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

Core Points - The FDA declined approval of Vivos Inc.'s Radiogel® IDE submission after a 30-day review period [1] - The company is focused on addressing the FDA's feedback and plans to have an initial call with the FDA within 10 days [2] - Vivos intends to participate in a pre-submission meeting with the FDA review team in the coming weeks to resubmit the application [2] - Radiogel® has received FDA Breakthrough Device Designation and has shown a strong safety profile and therapeutic ratio [2] Company Actions - Vivos Inc. is committed to pursuing approval for Radiogel® in the US market despite the recent setback [2] - The company is actively engaging with the FDA to resolve the issues raised in the rejection letter [2]