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

Rhea-AI Summary

Vivos Inc. (OTCQB: RDGL) announced that the FDA has declined approval of their Radiogel® Investigational Device Exemption (IDE) submission following the 30-day review period. The company plans to address the FDA's feedback and will have an initial call within 10 days, followed by a pre-sub meeting with the FDA review team to prepare for resubmission.

Despite this setback, Radiogel® maintains its FDA Breakthrough Device Designation and has demonstrated strong safety profile and therapeutic ratio. The company remains committed to pursuing US market approval for Radiogel®.

Positive

• Radiogel® maintains FDA Breakthrough Device Designation status
• Product has demonstrated strong safety profile and therapeutic ratio
• Company has opportunity for FDA discussion within 10 days

Negative

• FDA declined approval of Radiogel® IDE submission
• Delay in clinical trial timeline due to required resubmission
• Additional regulatory hurdles before potential approval

News Market Reaction

-37.27%

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-37.27% News Effect

On the day this news was published, RDGL declined 37.27%, reflecting a significant negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

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

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 was the FDA's decision on Vivos Inc's (RDGL) Radiogel® IDE application in August 2025?

The FDA declined approval of Vivos Inc's Radiogel® IDE submission following the 30-day review period.

What are the next steps for Vivos Inc (RDGL) after the FDA's IDE rejection?

Vivos will have an initial call with FDA within 10 days, participate in a pre-sub meeting with the FDA review team, and plan to resubmit the IDE application after addressing FDA's feedback.

Does Radiogel® still maintain its FDA Breakthrough Device Designation despite the IDE rejection?

Yes, Radiogel® maintains its FDA Breakthrough Device Designation and has demonstrated strong safety profile and therapeutic ratio.

When can Vivos Inc (RDGL) resubmit the Radiogel® IDE application?

The company plans to resubmit after addressing FDA's feedback and conducting pre-submission meetings, though no specific timeline was provided in the announcement.