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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 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" ]Vivos Inc. (OTCQB: RDGL) has reported new data demonstrating the high precision of its RadioGel® and IsoPet® radionuclide therapy technologies. The company's therapeutic solutions have shown exceptional results in both veterinary and human applications, achieving high therapeutic ratios that maximize tumor destruction while minimizing damage to surrounding healthy tissue.
Key clinical successes include successful treatment of Ocular Squamous Cell Carcinoma (OSCC) in horses with no damage to surrounding eye tissue, and effective treatment of cancerous lymph nodes near critical structures in human trials, with tumors becoming undetectable after 90 days. RadioGel® has received FDA Breakthrough Device designation, though it is not yet FDA-approved for commercial use in the United States.
Vivos Inc (OTCQB: RDGL) has filed a provisional patent (No. 63/873,014) for a new electron beam (E-Beam) sterilization process for their hydrogel technology. The process, validated under ISO 11137, achieves a sterility assurance level of 10-6 - the highest standard for critical medical devices.
The new sterilization method offers significant advantages over their current filtration process, including improved reliability, cost-effectiveness, and enhanced scalability. This advancement benefits both their Radiogel® (human) and IsoPet® (animal) therapy product lines, positioning the company for broader market penetration and increased revenue opportunities.
Vivos Inc. (OTCQB: RDGL) announced that the FDA has declined approval of their Radiogel® Investigational Device Exemption (IDE) submission following the 30-day review period. The company plans to address the FDA's feedback and will have an initial call within 10 days, followed by a pre-sub meeting with the FDA review team to prepare for resubmission.
Despite this setback, Radiogel® maintains its FDA Breakthrough Device Designation and has demonstrated strong safety profile and therapeutic ratio. The company remains committed to pursuing US market approval for Radiogel®.
Vivos Inc. (OTCQB: RDGL) has submitted an Investigational Device Exemption (IDE) application to the FDA for RadioGel®, their innovative hydrogel-based radioactive therapy designed for targeted tumor treatment. The submission represents a crucial advancement in their Precision Radionuclide TherapyTM (PRnT) program.
The IDE application was developed through extensive collaboration with the FDA under the Breakthrough Device sprint process, supported by comprehensive animal and human data. RadioGel® aims to deliver precise radiation to tumors while protecting surrounding healthy tissue, addressing an unmet medical need in cancer treatment.
Vivos Inc. (OTCQB: RDGL) has announced the certification of the University of Florida Veterinary Hospital to offer IsoPet® Precision Radionuclide Therapy™, a targeted cancer treatment for animals. This innovative therapy uses a proprietary radionuclide injection to treat solid tumors in pets, offering a minimally invasive alternative to traditional treatments.
The certification marks an expansion in Vivos' network of certified clinics, with the company providing comprehensive support through the licensing process and training to ensure safe and effective administration of IsoPet therapy. Additional veterinary hospitals are currently in the certification pipeline as part of the company's growth strategy.
Vivos Inc. (OTCQB: RDGL) reported record-breaking growth in its IsoPet® Animal Cancer Division for Q1 2025. The company's Precision Radionuclide Therapy™ treated 15 pets, marking a 150% year-over-year increase in treatment volume.
Key achievements include:
- Expansion to 14 certified clinics (8 small animal, 6 equine) with three new additions in Q1
- Breakthrough treatments in equine oncology, including four horses with ocular squamous cell carcinoma
- Biweekly production schedule of yttrium-90 hydrogel ensuring steady treatment supply
- Notable treatments at facilities like NorthStar Vets (NJ) and Brazos Equine Hospital (TX)
The company operates in the global veterinary oncology market, valued at $1.18 billion in 2023, with projected 11.3% CAGR through 2030. IsoPet® offers a non-invasive, single-session outpatient approach, positioning itself as a cost-competitive alternative to traditional radiation.
Vivos Inc. (OTCQB: RDGL) has reported significant progress in its India human clinical trial for RadioGel® Precision Radionuclide Therapy™, an FDA-designated Breakthrough Device for solid tumor treatment. The trial has successfully treated ten patients with cancerous nodes, demonstrating both safety and early efficacy signals.
Key highlights include:
- All patients met primary safety endpoints with precise Yttrium-90 isotope retention
- No adverse events or complications reported
- Successful treatment of high-risk tumors near trachea and carotid artery
- Trial approval expanded to treat up to 30 patients, with plans to request increase to 50 patients
The company plans to submit an IDE to FDA within 90 days and is establishing operations in India, including a corporate office and manufacturing facility. The Indian cancer treatment market, valued at USD 4.21 billion in 2023, is projected to reach USD 5.89 billion by 2030, representing a significant opportunity for RadioGel®.