Vivos Inc. announced that the U.S. Food and Drug Administration (FDA) declined approval of its Investigational Device Exemption (IDE) submission for RadioGel, intended for human clinical trials at the Mayo Clinic. This decision followed the FDA's 30-day review period. The company stated it is now focused on addressing the items outlined in the FDA's letter.
Vivos Inc. plans to have an initial call with the FDA within 10 days and intends to participate in a pre-submission meeting with the FDA review team in the coming weeks. The ultimate goal is to resubmit the application for the IDE. This setback delays the initiation of human clinical trials for RadioGel in the U.S.
Despite the decline, RadioGel previously received the FDA Breakthrough Device Designation and has demonstrated a high therapeutic ratio and strong safety profile in other studies. Vivos Inc. reiterated its commitment to pursuing approval for RadioGel in the U.S. market, indicating that addressing the FDA's feedback is a top priority.
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