Core Insights - Vivos Inc. is advancing its RadioGel technology, a Precision Radionuclide Therapy (PRnT), and is working towards securing FDA Investigational Device Exemption (IDE) approval for human clinical trials [1][6] Company Efforts - The company has engaged extensively with the FDA, addressing feedback from over 40 reviewers and finalizing key technical parameters to demonstrate the precision delivery of RadioGel [3] - Vivos has hired a top regulatory expert in brachytherapy to enhance its IDE submission, leveraging the expert's experience with successful IDE approvals for similar devices [4] - The company plans to submit the IDE by the end of Q1 or in April, indicating a strong commitment to advancing RadioGel towards human clinical trials [6] Submission Enhancements - The IDE submission will include fully addressing FDA concerns, incorporating new clinical human data, and reformatting pre-clinical data to better meet FDA expectations [8] - The submission will leverage extensive veterinary clinical data from IsoPet, showcasing over 100 safely administered therapies with no serious adverse events, to strengthen the evidence for safety and efficacy [8] - Specialized equine ocular applications will be highlighted, including successful treatments of ocular squamous cell carcinoma in horses, demonstrating the therapy's precision and minimal invasiveness [8]

Kennewick, WA, April 15, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) is pleased to share new developments in its ongoing human clinical trial in India for RadioGel® Precision Radionuclide Therapy™, an FDA-designated Breakthrough Device for the treatment of solid tumors. The latest results highlight both technical progress and growing clinical validation. This update builds upon the initial results released in February 2025, which confirmed the safety of RadioGel® in the first five patients. As of this ...