Vivos shares jump 10.31% intraday on progress toward FDA IDE submission for RadioGel® therapy.

Vivos Inc. surged 10.31% intraday after announcing significant progress toward FDA Investigational Device Exemption (IDE) submission for its RadioGel® Precision Radionuclide Therapy. The company highlighted addressing FDA feedback from over 40 reviewers, incorporating new clinical data, and leveraging veterinary trial outcomes from its IsoPet® product. Engaging a top regulatory expert with FDA CDRH experience further strengthens the submission, with plans to file by April. The update underscores advancing RadioGel® toward U.S. human trials, positioning the therapy as a precision oncology solution with minimal side effects, as demonstrated in equine and veterinary applications. The CEO emphasized confidence in the submission’s alignment with FDA expectations, fueling investor optimism about regulatory milestones and future market potential.