KENNEWICK, Wash., July 6, 2026
Vivos Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) application, allowing the initiation of its first U.S. human clinical feasibility study evaluating RadioGel® Precision Radionuclide Therapy™ (PRnT). The study will be conducted at Mayo Clinic in Jacksonville, Florida, where investigators will evaluate the safety and feasibility of the company’s injectable yttrium-90 hydrogel for the treatment of patients with non-resectable papillary thyroid carcinoma. The initial feasibility study is expected to enroll five patients, with findings intended to guide the design of future pivotal clinical trials.
RadioGel Uses Targeted Yttrium-90 Delivery for Localized Tumor Treatment
RadioGel® is an investigational injectable hydrogel designed to deliver yttrium-90, a therapeutic beta-emitting radioisotope, directly into solid tumors. The Precision Radionuclide Therapy platform is intended to provide localized radiation treatment while minimizing radiation exposure to surrounding healthy tissues. According to Vivos, extensive preclinical studies conducted in laboratory models and veterinary cancer patients, including cats, dogs, and horses, demonstrated favorable safety and effectiveness. Histopathological evaluations reportedly found no radiation-related damage to normal organs or surrounding tissues, supporting the technology’s progression into first-in-human clinical evaluation.
Mayo Clinic Study Marks Key Milestone in U.S. Clinical Development
The FDA’s IDE approval represents a significant regulatory milestone in Vivos’ effort to advance RadioGel toward potential commercialization for human oncology applications. Following FDA authorization, the study protocol will proceed through institutional review board (IRB) review at Mayo Clinic before patient enrollment begins. Company executives noted that the feasibility trial is expected to provide critical clinical data on device performance, safety, and procedural feasibility, establishing the foundation for larger pivotal studies required for future regulatory approval.
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Vivos Continues Multi-Track Oncology Development Strategy
In addition to advancing RadioGel through the U.S. regulatory pathway, Vivos continues to expand commercialization of IsoPet®, its veterinary oncology platform utilizing Precision Radionuclide Therapy, while pursuing international development opportunities for RadioGel and licensing opportunities for its PrecisionGel™ technology platform. Through these parallel development initiatives, the company aims to broaden access to minimally invasive, targeted radionuclide therapies designed to improve cancer treatment outcomes while reducing treatment-related toxicity for both veterinary and human patients.
Source: Vivos Inc press release
