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, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) is pleased to provide shareholders with a positive update on the ongoing human therapy demonstrations in India using RadioGel® Precision Radionuclide Therapy™. Initiated in December 2024, a prominent physician in India began treating patients to demonstrate safety and measure efficacy with RadioGel®. Patients have continued to attend their scheduled regulatory follow-up visits in accordance with the protocol. To date, no reports of se ...

Core Insights - Vivos Inc. has submitted an Investigational Device Exemption (IDE) application to the FDA for its innovative RadioGel therapy, aimed at delivering targeted radiation to solid tumors while minimizing damage to healthy tissue [1][2][3] - The IDE application is supported by extensive animal and human data, indicating strong evidence of RadioGel's safety and efficacy, which is crucial for addressing life-threatening conditions with unmet medical needs [2][3] Company Developments - The IDE application represents the most comprehensive submission by Vivos Inc. to date, developed through close collaboration with the FDA under the Breakthrough Device sprint process [2][3] - Dr. Michael Korenko, CEO of Vivos Inc., emphasized that the strong evidence of RadioGel's safety and efficacy brings the company closer to providing transformative therapy for cancer patients [3]