |
| ● | On January 13, 2026, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 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. |
These 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.
Financing and Strategy
In 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”).
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During 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.
Cumulative 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. Patent No. 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).
Upon 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.
Following 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. In 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 Q2 2026. 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.
Long-term, 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:
| (i) | securing 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); and |
| (iii) | successfully commercializing current products (RadioGel® for humans and IsoPet® for veterinary use), including scaling adoption and operationalizing new manufacturing facilities in 2026. |
Based 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.
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The 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.
As of December 31, 2025, the Company had $1,558,525 in 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 will be insufficient to cover the fixed and variable obligations of the Company.
The 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.
For the Animal Therapy Market (IsoPet®):
| ● | Increase 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. |
| ● | Support controlled IsoPet® studies by providing complimentary products in exchange for data and publications on specific cancers, ensuring broader treatment access for viable candidates. |
| ● | Assist new regional clinics with licensing, certification training, and therapy demonstrations (including margin therapy applications). |
| ● | Transition to volume pricing to drive broader adoption and revenue growth. |
For the Human Market (RadioGel®):
| ● | Expand 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. |
| ● | Strengthen the Quality Management System pedigree for regulatory compliance. |
| ● | Initiate automation in product manufacturing processes. |
| ● | Secure liability insurance for human clinical studies. |
| ● | Fund human clinical studies and trials in the U.S. (post-IDE approval) and India (ongoing demonstrations and expanded DCGI-permitted trials). |
| ● | Establish and operationalize Vivos Scientific India LLP (VSIL) to support local manufacturing, regulatory advancement, and commercialization in India. |
These 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.
Research 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.
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The 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. Thereafter, 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.
The 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.
There is no guarantee that the Company will secure additional funds or do so on favorable terms to stockholders.
The 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. There can 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.
IsoPet Animal Division
The 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 clinics. A second veterinarian at Vista has also been certified.
Clinical 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 risk.
Johns 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 treatments.
Animal therapy safety and efficacy data from IsoPet® contributed positively to RadioGel®’s Breakthrough Device designation.
As of December 31, 2025, the Company has 17 certified regional clinics nationwide, treating feline, canine, equine, and exotic animals:
| 1. | Vista Veterinary Hospital – Kennewick WA – (Drs. Michelle Meyer and Jeffrey Goebel) | |
| 2. | University of Missouri – Columbia MO – (Dr. Charle Maitz) | |
| 3. | Johns Hopkins University – Baltimore MD – (Dr. Rebecca Krimins) | |
| 4. | Indian Creek Veterinary Hospital - Fort Wayne IN – (Dr. Kevin Cawood) | |
| 5. | Hopkinton Animal Hospital - Weare NH – (Dr. Michael Dutton retiring, Dr. Jordan Gange) |
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| 6. | NorthStar VETS - Robbinsville, NJ - (Dr. Diana Sanchez) | |
| 7. | Animal Emergency & Specialty Center of Knoxville, Knoxville, NJ (Dr. Jeffrey Phillips) | |
| 8. | Sumner Veterinary Hospital, Sumner, WA (Dr. Vanessa Rizzo) | |
| 9. | New England Equine Practice – Patterson NY – (Dr. Bill Bradley) | |
| 10. | Myhre Equine Clinic – Rochester NH – (Dr. Michael Myhre) | |
| 11. | University of Wisconsin School of Veterinary Medicine - (Dr. Kayla Le) | |
| 12. | University of Illinois College of Veterinary Medicine, Urbana, IL (Dr, Kimberly Selting) | |
| 13. | Brazos Equine Hospital, Navasota, TX (Dr. Ben Buchanan) | |
| 14. | University of Florida Large Animal Hospital (Dr. Diego De Gasperid) | |
| 15. | Capital Veterinary Specialists (Drs. Kevin Drygas, Carl Jehn) | |
| 16. | University of Florida Small Animal Hospital (Dr. Gutti, Dr. Takada) | |
| 17. | Sun City Veterinary Surgical Center, El Paso, TX (Dr. Silverman) |
In 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™.
During 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 IsoPet® van. Active social media management on Facebook, Instagram, X, and LinkedIn drove engagement and website traffic.
The 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.
Objectives 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 strategies. This nationwide growth supports the goal of breakeven in the Animal Therapy Division in 2026.
FDA Regulatory Status- Recent Developments
Human Therapy
In November 2020 the Company submitted a request for a Breakthrough Device Designation. Ultimately, this was denied, but the FDA acknowledged, “The FDA does believe that RadioGel™ meets criterion #2a: Device represents breakthrough technology. Your device does meet this criterion because it is a novel application of a precision radionuclide therapy device outside of the liver.” More importantly, the process resulted in a rapid review of our existing data and approach. It led to a redirection of our efforts on writing the Investigational Device Exemptions (“IDEs”) and saved the Company much time in the review of that future application.
Based on advice from the FDA the Company scheduled a Pre-Submission meeting on November 30, 2021 to discuss a draft of an IDE for Early Feasibility Medical Device Clinical Studies, including certain First in Human (“FIH”) Studies. Using this process results in more rapid feedback to prepare the final IDE.
The FDA was supportive and had suggested this Q-Submission path for rapid turnaround and dialog. The Mayo Clinic physicians did an excellent job presenting the need for Radiogel™ to treat recurrent thyroid cancer and to answer a range of questions from the new FDA review team. The FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry to the Mayo Clinic protocol for clinical testing, and the need for some additional specific testing. They suggested having another Q-Sub Review and conference call dedicated to the details of the dosimetry calculations.
In May of 2022 the Company held another pre-submission meeting with the FDA. They concurred with our dosimetry techniques and requested one more animal test to confirm that the Y-90 stays at the injection site. We participated in another pre-submission meeting to discuss this new animal test of VX-2 tumors in rabbits at Johns Hopkins. We have a meeting scheduled with the FDA in October to obtain their feedback on our new animal test plan.
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We held another pre-submission meeting with the FDA on October 17, 2022 to obtain detailed feedback on the proposed VX-2/Rabbit Animal Test Plan and to submit the Risk Management Report (“RMR”). The RMR analyzed all hypothetical scenarios and concluded that RadioGel is inherently safe.
We participated in pre-submission meetings with the FDA on April 10, 2023, and September 29, 2023, to discuss the preliminary results of the VX2 tumor animal study and to obtain feedback on the genotoxicity protocol.
After providing addition information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication for Use.
Since September 2024 the company has been engaged in the sprint process to discuss several FDA comments in detail. There will continue through February 2024, at which time we will re-submit the request for an IDE. In parallel, the Company is working with the Mayo Clinic’s principal investigators to improve the clinical trial protocol for their Institutional Review Board.
In 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.
To 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®. His in-depth knowledge of this review team’s expectations, historical precedents, and common deficiency patterns has been instrumental in shaping the Company’s regulatory strategy.
Currently, 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.
The Medical Advisory Board (“MAB”) selected 18 applications for RadioGel™, each of which meet the criteria described above. This large number confirms the wide applicability of the device and defines the path for future business growth. The Company’s application establishes a single Indication for Use - treatment of cancerous tissue or solid tumors pathologically associated with locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma.
We anticipate that this initial application will facilitate each subsequent application for additional Indications for Use. After the second Indication for Use, our objective is to apply for a broad Indication for Use which we would target to obtain approval to treat all solid tumors
Radiogel™ Device Designation:
In 2014, the Company submitted a presubmission (Q130140) to obtain FDA feedback about the proposed product. The FDA requested that the Company file a request for designation with the Office of Combination Products (RFD130051), which led to the determination that RadioGel™ is a device for human therapy for non-resectable cancers, which must be reviewed and ultimately regulated by the Center for Devices and Radiological Health (“CDRH”). The Company then submitted a 510(k) notice for RadioGel™ (K133368), which was found Not Substantially Equivalent due to the lack of a suitable predicate, and RadioGel™ was assigned to the Class III product code NAW (microspheres). Class III products or devices are generally the highest risk devices and are therefore subject to the highest level of regulatory review, control, and oversight. Class III products or devices must typically be approved by FDA before they are marketed. Class II devices represent lower risk products or devices than Class III and require fewer regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. In contrast, Class I products and devices are deemed to be lower risk than Class I or II, and are therefore subject to the least regulatory controls.
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A pre-submission meeting (Q140496) was held with the FDA on June 17, 2014, during which the FDA maintained that RadioGel™ should be considered a Class III device and therefore subject to pre-market approval. On December 29, 2014, the Company submitted a de novo petition for RadioGel™ (DEN140043). The de novo petition was denied by the FDA on June 1, 2015, with the FDA providing numerous comments and questions. On September 29, 2015, the Company submitted a follow-up pre-submission informational meeting request with the FDA (Q151569). This meeting took place on November 9, 2015, at which time the FDA indicated acceptance of the Company’s applied dosimetry methods and clarified the FDA’s outstanding questions regarding RadioGel™. Following the November 2015 pre-submission meeting, the Company prepared a new pre-submission package to obtain FDA feedback on the proposed testing methods, intended to address the concerns raised by the FDA staff and to address the suitability of RadioGel™ for de novo reclassification. This pre-submission package was presented to the FDA in a meeting on August 29, 2017. During the August 2017 meeting, the FDA clarified their position on the remaining pre-clinical testing needed for RadioGel™. Specifically, the FDA addressed proposed dosimetry calculating techniques, dosimetry distribution between injections, hydrogel viscoelastic properties, and the details of the Company’s proposed animal testing.
Product Features
The Company’s RadioGel™ device has the following product features:
| ● | Beta particles only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the nearby normal tissues. In medical terms Y-90 beta emitter has a high efficacy rate; | |
| ● | Benefitting from the short penetration distance, the patient can go home immediately with no fear of exposure to family members, and there is a greatly reduced radiation risk to the doctor. A simple plastic tube around the syringe, gloves and safety glasses are all that is required. Other gamma emitting products require much more protection; | |
| ● | A 2.7-day half-life means that only 5% of the radiation remains after ten days. This is in contrast to the industry-standard gamma irradiation product, which has a half-life of 17 days; | |
| ● | The short half-life also means that any medical waste can be stored for thirty days then disposed as normal hospital waste; | |
| ● | RadioGel™ can be administered with small diameter needles (27-gauge) so there is minimal damage to the normal tissue. This contrasts with the injection of metal seeds, which does considerable damage; and | |
| ● | After about 120 days the gel resorbs by a normal biological cycle, called the Krebs Cycle. The only remaining evidence of the treatment are phosphate particles so small in diameter that it requires a high-resolution microscope to find them. This contrasts with permanent presence of metal seeds. |
Steps from Production to Therapy
Device Production
During 2025 the Company decided to expand its manufacturing capabilities and to target for on domestic and one international production center. Several candidates were assessed.
Production of the Hydrogel
RadioGel™ is manufactured with a proprietary process under ventilated sterile hood by following strict Good Management Practices (“GMP”) procedures. It is made in large batches that are frozen for up to three months. When the product is ready to ship, a small quantity of the gel is dissolved in a sterile saline solution. 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.
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Production of the Yttrium-90 Phosphate Particles
The Y-90 particles are produced with simple ingredients via a proprietary process, again following strict GMP procedures. They are then mixed into a phosphate-buffered saline solution. They can be produced in large batches for several shipments. The number of particles per shipment is determined by the dose prescribed by the doctor.
Pre-Mixing – Ready to Use (“RTU”)
The Company now pre-mixes the particle solution and the hydrogel and places the RTU IsoPet® in standard size vials. This innovation is cost effective and reduces the probability of any accidental spills or biological contamination at the therapy sites. It also simplified the certification training for new regional clinics.
Shipment
The vials are shipped inside the specially designed plastic shipping pigs via FedEx or UPS, all following the proper protocols.
At the User
The quantities and activities are in the information on the product label.
The specific injection technique described on the Instructions for Use. For small tumors, one centimeter in diameter or less, the cancer is treated with a single injection. For larger tumors, the cancer is treated with a series of small injections from the same syringe or multiple syringes.
Principal Markets
The Company is currently pursuing two synergistic business sectors, medical and veterinary, each of which are summarized below.
Medical Sector
RadioGel™ is currently fully developed, requiring only FDA approval before commercialization.
Building on the FDA’s ruling of RadioGel™ as a device, the Company incorporated the FDA suggestions and has invested in the pre-clinical testing required for IDE submittal. This included two years of effort on biocompatibility testing. The last remaining 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.
Clinical trials have initiated in India. It is anticipated that these data, when it is restructured and expanded, will help accelerate FDA approval in the USA. We have applied for the regulatory approval to complete the remaining designated patients.
Veterinary Sector
The 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 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.
Product 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 guidance. 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.
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Following 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.
The 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.
In 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. Starting 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.
To 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).
With 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 in 2026.
Competitors
The Company competes in a market characterized by technological innovation, extensive research efforts, and significant competition.
The pharmaceutical and biotechnology industries are intensely competitive and subject to rapid and significant technological changes. Several companies are pursuing the development of pharmaceuticals and products that target the same diseases and conditions that our products target. We cannot predict with accuracy the timing or impact of the introduction of potentially competitive products or their possible effect on our sales. Certain potentially competitive products to our products may be in various stages of development. Also, there may be many ongoing studies with currently marketed products and other developmental products, which may yield new data that could adversely impact the use of our products in their current and potential future Indications for Use. The introduction of competitive products could significantly reduce our sales, which, in turn would adversely impact our financial and operating results.
There are a wide variety of cancer treatments approved and marketed in the U.S. and globally. General categories of treatment include surgery, chemotherapy, radiation therapy and immunotherapy. These products have a diverse set of success rates and side effects. The Company’s Radiogel™ precision radionuclide therapy product would generally compete with brachytherapy devices currently marketed in the U.S. and globally. The traditional iodine-125 (“I-125”) and palladium-103 (“Pd-103”) technologies are well entrenched with powerful market players. The industry-standard I-125-based therapy was developed by Oncura, which is a unit of General Electric Healthcare. Additionally, C.R. Bard, a major industry player competes in the I-125 marketplace. These market competitors are also involved in the distribution of Pd-103 based products. Cs-131 brachytherapy products are marketed by GT MedTech. Several Y-90 therapies have been FDA approved including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK.
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Raw Materials
The 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.
Eckert & 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. suppliers.
To address single-source risks, the Company is advancing toward multiple production alternatives targeted for 2026 operational status:
| ● | One 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; equipment ordered, installation underway, and licensing applications submitted). | |
| ● | One 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). |
The Company will continue production with the existing Texas contract manufacturer through Q2 2026 to ensure continuity during the transition.
For 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.
These 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).
Customers
The 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.
For 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.
The 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 2026.
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Government Regulation
The Company’s present and future intended activities in the development, manufacturing, and sale of cancer therapy products, including RadioGel™, are subject to extensive laws, regulations, regulatory approvals, and guidelines. Within the United States, the Company’s therapeutic radiological devices must comply with the U.S. Federal Food, Drug and Cosmetic Act, which is enforced by FDA. The Company is also required to adhere to applicable FDA Quality System Regulations, also known as the Good Manufacturing Practices, which include extensive record keeping and periodic inspections of manufacturing facilities.
In the United States, the FDA regulates, among other things, new product clearances and approvals to establish the safety and efficacy of these products. We are also subject to other federal and state laws and regulations, including the Occupational Safety and Health Act and the Environmental Protection Act.
The Federal Food, Drug, and Cosmetic Act and other federal statutes and regulations govern or influence the research, testing, manufacture, safety, labeling, storage, record keeping, approval, distribution, use, reporting, advertising, and promotion of such products. Noncompliance with applicable requirements can result in civil penalties, recall, injunction or seizure of products, refusal of the government to approve or clear product approval applications, disqualification from sponsoring or conducting clinical investigations, preventing us from entering government supply contracts, withdrawal of previously approved applications, and criminal prosecution.
In the United States, medical devices are classified into three different categories over which the FDA applies increasing levels of regulation: Class I, Class II, and Class III. Most Class I devices are exempt from premarket notification 510(k); most Class II devices require premarket notification 510(k); and most Class III devices require premarket approval. RadioGel™ is currently classified as a Class III device.
Approval of new Class III medical devices is a lengthy procedure and can take several years and require the expenditure of significant resources. There is a shorter FDA review and clearance process for Class II medical devices, the premarket notification or 510(k) process, whereby a company can market certain Class II medical devices that can be shown to be substantially equivalent to other legally marketed devices.
As a registered medical device manufacturer with the FDA, we are subject to inspection to ensure compliance with FDA’s current Good Manufacturing Practices, or cGMP. These regulations require that we and any of our contract manufacturers design, manufacture, and service products, and maintain documents in a prescribed manner with respect to manufacturing, testing, distribution, storage, design control, and service activities. Modifications or enhancements that could significantly affect the safety or effectiveness of a device or that constitute a major change to the intended use of the device require a new 510(k) premarket notification for any significant product modification.
The Medical Device Reporting regulation requires that we provide information to the FDA on deaths or serious injuries alleged to be associated with the use of our devices, as well as product malfunctions that are likely to cause or contribute to death or serious injury if the malfunction were to recur. Labeling and promotional activities are regulated by the FDA and, in some circumstances, by the Federal Trade Commission.
As a medical device manufacturer, we are also subject to laws and regulations administered by governmental entities at the federal, state, and local levels. For example, our facility is licensed as a medical device manufacturing facility in the State of Washington and is subject to periodic state regulatory inspections. Our customers are also subject to a wide variety of laws and regulations that could affect the nature and scope of their relationships with us.
In the United States, as a manufacturer of medical devices and devices utilizing radioactive byproduct material, we are subject to extensive regulation by not only federal governmental authorities, such as the FDA and FAA, but also by state and local governmental authorities, such as the Washington State Department of Health, to ensure such devices are safe and effective. In Washington State, the Department of Health, by agreement with the federal Nuclear Regulatory Commission (“NRC”), regulates the possession, use, and disposal of radioactive byproduct material as well as the manufacture of radioactive sealed sources to ensure compliance with state and federal laws and regulations. RadioGel™ constitutes both medical devices and radioactive sealed sources and are subject to these regulations.
Moreover, our use, management, and disposal of certain radioactive substances and wastes are subject to regulation by several federal and state agencies depending on the nature of the substance or waste material. We believe that we follow all federal and state regulations for this purpose.
Vivos Inc has applied to Washington state for the manufacturing license to produce IsoPet and RadioGel.
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Environmental Regulation
Our business does not require us to comply with any extraordinary environmental regulations. Our RadioGel™ product is manufactured in an independently owned and operated facility. Any environmental effects or contamination event that could result would be from the shipping company during shipment and misuse by the treatment facility upon arrival.
Future operations in APEL have minimal environmental risk and are covered by liability insurance.
Human Capital
Since 2017, the Company has followed the cost-effective model of having had one full-time employee, the CEO. The Company utilizes several independent contractors to assist with its operations. This includes key positions, such as acting CFO and Quality Assurance Manager. The Company does not have a collective bargaining agreement with any of its personnel and believes its relations with its personnel are good. This enables the Company to operate on very low overhead, for cost-effective utilization of its investment and to manage our work scope like projects.
In 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.
Available Information
The 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 information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov. Moreover, the Company maintains a website at http://www.RadioGel.com that contains important information about the Company, including biographies of key management personnel, as well as information about the Company’s business. This information is publicly available and is updated regularly. The content on any website referred to in this Annual Report is not incorporated by reference into this Annual Report, unless (and only to the extent) expressly so stated herein.
ITEM 1A. RISK FACTORS.
Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this Annual Report, including our financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our securities. The occurrence of any of the events or developments described below could harm our business, financial condition, operating results, and growth prospects. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.
RISKS ASSOCIATED WITH THE COMPANY’S BUSINESS
Our independent registered public accounting firms’ reports on its financial statements questions the Company’s ability to continue as a going concern.
The Company’s independent registered public accounting firms’ reports on the Company’s financial statements for the years ended December 31, 2025 and 2024 express substantial doubt about the Company’s ability to continue as a going concern. The reports include an explanatory paragraph stating that the Company has suffered recurring losses, used significant cash in support of its operating activities and based on its current operating levels, require additional capital or restructuring to sustain its operation for the foreseeable future. There is no assurance that the Company will be able to obtain sufficient additional capital to continue its operations and to alleviate doubt about its ability to continue as a going concern. If the Company obtains additional financing, such funds may not be available on favorable terms and likely would entail considerable dilution to existing shareholders. Any debt financing, if available, may involve restrictive covenants that restrict its ability to conduct its business. It is extremely remote that the Company could obtain any financing on any basis that did not result in considerable dilution for shareholders. Inclusion of a “going concern qualification” in the report of its independent accountants or in any future report may have a negative impact on our ability to obtain debt or equity financing and may adversely impact our stock price.
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A combination of our current financial condition and the United States Food and Drug Administration’s (“FDA”) determinations to date regarding Radiogel™ raise material concerns about ability to continue as a going concern.
The Company will not be able to continue as a going concern unless the Company obtains financing. Depending upon the amount of financing, if any, the Company can obtain, the Company may not receive adequate funds to continue the approval process for RadioGel™ or other precision radionuclide therapy products with the FDA, which would disrupt our business operations or derail our business strategy, and materially and adversely affect our business, financial condition, and results of operations.
The Company has generated operating losses since inception, which are expected to continue, and has increasing cash requirements, which it may be unable to satisfy.
The Company has generated material operating losses since inception. The Company has had recurring net losses since inception which has resulted in an accumulated deficit of $88,427,246 and $85,361,229 as of December 31, 2025 and 2024, respectively, including net losses of $3,066,017 and $2,910,448 for the years ended December 31, 2025 and 2024, respectively. Historically, the Company has relied upon investor funds to maintain its operations and develop its business. The Company needs to raise additional capital from investors for working capital as well as business expansion, and there is no assurance that additional investor funds will be available on terms acceptable to the Company, or at all. If the Company is unable to unable to obtain additional financing to meet its working capital requirements, the Company likely would cease operations.
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 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. Thereafter, 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.
Recent geopolitical events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity in the capital markets, could also impact the Company’s ability to obtain financing and its ability to execute its business plan.
Recent economic events, the inherent instability in global capital markets, as well as the lack of liquidity in the capital markets, could adversely impact the Company’s ability to obtain financing and its ability to execute its business plan, which would materially and adversely affect our business and operations.
The Company has a limited operating history, which may make it difficult to evaluate its business and prospects.
The Company has a limited operating history upon which one can base an evaluation of its business and prospects. As a company in the development stage, there are substantial risks, uncertainties, expenses, and difficulties to which its business is subject. To address these risks and uncertainties, the Company must do the following:
| ● | successfully develop and execute the business strategy; | |
| ● | respond to competitive developments; and | |
| ● | attract, integrate, retain, and motivate qualified personnel. |
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There is no assurance that the Company will achieve or maintain profitable operations or that the Company will obtain or maintain adequate working capital to meet its obligations as they become due. The Company cannot be certain that its business strategy will be successfully developed and implemented or that the Company will successfully address the risks that face its business. If the Company does not successfully address these risks, its business, prospects, financial condition, and results of operations could be materially and adversely affected.
The Company’s products are regulated and require appropriate clearances and approvals to be marketed in the U.S. and globally.
There is no assurance the FDA or other global regulatory authorities will grant the Company permission to market the Company’s precision radionuclide therapy Y-90 RadioGel™ device.
The Company has repeatedly attempted to gain FDA approval for the IDE and obtain clearance for its precision radionuclide therapy Y-90 RadioGelTM device, but no assurances have been received.
The next attempt to submit an IDE request is targeted to be submitted in the near future buttressed by additional animal and human therapy communicated using the recommend format of a well-respected FDA advisor.
On December 23, 2014, the Company announced that it submitted a de novo application to the FDA for marketing clearance for its patented Y-90 RadioGelTM device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic Act (the “Act”). In June 2015, the FDA notified the Company the de novo application was not granted. In February 2014, the FDA found the same device under Section 510(k) of the Act not substantially equivalent and concluded that the device is classified by statute as a Class III medical device, unless the device is reclassified. The Company is seeking reclassification of the product to Class II. If the Company is successful in seeking reconsideration of the Company’s de novo application, as a regulatory matter, the device could be on an easier and faster path to market in the United States. However, there would still be the requirements to complete the in vitro and in vivo testing, and then some human clinical trials. That testing date is submitted in a de novo pre-market application and if accepted we could then go to market. As a practical matter, the Company would still need to secure funding and commercial arrangements before marketing could commence. If the de novo application is declined and if the Company obtains funding to permit it to continue operations, the Company will explore steps toward seeking approval for the device as a Class III medical device. Generally, the time and cost of seeking approval as a Class III medical device is materially greater than the time and cost of seeking approval as a Class II medical device. If the Company seeks approval as a Class III device, human clinical trials will be necessary. Generally, human trials for Class III products are larger, of longer duration and costlier than those for Class II devices.
There will be additional cost and time to reach marketing clearance or approval. Unless the Company obtains sufficient funding, it will be unable to undertake such activities. There can be no assurance that the product will be approved as either a Class II or Class III device by the FDA even if additional data is provided. There can be no assurance that the Company will receive FDA approval, or if it does, the timing thereof.
If the Company is successful in increasing the size of its organization, the Company may experience difficulties in managing growth.
The Company is a small organization with a minimal number of employees. If the Company is successful, it may experience a period of significant expansion in headcount, facilities, infrastructure and overhead and further expansion may be required to address potential growth and market opportunities. Any such future growth will impose significant added responsibilities on members of management, including the need to improve the Company’s operational and financial systems and to identify, recruit, maintain and integrate additional managers. The Company’s future financial performance and its ability to compete effectively will depend, in part, on the ability to manage any future growth effectively.
The Company’s business is dependent upon the continued services of the Company’s Chief Executive Officer, Michael Korenko. Should the Company lose the services of Dr. Korenko, the Company’s operations will be negatively impacted.
The Company’s business is dependent upon the expertise of its Chief Executive Officer, Michael Korenko. Dr. Korenko is essential to the Company’s operations. Accordingly, an investor must rely on Dr. Korenko’s management decisions that will continue to control the Company’s business affairs. The Company does not maintain life insurance on Dr. Korenko’s life. The loss of the services of Dr. Korenko would have a material adverse effect upon the Company’s business.
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To mitigate this risk Dr. Korenko has been working with two internal candidates with the potential to seamlessly assume authority. Both David Swanberg, Chief Operating Officer of the Company, and Brad Weeks, President of the Company, have been identified as high potential candidates to succeed Dr. Korenko. See “Directors, Executive Officers and Significant Consultants” on page 36.
The Company is heavily dependent on consultants for many of the services necessary to continue operations. The loss of any of these consultants could have a material adverse effect on the Company’s business, results of operations and financial condition.
The Company’s success is heavily dependent on the continued active participation of certain consultants and collaborating scientists. Loss of the services of any one or more of its consultants could have a material adverse effect upon the Company’s business, results of operations and financial condition.
If the Company is unable to hire and retain additional qualified personnel, the business and financial condition may suffer.
The Company’s success and achievement of its growth plans depend on its ability to recruit, hire, train and retain highly qualified technical, scientific, regulatory, and managerial employees, consultants, and advisors. Competition for qualified personnel among pharmaceutical and biotechnology companies is intense, and an inability to attract and motivate additional highly skilled personnel required for the expansion of the Company’s activities, or the loss of any such persons, could have a material adverse effect on its business, results of operations and financial condition.
The Company’s revenues have historically been derived from sales made to a small number of customers. The Company has discontinued prior operations related to its core business. To succeed, we will need to recommence our operations and achieve sales to a materially larger number of customers.
The Company’s revenues relate to their commercializing of its products and procedures performed. The Company had $68,379 and $27,995 in operating revenues, net of discounts, and the years ended December 31, 2025 and 2024, respectively
Many of the Company’s competitors have greater resources and experience than the Company has.
Many of the Company’s competitors have greater financial resources, longer history, broader experience, greater name recognition, and more substantial operations than the Company has, and they represent substantial long-term competition for us. The Company’s competitors may be able to devote more financial and human resources than the Company can to research, new product development, regulatory approvals, and marketing and sales. The Company’s competitors may develop or market products that are viewed by customers as more effective or more economical than the Company’s products. There is no assurance that the Company will be able to compete effectively against current and future competitors, and such competitive pressures may adversely affect the Company’s business and results of operations.
The Company’s future revenues depend upon acceptance of its current and future products in the markets in which they compete.
The Company’s future revenues depend upon receipt of financing, regulatory approval and the successful production, marketing, and sales of the various isotopes the Company might market in the future. The rate and level of market acceptance of each of these products, if any, may vary depending on the perception by physicians and other members of the healthcare community of its safety and efficacy as compared to that of any competing products; the clinical outcomes of any patients treated; the effectiveness of its sales and marketing efforts in the United States, Europe, Far East, Middle East, and Russia; any unfavorable publicity concerning its products or similar products; the price of the Company’s products relative to other products or competing treatments; any decrease in current reimbursement rates from the Centers for Medicare and Medicaid Services or third-party payers; regulatory developments related to the manufacture or continued use of its products; availability of sufficient supplies to either purchase or manufacture its products; its ability to produce sufficient quantities of its products; and the ability of physicians to properly utilize its products and avoid excessive levels of radiation to patients. Any material adverse developments with respect to the commercialization of any such products may adversely affect revenues and may cause the Company to continue to incur losses in the future.
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The Company currently relies on a single supplier for Y-90 particles, and that supplier is the only supplier in the United States. An inability to procure Y-90 particles will materially harm the Company’s business.
There is only one supplier of Y-90 particles in the United States, requiring us to rely entirely on this supplier to provide the Y-90 particles needed to produce RadioGelTM. If we are unable to obtain a sufficient supply of Y-90 particles, we will not be able to proceed with our development of RadioGelTM and our business would be materially harmed.
Eckert and Ziegler is the sole supplier of the Y-90 particles used by IsoTherapeutics and is the only supplier of Y-90 particles in the United States. In the event Eckert & Ziegler is unable to satisfy our supply requirements or stope producing Y-90 particles, we will be unable to continue with development of RadioGel™ and our business would be materially harmed.
The Company relies on a sole manufacturing contact with IsoTherapeutics.
The Company currently relies on a single contract manufacturer in Texas (previously IsoTherapeutics, acquired by Telix Pharmaceuticals in April 2024) for the production of RadioGel® and IsoPet®, including the yttrium-90 (Y-90) phosphate particles and their integration with sterile hydrogel to create individual patient doses. This arrangement has been identified as a risk factor in prior corporate filings due to potential single-source vulnerabilities.
To mitigate these risks and support scalable growth, the Company is actively diversifying its manufacturing base. For the domestic side, Vivos has signed a contract for production space at the Applied Process Engineering Laboratory (APEL) in Richland, Washington, where the Company will serve as the manufacturer of record. Equipment has been ordered, installation is underway, and licensing applications have been submitted to enable operational readiness.
For international production, the Company is in ongoing discussions with experienced radiopharmaceutical contract manufacturers in India, aligned with the activities of Vivos Scientific India LLP (VSIL), to establish a second facility. These efforts aim to reduce shipping costs, improve logistical efficiency, and expand global market access for both RadioGel® (human) and IsoPet® (veterinary) therapies.
The Company’s strategic target is to have one domestic production facility (with Vivos as manufacturer of record) and one international production facility operational in 2026. Production with the existing Texas contract manufacturer will continue through Q2 2026 to ensure continuity during the transition.
In parallel, the Company has secured alternate suppliers for the hydrogel polymer component (PrecisionGel™), including Akina, Inc. (engaged in 2021 and expanding to supply sterilized hydrogel) and SciPoly. For particle production, Vivos is actively assessing both domestic and international candidates to develop additional alternatives beyond the current arrangement. These diversification steps—announced in the February 17, 2026, press release—address sole-source dependencies, accommodate increasing demand (particularly in the IsoPet® division), and support broader commercialization following regulatory advancements.
The Company will rely heavily on a limited number of suppliers for the foreseeable future.
Some of the products the Company might market, and components thereof, are currently available only from a limited number of suppliers, several of which are international suppliers. Failure to obtain deliveries from these sources would have a material adverse effect on the Company’s ability to operate.
The Company may incur material losses and costs because of product liability claims that may be brought against it.
The Company faces an inherent business risk of exposure to product liability claims if products supplied by the Company fail to perform as expected or such products result, or is alleged to result, in bodily injury. Any such claims may also result in adverse publicity, which could damage the Company’s reputation by raising questions about the safety and efficacy of its products and could interfere with its efforts to market its products. A successful product liability claim against the Company more than its available insurance coverage or established reserves may have a material adverse effect on its business. Although the Company currently maintains liability insurance in amounts it believes are commercially reasonable, any product liability the Company may incur may exceed its insurance coverage.
The Company is subject to the risk that certain third parties may mishandle the Company’s products.
If the Company markets products, the Company likely will rely on third parties, such as commercial air courier companies, to deliver the products, and on other third parties to package the products in certain specialized packaging forms requested by customers. The Company thus would be subject to the risk that these third parties may mishandle its product, which could result in material adverse effects, particularly given the radioactive nature of some of the products.
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The Company is subject to uncertainties regarding reimbursement for use of its products.
Hospitals and freestanding clinics may be less likely to purchase the Company’s products if they cannot be assured of receiving favorable reimbursement for treatments using its products from third-party payers, such as Medicare and private health insurance plans. Third-party payers are increasingly challenging the pricing of certain medical services or devices, and there is no assurance that they will reimburse the Company’s customers at levels sufficient for it to maintain favorable sales and price levels for the Company’s products. There is no uniform policy on reimbursement among third-party payers, and there is no assurance that the Company’s products will continue to qualify for reimbursement from all third-party payers or that reimbursement rates will not be reduced. A reduction in or elimination of third-party reimbursement for treatments using the Company’s products would likely have a material adverse effect on the Company’s revenues.
The Company’s future growth is largely dependent upon its ability to develop new technologies that achieve market acceptance with appropriate margins.
The Company’s business operates in global markets that are characterized by rapidly changing technologies and evolving industry standards. Accordingly, future growth rates depend upon several factors, including the Company’s ability to (i) identify emerging technological trends in the Company’s target end-markets, (ii) develop and maintain competitive products, (iii) enhance the Company’s products by adding innovative features that differentiate the Company’s products from those of its competitors, and (iv) develop, manufacture, and bring products to market quickly and cost-effectively. The Company’s ability to develop new products based on technological innovation can affect the Company’s competitive position and requires the investment of significant resources. These development efforts divert resources from other potential investments in the Company’s business, and they may not lead to the development of new technologies or products on a timely basis or that meet the needs of the Company’s customers as fully as competitive offerings. In addition, the markets for the Company’s products may not develop or grow as it currently anticipates. The failure of the Company’s technologies or products to gain market acceptance due to more attractive offerings by the Company’s competitors could significantly reduce the Company’s revenues and adversely affect the Company’s competitive standing and prospects.
The Company may rely on third parties to represent it locally in the marketing and sales of its products in international markets and its revenue may depend on the efforts and results of those third parties.
The Company’s future success may depend, in part, on its ability to enter and maintain collaborative relationships with one or more third parties, the collaborator’s strategic interest in the Company’s products and the Company’s products under development, and the collaborator’s ability to successfully market and sell any such products.
The Company intends to pursue collaborative arrangements regarding the marketing and sales of its products; however, it may not be able to establish or maintain such collaborative arrangements, or if it is able to do so, the Company’s collaborators may not be effective in marketing and selling its products. To the extent that the Company decides not to, or is unable to, enter collaborative arrangements with respect to the sales and marketing of its products, significant capital expenditures, management resources and time will be required to establish and develop an in-house marketing and sales force with technical expertise. To the extent that the Company depends on third parties for marketing and distribution, any revenues received by the Company will depend upon the efforts and results of such third parties, which may or may not be successful.
The Company may pursue strategic acquisitions that may have an adverse impact on its business.
Executing the Company’s business strategy may involve pursuing and consummating strategic transactions to acquire complementary businesses or technologies. In pursuing these strategic transactions, even if the Company does not consummate them, or in consummating such transactions and integrating the acquired business or technology, the Company may expend significant financial and management resources and incur other significant costs and expenses. There is no assurance that any strategic transactions will result in additional revenues or other strategic benefits for the Company’s business. The Company may issue shares of the Company’s stock as consideration for acquisitions, joint ventures or other strategic transactions, and the use of stock as purchase consideration could dilute the interests of its current stockholders. In addition, the Company may obtain debt financing in connection with an acquisition. Any such debt financing may involve restrictive covenants relating to capital-raising activities and other financial and operational matters, which may make it more difficult for the Company to obtain additional capital and pursue business opportunities, including potential acquisitions. In addition, such debt financing may impair the Company’s ability to obtain future additional financing for working capital, capital expenditures, acquisitions, general corporate or other purposes, and a substantial portion of cash flows, if any, from the Company’s operations may be dedicated to interest payments and debt repayment, thereby reducing the funds available to the Company for other purposes.
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The Company will need to hire additional qualified accounting personnel in order to remediate a material weakness in its internal control over financial accounting, and the Company will need to expend any additional resources and efforts that may be necessary to establish and to maintain the effectiveness of its internal control over financial reporting and its disclosure controls and procedures.
As a public company, the Company is subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, and the Sarbanes-Oxley Act of 2002. The Company’s management is required to evaluate and disclose its assessment of the effectiveness of the Company’s internal control over financial reporting as of each year-end, including disclosing any “material weakness” in the Company’s internal control over financial reporting. A material weakness is a control deficiency, or combination of control deficiencies, that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected. As a result of its assessment, management has determined that there is a material weakness due to the lack of segregation of duties and, due to this material weakness, management concluded that, as of December 31, 2025 and 2024, the Company’s internal control over financial reporting was ineffective. This material weakness has the potential of adversely impacting the Company’s financial reporting process and the Company’s financial reports. Because of this material weakness, management also concluded that the Company’s disclosure controls and procedures were ineffective as of December 31, 2025 and 2024. The Company has engaged the services of both internal accounting and tax providers to resolve this material weakness. The Company also will need to expend any additional resources and efforts that may be necessary to establish and to maintain the effectiveness of the Company’s internal control over financial reporting and disclosure controls and procedures.
The Company’s patented or other technologies may infringe on other patents, which may expose us to costly litigation.
It is possible that the Company’s patented or other technologies may infringe on patents or other rights owned by others. The Company may have to alter its products or processes, pay licensing fees, defend infringement actions or challenge the validity of the patents in court, or cease activities altogether because of patent rights of third parties, thereby causing additional unexpected costs and delays to the Company. Patent litigation is costly and time consuming, and the Company may not have sufficient resources to pursue such litigation. If the Company does not obtain a license under such patents, if it is found liable for infringement, or if it is not able to have such patents declared invalid, the Company may be liable for significant money damages, may encounter significant delays in bringing products to market or may be precluded from participating in the manufacture, use or sale of products or methods of treatment requiring such licenses.
Protecting the Company’s intellectual property is critical to its innovation efforts.
The Company owns or has a license to use several U.S. and foreign patents and patent applications, trademarks, and copyrights. The Company’s intellectual property rights may be challenged, invalidated, or infringed upon by third parties, or it may be unable to maintain, renew or enter new licenses of third party proprietary intellectual property on commercially reasonable terms. In some non-U.S. countries, laws affecting intellectual property are uncertain in their application, which can adversely affect the scope or enforceability of the Company’s patents and other intellectual property rights. Any of these events or factors could diminish or cause the Company to lose the competitive advantages associated with the Company’s intellectual property, subject the Company to judgments, penalties, and significant litigation costs, or temporarily or permanently disrupt its sales and marketing of the affected products or services.
The Company may not be able to protect its trade secrets and other unpatented proprietary technology, which could give competitors an advantage.
The Company relies upon trade secrets and other unpatented proprietary technology. The Company may not be able to adequately protect its rights about such unpatented proprietary technology, or competitors may independently develop substantially equivalent technology. The Company seeks to protect trade secrets and proprietary knowledge, in part through confidentiality agreements with its employees, consultants, advisors and collaborators. Nevertheless, these agreements may not effectively prevent disclosure of the Company’s confidential information and may not provide the Company with an adequate remedy in the event of unauthorized disclosure of such information, and as result the Company’s competitors could gain a competitive advantage.
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The Company is subject to extensive government regulation in jurisdictions around the world in which it does business. Regulations address, among other things, environmental compliance, import/export restrictions, healthcare services, taxes and financial reporting, and those regulations can significantly increase the cost of doing business, which in turn can negatively impact operations, financial results, and cash flow.
If the Company is successful in developing manufacturing capability, the Company will be subject to extensive government regulation and intervention both in the U.S. and in all foreign jurisdictions in which it conducts business. Compliance with applicable laws and regulations will result in higher capital expenditures and operating costs, and changes to current regulations with which the Company complies can necessitate further capital expenditures and increases in operating costs to enable continued compliance. Additionally, from time to time, the Company may be involved in proceedings under certain of these laws and regulations. Foreign operations are subject to political instabilities, restrictions on funds transfers, import/export restrictions, and currency fluctuation.
RISKS RELATED TO THE COMPANY’S COMMON STOCK
The Company’s common stock is currently quoted on the OTCQB Marketplace. Failure to develop or maintain a more active trading market may negatively affect the value of the Company’s common stock, may deter some potential investors from purchasing the Company’s common stock or other equity securities, and may make it difficult or impossible for stockholders to sell their shares of common stock.
The Company’s average daily volume of shares traded for the years ended December 31, 2025 and 2024 was 1,085,874 and 1,268,973, respectively. Failure to develop or maintain an active trading market may negatively affect the value of the Company’s common stock, may make some potential investors unwilling to purchase the Company’s common stock or equity securities that are convertible into or exercisable for the Company’s common stock, and may make it difficult or impossible for the Company’s stockholders to sell their shares of common stock and recover any part of their investment.
The Company’s outstanding securities, the stock or other securities that it may become obligated to issue under existing agreements, and certain provisions of those securities, may cause immediate and substantial dilution to existing stockholders and may make it more difficult to raise additional equity capital.
The Company had 455,494,238 shares of common stock outstanding as of December 31, 2025. The Company also had outstanding on that date dilutive securities consisting of preferred stock, restricted stock units, options, and warrants (collectively, “Common Stock Equivalents”) that if they had been exercised and converted in full on December 31, 2025, would have resulted in the issuance of up to 81,927,379 additional shares of common stock. The issuance of shares upon the exercise of the Common Stock Equivalents may result in substantial dilution to each stockholder by reducing that stockholder’s percentage ownership of the Company’s total outstanding shares of common stock. The issuance of some or all those warrants and any exercise of those warrants will have the effect of further diluting the percentage ownership of the Company’s other stockholders.
Future sales of the Company’s securities, including sales following exercise or conversion of derivative securities, or the perception that such sales may occur, may depress the price of common stock, and could encourage short sales.
The sale or availability for sale of substantial amounts of the Company’s shares in the public market, including shares issuable upon exercise of the Common Stock Equivalents, or the perception that such sales may occur, may adversely affect the market price of the Company’s common stock. Any decline in the price of the Company’s common stock may encourage short sales, which could place further downward pressure on the price of the Company’s common stock.
The Company’s stock price is likely to be volatile.
For the year ended December 31, 2025, the reported low closing price for the Company’s common stock was $0.055 per share, and the reported high closing price was $0.1634 per share. For the year ended December 31, 2024, the reported low closing price for the Company’s common stock was $0.049 per share, and the reported high closing price was $0.255 per share. There is generally significant volatility in the market prices, as well as limited liquidity, of securities of early-stage companies, particularly early-stage medical product companies. Contributing to this volatility are various events that can affect the Company’s stock price in a positive or negative manner. These events include, but are not limited to: governmental approvals, refusals to approve, regulations or other actions; market acceptance and sales growth of the Company’s products; litigation involving the Company or the Company’s industry; developments or disputes concerning the Company’s patents or other proprietary rights; changes in the structure of healthcare payment systems; departure of key personnel; future sales of its securities; fluctuations in its financial results or those of companies that are perceived to be similar to us; investors’ general perception of us; and general economic, industry and market conditions. If any of these events occur, it could cause the Company’s stock price to fall, and any of these events may cause the Company’s stock price to be volatile.
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The Company’s common stock is subject to the “Penny Stock” rules of the SEC and the trading market in its securities is limited, which makes transactions in its common stock cumbersome and may reduce the value of an investment in the Company’s stock.
The SEC has adopted Rule 3a51-1, which establishes the definition of a “penny stock,” for the purposes relevant to us, as any equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject to certain exceptions. For any transaction involving a penny stock, unless exempt, Rule 15g-9 requires that a broker or dealer approve a person’s account for transactions in penny stocks and that the broker or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased.
To approve a person’s account for transactions in penny stocks, the broker or dealer must obtain financial information and investment experience and objectives of the person and must make a reasonable determination that the transactions in penny stocks are suitable for that person and that the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.
The broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to the penny stock market, which sets forth the basis on which the broker or dealer made the suitability determination, and that the broker or dealer received a signed, written agreement from the investor prior to the transaction.
Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more difficult for investors to dispose of the Company’s common stock and may cause a decline in the market value of its stock.
Disclosure also must be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies available to an investor in cases of fraud in penny stock transactions. Finally, monthly statements must be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.
As a result of the Company issuing preferred stock, the rights of holders of the Company’s common stock and the value of the Company’s common stock may be adversely affected.
The Company’s Board of Directors is authorized to issue classes or series of preferred stock, without any action on the part of the stockholders. The Company’s Board of Directors also has the power, without stockholder approval, to set the terms of any such classes or series of preferred stock, including voting rights, dividend rights and preferences over the common stock with respect to dividends or upon the liquidation, dissolution, or winding-up of its business, and other terms. The Company has issued preferred stock that has a preference over the common stock with respect to the payment of dividends or upon liquidation, dissolution, or winding-up, and with respect to voting rights. In accordance with that and with the issuance of preferred stock, our common stockholders voting rights have been diluted and it is possible that the rights of holders of the common stock or the value of the common stock have been adversely affected.
The Company does not expect to pay any dividends on common stock for the foreseeable future.
The Company has not paid any cash dividends on its common stock to date and does not anticipate it will pay cash dividends on its common stock in the foreseeable future. Accordingly, stockholders must be prepared to rely on sales of their common stock after price appreciation to earn an investment return, which may never occur. Any determination to pay dividends in the future will be made at the discretion of the Company’s board of directors and will depend on the Company’s results of operations, financial conditions, contractual restrictions, restrictions imposed by applicable law, and other factors that the Company’s board deems relevant.
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GENERAL RISK FACTORS
Volatility in raw material and energy costs, interruption in ordinary sources of supply, and an inability to recover from unanticipated increases in energy and raw material costs could result in lost sales or could increase significantly the cost of doing business.
Market and economic conditions affecting the costs of raw materials, utilities, energy costs, and infrastructure required to provide for the delivery of the Company’s products and services are beyond the Company’s control. Any disruption or halt in supplies, or rapid escalations in costs, could adversely affect the Company’s ability to manufacture products or to competitively price the Company’s products in the marketplace. To date, the ultimate impact of energy costs increases has been mitigated through price increases or offset through improved process efficiencies; however, continuing escalation of energy costs could have a negative impact upon the Company’s business and financial performance.
General economic conditions in markets in which the Company does business can impact the demand for the Company’s goods and services. Decreased demand for the Company’s products and services could have a negative impact on its financial performance and cash flow.
Demand for the Company’s products and services, in part, depends on the general economic conditions affecting the countries and industries in which the Company does business. A downturn in economic conditions in a country or industry that the Company serves may adversely affect the demand for the Company’s products and services, in turn negatively impacting the Company’s operations and financial results. Further, changes in demand for the Company’s products and services can magnify the impact of economic cycles on the Company’s businesses. Unanticipated contract terminations by customers can negatively impact operations, financial results and cash flow. The Company’s earnings, cash flow and financial position are exposed to financial market risks worldwide, including interest rate and currency exchange rate fluctuations and exchange rate controls. Fluctuations in domestic and world financial markets could adversely affect interest rates and impact the Company’s ability to obtain credit or attract investors.
ITEM 1B. UNRESOLVED STAFF COMMENTS.
This item is not applicable to the Company because the Company is a smaller reporting company as defined by Rule 12b-2 under the Securities Exchange Act of 1934.
ITEM 1C. CYBERSECURITY
Risk Management and Strategy
In
2024, we were part of an elaborate phishing scam that resulted in a loss. As a result, we enabled additional cybersecurity procedures
to mitigate any further losses. Other than this one incident,
Governance
ITEM 2. PROPERTIES.
The Company is headquartered in Kennewick, Washington. Our Chief Executive Officer currently works from his home office in virtual communication with key personnel. Cadwell Laboratories, which is controlled by Carl Cadwell, a director of the Company, provides office space to management on an as-needed basis until such time as the Company leases permanent office space. Management believes that the Company’s sites are adequate to support the business and suitable for present purposes, and the properties and equipment have been well maintained.
ITEM 3. LEGAL PROCEEDINGS.
The Company may, from time to time, be involved in various legal proceedings incidental to the conduct of our business. Historically, the outcome of all such legal proceedings has not, in the aggregate, had a material adverse effect on our business, financial condition, results of operations or liquidity. There are no material pending or threatened legal proceedings at this time.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
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PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Market Information
The Company’s common stock is traded on the OTCQB Marketplace under the symbol “RDGL.” The following table sets forth, in U.S. dollars, the high and low closing prices for each of the calendar quarters indicated, as reported by the OTCQB Marketplace, for the past two fiscal years. Such OTCQB Marketplace quotations reflect inter-dealer prices, without markup, markdown or commissions and, particularly because our common stock is traded infrequently, may not necessarily represent actual transactions or a liquid trading market.
| High | Low | |||||||
| 2025 | ||||||||
| Quarter ended December 31 | $ | 0.0919 | $ | 0.055 | ||||
| Quarter ended September 30 | $ | 0.1446 | $ | 0.0785 | ||||
| Quarter ended June 30 | $ | 0.149 | $ | 0.0959 | ||||
| Quarter ended March 31 | $ | 0.1634 | $ | 0.108 | ||||
| 2024 | ||||||||
| Quarter ended December 31 | $ | 0.1766 | $ | 0.0707 | ||||
| Quarter ended September 30 | $ | 0.1925 | $ | 0.085 | ||||
| Quarter ended June 30 | $ | 0.248 | $ | 0.078 | ||||
| Quarter ended March 31 | $ | 0.076 | $ | 0.05 | ||||
Holders
As of March 30, 2026, we had 482,688,356 shares of common stock, par value $0.001 per share, issued and outstanding, which were held by approximately 232 shareholders of record. Our transfer agent is Pacific Stock Transfer, 6725 Via Austi Pkwy, Suite 300, Las Vegas, NV 89119.
Securities Authorized for Issuance Under Equity Compensation Plans
The following table sets forth information as of December 31, 2025 with respect to the Company’s equity compensation plans previously approved by stockholders and equity compensation plans not previously approved by stockholders.
| Equity Compensation Plan Information | ||||||||||||
| Plan Category | Number of securities to be issued upon exercise of outstanding options, warrants and rights | Weighted-average exercise price of outstanding options, warrants and rights | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) | |||||||||
| (a) | (b) | (c) | ||||||||||
| Equity compensation plans approved by stockholders | 25,777,500 | $ | 0.09 | 32,836,047 | ||||||||
| Equity compensation plans not approved by stockholders | 34,115,309 | $ | 0.07 | - | ||||||||
| Total | 34,115,309 | (1) | $ | 0.07 | (1) | - | ||||||
| (1) | In addition to the 2015 Plan (defined below), the Company has individual compensation arrangements under which equity securities are authorized for issuance in exchange for consideration in the form of goods or services of certain individuals. |
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Recent Sales of Unregistered Securities
Below is a description of all unregistered securities issued by the Company during and subsequent to the quarter ended December 31, 2025, through the date of this report. Each of the issuances identified below were issued in transactions exempt from registration under the Securities Act of 1933, as amended, in reliance on Section 3(a)(9) and/or 4(2) thereof.
Issuances During the Quarter Ended December 31, 2025
In December 2025, the Company issued 329,281 shares of Common Stock for services rendered in the amount of $22,687 and issued 500,000 shares of Common Stock upon the vesting of RSUs.
Issuances Subsequent to December 31, 2025
In January 2026, the Company issued 44,118 shares of common stock for services rendered.
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.
ITEM 6. [RESERVED]
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion and analysis is intended as a review of significant factors affecting the Company’s financial condition and results of operations for the periods indicated. The discussion should be read in conjunction with the Company’s financial statements and the notes presented herein. In addition to historical information, the following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements that involve risks and uncertainties. The Company’s actual results could differ significantly from those anticipated in these forward-looking statements as a result of the risk factors set forth above in Item 1A and other factors discussed in this Annual Report.
Results of Operations
Comparison for the Year Ended December 31, 2025 and December 31, 2024
The following table sets forth information from our statements of operations for the years ended December 31, 2025 and 2024:
| Year Ended December 31, 2025 | Year Ended December 31, 2024 | |||||||
| Revenues | $ | 68,379 | $ | 27,995 | ||||
| Cost of goods sold | 128,134 | 30,979 | ||||||
| Gross loss | (59,755 | ) | (2,984 | ) | ||||
| Operating expense | (3,105,292 | ) | (2,601,400 | ) | ||||
| Operating loss | (3,165,047 | ) | (2,604,384 | ) | ||||
| Non-operating expense | 99,030 | (306,064 | ) | |||||
| Net loss | $ | (3,066,017 | ) | $ | (2,910,448 | ) | ||
Revenues and Cost of Goods Sold
Revenue was $68,379 and $27,995 for the years ended December 31, 2025 and 2024, respectively. All revenue recognized in the years ended December 31, 2025 and 2024 relate to the procedures performed with respect to the IsoPet® therapies, sales of IsoPet®and freight. In 2025, we recognized revenue for the licensing and certification of clinics approximating $27,000.
Management does not anticipate that the Company will generate sufficient revenue to sustain operations until such time as the Company secures multiple revenue-generating arrangements with respect to RadioGel™ and/or any of our other brachytherapy technologies.
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Commencing in 2025, the Company had started ordering Hydrogel to use in more than one treatment. This is anticipated to increase the number of treatments that can be handled in a particular clinic monthly. As a result, we have inventory built up that when used will increase our cost of goods sold over time.
Operating Expense
Operating expense for the years ended December 31, 2025 and 2024, respectively, consisted of the following:
| Year Ended December 31, 2025 | Year Ended December 31, 2024 | |||||||
| Professional fees, including stock-based compensation | $ | 2,039,407 | $ | 1,682,350 | ||||
| Payroll expense | 417,097 | 352,597 | ||||||
| Research and development expense | 352,232 | 324,629 | ||||||
| General and administrative expense | 296,556 | 241,824 | ||||||
| Total operating expense | $ | 3,105,292 | $ | 2,601,400 | ||||
Operating expense for the years ended December 31, 2025 and 2024 was $3,105,292 and $2,601,400, respectively. The increase in operating expense from 2024 to 2025 can be attributed to the increase in professional fees ($1,682,350 for the year ended December 31, 2024 compared to $2,039,407 for the year ended December 31, 2025) related to the fees incurred for the consultants engaged in 2025 versus 2024, including: stock-based compensation; the increase in general and administrative expense ($241,824 for the year ended December 31, 2024 compared to $296,556 for the year ended December 31, 2025); the increase in research and development expense ($324,629 for the year ended December 31, 2024 compared to $352,232 for the year ended December 31, 2025) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA; and, an increase in payroll expense ($352,597 for the year ended December 31, 2024 compared to $417,097 for the year ended December 31, 2025) related to our Chief Executive Officer’s employment contract and the addition of our Chief Operating Officer in the fourth quarter of 2025.
Non-Operating Expense
Non-operating expense for the years ended December 31, 2025 and 2024, respectively, consisted of the following:
| Years Ended December 31, 2025 | Years Ended December 31, 2024 | |||||||
| Interest income | $ | 99,030 | $ | 74,936 | ||||
| Loss on issuance of shares and exchange of warrants | - | (381,000 | ) | |||||
| Non-operating expense | $ | 99,030 | $ | 306,064 | ||||
Non-operating income (expense) for the year ended December 31, 2024 varied from the year ended December 31, 2025. In 2025, we recognized interest earned on our bank accounts of $99,030. In 2024, we recognized a loss on the exchange of warrants of $381,000, and incurred interest income of $74,936 related to our cash position in our bank accounts.
Net Loss
Our net loss for the years ended December 31, 2025 and 2024 was $(3,066,017) and $(2,910,448), respectively.
Liquidity and Capital Resources
At December 31, 2025, the Company had working capital of $1,533,177, compared to working capital of $2,147,247 at December 31, 2024. During the year ended December 31, 2025, the Company experienced negative cash flows from operations of $2,057,743, used $103,185 in cash flows from investing activities and realized $1,506,905 of cash flows from financing activities. As of December 31, 2025, the Company did not have any commitments for capital expenditures. During the year ended December 31, 2024, the Company experienced negative cash flows from operations of $1,684,039 and realized $2,304,300 of cash flows from financing activities. As of December 31, 2024, the Company did not have any commitments for capital expenditures.
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Cash used in operating activities was primarily a result of the Company’s non-cash items, such as loss from operations, and share based compensation. Cash used in investing activities in 2025 relate to purchases of fixed assets. Cash provided from financing activities decreased to $1,506,905 for the year ended December 31, 2025 from $2,304,300 for the year ended December 31, 2024. In 2025, the Company raised $1,506,250 from sales of common stock. In 2024, the Company raised $2,284,950 from sales of common stock and warrants.
The Company has generated material operating losses since inception. The Company had a net loss of $3,066,017 for the year ended December 31, 2025, and a net loss of $2,910,448 for the year ended December 31, 2024. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although the Company can provide no assurance that additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.
The Company requires funding of at least $3.0 million per year to maintain current 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, and clinical trials; (iii) activate several regional clinics to administer IsoPet® across the county; (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 principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies, which may possibly include clinical studies. Thereafter, 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 additional capital raises.
Recent geopolitical events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity in the capital markets, could also impact the Company’s ability to obtain financing and its ability to execute its business plan.
Our Chief Executive Officer currently works from his home office in virtual communication with key personnel. Cadwell Laboratories, which is controlled by Carl Cadwell, a director of the Company, provides office space to management on an as-needed basis until such time as the Company leases permanent office space.
Off-Balance Sheet Arrangements
The Company does not have any off-balance sheet arrangements that are reasonably likely to have a current or future effect on the Company’s financial condition, revenues, results of operations, liquidity, or capital expenditures.
Critical Accounting Policies
Consolidation
The Company has a relationship with Vivos India, which is considered a variable interest entity (VIE) under the guidance in ASC 810, Consolidations. A VIE is an entity in which the equity investors do not have sufficient equity investment at risk or lack the characteristics of a controlling financial interest. The Company evaluates the interests in such entities to determine whether it is the primary beneficiary and therefore required to consolidate the VIE in its financial statements.
The Company has determined that it is the primary beneficiary of Vivos India because it has both (i) the power to direct the activities that most significantly impact the VIE’s economic performance, and (ii) the obligation to absorb losses or the right to receive benefits that could potentially be significant to the VIE. Accordingly, the assets, liabilities, and results of operations of Vivos India will be included in the Company’s consolidated financial statements. As of December 31, 2025, the Company is still waiting on regulatory approval in India to commence operations.
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Use of Estimates
The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of financial statements and the reported amount of revenue and expense during the reporting period. Estimates the Company considers include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets. Actual results could differ from those estimates.
Revenue Recognition
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. The guidance introduces a five-step model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company adopted the updated guidance effective January 1, 2018 using the full retrospective method.
Under ASC 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to perform respective obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable. The adoption of ASC 606 did not have an impact on the Company’s operations or cash flows.
The Company recognized revenue as they (i) identified the contracts with each customer; (ii) identified the performance obligation in each contract; (iii) determined the transaction price in each contract; (iv) were able to allocate the transaction price to the performance obligations in the contract; and (v) recognized revenue upon the satisfaction of the performance obligation. Upon the sales of the product to complete the procedures on the animals, the Company recognized revenue as that was considered the performance obligation.
The Company in 2024 also implemented a license program for clinics that pay for certification to perform these therapies. These revenues are recognized upon the certification being completed. In addition, due to a pricing discount from the manufacturer, the Company sold to two of their customers the hydrogel vials that are used in the treatments. This practice is not likely to be continued in future periods.
Fair Value of Financial Instruments
The Company adopted ASC Topic 820 (“Fair Value Measurements”) as of January 1, 2008 for financial instruments measured as fair value on a recurring basis. ASC Topic 820 defines fair value, established a framework for measuring fair value in accordance with accounting principles generally accepted in the United States and expands disclosures about fair value measurements.
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC Topic 820 established a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements). These tiers include:
| - | Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets; | |
| - | Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and | |
| - | Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
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Stock-Based Compensation
The Company recognizes compensation costs under FASB ASC Topic 718, Compensation – Stock Compensation, and ASU No. 2018-07 – Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Companies are required to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share based compensation arrangements include stock options, restricted share plans, performance-based awards, share appreciation rights and employee share purchase plans. As such, compensation cost is measured on the date of grant at their fair value. Such compensation amounts, if any, are amortized over the respective vesting periods of the option grant.
Segment Reporting
The Company follows Financial Accounting Standards Board issued Accounting Standards Update 2023-07 (“ASU 2023-07”) for its segment reporting. ASU 2023-07 requires more detailed information about reportable segments and expenses including the requirement to disclose qualitative information about factors used to identify reportable segments and quantitative information about profit and loss measures and significant expense categories. The Company has not yet begun generating significant revenue from its planned principal operations and operates as a single reportable segment. The revenue associated with the services that the clinics perform by way of treatments and the licensure of these clinics are not considered two distinct segments for the years ended December 31, 2025 and 2024, respectively. The benefit the clinics get by being licensed will assist in increased revenues associated with the treatments being administered. The chief operating decision maker is the Company’s chief executive officer who assesses performance based on total expenses, cash flows, and progress made in the Company’s ongoing development efforts. With the formation of the VIE, Vivos India, and the fact that this is consolidated for financial reporting purposes, the activities of Vivos India are a defined segment for geographical purposes. As of December 31, 2025, the Company is still waiting on regulatory approval in India to commence operations. All of the Company’s long-lived assets as of December 31, 2025 are located in the United States.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
This item is not applicable to the Company because the Company is a smaller reporting company as defined by Rule 12b-2 under the Securities Exchange Act of 1934.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
All financial information required by this Item is included on the pages immediately following the Index to Financial Statements appearing on page F-1 and is hereby incorporated by reference.
ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None
ITEM 9A. CONTROLS AND PROCEDURES.
Disclosure Controls and Procedures
Based on an evaluation as of the date of the end of the period covered by this report, the Company’s Chief Executive Officer and Interim Chief Financial Officer conducted an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls and procedures, as required by Rule 13a-15 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, the Company’s Chief Executive Officer and Interim Chief Financial Officer concluded that, because of the disclosed material weaknesses in the Company’s internal control over financial reporting, the Company’s disclosure controls and procedures were ineffective as of the end of the period covered by this report to ensure that information required to be disclosed by the Company in the reports that the Company files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC’s rules and forms.
Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in the Company’s reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the Company’s reports filed under the Exchange Act is accumulated and communicated to management, including the Company’s Chief Executive Officer and the Company’s Interim Chief Financial Officer, to allow timely decisions regarding required disclosure.
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Management’s Annual Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Exchange Act Rule 13a-15(f). Management conducted an evaluation of the effectiveness of the internal control over financial reporting as of December 31, 2025, using the criteria established in Internal Control – Integrated Framework (2013 framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
A material weakness is a control deficiency, or combination of control deficiencies, that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected. As a result of its assessment, management has determined that there is a material weakness due to the lack of segregation of duties and, due to this material weakness, management concluded that, as of December 31, 2025 and 2024, the Company’s internal control over financial reporting was ineffective. This material weakness has the potential of adversely impacting the Company’s financial reporting process and the Company’s financial reports. Because of this material weakness, management also concluded that the Company’s disclosure controls and procedures were ineffective as of December 31, 2025 and 2024. The Company has engaged the services of both internal accounting and tax providers to resolve this material weakness.
Attestation Report of Registered Public Accounting Firm
This Annual Report does not include an attestation report of our registered independent public accounting firm regarding internal control over financial reporting pursuant to SEC rules for smaller reporting companies that permit us to provide only management’s report in this Annual Report.
Changes in Internal Control Over Financial Reporting
There have been no changes in the Company’s internal control over financial reporting that occurred during the Company’s last fiscal quarter (the Company’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
The term “internal control over financial reporting” is defined as a process designed by, or under the supervision of, the registrant’s principal executive and principal financial officers, or persons performing similar functions, and effected by the registrant’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
| (a) | Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the registrant; |
| (b) | Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the registrant are being made only in accordance with authorizations of management and directors of the registrant; and |
| (c) | Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the registrant’s assets that could have a material effect on the financial statements. |
ITEM 9B. OTHER INFORMATION.
During
the quarter ended December 31, 2025, none of our directors or executive officers
Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE.
The Company’s current directors and executive officers are as follows:
| NAME | AGE | POSITION | ||
| Michael K. Korenko | 80 | Chief Executive Officer and Director | ||
| Brad Allan Weeks | 44 | President | ||
| Michael Pollack | 59 | Interim Chief Financial Officer | ||
| David J. Swanberg | 69 | Chief Operating Officer | ||
| Carlton M. Cadwell | 81 | Chairman of the Board and Secretary |
Term of Office
All the Company’s directors hold office until the next annual meeting of the stockholders or until their successors is elected and qualified. The Company’s executive officers are appointed by the Company’s board of directors and hold office until their resignation, removal, death or retirement.
Background and Business Experience
The business experience during the past five years of each of the Company’s directors and executive officers is as follows:
Dr. Michael K. Korenko, Chief Executive Officer of the Company since December 2016, and a member of the Board of Directors since August 2017, joined the Company as an Advisor to the Board of the Company during 2009, served as member of the Board from May 2009 to March 2010 and served as President from December 2016 to September 2025. Dr. Korenko has also served on the Hanford Advisory Board since 2009. Dr. Korenko served as Business Development Manager for Curtiss-Wright from 2006 to 2009, as Chief Operating Officer for Curtiss-Wright from 2000 to 2005 and was Executive Vice President of Closure for Safe Sites of Colorado at Rocky Flats from 1994 to 2000. Dr. Korenko served as Vice President of Westinghouse from 1987 to 1994 and was responsible for the 300 and 400 areas, including the Fast Flux Testing Facility (“FFTF”) and all engineering, safety analysis, and projects for the Hanford site.
Dr. Korenko is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year. Dr. Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defense, reporting to Secretary Cap Weinberger.
Dr. Korenko brings to the Board over nine years’ experience working with and advising various small businesses, including companies involved in turnarounds. Dr. Korenko has also been involved as an advisor to the Company since 2009 in the development of medical isotopes.
Dr. Korenko was selected as President and CEO of Advanced Medical Isotopes (Vivos Inc) on December 14, 2016. Since then, has been credited with turning around the financial health and reputation of the Company, completing the product development, obtaining the device classification for animal therapy, and for setting the stage to obtaining IDE approval for human therapy.
Brad Allan Weeks, President of the Company since September 2025, is a seasoned leader with extensive experience in the medical device and biotechnology sectors. As President Brad plays a pivotal role in business development, team expansion, and strategic partnerships, contributing to the Company’s growth in targeted cancer therapies that deliver radioactive agents directly to tumors while minimizing damage to healthy tissue. Brad has built a distinguished career in healthcare innovation, holding leadership positions at organizations focused on advancing medical technologies and patient outcomes. His expertise includes forging international collaborations, such as recent engagements in India. Passionate about groundbreaking solutions that improve lives, Brad is actively involved in promoting the Company’s mission to revolutionize oncology through safer, more effective radionuclide therapies. Mr. Weeks holds a Master of Business Administration (MBA) with a focus on Technology Management.
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Michael Pollack CPA, the Interim Chief Financial Officer, joined the Company as interim Chief Financial Officer in December 2018. Mr. Pollack has been a partner in a certified public accounting firm for the past fifteen years and specializes in accounting and auditing for small public companies. Mr. Pollack has approximately 30 years of experience in public accounting and consulting to over 100 publicly traded and 250 private companies. Mr. Pollack has also held CFO and Controller positions in an array of industries. Mr. Pollack graduated from the University of Maryland with a Bachelor of Arts in Economics. Mr. Pollack is a member of the American Institute of Certified Public Accountants, as well as licensed to practice in New Jersey, and New York.
David J. Swanberg, M.S., P.E., Chief Operating Officer since September 2025, has over 35 years’ experience in Radiochemical Processing, Medical Isotope Production, Nuclear Waste Management, Materials Science, Regulatory Affairs, and Project Management. He has worked in diverse organizations ranging from small start-up businesses to corporations with multi-billion-dollar annual revenues. Most recently, he served as Technology Development Project Manager for Washington River Protection Solutions, from 2010 to 2024. Prior to 2010, she served as Senior Chemical/Environmental Engineer for Science Applications International Corporation since 2008. He has also previously served as Executive Vice President of Operations for IsoRay Medical Inc. managing day-to-day operations, R&D, and New Product Development. Mr. Swanberg was a co-founder of IsoRay and led the initial Cs-131 brachytherapy seed product development, FDA 510(k) submission/clearance, and NRC Sealed Source review and registration. He led the radiation dosimetry evaluations to meet American Association of Physicists in Medicine guidelines and is a current member of the AAPM. Mr. Swanberg served on the IsoRay Board of Directors and participated in several capital financing rounds totaling over $30.0 million. Mr. Swanberg has been actively engaged with the Company in his previous role as Chief Technical Manager since 2017. He has been integrally involved in product development, production, user training, regulatory submissions, and intellectual property development. He holds a BA in Chemistry from Bethel University (MN) and an MS in Chemical Engineering from Montana State University. He has numerous technical publications and holds several patents.
Mr. Swanberg has over 35 years’ experience in Radiochemical Processing, Medical Isotope Production, Nuclear Waste Management, Materials Science, Regulatory Affairs, and Project Management. He has worked in diverse organizations ranging from small start-up businesses to corporations with multi-billion-dollar annual revenues. Most recently, he served as Technology Development Project Manager for Washington River Protection Solutions, from 2010 to 2024. Prior to 2010, she served as Senior Chemical/Environmental Engineer for Science Applications International Corporation since 2008. He has also previously served as Executive Vice President of Operations for IsoRay Medical Inc. managing day-to-day operations, R&D, and New Product Development. Mr. Swanberg was a co-founder of IsoRay and led the initial Cs-131 brachytherapy seed product development, FDA 510(k) submission/clearance, and NRC Sealed Source review and registration. He led the radiation dosimetry evaluations to meet American Association of Physicists in Medicine guidelines and is a current member of the AAPM. Mr. Swanberg served on the IsoRay Board of Directors and participated in several capital financing rounds totaling over $30.0 million. Mr. Swanberg has been actively engaged with the Company in his previous role as Chief Technical Manager since 2017. He has been integrally involved in product development, production, user training, regulatory submissions, and intellectual property development. He holds a BA in Chemistry from Bethel University (MN) and an MS in Chemical Engineering from Montana State University. He has numerous technical publications and holds several patents.
Carlton M. Cadwell, Chairman of the Board and Secretary since December 2016, joined the Company as a director in 2006. Dr. Cadwell brings over 30 years of experience in business management, strategic planning, and implementation. He co-founded Cadwell Laboratories, Inc. in 1979 and has served as its President since its inception. Cadwell Laboratories, Inc. is a major international provider of neurodiagnostic medical devices. After receiving his bachelor’s degree from the University of Oregon in 1966 and a doctoral degree from the University of Washington in 1970, he began his career serving in the United States Army as a dentist for three years. From 1973 to 1980, Dr. Cadwell practiced dentistry in private practice and since has started several businesses.
Mr. Cadwell brings to the Board over ten years of service on the Board and over forty-five years of experience as a successful entrepreneur, as well as medical expertise.
Significant Consultants
Fredrick Swindler is the Quality Assurance Manager for Vivos Inc. Fred provides expertise in quality assurance and regulatory affairs in the medical device industry specific emphasis in development and auditing of quality systems as well as product submissions. Fred holds an MBA and brings over 55 years of extensive experience to the Company.
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Medical and Veterinarian Advisory Boards
Dr. Barry D. Pressman MD, FACR - Chairman Medical Advisory Board. Dr. Pressman is Professor and Chairman of the S. Mark Taper Foundation Imaging Centre and Department, and Chief of the Section of Neuroradiology and Head and Neck Radiology at Cedars-Sinai Medical Center, located in Los Angeles, California.
Dr. Pressman is a past President of The American College of Radiology, the Western Neuroradiological Society, as well as past President of the California Radiological Society. Currently he is a member of the American Society of Neuroradiology and the American Society of Pediatric Neuroradiology.
Dr. Pressman earned his medical degree Cum Laude from Harvard Medical School after graduating Summa Cum Laude from Dartmouth College. After a surgical internship at Harvard’s Peter Bent Brigham Hospital in Boston, he completed a diagnostic radiology residency at Columbia-Presbyterian Medical Center in New York and a Neuroradiology fellowship at George Washington University Hospital. During this period, he wrote many original papers for Computer Tomography (CT).
Dr. Albert S. DeNittis MD, MS, FCPP - Medical Advisory Board. Dr. Albert S. DeNittis is currently is the Chief of Radiation Oncology at Lankenau Medical Center and Clinical Professor at Lankenau Institute for Medical Research in Wynnewood, Pennsylvania, and the Director of Radiation Oncology at Brodesseur Cancer Center in New Jersey. He is also the Principal Investigator and in charge of a grant awarded by the NIH for its National Cancer Oncology Research Program (NCORP) at Main Line Health. Dr. DeNittis’ practice experience includes image-guided radiosurgery, stereotactic body radiation therapy (SBRT), intensity modulated radiation therapy (IMRT), image guided radiation therapy (IGRT), high-dose rate (HDR) precision radionuclide therapy, cranial and extracranial stereotactic radiosurgery, respiratory gating, and Cyberknife.
Dr. DeNittis has served on numerous regional, national and government committees related to key issues in Dr. DeNittis earned a BA and a MS at Rutgers University and a MD from the Robert Wood Johnson Medical School at the University of Medicine and Dentistry of New Jersey. He completed postdoctoral training internships and residency at the Department of Radiation Oncology at the Hospital of the University of Pennsylvania. Dr. DeNittis is board certified by the American Board of Radiology and Licensed in New Jersey and Pennsylvania.
Dr. Beau Toskich, MD, FCPP - Medical Advisory Board. Dr. Toskich is currently Mayo Clinic Senior Associate Consultant, Vascular and Interventional Radiology, Mayo Clinic, Florida Campus, Board Certified Diagnostic Radiology, Vascular and Interventional Radiology, and Nuclear Regulatory Commission Authorized User
Dr. Richard Weller, DVM, DACVIM (Internal Medicine; Oncology) DipMS - Veterinary Medicine Advisory Board Chairman. Prior to his retirement in 2014, Dr. Weller was a Senior Program Manager in the Radiation Biology Group of the Biological Sciences Division at Pacific Northwest National Laboratory (PNNL), where he was involved in the development of RadioGel. A 1973 graduate of Washington State University. Dr. Weller has extensive experience in designing and executing clinical studies, treatment planning, mechanisms of carcinogenesis, radiation biology, targeted delivery systems for chemotherapeutic and radio-therapeutic agents, bio-markers of disease, and comparative oncology; as well as over 30 years of experience developing and using animal models, including the use of spontaneous tumors in companion animals, for bio-medical applications.
Dr. Weller is board-certified by the American College of Veterinary Internal Medicine in Internal Medicine (1980) and Oncology (1987), Past Chairperson of the Organizing Committee for the Specialty of Veterinary Medical Oncology, Past Chairperson of the Board of Regents of the American College of Veterinary Internal Medicine, Past President of the Board of Regents of the American College of Veterinary Internal Medicine, Past President of the Specialty of Oncology, and a Charter Member of the Veterinary Cancer Society which he served as Treasurer for 16 years. He is an Honorary Professor of the Institute of Veterinary Medicine in Kyiv, Ukraine. Dr. Weller has lectured and trained veterinarians worldwide and has authored or co-authored over 250 articles, technical reports, book chapters, and presentations in his fields of expertise.
Dr. John Heindrick, DVM - Veterinary Medicine Advisory Board Member – Dr. Heindrick is a recently retired co-owner of VCA Ventana Animal Hospital in Albuquerque NM. He brings practical experience in veterinary medicine and has accompanied us at our conference booths.
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Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Securities Exchange Act of 1934 requires the Company’s executive officers, directors and persons who own more than 10% of the Company’s common stock to file with the SEC initial reports of beneficial ownership on Form 3, changes in beneficial ownership on Form 4, and an annual statement of beneficial ownership on Form 5. Such executive officers, directors and greater than 10% stockholders are required by SEC rules to furnish the Company with copies of all such forms that they have filed.
Based solely on its review of such forms filed with the SEC and received by the Company and representations from certain reporting persons, the Company believes that all reports required to be filed by each of each of its executive officers, directors and 10% stockholders were filed during the year ended December 31, 2025 and that such reports were timely.
Code of Ethics
The Company’s Board of Directors has not adopted a code of ethics that applies to the principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions, because of the Company’s limited number of executive officers and employees that would be covered by such a code and the Company’s limited financial resources. The Company anticipates that it will adopt a code of ethics after it increases the number of executive officers and employees and obtain additional financial resources.
Audit Committee and Audit Committee Financial Expert
As of the date of this Annual Report, the Company has not established an audit committee, and therefore, the Company’s full board of directors performs the functions that customarily would be undertaken by an audit committee. The Company’s Board of Directors during 2025 and 2024 was comprised of two directors, one of whom the Company had determined satisfied the general independence standards of the NASDAQ listing requirements.
The Company’s Board of Directors has determined that none of its current members qualifies as an “audit committee financial expert,” as defined by the rules of the SEC. In the future, the Company intends to establish board committees and to appoint such persons to those committees as are necessary to meet the corporate governance requirements imposed by a national securities exchange, although it is not required to comply with such requirements until the Company elects to seek listing on a national securities exchange.
Board of Directors; Attendance at Meetings
The Board held three meeting and acted by unanimous written consent three time during the year ended December 31, 2025. The Board held no meetings and acted by unanimous written consent two times during the year ended December 31, 2024. We have no formal policy with respect to the attendance of Board members at annual meetings of shareholders but encourage all incumbent directors and director nominees to attend each annual meeting of shareholders.
ITEM 11. EXECUTIVE COMPENSATION.
Summary Compensation Table
The following table sets forth the compensation paid to the Company’s Chief Executive Officer and those executive officers that earned in excess of $100,000 during the year ended December 31, 2025 (collectively, the “Named Executive Officers”):
| Name and Principal Position | Year | Salary ($) | Bonus ($) | Stock Awards ($)(1) | Option Awards ($)(1) | Total ($) | ||||||||||||||||||
| Dr. Michael K. Korenko | 2025 | $ | 307,320 | $ | 40,000 | $ | - | $ | - | $ | 347,320 | |||||||||||||
| CEO and Director | 2024 | $ | 295,500 | $ | 40,000 | $ | - | $ | - | $ | 335,500 | |||||||||||||
| Brad Weeks | 2025 | $ | 181,500 | $ | - | $ | 12,000 | $ | - | $ | 193,500 | |||||||||||||
| President | 2024 | $ | 155,764 | $ | - | $ | - | $ | - | $ | 155764 | |||||||||||||
| Dave Swanberg | 2025 | $ | 132,125 | $ | - | $ | 12,000 | $ | - | $ | 145,125 | |||||||||||||
| Chief Operating Officer | 2024 | $ | 111205 | $ | - | $ | - | $ | - | $ | 111,205 | |||||||||||||
| (1) | The amounts in this column represent the grant date fair value of stock option awards, computed in accordance with FASB ASC Topic 718. |
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Narrative Disclosure to Summary Compensation Table
Dr. Michael K. Korenko. On October 24, 2018, Mr. Korenko entered into an employment agreement with the Company (the “Old Employment Agreement”), which was scheduled to terminate on December 31, 2019. On June 4, 2019, the Company entered into an Executive Employment Agreement (“Korenko Employment Agreement”) with Dr. Michael K. Korenko, the Company’s Chief Executive Officer. The employment term under the Korenko Employment Agreement commenced with an effective date of June 11, 2019 and expires on December 31, 2020, and December 31 of each successive year if the Korenko Employment Agreement is extended, unless terminated earlier as set forth in the Korenko Employment Agreement. The Company on December 31, 2020 extended this agreement through December 31, 2021 while renegotiating terms of a new employment agreement. On May 3, 2021, the Company and the Chief Executive Officer agreed the terms of a new employment agreement with an effective date of January 1, 2021 that has a term of three years and expired December 31, 2023. On December 19, 2023, the Company renewed the employment agreement for a term of two years expiring December 31, 2025.
Under the terms of the Employment Agreement effective January 1, 2024, the Company shall pay to Dr. Korenko a base compensation of $295,500. In addition, there is a discretionary bonus to be earned in the amount of $10,000 per quarter upon the satisfaction of conditions to be determined by the Board of Directors of the Company. In addition, the Company granted Dr. Korenko 20,000,000 restricted stock units on January 1, 2024 that vest over the two-year period.
Brad Allen Weeks. On September 15, 2025, Mr. Weeks entered into an employment agreement with the Company (the “Weeks Employment Agreement”). The Weeks Employment Agreement provides that Mr. Weeks shall serve as President of the Company for a term effective September 1, 2025, ending on December 31, 2027, which term may be extended by written agreement of both parties. Pursuant to the Weeks Employment Agreement, Mr. Weeks shall receive: (i) an annual base salary of $192,000; (ii) a monthly grant of $3,000 in shares common stock of the Company at the end of each fiscal quarter based on the closing price of the Company’s common stock at the end of such fiscal quarter; and (iii) customary benefits and reimbursement for reasonable out-of-pocket business expenses. The Weeks Employment Agreement also provides customary provisions relating to, among other things, clawback rights, confidentiality, non-competition, and non-solicitation.
David J. Swanberg. On September 15, 2025, Mr. Swanberg entered into an executive consulting agreement withthe Company (the “Consulting Agreement”). The Consulting Agreement provides that Mr. Swanberg shall serve as Chief Operating Officer for a term effective September 1, 2025, ending on December 31, 2028, which term may be extended by written agreement of both parties. Pursuant to the Agreement, Mr. Swanberg shall receive: (i) compensation for consulting a rate of $12,000 per month; and (ii) a monthly grant of $3,000 in shares common stock of the Company at the end of each fiscal quarter based on the closing price of the Company’s common stock at the end of such fiscal quarter. The Consulting Agreement also provides customary provisions relating to, among other things, confidentiality, non-competition, and non-solicitation.
Outstanding Equity Awards at Fiscal Year-End Table
As of December 31, 2025, there were no outstanding equity awards held by the Company’s Named Executive Officers
Compensation of Directors
During the year ended December 31, 2025, the Company’s non-employee directors were not paid any compensation.
There are no employment contracts or compensatory plans or arrangements with respect to any director that would result in payments by the Company to such person because of his or her resignation as a director or any change in control of the Company.
Compensation Committee Interlocks and Insider Participation
None of our officers currently serves, or has served during the last completed fiscal year, on the compensation committee or board of directors of any other entity that has one or more officers serving as a member of our Board of Directors.
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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
The following tables sets forth, as of March 30, 2026, the number of shares of our Common Stock, Series A Convertible Preferred, Series B Convertible Preferred, and Series C Convertible Preferred beneficially owned by the following persons:
| (i) | all persons the Company knows to be beneficial owners of at least 5% of the Company’s common stock; | |
| (ii) | the Company’s current directors; | |
| (iii) | the Company’s current executive officers; and | |
| (iv) | all current directors and executive officers as a group. |
Beneficial Ownership of Common Stock
Applicable percentage is based on 482,688,356 shares of Common Stock outstanding as of March 30, 2026. In computing the percentage of shares of common stock beneficially owned, we deemed to be outstanding all shares of Common Stock subject to options or warrants held by that person or entity that are currently exercisable or exchangeable or that will become exercisable or exchangeable within 60 days of March 30, 2026.
| Name and Address of Beneficial Owner(1) | Amount and Nature of Beneficial Ownership(2) | Percent of Class | ||||||
| Named Executive Officers and Directors: | ||||||||
| Michael K. Korenko (3) | 15,435,090 | 3 | % | |||||
| Brad Weeks | - | * | ||||||
| Dave Swanberg | - | * | ||||||
| Carlton M. Cadwell (4) | 15,433,891 | 3 | % | |||||
| Michael Pollack | - | * | ||||||
| All executive officers and directors as a group (3 individuals) | 30,868,981 | 6 | % | |||||
* Less than 1%
| (1) | The address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352, except that the address of the Cadwell Family Irrevocable Trust (the “Cadwell Trust”) is 909 North Kellogg Street, Kennewick, WA 99336. |
| (2) | In determining beneficial ownership of the Company’s common stock as of a given date, the number of shares shown includes shares of common stock which may be acquired upon exercise of the common stock equivalents within 60 days of that date. In determining the percent of common stock owned by a person or entity on February 13, 2026, (a) the numerator is the number of shares of the class beneficially owned by such person or entity, including shares which may be acquired within 60 days on exercise of the common stock equivalents, and (b) the denominator is the sum of (i) the total shares of common stock outstanding on February 13, 2026, and (ii) the total number of shares that the beneficial owner may acquire upon conversion of the common stock equivalents. Subject to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of its shares, except that under the terms of the Cadwell Trust, Dr. Cadwell does not have or share voting or investment power over the shares beneficially owned by the Cadwell Trust. |
| (3) | Includes 55,000,000 shares issuable for vested RSUs. |
| (4) | Includes 1,136,137 shares issuable upon conversion of Series A Preferred; and 4,816,275 shares issuable upon conversion of Series C Preferred, 26,912 shares held by the Cadwell Family Irrevocable Trust, of which Mr. Cadwell is a trustee, and 2,316,830 shares of common stock issued to AMIC Gift, LLC, an LLC controlled by Mr. Cadwell and his wife. |
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Beneficial Ownership of Series A Convertible Preferred Stock
As of March 30, 2026, there were 2,071,007 shares of Series A Preferred issued and outstanding, convertible into 2,588,758 shares of the Company’s common stock. Applicable percentage is based on 2,071,007 shares of Series A Preferred outstanding as of March 30, 2026.
| Name and Address of Beneficial Owner (1)(2) | Amount and Nature of Beneficial Ownership (3) | Percent of Class | ||||||
| Named Executive Officers and Directors: | ||||||||
| Carlton M. Cadwell | 1,057,219 | 51.05 | % | |||||
| All Current Directors and Executive Officers as a group (1 individual)(3) | 1,057,219 | 51.05 | % | |||||
| 5%+ Stockholders: | ||||||||
| L. Bruce Jolliff | 197,979 | 9.56 | % | |||||
| Stoel Rives | 133,333 | 6.44 | % | |||||
| (1) | The address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352, except that the address of (i) the Cadwell Family Irrevocable Trust (the “Cadwell Trust”) is 909 North Kellogg Street, Kennewick, WA 99336; (ii) L. Bruce Jolliff is 206 N 41st St. Unit 1, Yakima, WA 98901; and (iii) Stoel Rives is One Union Square, 600 University Street, Suite 3600, Seattle, WA 98101. |
| (2) | Executive Officers and Directors of the Company that do not hold any Series A Convertible Preferred have been omitted from this table. |
| (3) | Subject to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of its shares, except that Dr. Cadwell under the terms of the Cadwell Trust does not have or share voting or investment power over the Series A Convertible Preferred beneficially owned by the Cadwell Trust. |
| (4) | Includes 148,309 shares held by the Cadwell Family Irrevocable Trust, of which. Mr. Cadwell is a Trustee. |
Beneficial Ownership of Series B Convertible Preferred Stock
As of March 30, 2026, there were 363 shares of Series B Preferred issued and outstanding, convertible into 4,538 shares of the Company’s common stock. Applicable percentage is based on 363 shares of Series B Preferred outstanding as of March 30, 2026.
| Name and Address of Beneficial Owner (1) | Amount and Nature of Beneficial Ownership (2) | Percent of Class | ||||||
| 5%+ Stockholders: | ||||||||
| Firstfire Global Opportunities Fund(1) | 363 | 100 | % | |||||
* Less than 1%
| (1) | None of the Company’s named executive officers or directors hold any shares of the Company’s Series B Convertible Preferred, and they have therefore been omitted from this table. The address of the beneficial owners is as follows: (i) Firstfire Global Opportunities Fund, 1040 1st Avenue, STE 190, New York, NY 10022 |
| (2) | Subject to community property laws where applicable, the Company believes that each beneficial owner has sole power to vote and dispose of its shares. |
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Beneficial Ownership of Series C Convertible Preferred Stock
As of March 30, 2026, there were 385,302 shares of Series C Preferred issued and outstanding, convertible into 4,816,275 shares of the Company’s common stock. Applicable percentage is based on 385,302 shares of Series C Preferred outstanding as of March 30, 2026.
| Name and Address of Beneficial Owner (1) | Amount and Nature of Beneficial Ownership (2) | Percent of Class | ||||||
| Carlton M. Cadwell | 385,302 | 100 | % | |||||
| All Current Directors and Executive Officers as a group (3 individuals) (3) | 385,302 | 100 | % | |||||
| (1) | The address of each of the beneficial owners above is c/o Vivos Inc, 1030 N Center Parkway, Kennewick, WA 99352. |
| (3) | Executive Officers and Directors of the Company that do not hold any Series C Convertible Preferred have been omitted from this table. |
Changes in Control
The Company does not know of any arrangements, including any pledges of the Company’s securities that may result in a change in control of the Company.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
Indebtedness from Related Parties
There has been no indebtedness from related parties for the years ended December 31, 2025 and 2024, except for a brief period in December 2024 in the amount of $40,949.
Independent Directors
The Company’s common stock is traded on the OTCQB Marketplace, which does not impose any independence requirements on the Board of Directors or the board committees of the companies whose stock is traded on that market. The Company has decided to adopt the independence standards of the Nasdaq listing rules in determining whether the Company’s directors are independent. Generally, under those rules a director does not qualify as an independent director if the director or a member of the director’s immediate family has had in the past three years certain relationships or affiliations with the Company, the Company’s auditors, or other companies that do business with the Company. The Company’s Board of Directors has determined that Mr. Cadwell is qualified as an independent director under those Nasdaq rules, and accordingly, would have been qualified under those rules to serve on a compensation committee or a nominating committee, if the Company had established such committees of the Company’s Board of Directors. Dr. Korenko is not an independent director due to his employment by the Company as an executive officer.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
Audit Fees
The aggregate fees incurred by the Company’s principal accountant for the audit of the Company’s annual financial statements, review of financial statements included in the quarterly reports and other fees that are normally provided by the accountant in connection with statutory and regulatory filings or engagements for the years ended December 31, 2025 and 2024 were $42,400 and $38,500, respectively, all of which was paid to Fruci & Associates II, PLLC.
Audit Related Fees
The aggregate fees billed for professional services that are reasonably related to the performance of the audit or review of the Company’s financial statements but are not reported “Audit Fees” for the years ended December 31, 2025 and 2024 in the amounts of $0 and $4,500, respectively. All services performed by the Company’s Registered Public Accounting Firm, Fruci & Associates II, PLLC have been pre-approved by the Company’s Board of Directors.
Tax Fees
The aggregate fees billed for professional services rendered by principal accountant for tax compliance, tax advice and tax planning during the years ended December 31, 2025 and 2024 were $4,350 and $3,850, respectively, all of which was paid to Fruci & Associates II, PLLC.
All Other Fees
All other fees include fees billed for products or services provided by the Company’s principal accountant during the years ended December 31, 2025 and 2024 other than those described above. During the years ended December 31, 2025 and 2024, there were no such fees billed by Fruci & Associates II, PLLC.
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PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
(a) Documents filed as part of this Report.
| 1. | Financial Statements. The Vivos Inc. Balance Sheets as of December 31, 2025 and 2024, the Statements of Operations for the years ended December 31, 2025 and 2024, the Statements of Changes in Stockholders’ Equity for the years ended December 31, 2025 and 2024, and the Statements of Cash Flows for the years ended December 31, 2025 and 2024, together with the notes thereto and the reports of Fruci & Associates II, PLLC as required by Item 8 are included in this 2025 Annual Report on Form 10-K as set forth in Item 8 above. |
| 2. | Financial Statement Schedules. All financial statement schedules have been omitted since they are either not required or not applicable, or because the information required is included in the financial statements or the notes thereto. |
| 3. | Exhibits. The following exhibits are either filed as a part hereof or are incorporated by reference. Exhibit numbers correspond to the numbering system in Item 601 of Regulation S-K. |
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* Filed herewith.
Item 16. Form 10-K Summary
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| VIVOS INC. | ||
| Date: March 30, 2026 | By: | /s/ Michael K. Korenko |
| Name: | Michael K. Korenko | |
| Title: | Chief Executive Officer | |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
| Date: March 30, 2026 | By: | /s/ Michael K. Korenko |
| Name: | Michael K. Korenko | |
| Title: | Chief Executive Officer | |
| (Principal Executive Officer) | ||
| Date: March 30, 2026 | By: | /s/ Michael Pollack |
| Name: | Michael Pollack | |
| Title: | Interim Chief Financial Officer | |
| (Principal Financial and Accounting Officer) | ||
| Date: March 30, 2026 | By: | /s/ Carlton M. Cadwell |
| Name: | Carlton M. Cadwell | |
| Title: | Secretary and Chairman of the Board |
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Vivos Inc.
Index to Consolidated Financial Statements
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Vivos, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Vivos, Inc. (“the Company”) as of December 31, 2025 and 2024, and the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2025, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has had recurring losses and has used significant cash in supports of its operating activities. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there were no critical audit matters.
We have served as the Company’s auditor since 2016.
March 30, 2026
| F-1 |
VIVOS INC
CONSOLIDATED BALANCE SHEETS
DECEMBER 31, 2025 AND 2024
| DECEMBER 31, | DECEMBER 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | $ | ||||||
| Accounts receivable | ||||||||
| Inventory | ||||||||
| Prepaid expenses | ||||||||
| Total Current Assets | ||||||||
| Fixed assets, net | ||||||||
| Other Assets: | ||||||||
| Right of use assets | ||||||||
| Other assets | ||||||||
| Total Other Assets | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| LIABILITIES | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | $ | ||||||
| Current portion of lease liability | ||||||||
| Total Current Liabilities | ||||||||
| Non-current Liabilities: | ||||||||
| Lease liability, net of current portion | ||||||||
| Total Non-current Liabilities | ||||||||
| Total Liabilities | ||||||||
| Commitments and contingencies | ||||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, par value, $, shares authorized, Series A Convertible Preferred, shares authorized, shares issued and outstanding, respectively | ||||||||
| Additional paid in capital - Series A Convertible preferred stock | ||||||||
| Series B Convertible Preferred, shares authorized, shares issued and outstanding, respectively | ||||||||
| Additional paid in capital - Series B Convertible preferred stock | ||||||||
| Series C Convertible Preferred, shares authorized, shares issued and outstanding, respectively | ||||||||
| Preferred stock, value | ||||||||
| Additional paid in capital - Series C Convertible preferred stock | ||||||||
| Common stock, par value, $, shares authorized, and issued and outstanding, respectively | ||||||||
| Additional paid in capital - common stock | ||||||||
| Subscriptions receivable | ( | ) | ||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total Stockholders’ Equity | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | $ | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-2 |
VIVOS INC
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024
| YEARS ENDED | ||||||||
| DECEMBER 31, | DECEMBER 31, | |||||||
| 2025 | 2024 | |||||||
| Revenues, net | $ | $ | ||||||
| Cost of Goods Sold | ||||||||
| Gross (loss) profit | ( | ) | ( | ) | ||||
| OPERATING EXPENSES | ||||||||
| Professional fees, including stock-based compensation | ||||||||
| Payroll expenses | ||||||||
| Research and development | ||||||||
| General and administrative expenses | ||||||||
| Total Operating Expenses | ||||||||
| OPERATING LOSS | ( | ) | ( | ) | ||||
| NON-OPERATING INCOME | ||||||||
| Interest income | ||||||||
| Loss on issuance of shares and warrant exchange | ( | ) | ||||||
| Total Non-Operating Income | ( | ) | ||||||
| NET LOSS BEFORE PROVISION FOR INCOME TAXES | ( | ) | ( | ) | ||||
| Provision for income taxes | ||||||||
| NET LOSS | $ | ( | ) | $ | ( | ) | ||
| Net loss per share - basic and diluted | $ | ) | $ | ) | ||||
| Weighted average common shares outstanding | ||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-3 |
VIVOS INC
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024
| Series A Preferred | Additional Capital - Series A | Series B Preferred | Additional Capital - Series B | Series C Preferred | Additional Capital - Series C | Common Stock | Additional Capital - | Subscription | Accumulated | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Preferred | Shares | Amount |
Preferred | Shares | Amount |
Preferred | Shares | Amount |
Common |
Receivable |
Deficit | Total | ||||||||||||||||||||||||||||||||||||||||||||||
| Balance - December 31, 2023 | $ | $ | $ | $ | | $ | $ | | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||||
| Stock issued for: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Services | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Exercise of warrants (cash and cashless) | - | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Conversion of preferred stock to common stock | - | ( | ) | ( | ) | ( | ) | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Vested RSUs | - | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Adjustment for vested RSUs | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Warrants purchased for cash | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RSUs granted to consultants that have vested | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net loss for the year | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - December 31, 2024 | $ | $ | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||||
| Balance - December 31, 2024 | $ | $ | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||||
| Balance | $ | $ | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||||
| Stock issued for: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Services | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Exercise of warrants (cash and cashless) | - | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Vested RSUs | - | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Warrants purchased for cash | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RSUs granted to consultants that have vested | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net loss for the year | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - December 31, 2025 | $ | $ | $ | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||||||
| Balance | $ | $ | $ | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-4 |
VIVOS INC
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024
| 2025 | 2024 | |||||||
| CASH FLOW FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities | ||||||||
| Depreciation | ||||||||
| Common stock, stock options and warrants for services | ||||||||
| RSUs issued for services | ||||||||
| Loss on issuance of shares and warrant exchange | ||||||||
| Changes in assets and liabilities | ||||||||
| Accounts receivable | ( | ) | ( | ) | ||||
| Inventory | ( | ) | ||||||
| Prepaid expenses and other assets | ( | ) | ||||||
| Accounts payable and accrued expenses | ( | ) | ||||||
| Operating lease expense | ||||||||
| Total adjustments | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Purchases of fixed assets | ( | ) | ||||||
| Net cash provided by investing activities | ( | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from short-term advances from related party | ||||||||
| Payments of related party notes | ( | ) | ||||||
| Payments of lease liability | ( | ) | ||||||
| Exercise of warrants | ||||||||
| Proceeds from common stock and warrants | ||||||||
| Net cash provided by financing activities | ||||||||
| NET (DECREASE) INCREASE IN CASH | ( | ) | ||||||
| CASH - BEGINNING OF YEAR | ||||||||
| CASH - END OF YEAR | $ | $ | ||||||
| CASH PAID DURING THE YEAR FOR: | ||||||||
| Interest expense | $ | $ | ||||||
| Income taxes | $ | $ | ||||||
| SUPPLEMENTAL INFORMATION - NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||||||||
| Common stock issued in cashless exercise of warrants | $ | $ | ||||||
| RSUs vested into common stock | $ | $ | ||||||
| ROU assets for lease liability | $ | $ | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-5 |
VIVOS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
NOTE 1: BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
Vivos Inc. (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™. 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 for cancer.
In 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.
In January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel™ 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.
Based 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®” name. 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.
The 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 therapy, human therapy, and recently other applications of its patented technologies.
We refer you to Item 7– Management’s Discussion and Analysis of Financial Condition and Results of Operations of this Form 10-K for more information about our business.
On September 17, 2025, the Board of Directors of the Company approved the creation of Vivos Scientific India LLP (“Vivos India” or the “LLP”), a wholly owned separate legal entity in India. Vivos India expands the Company’s strategic initiatives, with the objective of establishing a manufacturing center, expanding human therapies and pursuing commercialization of therapies in India. In addition, we will generate additional human trial data to support our process with the Food and Drug Administration (“FDA”). Vivos India was established on October 1, 2025 (deemed to have commenced on October 15, 2025). Pursuant to the LLP dated as of November 18, 2025, ownership of Vivos India is held jointly by Michael Korenko the Company’s CEO, and Sandip Bali, a consultant of the Company based in India. Since the Company will by the sole source of funding for Vivos India and the Company will control the activities of Vivos India, the Company has consolidated this entity as a variable interest entity in accordance with ASC 810. Additionally, the business of the LLP is the research and development of the patents held by the Company in India pursuant to the Product Transfer and License Deed entered into November 18, 2025. It is not anticipated that this entity will incur revenues in the near term.
On November 18, 2025, the Company and Vivos India entered into a Product Transfer and License Deed whereby the Company will grant Vivos India an exclusive license and product transfer to develop, seek regulatory approvals, import, market, distribute, and commercialize the Products in India, subject to the terms and conditions of the Deed. In accordance with this agreement, any inventions, improvements, data or know-how developed by Vivos India in connection with the Company’s products shall be promptly disclosed in writing and are hereby irrevocably assigned to the Company.
| F-6 |
Going Concern
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business. As shown in the accompanying financial statements, the Company has suffered recurring
losses and used significant cash in support of its operating activities and the Company’s cash position is not sufficient to support
the Company’s operations and thus raises significant doubt about the Company’s ability to continue as a going concern. Research
and development of the Company’s brachytherapy product line has been funded with proceeds from the sale of equity and debt securities
as well as a series of grants. The Company requires funding of approximately $
Financing and Strategy
In
November 2019, the SEC qualified the Company’s offering of its Common Stock, under Regulation A of Section 3(6) of the
Securities Act of 1933, as amended (the “Securities Act”) (“Regulation A”), which offering was
amended from time to time thereafter (the “2019 Regulation A+ Offering”). In September 2021, the SEC qualified
the Company’s offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (the
“2021 Regulation A Offering”). On July 17, 2024, the SEC qualified the Company’s offering under Regulation
A to offer up to $
During
the year ended December 31, 2023, we raised $
In March 2026, the Company raised
$
Following receipt of required regulatory approvals and necessary financing to fund our working capital requirements, the Company intends to outsource material aspects of manufacturing, distribution, sales, and marketing for operations within the U.S. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.
Long-term, the Company intends to consider resuming research efforts with respect to other products and technologies intended to help improve the diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company: (i) receiving adequate funding; (ii) receiving regulatory approval for RadioGel™ and other brachytherapy products; and (iii) being able to successfully commercialize its brachytherapy products.
Based 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.
The Company’s headquarters are in Northeast Washington, however, our focus on the animal therapy market has been the Northwestern sector of the U.S. The Company continues its marketing efforts on the animal therapy market and our attempts to increase the exposure to our product, and generate revenue accordingly.
As
of December 31, 2025, the Company had $
| F-7 |
The Company anticipates using additional proceeds from the July 2024 Regulation A+ Offering as follows:
For the animal therapy market:
| ● | Expand communication on our website, the Company’s social media presence, conferences, and journals, each intended to increase the number of certified clinics for small animal and equine therapy and to increase the number of patients; | |
| ● | Subsidize certain IsoPet® therapies, if necessary, to ensure that all viable candidates are treated; and. | |
| ● | Assist a new regional clinic with their license and certification training. |
For the human market:
| ● | Enhance the pedigree of the Quality Management System; | |
| ● | Construct and validate two new production facilities; and | |
| ● | Fund human clinical studies in the US and India. |
Research
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 prior Regulation A+ Offerings. The Company requires additional funding of approximately $
The continued deployment of the 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. Thereafter, 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.
The Company intends to expand the indications for use in phases: first, for lymph nodes associated with thyroid cancer, secondly, cancerous lung nodules, and finally, all non-sectable solid tumors.
Consolidation
The Company has a relationship with Vivos India, which is considered a variable interest entity (VIE) under the guidance in ASC 810, Consolidations. A VIE is an entity in which the equity investors do not have sufficient equity investment at risk or lack the characteristics of a controlling financial interest. The Company evaluates the interests in such entities to determine whether it is the primary beneficiary and therefore required to consolidate the VIE in its financial statements.
The Company has determined that it is the primary beneficiary of Vivos India because it has both (i) the power to direct the activities that most significantly impact the VIE’s economic performance, and (ii) the obligation to absorb losses or the right to receive benefits that could potentially be significant to the VIE. Accordingly, the assets, liabilities, and results of operations of Vivos India will be included in the Company’s consolidated financial statements. All intercompany activity will be eliminated in consolidation. As of December 31, 2025, the Company is still waiting on regulatory approval in India to commence operations.
Use of Estimates
The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of financial statements and the reported amount of revenue and expense during the reporting period. Estimates the Company considers include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets. Actual results could differ from those estimates.
| F-8 |
Financial Statement Reclassification
Certain account balances from prior periods have been reclassified in these financial statements so as to conform to current period classifications. There were no changes to the net loss as a result of these reclassifications.
Cash Equivalents
For the purposes of the statement of cash flows, the Company considers all highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents.
The Company occasionally maintains cash balances in excess of the FDIC insured limit. The Company does not consider this risk to be material.
Fair Value of Financial Instruments
Fair value of financial instruments requires disclosure of the fair value information, whether or not recognized in the balance sheet, where it is practicable to estimate that value. As of December 31, 2025 and 2024, the balances reported for cash, prepaid expense, accounts receivable, accounts payable, and accrued expense, approximate the fair value because of their short maturities.
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Accounting Standards Codification (“ASC”) Topic 820 established a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements). These tiers include:
Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets;
Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and
Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
The Company measures certain financial instruments including options and warrants issued during the period at fair value on a recurring basis.
Fixed Assets
Fixed assets are recorded at cost. Expenditures for renewals and improvements that significantly add to the productive capacity or extend the useful life of an asset are capitalized. Expenditures for maintenance and repairs are expensed as incurred. When equipment is retired or sold, the cost and related accumulated depreciation are eliminated from the balance sheet accounts and the resultant gain or loss is reflected in income.
Depreciation
is provided using the straight-line method, based on useful lives of the assets which range from
The Company reviews the carrying value of its fixed assets for impairment whenever events and circumstances indicate that the carrying value of an asset may not be recoverable from the estimated future cash flows expected to result from its use and eventual disposition. In cases where undiscounted expected future cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of assets. The factors considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used, and the effects of obsolescence, demand, competition, and other economic factors.
Patents and Intellectual Property
While
patents are being developed or pending, they are not being amortized. Management has determined that the economic life of the patents
to be
The Company evaluates the recoverability of intangible assets, including patents and intellectual property on a continual basis. Several factors are used to evaluate intangibles, including, but not limited to, management’s plans for future operations, recent operating results and projected and expected undiscounted future cash flows.
There have been no such capitalized costs in the periods ended December 31, 2025 and 2024, respectively. However, a patent was filed by Michael Korenko and David Swanberg on July 1, 2019 (No. 1811.191) and assigned to the Company based on the Company’s proprietary particle manufacturing process. The timing of this filing was important given the Company’s plans to make IsoPet® commercially available, which it did on or about July 9, 2019. This additional patent protection will strengthen the Company’s competitive position. It is the Company’s intention to further extend this patent protection to several key countries within one year, as permitted under international patent laws and treaties.
| F-9 |
Revenue Recognition
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. The guidance introduces a five-step model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company adopted the updated guidance effective January 1, 2018 using the full retrospective method.
Under ASC 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to perform respective obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable. The adoption of ASC 606 did not have an impact on the Company’s operations or cash flows.
The Company recognized revenue as they (i) identified the contracts with each customer; (ii) identified the performance obligation in each contract; (iii) determined the transaction price in each contract; (iv) were able to allocate the transaction price to the performance obligations in the contract; and (v) recognized revenue upon the satisfaction of the performance obligation. Upon the sales of the product to complete the procedures on the animals, the Company recognized revenue as that was considered the performance obligation.
The Company in 2024 also implemented a license program for clinics that pay for certification to perform these therapies. These revenues are recognized upon the certification being completed. In addition, due to a pricing discount from the manufacturer, the Company sold to two of their customers the hydrogel vials that are used in the treatments. This practice is not likely to be continued in future periods.
The following table disaggregates the Company’s revenue by major source for the years ended December 31, 2025 and 2024:
SCHEDULE OF DISAGGREGATION OF REVENUE
| 2025 | 2024 | |||||||
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenue: | ||||||||
| Services - Treatments | $ | $ | ||||||
| IsoPet | ||||||||
| Certification | ||||||||
| Freight | ||||||||
| Polymer | ||||||||
| Discount - Services | ( | ) | ( | ) | ||||
| Discount - IsoPet | ( | ) | ||||||
| Discount - Certifications | ( | ) | ||||||
| Total | $ | $ | ||||||
Inventory
Since
the Company is selling a tangible good (IsoPet, which is considered a medical device) for the use in treatments, this is considered inventory
as it is awaiting consumption into the final product. Inventory is valued at the lower of cost or net realizable value. Management evaluates
quantities on hand and physical condition as these characteristics may be impacted by anticipated customer demand for current products.
Inventory as of December 31, 2025 amounts to $
The Company purchases materials from two vendors that each ship to a third vendor who assembles the materials into a finished product which is then shipped to the clinics for use in the treatments being performed. This vendor who completes the process is charged a fixed fee which is directly charged to cost of sales. The only inventory not maintained by the Company is held at the vendor who assembles the product.
There have been no write-downs of inventory as of December 31, 2025, and the Company evaluates the inventory monthly for obsolescence. The Company from time to time will write-off items for spoilage when the need arises in the normal course of business.
| F-10 |
The Company accounts for its loss per common share by replacing primary and fully diluted earnings per share with basic and diluted earnings per share. Basic loss per share is computed by dividing loss available to holders of our Common Stock (the numerator) by the weighted-average number of common shares outstanding (the denominator) for the period, and does not include the impact of any potentially dilutive Common Stock equivalents since the impact would be anti-dilutive. The computation of diluted earnings per share is similar to basic earnings per share, except that the denominator is increased to include the number of additional common shares that would have been outstanding if potentially dilutive common shares had been issued. For the given periods of loss, of the periods ended December 31, 2025 and 2024, the basic earnings per share equals the diluted earnings per share.
SCHEDULE OF DILUTIVE EARNINGS PER SHARE
| December 31, 2025 | December 31, 2024 | |||||||
| Preferred stock | ||||||||
| Restricted stock units | ||||||||
| Common stock options | ||||||||
| Common stock warrants | ||||||||
| Total potential dilutive securities | ||||||||
Research and Development Costs
Research and developments costs, including salaries, research materials, administrative expense and contractor fees, are charged to operations as incurred. The cost of equipment used in research and development activities which has alternative uses is capitalized as part of fixed assets and not treated as an expense in the period acquired. Depreciation of capitalized equipment used to perform research and development is classified as research and development expense in the year computed.
The
Company incurred $
Advertising and Marketing Costs
Advertising and marketing costs are expensed as incurred except for the cost of tradeshows which are deferred until the tradeshow occurs. During the years ended December 31, 2025 and 2024, the Company incurred nominal advertising and marketing costs.
Contingencies
In the ordinary course of business, the Company is involved in legal proceedings involving contractual and employment relationships, product liability claims, patent rights, and a variety of other matters. The Company records contingent liabilities resulting from asserted and unasserted claims against it, when it is probable that a liability has been incurred and the amount of the loss is reasonably estimable. The Company discloses contingent liabilities when there is a reasonable possibility that the ultimate loss will exceed the recorded liability. Estimated probable losses require analysis of multiple factors, in some cases including judgments about the potential actions of third-party claimants and courts. Therefore, actual losses in any future period are inherently uncertain. The Company has entered into various agreements that require them to pay certain fees to consultants and/or employees that have been fully accrued for as of December 31, 2025 and 2024.
Income Taxes
To address accounting for uncertainty in tax positions, the Company clarifies the accounting for income taxes by prescribing a minimum recognition threshold that a tax position is required to meet before being recognized in the financial statements. The Company also provides guidance on de-recognition, measurement, classification, interest, and penalties, accounting in interim periods, disclosure and transition.
| F-11 |
The Company files income tax returns in the U.S. federal jurisdiction. The Company did not have any tax expense for the periods ended December 31, 2025 and 2024. The Company did not have any deferred tax liability or asset on its balance sheets as of December 31, 2025 and 2024.
Interest costs and penalties related to income taxes, if any, will be classified as interest expense and general and administrative costs, respectively, in the Company’s financial statements. For the periods ended December 31, 2025 and 2024, the Company did not recognize any interest or penalty expense related to income taxes. The Company believes that it is not reasonably possible for the amounts of unrecognized tax benefits to significantly increase or decrease within the next twelve months.
The Company recognizes compensation costs under FASB ASC Topic 718, Compensation – Stock Compensation and ASU 2018-07. Companies are required to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share based compensation arrangements include stock options, restricted share plans, performance-based awards, share appreciation rights and employee share purchase plans. As such, compensation cost is measured on the date of grant at their fair value. Such compensation amounts, if any, are amortized over the respective vesting periods of the option grant.
Segment Reporting
The Company follows Financial Accounting Standards Board issued Accounting Standards Update 2023-07 (“ASU 2023-07”) for its segment reporting. ASU 2023-07 requires more detailed information about reportable segments and expenses including the requirement to disclose qualitative information about factors used to identify reportable segments and quantitative information about profit and loss measures and significant expense categories. The Company has not yet begun generating significant revenue from its planned principal operations and operates as a single reportable segment. The revenue associated with the services that the clinics perform by way of treatments and the licensure of these clinics are not considered two distinct segments for the years ended December 31, 2025 and 2024, respectively. The benefit the clinics get by being licensed will assist in increased revenues associated with the treatments being administered. The chief operating decision maker is the Company’s chief executive officer who assesses performance based on total expenses, cash flows, and progress made in the Company’s ongoing development efforts. With the formation of the VIE, Vivos India, and the fact that this is consolidated for financial reporting purposes, the activities of Vivos India are a defined segment for geographical purposes. As of December 31, 2025, the Company is still waiting on regulatory approval in India to commence operations. All of the Company’s long-lived assets as of December 31, 2025 are located in the United States.
Recent Accounting Pronouncements
Adoption of ASU 2023-09
In December 2023, the Financial Accounting Standards Board issued ASU 2023-09, which requires enhanced disclosures related to the effective tax rate reconciliation and income taxes paid. The guidance is intended to improve transparency regarding the nature and magnitude of factors contributing to differences between the statutory tax rate and the effective tax rate, as well as cash taxes paid by jurisdiction.
The Company adopted this standard effective January 1, 2025 on a prospective basis. The adoption did not have a material impact on the Company’s consolidated financial position, results of operations, or cash flows, as the amendments are disclosure-only in nature. Prior-period amounts have been recast to conform to the current-period presentation, where applicable.
The Company does not discuss recent pronouncements that are not anticipated to have an impact on or are unrelated to its financial condition, results of operations, cash flows or disclosures.
NOTE 2: RELATED PARTY TRANSACTIONS
In
December 2024, our Chief Executive Officer advanced $
NOTE 3: FIXED ASSETS
As of December 31, 2025 and 2024, the Company has the following fixed assets:
SCHEDULE OF FIXED ASSETS
| December 31, 2025 | December 31, 2024 | |||||||
| Production equipment – | $ | $ | ||||||
| Office equipment – | ||||||||
| Accumulated depreciation | ( | ) | ||||||
| Fixed assets, net | $ | $ | ||||||
Depreciation
expense for the years ended December 31, 2025 and 2024 was $
| F-12 |
NOTE 4: STOCKHOLDERS’ EQUITY
Common Stock
The Company has authorized shares of Common Stock. As of December 31, 2025 and 2024, there are and shares of Common Stock issued and outstanding, respectively.
Preferred Stock
The Company has authorized shares of Preferred Stock. There are currently three series of Preferred Stock outstanding; Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock. The Company’s Board of Directors is authorized to provide for the issuance of shares of Preferred Stock in one or more series, fix or alter the designations, preferences, rights, qualifications, limitations or restrictions of the shares of each series, including the dividend rights, dividend rates, conversion rights, voting rights, term of redemption including sinking fund provisions, redemption price or prices, liquidation preferences and the number of shares constituting any series or designations of such series without further vote or action by the shareholders. The issuance of Preferred Stock may have the effect of delaying, deferring, or preventing a change in control of management without further action by the shareholders and may adversely affect the voting and other rights of the holders of Common Stock. The issuance of Preferred Stock with voting and conversion rights may adversely affect the voting power of the holders of Common Stock, including the loss of voting control to others.
Series A Convertible Preferred Stock
On June 30, 2015, a certificate of designations was filed with the Delaware Secretary of State to designate shares of the Company’s Preferred Stock as Series A Convertible Preferred Stock, par value $ per share (“Series A Preferred”) (the “Series A COD”). Effective March 31, 2016, the Company amended the Series A COD, increasing the maximum number of shares of Series A Preferred from shares to shares. As of December 31, 2025 and 2024, there are shares of Series A Preferred issued and outstanding, respectively.
The following summarizes the current rights and preferences of the Series A Preferred:
Liquidation
Preference. The Series A Preferred has a liquidation preference of $
Dividends. Shares of Series A Preferred do not have any separate dividend rights.
Conversion.
Subject to certain limitations set forth in the Series A COD, each share of Series A Preferred is convertible, at the option of the holder,
into that number of shares of Common Stock (the “Series A Conversion Shares”) equal to the liquidation preference
thereof, divided by Conversion Price (as such term is defined in the Series A COD), currently $
In
the event the Company completes an equity or equity-based public offering, registered with the SEC, resulting in gross proceeds to the
Company totaling at least $
Redemption.
Voting
Rights.
| F-13 |
Liquidation. Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”), the holders of Series A Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount equal to the liquidation preference of the Series A Preferred before any distribution or payment shall be made to the holders of any junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed to the holders of the Series A Preferred shall be ratably distributed among the holders in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were paid in full.
Certain Price and Share Adjustments.
a) Stock Dividends and Stock Splits. If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents; (ii) subdivides outstanding shares of Common Stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock of the Company, then the conversion price shall be adjusted accordingly.
b) Merger or Reorganization. If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series A Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of shares of Common Stock issuable upon conversion of one share of Series A Preferred prior to any such merger or reorganization would have been entitled to receive pursuant to such transaction.
Series B Convertible Preferred Stock
On October 10, 2018, a certificate of designation was filed with the Delaware Secretary of State to designate shares of our Preferred Stock as Series B Convertible Preferred Stock, par value $ per share (“Series B Preferred”) (the “Series B COD”). As of December 31, 2025 and 2024, there are shares of Series B Preferred issued and outstanding, respectively.
The following summarizes the current rights and preferences of the Series B Preferred:
Liquidation
Preference. The Series B Preferred has a liquidation preference of $
Dividends. Shares of Series B Preferred do not have any separate dividend rights.
Conversion.
Subject to certain limitations set forth in the Series B COD, each share of Series B Convertible is convertible, at the option of the
holder, into that number of shares of Common Stock (the “Series B Conversion Shares”) equal to the liquidation preference
thereof, divided by the Conversion Price (as such term is defined in the Series B COD), currently $
Redemption.
Voting
Rights.
Liquidation. Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”), the holders of Series B Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount equal to the liquidation preference of the Series B Preferred before any distribution or payment shall be made to the holders of any junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed to the holders of the Series B Preferred shall be ratably distributed among the holders in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were paid in full.
| F-14 |
Certain Price and Share Adjustments.
(a) Stock Dividends and Stock Splits. If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents; (ii) subdivides outstanding shares of Common Stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock of the Company, then the conversion price shall be adjusted accordingly.
(b) Merger or Reorganization. If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series B Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of shares of Common Stock issuable upon conversion of one share of Series B Preferred prior to any such merger or reorganization would have been entitled to receive pursuant to such transaction.
On December 16, 2024, Series B Preferred shares were converted into shares of Common Stock. There were no conversions in 2025.
Series C Convertible Preferred Stock
On March 27, 2019, a certificate of designation was filed with the Delaware Secretary of State to designate shares of our Preferred Stock as Series C Convertible Preferred Stock, par value $ per share (“Series C Preferred”) (the “Series C COD”). As of December 31, 2025 and 2024, there were shares of Series C Preferred issued and outstanding, respectively.
The following summarizes the current rights and preferences of the Series C Preferred:
Liquidation
Preference. The Series C Preferred has a liquidation preference of $
Dividends. Shares of Series C Preferred do not have any separate dividend rights.
Conversion.
Subject to certain limitations set forth in the Series C COD, each share of Series C Preferred is convertible, at the option of the holder,
into that number of shares of Common Stock (the “Series C Conversion Shares”) equal to the liquidation preference
thereof, divided by Conversion Price (as such term is defined in the Series C COD), currently $
The Series C Preferred will only be convertible at any time after the date that the Company shall have amended its Certificate of Incorporation to increase the number of shares of Common Stock authorized for issuance thereunder or effect a reverse stock split of the outstanding shares of Common Stock by a sufficient amount to permit the conversion of all Series C Preferred into shares of Common Stock (“Authorized Share Approval”) (such date, the “Initial Convertibility Date”), each share of Series C Preferred shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock on the terms and conditions set forth in the Series C COD under the definition “Conversion Rights”.
Redemption.
Voting
Rights.
| F-15 |
Liquidation. Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”), the holders of Series C Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the Company an amount equal to the liquidation preference of the Series C Preferred before any distribution or payment shall be made to the holders of any junior securities, and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed to the holders of the Series C Preferred shall be ratably distributed among the holders in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were paid in full.
Certain Price and Share Adjustments.
(a) Stock Dividends and Stock Splits. If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions payable in shares of Common Stock on shares of Common Stock or any other Common Stock equivalents; (ii) subdivides outstanding shares of Common Stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock of the Company, then the conversion price shall be adjusted accordingly.
(b) Merger or Reorganization. If the Company is involved in any reorganization, recapitalization, reclassification, consolidation or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series C Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of shares of Common Stock issuable upon conversion of one share of Series C Preferred prior to any such merger or reorganization would have been entitled to receive pursuant to such transaction.
Common and Preferred Stock Issuances
Common and Preferred Stock Issuances – Year Ended December 31, 2025
In
January 2025, the Company received $
In
February 2025, the Company issued shares of Common Stock pursuant to the Regulation A+ Offering, and
In
March 2025, the Company issued shares of Common Stock for services rendered valued at $
In April 2025, the Company issued shares of Common Stock upon the vesting of Restricted Stock Units (“ RSUs”).
In
June 2025, the Company issued shares of Common Stock upon the vesting of RSUs, and shares for services rendered in the
amount of $
In July 2025, shares of Common Stock were issued for the cashless exercise of warrants.
In
September 2025, the Company issued shares of Common Stock for services rendered in the amount of $
In
December 2025, the Company issued shares of Common Stock for services rendered in the amount of $
Common and Preferred Stock Issuances – Year Ended December 31, 2024
The
Company issued shares of Common Stock pursuant to the Regulation A+ Offerings for cash proceeds of $
The
Company issued shares of Common Stock for services rendered valued at $
The
Company issued shares of Common Stock in the cashless exercise of
| F-16 |
The
Company issued shares of Common Stock in the exchange of warrants and recognized a loss on the exchange of $
There were Series B Preferred shares converted into common shares.
The Company settled RSUs for Common Stock.
The Company adjusted their common shares for vested RSUs in prior periods that were cancelled.
Common Stock Options
The Company recognizes in the financial statements compensation related to all stock-based awards, including stock options and warrants, based on their estimated grant-date fair value. The Company has estimated expected forfeitures and is recognizing compensation expense only for those awards expected to vest. All compensation is recognized by the time the award vests.
SCHEDULE OF CHANGES IN STOCK OPTION
| Options Outstanding | Weighted Average | Weighted Average | ||||||||||||||||||
| Number Of Shares | Exercise Price Per Share | Remaining Contractual Life | Aggregate Intrinsic Value | Exercise Price Per Share | ||||||||||||||||
| Year Ended December 31, 2024 | ||||||||||||||||||||
| Outstanding at January 1, 2024 | $ | - | years | $ | $ | |||||||||||||||
| Granted | $ | - | $ | |||||||||||||||||
| Exercised | $ | - | $ | |||||||||||||||||
| Expired/cancelled | $ | - | $ | |||||||||||||||||
| Outstanding at December 31, 2024 | $ | - | years | $ | $ | |||||||||||||||
| Exercisable at December 31, 2024 | $ | - | years | $ | $ | |||||||||||||||
| Year Ended December 31, 2025 | ||||||||||||||||||||
| Outstanding at January 1, 2025 | $ | - | years | $ | $ | |||||||||||||||
| Granted | $ | - | $ | |||||||||||||||||
| Exercised | $ | - | $ | |||||||||||||||||
| Expired/cancelled | $ | - | $ | |||||||||||||||||
| Outstanding at December 31, 2025 | $ | - | years | $ | $ | |||||||||||||||
| Exercisable at December 31, 2025 | $ | - | years | $ | $ | |||||||||||||||
During the years ended December 31, 2025 and 2024, the Company recognized $ of stock-based compensation expense related to the vesting of stock options.
| F-17 |
Common Stock Warrants
The following schedule summarizes the changes in the Company’s stock warrants:
SCHEDULE OF CHANGES IN STOCK WARRANTS
| Warrants Outstanding | Weighted Average | Weighted Average | ||||||||||||||||||
| Number Of Shares | Exercise Price Per Share | Remaining Contractual Life | Aggregate Intrinsic Value | Exercise Price Per Share | ||||||||||||||||
| Year Ended December 31, 2024 | ||||||||||||||||||||
| Outstanding at January 1, 2024 | $ | - | years | $ | $ | |||||||||||||||
| Granted | $ | - | $ | - | $ | |||||||||||||||
| Redeemed | $ | - | $ | - | $ | - | ||||||||||||||
| Exercised | ( | ) | $ | - | $ | - | $ | - | ||||||||||||
| Exchanged | ( | ) | $ | - | $ | - | $ | - | ||||||||||||
| Expired/cancelled | $ | - | $ | - | $ | - | ||||||||||||||
| Outstanding at December 31, 2024 | $ | years | $ | $ | ||||||||||||||||
| Exercisable at December 31, 2024 | $ | years | $ | $ | ||||||||||||||||
| Year Ended December 31, 2025 | ||||||||||||||||||||
| Outstanding at January 1, 2025 | $ | years | $ | $ | ||||||||||||||||
| Granted | $ | - | $ | - | $ | |||||||||||||||
| Redeemed | $ | - | $ | - | $ | - | ||||||||||||||
| Exercised | ( | ) | $ | - | $ | - | $ | - | ||||||||||||
| Exchanged | $ | - | $ | - | $ | - | ||||||||||||||
| Expired/cancelled | $ | - | $ | - | $ | - | ||||||||||||||
| Outstanding at December 31, 2025 | $- | years | $ | $ | ||||||||||||||||
| Exercisable at December 31, 2025 | $- | years | $ | $ | ||||||||||||||||
Changes to these inputs could produce a significantly higher or lower fair value measurement. The fair value of each option/warrant is estimated using the Black-Scholes valuation model. The following assumptions were used for the periods as follows:
| Year Ended | Year Ended | |||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Expected term | - | - | ||||||
| Expected volatility | % | % | ||||||
| Expected dividend yield | ||||||||
| Risk-free interest rate | % | % |
The
Company granted
warrants in their Regulation A+ Offering in January 2024, with
an exercise price of $
and a
three-year term and
In
November 2024, the Company sold warrants,
In 2024, the Company issued shares of Common Stock in the exercise of warrants.
The Company granted warrants in February 2025, with an exercise price of $ that expire June 30, 2028. In July 2025, warrants were exercised into shares of Common Stock.
| F-18 |
Restricted Stock Units
SCHEDULE OF CHANGES IN RESTRICTED STOCK UNITS
| Number Of Shares | Weighted Average Grant Date Fair Value | |||||||
| Year Ended December 31, 2024 | ||||||||
| Outstanding at January 1, 2024 | $ | |||||||
| Granted | $ | |||||||
| Vested | ( | ) | $ | |||||
| Forfeited | $ | |||||||
| Outstanding at December 31, 2024 | $ | |||||||
| Year Ended December 31, 2025 | ||||||||
| Outstanding at January 1, 2025 | $ | |||||||
| Granted | $ | |||||||
| Vested | ( | ) | $ | |||||
| Forfeited | $ | |||||||
| Outstanding at December 31, 2025 | $ | |||||||
During
the years ended December 31, 2025 and 2024, the Company recognized $
On January 1, 2024, the Company granted restricted stock units to its Chief Executive Officer as part of his new employment agreement that vest in four equal installments over a two-year period beginning February 1, 2024. In May 2024, the Company granted restricted stock units to consultants that vest through December 31, 2025. In November 2024, the Company granted restricted stock units that vest in May 2025. During the year ended December 31, 2024, of these restricted stock units vested.
During the year ended December 31, 2025, restricted stock units were granted to consultants that vest through December 31, 2028, and restricted stock units vested.
NOTE 6: LEASES
The Company has adopted ASU No. 2016-02, Leases (Topic 842) and as such accounted for our leases in terms of the right of use assets and offsetting lease liability obligations under this pronouncement. The Company had had only short-term leases through entering into a long-term lease agreement on November 1, 2025. The Company recorded these amounts at present value, in accordance with the standard, using a discount rate of 4.5%. The right of use asset is composed of the sum of all lease payments, at present value, and is amortized straight line over the life of the expected lease term. For the expected term of the lease the Company used the initial terms of 48 months. Upon the election by the Company to extend the lease for additional years, that election will be treated as a lease modification and the lease will be reviewed for re-measurement.
The Company has chosen to implement this standard using the modified retrospective model approach with a cumulative-effect adjustment, which does not require the Company to adjust the comparative periods presented when transitioning to the new guidance. The Company has also elected to utilize the transition related practical expedients permitted by the new standard. The modified retrospective approach provides a method for recording existing leases at adoption and in comparative periods that approximates the results of a modified retrospective approach. Adoption of the new standard did not result in an adjustment to retained earnings for the Company.
As
of December 31, 2025, the value of the unamortized lease right of use asset was $
SCHEDULE OF OPERATING LEASE MATURITY
| Maturity of lease liability for the operating lease for the period ended December 31, | ||||
| 2026 | $ | |||
| 2027 | $ | |||
| 2028 | $ | |||
| 2029 | $ | |||
| Imputed interest | $ | ( | ) | |
| Total lease liability | $ | |||
| Disclosed as: | ||||
| Current portion | $ | |||
| Non-current portion | $ | |||
| F-19 |
SCHEDULE OF LESSEE RIGHT OF USE OF ASSET AMORTIZATION
| Amortization of the right of use asset for the period ended December 31, 2026 | $ | |||
| 2027 | $ | |||
| 2028 | $ | |||
| 2029 | $ | |||
| Total | $ |
Total Lease Cost
Individual components of the total lease cost incurred by the Company is as follows:
Year ended December 31, 2025 | Year ended December 31, 2024 | |||||||
| Operating lease expense | $ | $ | ||||||
NOTE 7: CONCENTRATIONS
Four
and three customers accounted for all of the revenues, each, more than 10% of total revenue. As of December 31, 2025 and 2024, six and
two customers represented
NOTE 8: COMMITMENT
On
June 4, 2019, the Company entered into an Executive Employment Agreement (“Employment Agreement”) with Dr. Michael
K. Korenko, the Company’s Chief Executive Officer.
Under
the terms of the Employment Agreement effective January 1, 2024, the Company shall pay to Dr. Korenko a base compensation of $
NOTE 9: INCOME TAXES
Deferred taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry-forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.
| F-20 |
The following table summarizes the significant differences between the U.S. Federal statutory tax rate and the Company’s effective tax rate for financial statement purposes for the years ended December 31, 2025 and 2024:
SCHEDULE OF EFFECTIVE TAX RATE
| 2025 | 2024 | |||||||
| Federal income taxes at statutory rate | % | % | ||||||
| State income taxes at statutory rate | % | % | ||||||
| Stock for services | % | % | ||||||
| Change in valuation allowance | ( | )% | ( | )% | ||||
| Totals | % | % | ||||||
Net deferred tax assets consist of the following components as of December 31, 2025 and 2024:
SCHEDULE OF NET DEFERRED TAX ASSETS
| December 31, 2025 | December 31, 2024 | |||||||
| Deferred tax assets: | ||||||||
| Net operating loss carryover | $ | $ | ||||||
| Capital Loss Carryover | ||||||||
| Valuation allowance | ( | ) | ( | ) | ||||
| Net deferred tax asset | $ | $ | ||||||
The income tax provision differs from the amount of income tax determined by applying the U.S. Federal income tax rate to pretax income from continuing operations for the years ended December 31, 2025 and 2024 due to the following:
SCHEDULE OF FEDERAL INCOME TAX RATE
| December 31, 2025 | December 31, 2024 | |||||||
| Book income (loss) | $ | ( | ) | $ | ( | ) | ||
| Depreciation | ( | ) | ( | ) | ||||
| Stock for services | ||||||||
| Valuation allowance | ||||||||
| Income tax expense | $ | $ | ||||||
At
December 31, 2025, the Company had a net operating loss carryforward of approximately $
ASC Topic 740 – Income Taxes (“ASC 740”) provides guidance on the accounting for uncertainty in income taxes recognized in a company’s financial statements. ASC 740 requires a company to determine whether it is more likely than not that a tax position will be sustained upon examination based upon the technical merits of the position. If the more-likely-than-not threshold is met, a company must measure the tax position to determine the amount to recognize in the financial statements. At the adoption date of January 1, 2007, the Company had no unrecognized tax benefit, which would affect the effective tax rate if recognized.
The
Company includes interest and penalties arising from the underpayment of income taxes in the statements of operations in the provision
for income taxes. As of December 31, 2025, the Company had
The Company files income tax returns in the U.S. federal jurisdiction. The Company is located in the state of Washington and Washington state does not require the filing of income taxes. With few exceptions, the Company is no longer subject to U.S. federal, state and local, or non-U.S. income tax examinations by tax authorities for years before 2017.
NOTE 10: SUBSEQUENT EVENTS
The Company has evaluated subsequent events through the date of this report and there were no items noted to be disclosed except for the items below.
In January 2026, the Company issued shares of common stock for services rendered.
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 $
In March 2026, the Company raised
$
In addition, the Company issued
| F-21 |
Exhibit 23
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Post-Qualification Amendment #1 to the Offering Statements on Form 1-A (File No. 024-11627 and 024-12456) of our audit report dated March 30, 2026, with respect to the consolidated balance sheets of Vivos, Inc. as of December 31, 2025 and 2024, and the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2025. Our report relating to those financial statements includes an emphasis of matter paragraph regarding substantial doubt as to the Company’s ability to continue as a going concern.
We also consent to the reference to us under the heading “Experts” in such Amendments to the Offering Statements.
Fruci & Associates II, PLLC – PCAOB ID #05525
Spokane, Washington
March 30, 2026
EXHIBIT 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael K. Korenko, certify that:
1. I have reviewed this annual report on Form 10-K of VIVOS INC;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: March 30, 2026
| /s/ Michael K. Korenko | |
| Michael K. Korenko | |
| Chief Executive Officer | |
| (Principal Executive Officer) |
EXHIBIT 31.2
CERTIFICATION OF INTERIM CHIEF FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael Pollack, certify that:
1. I have reviewed this annual report on Form 10-K of VIVOS INC;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: March 30, 2026
| /s/ Michael Pollack | |
| Michael Pollack | |
| Interim Chief Financial Officer | |
| (Interim Principal Financial Officer) |
EXHIBIT 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the accompanying annual report of VIVOS INC (the “Company”) on Form 10-K for the year ended December 31, 2025 (the “Report”), the undersigned, Michael K. Korenko, Chief Executive Officer of the Company, and Michael Pollack, Interim Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: March 30, 2026
| /s/ Michael K. Korenko | |
| Name: Michael K. Korenko | |
| Title: Chief Executive Officer | |
| /s/ Michael Pollack | |
| Name: Michael Pollack | |
| Title: Interim Chief Financial Officer |