Vivos Inc (RDGL)

[overunder]

Radiogel was never classified as a drug. It was originally classified as a class 3 medical device.

The dogs are the clinical studies. Also data will be collected as people are being treated. Once approved as a device it can be used/administered under the guidelines for the devices classification.

This doesn't diminish safety. It is a legitimate process. It doesn't take away value.

Of course there will be testing. But they can't test in humans until approved as a device which will be either a class 2 or worst case class 3. Class 3 would require more time and testing at a cost to shareholders, hence the de novo

At least thats my understanding.




At least thats my understanding.