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.
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