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Investigational Device Exemption (IDE) Application for Human Clinical Trials at Mayo Declined By FDA

Written by Customer Service on . Posted in Public Companies.

Kennewick, WA, Aug. 14, 2025 (GLOBE NEWSWIRE) — Vivos Inc. (OTCQB: RDGL) Following the 30-day review period, the FDA declined approval of the Radiogel® IDE submission.

We are now focused on addressing the items we received in the FDA letter and will have an initial call with the FDA within 10 days as provided in the FDA correspondence. We also intend to participate in a pre-sub meeting with the FDA review team in the coming weeks, with the goal of resubmitting the application for the IDE. Radiogel® received the FDA Breakthrough Device Designation and has demonstrated an unparalleled therapeutic ratio and strong safety profile. Vivos remains committed to pursuing approval for Radiogel® in the US market.

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

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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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