Vivos Inc. (OTCQB: RDGL) received U.S. Patent 12,521,452 B2 on January 13 2026 for its RadioGel radiotherapy gel and method of preparation. The patent protects a biodegradable, thermosensitive PLGA‑g‑PEG hydrogel that solidifies at body temperature and incorporates insoluble yttrium‑90 phosphate particles, the core of the company’s RadioGel and IsoPet products.
The company also secured approval for the PRECISIONGEL™ trademark in the United States and New Zealand, adding another layer of brand protection for its hydrogel platform.
The patent and trademark approvals reinforce Vivos’s intellectual‑property position, which underpins its dual‑market strategy of delivering precision radionuclide therapy to both human patients and veterinary oncology clients. The new patent expands the scope of protection around the hydrogel’s formulation and its ability to immobilize Y‑90 particles, thereby extending the company’s exclusive rights and creating a stronger moat against competitors. However, the company’s progress toward U.S. human trials remains stalled, following the FDA’s denial of its Investigational Device Exemption application in August 2025. The company has indicated it will address the FDA’s concerns and resubmit, but the setback highlights the regulatory risk that still faces the human‑therapy segment.
CEO Dr. Mike Korenko said the IP milestones “materially enhance the strength and scope of our intellectual property estate and extend our patent protection well into the future.” He added that a robust IP portfolio is a core strategy to drive shareholder value, support clinical progress, and enable global commercial expansion.
The veterinary oncology market, valued at $923.5 million in 2023, is projected to grow to $1.7 billion by 2032, while the broader radionuclide therapy market is expected to reach $13 billion by 2030. Vivos’s dual‑market approach positions it to capture growth in both segments, but the company must navigate regulatory hurdles for the human product and maintain competitive differentiation in the veterinary space.
Overall, the patent and trademark approvals strengthen Vivos’s competitive position and provide a clearer path to future revenue growth, while the FDA setback underscores the importance of regulatory success for the company’s human‑therapy ambitions.
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