Vivos Inc. Announces Significant Progress Toward FDA Investigational Device Exemption (IDE) Submission for RadioGel® Precision Radionuclide Therapy™

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]