Vivos Inc (RDGL)

[MikeD]

I like the fact “The FDA does believe that RadioGel™ meets criterion #2a: Device represents breakthrough technology. Your device does meet this criterion because it is a novel application of a brachytherapy device outside of the liver.” This imo can be interpreted positively as the FDA is on board (along with the Mayo Clinic) with further studies such as a FDA Authorized Pivotal Study justified by the clinical and nonclinical data provided from the Mayo Clinic and Dr. K.

https://www.globenewswire.com/en/news-release/2021/01/19/2160754/0/en/Vivos-Inc-Receives-Feedback-from-FDA-on-Breakthrough-Designation-Request.html