Vivos Receives FDA IDE Approval for First-in-Human RadioGel Trial in Non-Resectable Papillary Thyroid Carcinoma
Key Insights
Vivos Inc. (search) received FDA Feasibility IDE approval to begin its first U.S. human clinical study of RadioGel (search), a yttrium-90-based injectable hydrogel for targeted cancer treatment.
The initial trial at Mayo Clinic in Jacksonville, FL will enroll five patients with non-resectable papillary thyroid carcinoma (search) to evaluate safety and feasibility.
The FDA reduced the required safety follow-up period from five years to 24 months following discussions with the company.
Vivos Inc. (search) (RDGL), a medical device company focused on Precision Radionuclide Therapy (PRnT) for cancerous tumors, announced it has received FDA approval for its Feasibility Investigational Device Exemption (IDE) application for RadioGel (search). The regulatory greenlight enables the company to launch its first U.S.-based first-in-human feasibility study, marking what CEO Mike Korenko described as the "culmination of years of dedicated work."
Following the news, RDGL shares surged 77.14%, trading at $0.09.
The study will be conducted at Mayo Clinic in Jacksonville, Florida, and will evaluate the safety and feasibility of RadioGel (search) in patients with non-resectable papillary thyroid carcinoma (search). The initial feasibility trial is expected to enroll five patients and will help inform the design of subsequent pivotal trials.
RadioGel (search) is a yttrium-90-based injectable hydrogel designed for the targeted treatment of cancerous tumors. According to the company, preclinical studies in veterinary patients — including cats, dogs, and horses — as well as laboratory animals such as rabbits, have demonstrated the safety and effectiveness of Yttrium-90 RadioGel precision radionuclide therapy in cancer treatment.
Regulatory and Trial Design Details
In discussions with the FDA, Vivos secured a notable modification to the study protocol: the required safety follow-up period was reduced from five years to 24 months. This adjustment may accelerate the timeline for generating meaningful clinical data and advancing toward pivotal trials.
The feasibility study represents the first human clinical investigation of RadioGel (search) in the United States. Vivos develops Yttrium-90 PRnT treatments under two brand names — RadioGel for human oncology and IsoPet for veterinary applications.
International and Veterinary Program Expansion
Beyond the U.S. clinical milestone, Vivos reported continued progress in India, where patient data from ongoing clinical work is expected to support a peer-reviewed publication. Treatments at the participating hospital remain temporarily paused due to an internal review by hospital management; however, the company stated the interruption is unrelated to RadioGel (search) or study results and expects approval to resume treatments under the FDA-aligned protocol by the end of 2026.
On the veterinary front, IsoPet therapy is now available through 17 certified U.S. clinics, which have collectively treated more than 200 small animals and horses. The company also signed agreements with three additional veterinary clinics. Vivos expects its Applied Process Engineering Laboratory facility in Washington to begin supplying IsoPet products for veterinary use by the end of the current quarter, while also supporting future human studies and international expansion.
Broader Platform Potential
Vivos disclosed that it is evaluating broader applications for its proprietary PrecisionGel hydrogel technology and has received research interest from universities and pharmaceutical companies. Management characterized this as a secondary opportunity relative to its core oncology programs.
RDGL has traded between $0.04 and $0.15 over the last year, with the stock closing at $0.056 prior to the announcement.