Executive Summary / Key Takeaways

• Vivos Inc. ($RDGL) is a medical device company developing Precision Radionuclide Therapy™ using a proprietary yttrium-90 (Y-90) particle-gel technology (RadioGel/IsoPet) for targeted cancer treatment in both animals and humans.
• The company is pursuing a dual-market strategy, actively commercializing its IsoPet product in the veterinary oncology market while simultaneously advancing RadioGel towards human clinical trials, bolstered by FDA Breakthrough Device designation.
• Recent performance in Q1 2025 shows significant growth in the small veterinary segment, with treatment volume increasing 150% year-over-year and the introduction of clinic certification revenue, though overall revenue remains limited ($26,748 in Q1 2025).
• Despite technological promise and veterinary traction, RDGL faces substantial financial challenges, operating at a significant net loss ($834,696 in Q1 2025) with auditors expressing substantial doubt about its ability to continue as a going concern without significant additional capital.
• The investment thesis is highly dependent on the successful execution of human clinical trials and securing necessary funding (estimated $3M annually for operations, $9M over 36 months for key milestones) in a competitive landscape dominated by larger, financially stronger players.

Setting the Scene: A Niche Player in Radiation Oncology

Vivos Inc. operates within the specialized field of radiation oncology, focusing on the development and potential commercialization of brachytherapy devices. The company's journey began in 1994 as Savage Mountain Sports Corporation, evolving through name changes to Advanced Medical Isotope Corporation and finally Vivos Inc. in 2017. Early on, in 2013, the U.S. FDA classified its core technology, a yttrium-90 (Y-90) based precision radionuclide therapy device known as RadioGel, as a device for human therapy for non-resectable cancers, a classification anticipated to offer a more streamlined regulatory pathway compared to drug approvals.

At the heart of Vivos's strategy is this proprietary technology: a particle-gel system where small Y-90 phosphate particles are suspended within a hydrogel. This hydrogel is designed to be liquid at room temperature, gelling upon injection into a tumor as it warms to body temperature. This mechanism aims to lock the radioactive particles in place, delivering a very high local radiation dose directly to the cancerous tissue. The Y-90 emits beta radiation, high-speed electrons with a short travel distance, allowing for intense radiation within the tumor boundary while minimizing exposure to surrounding healthy tissue. The Y-90 isotope has a half-life of 2.7 days, meaning radioactivity significantly diminishes within about ten days, potentially allowing for outpatient treatment with reduced risk of radiation exposure to others.

Vivos is pursuing a dual-market strategy, leveraging its core technology in both veterinary and human oncology. The veterinary application, marketed as IsoPet, has been the primary commercial focus to date, while the human application, RadioGel, represents the significant future growth opportunity contingent on clinical and regulatory success. This positions RDGL as a niche player in the broader radiation therapy market, competing against much larger, established medical device companies like Accuray Inc. (ARAY), Elekta AB (publ) (EKTAY), and Boston Scientific Corporation (BSX), who offer a wider range of radiation delivery systems and oncology solutions. While these larger players dominate the market with scale and extensive product portfolios, Vivos aims to carve out its space through the unique delivery mechanism and precision offered by its injectable particle-gel technology.

Technology at the Core: Precision Radionuclide Therapy

The foundational technology for Vivos is its Y-90 based particle-gel system. This system utilizes Y-90 phosphate particles, less than two microns in size, suspended in a hydrogel. The hydrogel's unique property of gelling at body temperature after injection is critical, designed to ensure the radioactive particles remain localized within the tumor. This contrasts with systemic radionuclide therapies or external beam radiation, offering the potential for highly targeted treatment.

The tangible benefits of this precision delivery mechanism are central to Vivos's value proposition. By delivering high-energy beta radiation directly within the tumor, the technology aims to maximize cell kill in the target area while significantly limiting the dose to adjacent healthy tissues. Studies conducted with partners like Washington State University and Johns Hopkins University have consistently confirmed that the Y-90 remains at the injection site with insignificant distribution outside that boundary. This localized delivery is intended to reduce side effects and potentially improve patient outcomes compared to less targeted approaches. The short half-life of Y-90 also means the treated area's radioactivity quickly decays, potentially enabling outpatient procedures and reducing the need for lengthy hospital stays or isolation.

Vivos continues to invest in refining its core technology and exploring new applications. The company has spent years developing its hydrogel component, focusing on controlling its gelation and resorption characteristics. Recognizing the potential beyond cancer treatment, Vivos is exploring leveraging the hydrogel (trademarked as Precision Gel™) for the retention, transport, and release of a broad range of agents, including radioactive and non-radioactive materials, particles, molecules, cells, and viruses. A new provisional patent covering the control, transport, and delivery of PrecisionGel was filed in January 2025. While specific quantitative performance targets for these new applications were not detailed, the strategic intent is to diversify the technology's use and create new business opportunities, potentially through licensing or spin-offs, leveraging the hydrogel's unique properties.

For investors, the technology represents the primary potential competitive moat. While larger competitors offer established and widely used radiation therapies, Vivos's injectable, localized approach could offer advantages in specific tumor types or patient populations, particularly where minimizing damage to surrounding tissue is critical. The potential for outpatient treatment could also offer cost and convenience benefits. However, translating these technological advantages into significant market share and profitability requires successful clinical validation, regulatory approval, and effective commercialization, particularly in the highly competitive human oncology market.

The Dual Path: Veterinary Traction and Human Ambition

Vivos's strategy unfolds along two parallel paths: establishing a commercial presence in the veterinary market with IsoPet and pursuing regulatory approval and clinical trials for RadioGel in human oncology.

The IsoPet Solutions division, established in 2016, has focused on the veterinary market, initially targeting feline and canine sarcomas based on FDA classification. The company believes this classification extends to most solid tumors in animals, requiring no additional premarket regulatory approvals for broader veterinary use. Vivos has collaborated with university veterinary hospitals to develop therapy procedures and gather data, which it intends to use to support its human therapy efforts.

Recent performance highlights the growing traction in the veterinary segment. For the three months ended March 31, 2025, Vivos reported total revenue of $26,748, a significant increase from $4,500 in the same period in 2024. This growth was driven by a substantial increase in revenue from treatments ($66,195 in Q1 2025 vs. $6,500 in Q1 2024) and the introduction of revenue from clinic certification ($29,983 in Q1 2025 vs. $0 in Q1 2024). News reports indicated a record-breaking first quarter for the IsoPet division, with a 150% year-over-year increase in treatment volume. While still generating a gross loss ($9,083 in Q1 2025), this segment provides operational experience and initial revenue streams. The company is actively working to expand its presence in the animal therapy market by increasing certified clinics and patient treatments, including subsidizing therapies if needed and assisting new regional clinics.

Simultaneously, Vivos is pushing forward with its human therapy ambitions for RadioGel. Following the 2013 FDA device classification, the company refined its indication for use to locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma in specific patient groups. A significant milestone was achieved in December 2023 with the FDA's Breakthrough Device designation, providing access to a rapid review process for Investigational Device Exemption (IDE) comments.

In early 2025, Vivos began actively pursuing human clinical trials in India. This involved a series of critical steps, including securing regulatory clearances from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organization (CDSCO), resulting in the issuance of the Clinical Trial Registry-India (CTRI) number. Logistical coordination, including liability insurance, expanding radioactive material licenses, and establishing international shipping protocols, was successfully implemented. Protocol development incorporated feedback from FDA pre-submission discussions and Mayo Clinic study designs. Manufacturing at IsoTherapeutics was re-validated to meet quality standards, and the treatment team received comprehensive certification training. The successful completion of these requirements was essential to proceed with the trials.

This dual approach allows Vivos to gain commercial experience and generate some revenue in the less regulated veterinary market while navigating the complex and costly path towards human clinical trials and potential FDA approval, which remains the larger, albeit more distant, market opportunity.

Financial Performance and Liquidity: A Development Stage Reality

Vivos's financial statements reflect its status as a development-stage company with limited commercial revenue and significant ongoing expenses related to R&D and operational infrastructure. For the three months ended March 31, 2025, the company reported total revenue of $26,748, an increase from $4,500 in the prior year period, primarily driven by the growth in IsoPet treatments and the new certification revenue. However, the cost of goods sold ($35,831) exceeded revenue, resulting in a gross loss of $9,083.

Operating expenses saw a substantial increase, rising to $854,449 in Q1 2025 from $575,629 in Q1 2024. This increase was attributed to higher professional fees ($588,268 vs. $403,637), general and administrative expenses ($52,203 vs. $23,420), and research and development costs ($119,281 vs. $57,447). The increase in R&D reflects the ramp-up in product development and efforts towards FDA acceptance and clinical trials in India and the U.S. Payroll expense also saw a slight increase ($94,697 vs. $91,125), partly related to the CEO's employment contract.

The net result was a net loss of $834,696 for the three months ended March 31, 2025, compared to a net loss of $558,539 for the same period in 2024. On a trailing twelve-month basis, revenue stands at $27,995, with a net loss of approximately -$2.91 million and negative operating cash flow of -$1.68 million. These figures underscore the significant cash burn associated with the company's development activities.

As of March 31, 2025, Vivos had cash on hand of $3.27 million. Net cash used in operating activities during Q1 2025 was $455,198. Historically, the company has relied heavily on external financing to fund its operations and development. During the three months ended March 31, 2025, Vivos raised $1.51 million through the issuance of common stock and warrants via Regulation A Offerings and concurrent private placements, following $2.27 million raised in 2024 and $1.18 million in 2023 through similar means.

The company's independent registered public accounting firm has expressed substantial doubt about Vivos's ability to continue as a going concern, citing recurring losses and insufficient cash to support operations. The current cash position is not adequate to cover the company's fixed and variable obligations required for continued product development.

Outlook and Funding Needs: The Path Forward

Vivos's outlook is intrinsically linked to its ability to secure significant additional funding and achieve key regulatory and clinical milestones. The company estimates it requires approximately $3.00 million annually to maintain current operating activities. Looking further ahead, Vivos believes it will need approximately $9.00 million in additional capital over the next 36 months to execute its strategic plan.

This capital is earmarked for several critical initiatives: funding the FDA approval process for human clinical trials, conducting Phase I and pilot clinical trials, activating several regional clinics to expand IsoPet administration across the U.S., creating an independent production center to serve as a template for international manufacturing, and initiating regulatory approval processes outside of the United States. The proceeds from the July 2024 Regulation A Offering are intended to support these development efforts.

The company plans to expand the indications for human use in phases, starting with lymph nodes associated with thyroid cancer, followed by cancerous lung nodules, and eventually all non-resectable solid tumors. The timing and amount of future spending are highly dependent on the FDA's classification of RadioGel (Class II or Class III) and any requirements for additional studies. Beyond regulatory approval, the pace of spending and financing needs will be influenced by the nature of arrangements with third parties for manufacturing, sales, distribution, and licensing, as well as the product's market success.

Vivos intends to fund these activities through strategic transactions like licensing and partnership agreements or further capital raises, such as through Regulation A Offerings. However, there is no guarantee that the company will be able to raise additional funds or do so on favorable terms. The company's long-term goals, including resuming research on other potential products like Gamma Gel and Alpha Gel, are contingent upon securing adequate funding, receiving regulatory approvals, and successfully commercializing its brachytherapy products.

Competitive Positioning and Challenges

Vivos operates in a highly competitive medical device market, specifically within the radiation oncology sector, where it is a significantly smaller player compared to industry giants. While precise, directly comparable market share figures for all niche competitors are not publicly detailed, Vivos holds an estimated aggregate market share of only 1-2% in radiation oncology, primarily within brachytherapy. This contrasts sharply with major competitors like Elekta AB (publ) and Accuray Inc. , which command estimated market shares of 15-20% and 10-15% respectively in the broader radiation therapy market, and Boston Scientific Corporation, which has a growing 10-15% share in oncology devices including brachytherapy.

Financially, the disparity is stark. Vivos operates with negative gross and operating margins (TTM Gross Profit Margin -21.03%, TTM Operating Profit Margin -5753.61%), reflecting its development stage and limited revenue scale. In contrast, competitors like Accuray Inc. (32% Gross Margin), Elekta AB (publ) (37% Gross Margin), and Boston Scientific Corporation (69% Gross Margin) demonstrate established profitability and scale. Vivos's lower Return on Invested Capital (ROIC) and Return on Equity (ROE), estimated at 1-2%, significantly trail competitors like Accuray Inc. (2-5%), Elekta AB (publ) (10-12%), and Boston Scientific Corporation (12-15%), indicating poorer capital efficiency.

Despite its smaller scale and financial challenges, Vivos's competitive advantages lie in its proprietary technology and niche focus. The injectable particle-gel system offers a unique delivery mechanism for brachytherapy, potentially providing 25-30% higher energy efficiency in radiation delivery compared to some alternatives, which could translate to superior margins through pricing power if successfully commercialized at scale. The company's focus on the veterinary market with IsoPet is a distinct niche where major human oncology players like Elekta AB (publ) and Accuray Inc. have minimal or no presence, offering Vivos a unique market segment and a source of operational experience and initial revenue.

However, Vivos faces significant competitive disadvantages. Its limited scale results in higher operating costs per unit compared to mass-produced devices from larger companies. The pace of technological innovation, while focused on its core platform, may lag behind the rapid development cycles of larger, better-funded competitors, particularly in areas like software integration and treatment planning, where companies like Elekta AB (publ) excel. Indirect competitors offering alternative cancer treatments like immunotherapy (e.g., Merck (MRK)) or proton therapy also pose a challenge, potentially encroaching on the market for traditional radiation therapies and pressuring pricing.

Barriers to entry in the radiation oncology market, particularly regulatory hurdles and the high cost of R&D, are substantial. While these barriers help protect Vivos's niche technology from direct replication by smaller entrants, they also make it challenging for Vivos to compete head-to-head with large, established players who have extensive regulatory experience, vast R&D budgets, and existing distribution networks. Customer concentration is also a risk, as evidenced by two customers accounting for 100% of accounts receivable as of March 31, 2025. Vivos's strategy to outsource manufacturing and distribution in the U.S. and pursue licensing internationally is a response to its limited scale and aims to leverage third-party infrastructure to overcome some of these disadvantages.

Key Risks to the Investment Thesis

Investing in Vivos Inc. involves significant risks, primarily centered around its financial viability, regulatory pathway, and ability to commercialize its technology in competitive markets.

The most immediate risk is the company's ability to secure sufficient additional funding. Vivos has a history of operating losses and negative cash flow, and its current cash position is insufficient to meet its operating obligations and fund its strategic development plans. The auditors' expression of substantial doubt about the company's ability to continue as a going concern highlights this critical dependency on future capital raises, which may not be available on favorable terms or at all.

Success in the human oncology market hinges on the outcome of clinical trials and obtaining regulatory approval from the FDA and international bodies. Despite the Breakthrough Device designation, the clinical trial process is lengthy, expensive, and carries inherent risks of failure. Any delays or unfavorable results could significantly impact the company's timeline and ability to commercialize RadioGel for human use.

Even if regulatory approval is obtained, successful commercialization in the highly competitive human and veterinary markets is not guaranteed. Larger competitors have established relationships with hospitals and clinics, extensive sales and marketing infrastructure, and broader product portfolios. Vivos must effectively demonstrate the clinical and economic benefits of its technology to gain market acceptance.

Competition from both direct brachytherapy providers and alternative cancer treatments could limit market share and pressure pricing, impacting Vivos's potential revenue and profitability. The company's smaller scale and higher relative operating costs could make it challenging to compete on price.

Dependence on key personnel, intellectual property protection, and reliance on third-party manufacturers and suppliers also pose risks. The loss of key individuals, inability to protect its patents and trademarks, or disruptions in the supply chain for isotopes or hydrogel components could adversely affect operations. Furthermore, the concentration of revenue and receivables in a small number of customers in the veterinary segment creates vulnerability.

Conclusion

Vivos Inc. presents a compelling, albeit high-risk, investment narrative centered on its innovative Precision Radionuclide Therapy technology. The company's Y-90 particle-gel system offers a unique approach to brachytherapy with the potential for highly localized, precise radiation delivery, minimal off-target exposure, and outpatient treatment. The recent traction and growth in the veterinary IsoPet segment provide some operational validation and initial revenue, demonstrating a market need for targeted animal cancer therapies. The pursuit of human clinical trials, supported by the FDA's Breakthrough Device designation and successful preparatory steps for trials in India, represents the primary catalyst for potential future value creation.

However, the path forward is fraught with significant challenges, most notably the critical need for substantial additional funding to sustain operations and finance the costly human clinical development and regulatory approval processes. The company's current financial state, marked by recurring losses and a going concern warning, underscores this dependency. In a competitive landscape dominated by well-capitalized, diversified players, Vivos must effectively leverage its technological differentiation to overcome its scale disadvantages and secure market adoption. The investment thesis for RDGL is fundamentally a bet on the successful clinical validation and commercialization of its precision technology in human oncology, requiring investors to weigh the potential long-term rewards against the immediate and significant financial and execution risks.