Vivos Inc. (OTCQB: RDGL), Vivos Inc. filed the application for an Investigational Device Exemption (“IDE”).
The filing was an amendment, addressing the FDA comments to our previous application (Q211938/S001). Today’s IDE submission marks our first filing with the FDA following the grant of the FDA Breakthrough Device Designation for the Radiogel™ Precision Radionuclide Therapy. We are appreciative of the improved communication with the FDA since receiving the breakthrough designation. Our 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, we repeated underlying testing to strengthen our answers with current data. Dr. Korenko stated, “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly.”
In closing Dr. Korenko stated, “We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic’s Independent Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.
