Vivos files IDE amendment with FDA to initiate human trials of Radiogel therapy

VIVOS INC

Filed IDE amendment with FDA for Radiogel™ Precision Radionuclide Therapy, addressing 63 prior FDA comments.
Submission includes genotoxicity and retention study reports; builds on FDA Breakthrough Device Designation.
Plans to submit to Mayo Clinic IRB for first-in-human trial targeting solid metastatic tumors in papillary thyroid cancer.
Previous IDE (Q211938/S001) commented by 12 FDA reviewers; company prepared to address further questions promptly.

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