Vivos Inc. filed the application for an Investigational Device Exemption (?IDE?). The filing was an amendment, addressing the FDA comments to previous application (Q211938/S001). Today?s IDE submission marks first filing with the FDA following the grant of the FDA Breakthrough Device Designation for the Radiogel?

Precision Radionuclide Therapy. Its are appreciative of the improved communication with the FDA since receiving the breakthrough designation. Its IDE filing contained reports on two complex studies, RadioGel® genotoxicity and the retention of RadioGel® at the injection site in VX2 tumors in rabbits.

This current IDE submission addressed the 63 FDA comments received in previous FDA correspondences. In some cases, repeated underlying testing to strengthen answers with current data.