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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 (RDGL) announced the peer-reviewed publication of a paper characterizing its PrecisionGel™ thermogel polymer platform in the Journal of Drug Delivery Science and Technology, an Elsevier journal focused on drug formulation and controlled release technology.
The paper, co-developed with research partner Akina Inc., details three years of development work examining biomolecular release properties of the injectable thermogel poly(lactide-co-glycolide)-graft-(polyethylene glycol) across different concentrations and polymer compositions. PrecisionGel™ is the polymer carrier used in Vivos’ RadioGel® and IsoPet® products and is also offered as an independent universal drug delivery carrier for pharmaceutical and biomedical companies.
The company states that this publication supports clinical program credibility for its PRnT platforms, strengthens PrecisionGel™’s position as a licensing candidate, and adds to the scientific record that may aid future regulatory submissions in key international markets.
Vivos (OTCQB: RDGL) reported two major milestones: first IsoPet® shipments from its new in-house U.S. production facility at APEL in Richland, Washington, and authorization from India’s Atomic Energy Regulatory Board (AERB) to proceed with an international manufacturing center operated via its India-based partner.
According to Vivos, APEL now produces IsoPet® and RadioGel®, with an ISO Class 7 clean room being installed, while the India site will supply clinical and commercial programs across Asia, the Middle East, and Africa within a 7.5-hour air transit window for Yttrium-90 therapy.
Vivos (OTCQB: RDGL) reported Q2 2026 progress centered on its Precision Radionuclide Therapy platform. On July 2, 2026, the FDA approved a Feasibility IDE, allowing a first-in-human RadioGel study at Mayo Clinic Jacksonville in non-resectable papillary thyroid carcinoma, initially enrolling five patients, with safety follow-up reduced from five years to 24 months.
According to Vivos, human trials in India have generated sufficient data for peer-reviewed publication, though treatments at Healthcare Global Enterprises Hospital are temporarily paused during an internal review unrelated to RadioGel. The company supports 17 U.S. IsoPet clinics that have treated 200+ animals, is ramping dual manufacturing in Washington and India, and is commercializing its PrecisionGel hydrogel for research use.
Vivos (OTCQB: RDGL) reported Q2 2026 progress focused on advancing its Precision Radionuclide Therapy™ platform, including RadioGel® for human tumors and IsoPet® for animals.
On July 22, 2026, Vivos received FDA approval for a Feasibility IDE, allowing a first‑in‑human safety and feasibility study at Mayo Clinic for non‑resectable papillary thyroid carcinoma. The trial will enroll five patients, with a follow‑up period reduced by the FDA from five years to 24 months, and is aligned with the company’s Breakthrough Device Designation.
In India, Vivos’ human trial at HCG generated sufficient data for a planned peer‑reviewed publication, though treatments were temporarily paused under a hospital‑wide audit; regulatory approvals remain in place, and DCGI clearance to resume is anticipated by year‑end 2026. The IsoPet animal business now includes 17 certified clinics that have treated 200+ animals, supporting safety and effectiveness.
Validation at the APEL facility in Washington is nearing completion, with IsoPet shipments targeted by quarter‑end and added ISO Class 7 capacity. A contract manufacturing build‑out in India is underway to mirror APEL capabilities. Vivos is also commercializing its PrecisionGel™ hydrogel for research use, which it expects to deliver moderate cash flow while maintaining focus on oncology.
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.