Vivos Inc (RDGL)

[konshe]

Breakthrough Designation



The Food and Drug Administration has granted RadioGelTM Precision Radionuclide TherapyTM the

designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program. Our Risk

Management Report and supporting data concludes that RadioGel™ is intrinsically safe and our animal

therapy data verifies its effectiveness. The FDA’s Breakthrough Devices program will enhance the

schedule priority for our upcoming IDE submission seeking authorization to begin human clinical trials.