Vivos Inc. (OTCQB: RDGL) Receives U.S. FDA Approval for Investigational Device Exemption (IDE) to Initiate Human Clinical Feasibility Study for RadioGel® Precision Radionuclide Therapy™
Rhea-AI Summary
Vivos (OTCQB: RDGL) received U.S. FDA approval for a Feasibility Investigational Device Exemption (IDE), allowing a first-in-human U.S. clinical feasibility study of RadioGel® Precision Radionuclide Therapy for non-resectable papillary thyroid carcinoma.
The Mayo Clinic study in Jacksonville will initially enroll five patients and assess safety and feasibility of yttrium-90-based RadioGel®. Vivos also continues commercial IsoPet® expansion and international PrecisionGel™ licensing efforts.
Positive
- FDA IDE approval enabling first-in-human U.S. RadioGel® feasibility study
- Mayo Clinic Jacksonville selected as study site for papillary thyroid carcinoma
- Initial protocol to enroll five patients to assess safety and feasibility
- Preclinical and veterinary studies reported no radiation-associated adverse effects in normal organs
- FDA determined data were sufficient to support initiation of the investigation
- Multi-track strategy including IsoPet® commercialization and international PrecisionGel™ licensing
Negative
- None.
News Market Reaction – RDGL
In the Jul 6 session, RDGL gained 50.00%, reflecting a significant 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, July 06, 2026 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a medical device company pioneering Precision Radionuclide Therapy™ (PRnT) for the treatment of cancerous tumors, is pleased to announce that it has received approval from the U.S. Food and Drug Administration (FDA) for its Feasibility Investigational Device Exemption (IDE) application. This approval allows the Company to begin the US based first-in-human feasibility study using RadioGel®, an innovative yttrium-90-based injectable hydrogel for the targeted treatment of cancerous tumors.
The study will be conducted at Mayo Clinic in Jacksonville, FL and will evaluate the safety and feasibility of RadioGel® in patients with non-resectable papillary thyroid carcinoma. The protocol is expected to initially enroll five patients. Results will help shape subsequent pivotal trials.
“This IDE approval is a major milestone for Vivos and validates the strength of our preclinical and clinical data, along with our regulatory efforts,” said Brad Weeks, President of Vivos Inc. “Advancing RadioGel® into human studies in the U.S. brings us closer to delivering a precise, minimally invasive cancer therapy that can meaningfully improve patient outcomes. We are now focused on initiating the study and working closely with our clinical partners to move RadioGel® forward.”
Dr. Darrell R. Fisher, nuclear medicine physicist with Versant Medical Physics and Radiation Safety, stated: “Yttrium-90 RadioGel® is designed to efficiently deliver targeted radiation to cancerous tumors while minimizing treatment-related side effects. Over many years, preclinical studies in veterinary patients (cats, dogs, and horses) and laboratory animals (rabbits) demonstrated the safety and effectiveness of Yttrium-90 RadioGel® precision radionuclide therapy (PRnT) in cancer treatment. Across multiple studies, histopathology confirmed no radiation-associated adverse effects in any normal organs or tissues. I am pleased that the Food and Drug Administration has recognized the safety profile of this device, permitting its use in human patients as part of the Mayo study.”
Mike Korenko, CEO of Vivos Inc., added, “Receiving FDA IDE approval represents the culmination of years of dedicated work by our team. FDA has determined that we have provided sufficient data to support initiation of the investigation. The conditions of this approval will be incorporated into the protocol for Mayo IRB review. We are excited to partner with Mayo Clinic and take this important step toward bringing RadioGel® to patients who need better treatment options. This clearance reinforces our confidence in RadioGel® as a Breakthrough approach in precision radionuclide therapy.”
Vivos continues to advance its multi-track strategy by expanding commercial adoption of IsoPet® for veterinary oncology; advancing non-U.S. clinical research and commercialization opportunities for RadioGel®; pursuing international licensing and monetization opportunities for the PrecisionGel™ platform; and progressing RadioGel® through the U.S. regulatory pathway for human cancer therapy.
About Vivos Inc.
Vivos Inc. is developing advanced Yttrium-90 Precision Radionuclide Therapy™ (PRnT) treatments for tumors in both animals (IsoPet®) and humans (RadioGel®). The Company is committed to delivering safer, more effective, and accessible cancer therapies with a high therapeutic index (TI) through Precision Radionuclide Therapy™.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of applicable securities laws. Actual results may differ materially from those expressed or implied due to various risks and uncertainties.
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
