Vivos Inc. Retains Top FDA Regulatory Expert Dr. John J. Smith, M.D., J.D., to Support IDE Submission for RadioGel®
Rhea-AI Summary
Vivos Inc (OTCQB: RDGL) announced on October 27, 2025 that it retained Dr. John J. Smith, M.D., J.D., and his team at Hogan Lovells as lead regulatory advisors to support its FDA Investigational Device Exemption (IDE) submission for RadioGel®. The company said Dr. Smith has direct experience with the FDA Division reviewing radiological devices and will help address remaining IDE deficiencies.
RadioGel® is described as an injectable, high‑dose, localized radiation device intended for tumors. Securing IDE approval is stated as a critical step toward initiating U.S. clinical trials at the Mayo Clinic. RadioGel® is not yet authorized for pre‑market use.
Positive
- Retained experienced FDA regulatory lead (Dr. John J. Smith)
- Advisors familiar with RadioGel® and FDA review panel
- Move intended to address remaining IDE deficiencies
Negative
- RadioGel® is not authorized for pre‑market use
- IDE submission currently has remaining deficiencies
News Market Reaction – RDGL
On the day this news was published, RDGL gained 3.17%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Richland, WA, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) announced today that they have appointed Dr. John J. Smith, M.D., J.D., and his team at Hogan Lovells as the company’s lead regulatory advisors for its FDA Investigational Device Exemption (IDE) submission for RadioGel®.
Dr. Smith, a board-certified diagnostic radiologist and former associate professor at Harvard Medical School, is widely recognized as one of the nation’s leading FDA regulatory consultants in the medical device sector. He is currently a partner in the Global Regulatory group at Hogan Lovells, based in Washington, D.C.
“We are excited to re-engage Dr. Smith—someone we have worked with before and who is very familiar RadioGel®, said Dr. Michael Korenko, CEO of Vivos Inc. He brings not only unmatched expertise but current, first-hand experience with the FDA’s Division of Radiological Imaging and Radiation Therapy Devices review panel where we are working through the remaining deficiencies in our IDE submission. Bringing Dr. Smith and his team on-board positions us to move forward with confidence and clarity.”
Vivos’ RadioGel® is a groundbreaking injectable device designed to deliver a high-dose, localized, targeted radiation safely and effectively to tumors. Securing IDE approval remains a critical step toward initiating U.S. clinical trials at the Mayo Clinic. RadioGel® is not yet authorized for pre-market use.
Mike Korenko, ScD
CEO Vivos Inc
Contact:
Investor Relations
Vivos Inc.
Email: info@vivosinc.com
Website: 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
Who did Vivos (RDGL) retain to support the RadioGel IDE submission?
What is the goal of hiring Dr. John J. Smith for RDGL's RadioGel program?
Does RadioGel (RDGL) have FDA pre‑market authorization as of October 27, 2025?
What is the next clinical milestone mentioned for RDGL's RadioGel?
What expertise does Vivos say Dr. Smith brings to the RDGL RadioGel IDE work?
