Welcome to our dedicated page for Vivos news (Ticker: RDGL), a resource for investors and traders seeking the latest updates and insights on Vivos stock.
Vivos Inc. (OTCQB: RDGL) generates news centered on its development of radiotherapeutic devices and hydrogel-based technologies for oncology in both humans and animals. Company updates frequently highlight progress with its core platforms, RadioGel® for human use and IsoPet® for veterinary applications, which are designed to deliver targeted radiation directly to tumors while limiting exposure to healthy tissue.
Investors and observers following RDGL news will see detailed coverage of regulatory milestones for RadioGel, including Investigational Device Exemption (IDE) submissions to the U.S. Food and Drug Administration, FDA feedback, and the company’s use of pre-submission processes to refine its data on dosimetry, migration, and sterilization. Releases also describe international clinical activity, such as human trials conducted under U.S. regulatory standards and expansion efforts through Vivos Scientific India LLP.
Another major theme in Vivos news is the IsoPet animal therapy division. The company reports year-over-year growth in administered IsoPet therapies, case studies across dogs, cats, horses, and exotic animals, and certifications of new veterinary clinics, including equine and small animal hospitals. Updates often discuss clinical outcomes like equine ocular squamous cell carcinoma treatments without ocular damage, as well as subsidized case study programs intended to generate publishable data.
Additional RDGL coverage includes manufacturing and intellectual property developments, such as validation of an electron beam sterilization process under ISO 11137 and patent filings related to sterile thermogels and PrecisionGel agent-release characteristics. Vivos also issues news on strategic collaborations, notably with Exubrion Therapeutics, to coordinate clinic relationships and co-market IsoPet in equine oncology. For readers tracking the evolution of targeted radionuclide therapies and related medical devices, the Vivos Inc. news stream provides ongoing insight into clinical, regulatory, and operational progress.
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.
Vivos Inc. (OTCQB: RDGL) announced on October 29, 2025 an expanded strategic collaboration with Exubrion Therapeutics to advance targeted radioactive isotope technology for multiple companion-animal indications.
Agreed areas include shared clinic relationships, licensing coordination, and manufacturing optimization, building on prior cooperation on device classification, clinician training modules, and educational seminars. Both CEOs said the partnership aims to align scientific and operational strengths to accelerate innovation across distinct veterinary therapy markets.
Vivos Inc (OTCQB: RDGL) announced on October 27, 2025 that it retained Dr. John J. Smith, M.D., J.D., and his team at Hogan Lovells as lead regulatory advisors to support its FDA Investigational Device Exemption (IDE) submission for RadioGel®. The company said Dr. Smith has direct experience with the FDA Division reviewing radiological devices and will help address remaining IDE deficiencies.
RadioGel® is described as an injectable, high‑dose, localized radiation device intended for tumors. Securing IDE approval is stated as a critical step toward initiating U.S. clinical trials at the Mayo Clinic. RadioGel® is not yet authorized for pre‑market use.
Vivos Inc (OTCQB:RDGL) has received board authorization to establish a wholly-owned subsidiary, Vivos Scientific India LLP, marking a significant expansion into the Indian market. This strategic move follows the company's initiation of first-in-human trials announced in December 2024.
The company is actively pursuing DCGI approval for expanded human trials in India, which will support their IDE process with the FDA. The new protocol will include post-treatment PET full-body scans to validate RadioGel's safety profile. This expansion aligns with Vivos's long-term strategy to establish their first international manufacturing center for RadioGel and IsoPet products, expand developmental animal testing, and provide commercial treatments for both humans and animals in India.
[ "Establishment of wholly-owned subsidiary in India demonstrates international expansion", "Progress in human trials with potential FDA IDE application support", "Plans for first international manufacturing center for RadioGel and IsoPet", "Strategic expansion of both human and animal treatment capabilities" ]