Vivos Inc (RDGL)

[HoneyBager]

Vivos Inc met with the Food and Drug Administration to obtain suggestions on improving the current draft of the Investigational Device Exemption, which is necessary to initiate clinical testing in humans. Two physicians from Mayo Clinic, Dr. Paz Fumagalli and Dr. Beau Toskich did an excellent job presenting the need for Radiogel™ to treat recurrent thyroid cancer and to answer a range of questions from the new FDA review team.

The FDA was very supportive and had suggested this Q-Submission path for rapid turnaround and dialog. The FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry to the Mayo protocol for clinical testing, and the need for some additional specific testing. They suggested having another Q-Sub Review and conference call dedicated to the details of the dosimetry calculations.

Mike Korenko stated “Obtaining FDA approval is challenging, but we made significant progress with this meeting. This was the first time the Mayo Clinic Doctors met with the FDA regarding RadioGel. They were able to communicate the unmet medical need that RadioGel could address and successfully fielded several key questions from the FDA reviewers. If we did not take this interim step our IDE submittal would likely have been rejected and it would have cost us significantly more effort and time to recover. We already have sufficient funding in hand to complete all the scope necessary to submit the final IDE.”