KENNEWICK, Wash., June 5, 2026
Vivos Inc. announced the submission of an Early Feasibility Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for its proprietary RadioGel® Precision Radionuclide Therapy™, marking an important regulatory milestone in the company’s effort to advance the technology into human clinical studies. The submission builds on prior regulatory discussions with the FDA and includes enhanced technical, manufacturing, preclinical, and clinical data designed to support the initiation of early feasibility trials in patients with solid tumors.
RadioGel Designed for Targeted Tumor Treatment
RadioGel® is a precision radiotherapy hydrogel engineered to deliver localized beta radiation directly into solid tumors while limiting exposure to surrounding healthy tissue. The technology is being developed as a potential treatment option for difficult-to-treat cancers, including metastatic tumors. According to the company, the IDE package includes strengthened evidence demonstrating accurate delivery, localized retention of radioactive material, and additional clinical insights from an ongoing international human study. The submission also incorporates updated preclinical data addressing previous FDA questions and real-world safety information collected from more than 200 IsoPet® veterinary patients treated across multiple tumor types.
Regulatory Progress and Clinical Development Strategy
The company stated that the Early Feasibility IDE application was prepared with specialized regulatory guidance and reflects an iterative review process with the FDA. If accepted, the application would enable the evaluation of RadioGel® in early-stage human feasibility studies at leading clinical institutions. Vivos expects to receive FDA feedback or a regulatory decision within the standard 30-day review period. Company leadership noted that advancing RadioGel® into human clinical evaluation remains a key priority as it seeks to expand treatment options for cancer patients while continuing to build evidence supporting the platform’s safety and effectiveness.
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Expanding Opportunities in Human and Veterinary Oncology
Beyond its U.S. regulatory efforts, Vivos Inc. continues to pursue a multi-pronged growth strategy that includes expanding commercial adoption of IsoPet® in veterinary oncology, advancing international clinical development through Vivos Scientific India LLP, and exploring global licensing opportunities for RadioGel®, PrecisionGel®, and related technologies. The company also recently participated in the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting in Los Angeles, where it engaged with nuclear medicine experts and researchers interested in the clinical potential of targeted radionuclide therapies. Vivos believes growing interest from the oncology community, combined with continued regulatory progress, positions RadioGel® as a promising investigational treatment for both human and veterinary cancer care.
Source: Vivos Inc. press release
