Vivos Inc (RDGL)

[Malibew66]

Building on the FDA’s ruling of RadioGel™ as a device, the Company is currently developing test plans to address issues raised in the Company’s prior FDA submittal regarding RadioGel™. The two primary FDA comments at the Company’s FDA pre-submission meeting concerned the dosimetry calculations and the belief of the FDA that RadioGel formed a bolus, or a solid lump, upon injection. The advanced version of the PET-CT equipment at the University of Missouri proved both that the Vivos Inc dosimetry approach was correct, and that the product perfused between the cell interstices and did not form a bolus, potentially resolving the concerns raised by the FDA at the pre-submission meeting. The Company intends to request FDA approval to submit RadioGel™ for de novo classification, which would reclassify the device from a Class III device to a Class II device and accelerate the regulatory approval path.