Investigational Device Exemption (IDE) Application for Human Clinical Trials at Mayo Declined By FDA
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.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
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
Details
News Market Reaction – RDGL
On Aug 14, the day this news came out, RDGL closed 37.27% below the previous close.
Data tracked by StockTitan Argus for the Aug 14 session.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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.
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