Vivos Inc (RDGL)

[Milo1]

"The Company recently obtained clarification from the FDA Center for Veterinary Medicine that IsoPet is classified as a device for skin cancer therapy in cats and dogs. The FDA also reviewed and approved the product labeling. 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. RDGL is positioning itself so that after this demonstration phase, The Company can begin to generate revenues through the sale of IsoPetTM to University animal hospitals and private veterinary clinic consortiums.

The Company is also engaging the FDA for permission to use RadioGelTM for the treatment of advanced basal and squamous cell skin cancers in humans."

from a PR May 31, 2018