Vivos Inc. (OTCQB: RDGL) announced that it has made significant progress toward filing a U.S. Food and Drug Administration Investigational Device Exemption (IDE) for its RadioGel precision radionuclide therapy. The company said it has addressed feedback from more than 40 FDA reviewers and finalized key technical parameters that demonstrate precise delivery of the Y‑90‑based hydrogel to tumor sites while limiting exposure to non‑target tissues, following a prior IDE rejection in August 2025.
RadioGel is an injectable hydrogel that contains Yttrium‑90 phosphate microparticles. Once injected, the gel solidifies within the tumor’s interstitial spaces, localizing the beta radiation and sparing surrounding healthy tissue. The device has received FDA “Breakthrough Device” designation, and Vivos is pursuing a dual‑track strategy that includes clinical studies in India to accelerate global data collection.
The company engaged a top regulatory expert with prior FDA experience to guide the IDE submission, incorporating new human clinical data and refined pre‑clinical information. Management indicated that the IDE will be submitted by the end of the first quarter or in April, positioning RadioGel for U.S. human trials in advanced oncology indications.
CEO Michael K. Korenko said, “With guidance from one of the field’s leading regulatory experts, combined with our incorporation of newly available human clinical data and a refined presentation of pre‑clinical information, we are strongly positioned to achieve IDE approval and bring this innovative therapy to patients in need.”
Vivos also markets IsoPet®, a similar Y‑90 hydrogel therapy for veterinary use, which reported an 800 % year‑over‑year increase in administered therapies from 2024 to 2025. While the company has not yet reported revenue from RadioGel, the IDE milestone could unlock significant revenue streams from both veterinary and human oncology applications once clinical trials and eventual market approvals are achieved.
The IDE approval is a prerequisite for initiating U.S. clinical studies. Successful filing would accelerate Vivos’ path to market entry, potentially unlocking substantial revenue streams and addressing the capital requirements needed to sustain its development program.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.