Vivos Inc (RDGL)

[SC8]

Again, It's been in human use that brachytherapy migration has come under FDA radar. Maybe had RDGL submitted IDE application early in 2021, their data on hand may have been sufficient. But they didn't submit then. So point is moot.

At first pre-submission meeting in late 2021, FDA suggested additional specific testing. Here we are in 2023 still waiting on RDGL to commence animal tumor containment verification via direct imaging PET scan.