Vivos Inc. announced the submission of its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel. This novel hydrogel-based radioactive therapy is designed to deliver targeted radiation to solid tumors. The submission represents a significant milestone in Vivos Inc.'s mission to provide innovative cancer treatments.
The comprehensive IDE application was developed through months of collaboration with the FDA under the Breakthrough Device sprint process. It addresses regulatory concerns with robust evidence of RadioGel's safety and promising efficacy, supported by extensive animal and human data. The Breakthrough Device designation expedites development for devices addressing life-threatening conditions with unmet medical needs.
This submission is a critical step towards initiating human clinical trials for RadioGel at the Mayo Clinic in the United States. Successful approval of the IDE would allow Vivos to proceed with these trials, which are essential for potential future commercialization of RadioGel in the U.S. market.
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