Vivos Inc. Submitted the Investigational Device Exemption (IDE) Application for Human Clinical Trials at Mayo Clinic

Core Insights - Vivos Inc. has submitted an Investigational Device Exemption (IDE) application to the FDA for its innovative RadioGel therapy, aimed at delivering targeted radiation to solid tumors while minimizing damage to healthy tissue [1][2][3] - The IDE application is supported by extensive animal and human data, indicating strong evidence of RadioGel's safety and efficacy, which is crucial for addressing life-threatening conditions with unmet medical needs [2][3] Company Developments - The IDE application represents the most comprehensive submission by Vivos Inc. to date, developed through close collaboration with the FDA under the Breakthrough Device sprint process [2][3] - Dr. Michael Korenko, CEO of Vivos Inc., emphasized that the strong evidence of RadioGel's safety and efficacy brings the company closer to providing transformative therapy for cancer patients [3]