Vivos Inc. (OTCQB: RDGL) submits Early Feasibility Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel® Precision Radionuclide Therapy™
Rhea-AI Summary
Vivos (OTCQB: RDGL) submitted an Early Feasibility Investigational Device Exemption (IDE) application to the FDA for RadioGel Precision Radionuclide Therapy for solid tumors.
The submission includes enhanced technical, manufacturing, preclinical, clinical, and veterinary safety data and is intended to support early human feasibility studies, with FDA feedback expected within 30 days.
Positive
- Early Feasibility IDE application for RadioGel submitted to FDA
- Submission includes strengthened technical, manufacturing, and updated preclinical data
- Over 200 IsoPet veterinary patients support a favorable safety profile
- Early human feasibility studies planned following IDE review
- Standard 30-day FDA review timeline expected for feedback or decision
- Multi-track strategy spans IsoPet adoption, India research, and global licensing
Negative
- None.
News Market Reaction – RDGL
In the Jun 5 session, RDGL gained 0.16%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Kennewick, WA, June 05, 2026 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a company pioneering Precision Radionuclide Therapy™ (PRnT) with its innovative RadioGel® technology, today announced the submission of its Early Feasibility IDE application to the FDA. This milestone represents a significant advancement in the Company’s regulatory pathway and builds directly on the substantial progress detailed in its February 10, 2026 update.
RadioGel® delivers precise, localized beta radiation to solid tumors while minimizing exposure to surrounding healthy tissue. This targeted approach offers significant potential as a new treatment option for patients with difficult-to-treat tumors, including those with metastatic disease.
The Early Feasibility IDE application, developed with expert regulatory guidance from our experienced IDE approval specialists, reflects Vivos’ iterative engagement with the FDA. It includes strengthened technical and manufacturing data confirming precise delivery and highly localized retention, additional clinical insights from the ongoing international human trial, updated preclinical evidence addressing prior Agency questions, and compelling real-world safety data from over 200 IsoPet® veterinary patients across a wide range of tumor types with a favorable safety profile.
This refined submission underscores the Company’s commitment to a thorough, data-driven regulatory process and positions RadioGel® for advancement into early human feasibility studies. The Company expects to receive FDA feedback or decision within the standard 30-day review period.
As interest in Vivos’ product portfolio and market potential continues to grow, the Company recently participated in the SNMMI 2026 Annual Meeting in Los Angeles (May 30–June 2). During the conference, Vivos engaged with numerous key leaders in nuclear medicine and molecular imaging, resulting in several productive discussions and valuable new contacts that further indicate the significant clinical interest in RadioGel®.
“We are pleased to have reached this key regulatory milestone,” said Dr. Michael Korenko, CEO of Vivos Inc. “Building on the foundation shared earlier this year, the submission of our Early Feasibility IDE application represents meaningful progress toward bringing RadioGel® into human clinical evaluation at leading institutions. We look forward to continued collaboration with the FDA as we advance this promising therapy for patients who need better treatment options.”
Vivos Inc. continues to execute its multi-tracked strategy by: 1) expanding commercial adoption of IsoPet® in veterinary oncology, 2) advancing non-U.S. clinical research and commercialization opportunities for RadioGel® through Vivos Scientific India LLP, 3) pursuing international licensing and monetization opportunities for RadioGel®, PrecisionGel®, and related technologies, and 4) progressing RadioGel® through the U.S. regulatory pathway for human use. The Company remains committed to working closely with the FDA to initiate early feasibility studies as efficiently as possible, while also advancing international growth opportunities and building on the positive momentum surrounding IsoPet®.
About Vivos Inc.
Vivos Inc. is a clinical-stage medical device company developing RadioGel®, a precision radiotherapy hydrogel for human and veterinary oncology applications. IsoPet® is commercially available for veterinary use in certified clinics nationwide.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update any forward-looking statements.
Contact:
| Mike Korenko, ScD | Brad Weeks |
| CEO, Vivos Inc. | President, Vivos Inc. |
| mkorenko@radiogel.com | brad.weeks@vivosinc.com |
Follow Vivos Inc. on X (Twitter): @VivosIncUSA
Learn more about RadioGel® and IsoPet® at www.VivosInc.com
