Investigational Device Exemption (IDE) Application for Human Clinical Trials at Mayo Declined By FDA
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.
Related Questions
What are the specific reasons for the FDA's rejection and can they be addressed quickly?
What is the likely impact on Vivos Inc.'s cash burn rate and upcoming financing needs?
How will the FDA's decline of the Radiogel® IDE affect Vivos Inc.'s short-term stock volatility?
Is there a timeline for a resubmission or alternative regulatory pathway?
How does this setback compare to similar setbacks faced by competitors in the medical device space?
Will the decline impact existing partnerships, licensing agreements, or potential collaborations?
Are there any contingent milestones or earn-outs tied to the IDE approval that could be affected?
How might this news influence analyst ratings and target price revisions for RDGL?
What is the market's perception of management's ability to navigate regulatory hurdles moving forward?
Could this event trigger any covenant breaches or affect debt covenants in Vivos Inc.'s financing agreements?