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Vivos Inc. develops isotope-based radiotherapeutic products for targeted cancer treatment and related therapeutic applications. News about RDGL centers on RadioGel® for human use, IsoPet® for veterinary applications, and the company’s Precision Radionuclide Therapy™ approach, which is designed to deliver localized beta radiation directly to tumor sites while limiting exposure to surrounding tissue.
Recurring developments include FDA IDE-related work for RadioGel®, international human therapy demonstrations, veterinary clinic certification and IsoPet adoption, intellectual-property protection for hydrogel and radiotherapy technology, manufacturing arrangements for yttrium-90 phosphate particles and sterile hydrogel doses, and strategic collaborations in companion-animal radiotherapeutics.
Vivos (OTCQB: RDGL) received U.S. FDA approval for a Feasibility Investigational Device Exemption (IDE), allowing a first-in-human U.S. clinical feasibility study of RadioGel® Precision Radionuclide Therapy for non-resectable papillary thyroid carcinoma.
The Mayo Clinic study in Jacksonville will initially enroll five patients and assess safety and feasibility of yttrium-90-based RadioGel®. Vivos also continues commercial IsoPet® expansion and international PrecisionGel™ licensing efforts.
Vivos (OTCQB: RDGL) received its Washington State Radioactive Materials License for IsoPet manufacturing at its new facility in Richland, Washington. This regulatory milestone enables compliant, in-house production for the animal health division.
The license supports expansion of certified IsoPet treatment centers and underpins a planned amendment to add RadioGel for clinical trials in the US and abroad.
Vivos (OTCQB: RDGL) submitted an Early Feasibility Investigational Device Exemption (IDE) application to the FDA for RadioGel Precision Radionuclide Therapy for solid tumors.
The submission includes enhanced technical, manufacturing, preclinical, clinical, and veterinary safety data and is intended to support early human feasibility studies, with FDA feedback expected within 30 days.
Vivos Inc. (OTCQB: RDGL) plans two new production sites to diversify manufacturing for its RadioGel® and IsoPet® therapies, targeting one U.S. facility and one international site operational in 2026.
The company signed a production-space contract at APEL in Richland, Washington; equipment has been ordered, installation is underway, and licensing applications have been submitted. Vivos will continue with its current Texas contract manufacturer through Q2 2026 while pursuing talks with radiopharmaceutical producers in India to reduce shipping costs and expand global access.
Vivos (OTCQB: RDGL) reported material progress toward an FDA Investigational Device Exemption (IDE) submission for its RadioGel® Precision Radionuclide Therapy™.
The company addressed feedback from over 40 individual FDA reviewers, engaged a senior brachytherapy regulatory expert with prior FDA experience, integrated newly available human clinical data, reformatted preclinical data, and leveraged veterinary outcomes from 100+ administered therapies with zero reportable serious adverse events. Vivos plans to submit the IDE by the end of Q1 or in April 2026 to advance human clinical trials.
Vivos Inc (OTCQB: RDGL) provided an update on human therapy demonstrations in India using RadioGel® Precision Radionuclide Therapy. Initiated December 2024, treated patients have completed follow-ups with no reported serious adverse events and several one-year exams showing no adverse effects. Preliminary tumor size reductions and no damage to adjacent critical organs were observed. The company expects DCGI regulatory clearance later this quarter to expand the trial and will update an IDE submission with demonstration data to support the U.S. regulatory pathway.
Vivos (OTCQB: RDGL) announced U.S. Patent No. 12,521,452 B2 issued January 13, 2026, for a radiotherapy thermogel and received PRECISIONGEL™ trademark approvals in the United States and New Zealand.
The patent protects PRnT platform innovations using a biodegradable PLGA-g-PEG thermosensitive hydrogel with yttrium-90 particles for localized beta radiation delivery into solid tumors. A new patent application expands claims to use the hydrogel as a carrier for anti-cancer agents, gene therapy agents, proteins, peptides, and timed release delivery.
Vivos Inc (OTCQB: RDGL) summarized progress for its IsoPet animal therapy division on December 22, 2025. Key operational metrics include a 1,200% year-over-year increase in administered therapies from 2024 to 2025, more than 100 IsoPet treatments performed across dogs, cats, horses and exotics, and a total of 17 certified clinics by the end of 2025.
The company completed case study therapies and plans publications in 2026 to support clinician adoption; some therapies were provided at subsidized rates and revenue generation for those therapies is expected after study completion.
Vivos Inc (OTCQB: RDGL) reported rapid adoption of its IsoPet animal therapy in 2025, citing an 800% year-over-year increase in administered therapies and more than 100 treatments delivered across dogs, cats, horses and exotics. The company added two certified clinics (Sun City and University of Florida), bringing the total to 17 clinics by year-end and five operational equine clinics. Case study therapies are 80% completed, with planned publications in 2026. IsoPet will implement profitability-focused initiatives starting Q1 2026 while continuing clinic expansion and co-marketing with Exubrion.
Vivos (OTCQB: RDGL) provided a shareholder update dated November 6, 2025 outlining regulatory, commercial, clinical, manufacturing, and IP progress for RadioGel and IsoPet.
Key points: Vivos is pursuing an FDA IDE for Mayo Clinic studies, filed a sterilization Pre-Submission and is preparing a second Pre-Submission with a retained regulatory consultant with prior FDA device review experience. The Board authorized formation of Vivos Scientific India LLP in September 2025 to support Indian Phase II trials and future commercial entities. IsoPet reported an 800% YoY increase in therapies (2024–2025) with >100 treatments to date. The company plans to end fully outsourced manufacturing in H1 2026 and bring up to three production centers online by Q2 2026. Vivos maintains patents in 63 countries and is advancing PrecisionGel and related technologies.