Vivos Inc. Submitted the Investigational Device Exemption (IDE) Application for Human Clinical Trials at Mayo Clinic

Rhea-AI Summary

Vivos Inc. (OTCQB: RDGL) has submitted an Investigational Device Exemption (IDE) application to the FDA for RadioGel®, their innovative hydrogel-based radioactive therapy designed for targeted tumor treatment. The submission represents a crucial advancement in their Precision Radionuclide TherapyTM (PRnT) program.

The IDE application was developed through extensive collaboration with the FDA under the Breakthrough Device sprint process, supported by comprehensive animal and human data. RadioGel® aims to deliver precise radiation to tumors while protecting surrounding healthy tissue, addressing an unmet medical need in cancer treatment.

Positive

• Breakthrough Device designation status expedites the development process
• IDE submission includes both animal and human data supporting safety and efficacy
• Close collaboration with FDA through Breakthrough Device sprint process enhances submission quality

Negative

• FDA approval is not guaranteed and review process may take considerable time
• Regulatory challenges and potential delays could impact development timeline

Kennewick, WA, July 14, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a pioneer in Precision Radionuclide Therapy^TM (PRnT) solutions, today announced the submission of its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel^®, a novel hydrogel-based radioactive therapy designed to deliver targeted radiation to solid tumors. This comprehensive submission, supported by extensive animal and human data, marks a significant milestone in Vivos Inc.’s mission to provide innovative cancer treatments.

RadioGel^® is a novel medical device that enables precise radiation delivery to tumors, while minimizing damage to surrounding healthy tissue. The IDE application, developed through months of close collaboration with the FDA under the Breakthrough Device sprint process, addresses regulatory concerns with robust evidence of RadioGel’s safety and promising efficacy. The Breakthrough Device designation expedites development for devices that address life-threatening conditions with unmet medical needs.

“This is our most comprehensive IDE submission to date, backed by both animal and human data and months of productive dialogue with the FDA,” said Dr. Michael Korenko, CEO of Vivos Inc. “The strong evidence of RadioGel’s safety and efficacy brings us closer to delivering a transformative therapy to cancer patients in need.”

Michael K. Korenko, Sc.D.
President & CEO, Vivos Inc.

Email: MKorenko@RadioGel.com 

Follow Vivos Inc. on X (Twitter): @VivosIncUSA

Learn more about RadioGel^® and IsoPet^® at www.VivosInc.com

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, identified by terms such as “will,” “expects,” “plans,” “anticipates,” and “intends.” These statements involve risks and uncertainties that may cause actual results to differ materially, including challenges in executing business strategies, economic conditions, competition, regulatory changes, delays in clinic certifications, and other factors beyond Vivos Inc.’s control. For a detailed discussion of these risks, refer to the company’s filings with the Securities and Exchange Commission.

FAQ

What is the significance of Vivos Inc's (RDGL) IDE submission to the FDA?

The IDE submission is a crucial regulatory step that, if approved, will allow Vivos Inc. to conduct human clinical trials for RadioGel®, their innovative cancer treatment device, at Mayo Clinic.

What is RadioGel® and how does it work?

RadioGel® is a hydrogel-based radioactive therapy designed to deliver targeted radiation to solid tumors while minimizing damage to surrounding healthy tissue.

What advantages does Vivos Inc's Breakthrough Device designation provide?

The Breakthrough Device designation expedites the development process for devices addressing life-threatening conditions with unmet medical needs, potentially accelerating FDA review.

What type of data supports Vivos Inc's (RDGL) IDE application?

The IDE application is supported by comprehensive animal and human data demonstrating RadioGel's safety and promising efficacy, developed through months of collaboration with the FDA.

Who is leading Vivos Inc's RadioGel® development?

Dr. Michael Korenko, CEO of Vivos Inc., is leading the development of RadioGel®, overseeing the IDE submission process and collaboration with the FDA.