Replies to post #176774 on Vivos Inc (RDGL)

[wrinklesobw]

That’s through the Mayo Clinic so nothing to worry about there.

The Mayo Clinic has been extremely proactive with Radiogel.

[mc73]

That is for a non-significant risk device such as contact lenses. That doesn't apply here imo...anyone else on the board have any thoughts?

[WhAtEvA1]

That Mayo Clinic IRB approval is required post FDA approval of VIVOS IDE is no news. The Mayo clinic has been working with Vivos for years and both parties are aware of this important requirement. In anticipation of Vivos IDE submittal to the FDA, the Mayo Clinic medical personnel who'll be directly involved in the proposed clinical trials were trained up and this fact is part of the IDE application. The prep training wouldn't have happened in the first place without prior Mayo Clinic authorization. With that being said, feel free to reach whatever conclusions from there. IMO, based on the above mentioned facts, the logical conclusion shouldn't be so mysterious or too difficult to discern by anyone who has been following this for a while. Still, to each their own. GLTA