Vivos Inc.
Business Overview: Vivos Inc. (OTC Pink: RDGL)
Executive Summary
Vivos Inc. is a Kennewick, Washington-based radiation oncology medical device company developing RadioGel™, an injectable, yttrium-90 (Y-90) based "Precision Radionuclide Therapy" gel for treating non-resectable tumors. The same core technology is sold commercially today for veterinary use under the brand IsoPet®.
Vivos is an early-stage, pre-revenue-scale company: it reported only $27,995 in operating revenue for 2024 and a $2.9 million net loss, operates with a single full-time employee (the CEO) using an asset-light, outsourced-manufacturing model, and its auditors have expressed substantial doubt about its ability to continue as a going concern.
1. Core Business Model & How They Work
[ Y-90 Gel Formulation ] ➡️ [ Shipped Ready-to-Use to Clinic/Vet ] ➡️ [ Injected Directly Into Tumor ] ➡️ [ Localized Beta Radiation (short range, ~2.7-day half-life) ] ➡️ [ Gel Resorbs (~120 days) ]The company's RadioGel/IsoPet technology is an injectable gel, liquid at room temperature and solid at body temperature, that holds Y-90 phosphate particles in place directly inside a tumor. Because Y-90's beta particles travel only a short distance, the radiation dose concentrates on the tumor while limiting exposure to surrounding tissue — and because the product is pre-mixed and shipped ready-to-use, it can be administered through a standard needle without on-site radiopharmacy preparation.
2. Business Segments
Vivos operates across two sectors rather than formal reporting segments:
- Veterinary (commercial today) — the IsoPet division sells direct product and clinic-certification services. Certified clinics grew from 4 (2023) to 13 (end of 2024), treating feline, canine, equine, and exotic-animal tumors, with the company targeting roughly 10 more certifications in 2025.
- Human medical (pending FDA approval) — RadioGel is currently classified as a Class III device; the company is seeking Class II reclassification and received FDA Breakthrough Device designation in December 2023 for papillary thyroid carcinoma, with clinical trials beginning in India in early 2025.
3. Product Portfolio
| Product | Market | Purpose | Why It Matters |
|---|---|---|---|
| IsoPet® | Veterinary (commercial) | Y-90 radiotherapy gel for feline/canine/equine tumors | Vivos's only current revenue source; small but growing certified-clinic network. |
| RadioGel™ | Human (pre-approval) | Same Y-90 technology for non-resectable human tumors | Breakthrough Device designation for thyroid cancer could materially accelerate the regulatory path if trials succeed. |
| Precision Gel™ | Adjacent (early) | Separate hydrogel business with partner Akina | Optionality beyond the core radiotherapy product, though pre-commercial. |
4. Competitive Landscape
Vivos's product would compete against established brachytherapy devices — iodine-125 (Oncura/GE Healthcare, C.R. Bard), palladium-103, and cesium-131 (GT MedTech) — and against approved Y-90 microsphere therapies like SIR-Spheres (Sirtex) and TheraSphere (Biocompatibles UK). More broadly, any localized cancer therapy competes with surgery, chemotherapy, external radiation, and immunotherapy, where far larger, better-capitalized companies operate.
5. Strategic Strengths & Risks
Strengths
- FDA Breakthrough Device designation (thyroid cancer indication) can accelerate review and increase regulatory engagement.
- Asset-light operating model — one employee, outsourced manufacturing — minimizes fixed cost while the company is pre-scale.
- Established, if tiny, commercial veterinary beachhead that generates real-world safety and handling experience ahead of any human approval.
Risks
- Going concern doubt stated explicitly by the company's auditors — a near-term financing risk that overshadows every other consideration.
- Minimal current revenue ($27,995 in 2024) against an estimated $10 million needed over 36 months for human trials, clinic activation, and manufacturing expansion.
- Human-use approval remains years away and contingent on Class III-to-II reclassification and successful trials now beginning in India.
- Single full-time employee creates significant key-person and execution risk.
6. Financial Overview
| Metric | FY2024 | Strategic Context |
|---|---|---|
| Operating revenue | $27,995 | Essentially pre-revenue; veterinary sales are still in early ramp. |
| Net loss | $2,910,448 | Modest in absolute dollar terms but large relative to revenue, reflecting the cost of maintaining regulatory and clinical programs. |
| Cash on hand (12/31/2024) | $2,212,548 | Limited runway against a stated ~$10 million, 36-month funding need. |
7. Summary Conclusion
Vivos Inc. is a speculative, pre-revenue-scale medical device company whose entire investment case rests on whether its patented Y-90 gel technology can clear the much higher regulatory bar for human cancer treatment after first proving itself commercially, in a small way, in veterinary oncology. The Breakthrough Device designation for thyroid cancer is a genuine positive signal, but the company's going-concern doubt and reliance on future financing make near-term capital access the dominant risk to watch.