Vivos Inc (RDGL)

[Paulness]

FDA does not require pre-market approval for veterinary devices so no additional approval is required for treating skin cancer, which is the largest market sector. Following this demonstration phase, Vivos can begin to generate revenues through the sale of IsoPet® to University animal hospitals and private veterinary clinic consortiums.

IsoPet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.

The Company is also engaging the FDA for premarket clearance to market RadioGel™ for the treatment of advanced basal and squamous cell skin cancers in humans.