How exactly do you expect human proof of safety or efficacy when FDA has not yet authorized human use of RadioGel?
The purpose of the IDE submission process is precisely to gain FDA authorization to begin human studies so that safety and efficacy can be demonstrated under regulatory supervision.
What has been proven already.... and documented.... are:
• IsoPet has been successfully and safely used in veterinary oncology for multiple cancer types.
• Those animal results, along with GLP biocompatibility and dosimetry studies, form the scientific basis for the human IDE.
• The FDA’s Center for Devices and Radiological Health (CDRH) already classified RadioGel® as a medical device, not a drug — meaning safety is assessed by physical performance and containment of radiation, both of which have been validated in bench and animal testing.
So saying it “hasn’t proven to work safely” is a circular argument. You can’t have human proof until FDA allows human trials, and you can’t have human trials until the IDE is cleared — that’s exactly the regulatory step Vivos is now following.
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