VIVOS INC

Vivos Inc. is a radiation oncology medical device company that develops yttrium-90 (Y-90) based precision radionuclide therapy devices. These include RadioGel® Precision Radionuclide Therapy™ for treating solid tumors and positive surgical margins in humans, and IsoPet® for treating solid tumors in animals. The company also sells PLGA-g-PEG polymers and PrecisionGel™, a hydrogel polymer platform designed for delivering active pharmaceutical ingredients and therapeutic agents. Its development efforts are led by a team of radiochemists, scientists, and engineers, working with strategic partners such as national laboratories, universities, and private corporations. In 2013, the United States Food and Drug Administration (FDA) determined that RadioGel® is a device for human therapy for non-resectable cancers. In January 2018, the Center for Veterinary Medicine Product Classification Group classified RadioGel® (now IsoPet® for veterinary use) as a medical device for animal therapy, initially specified for feline sarcomas and canine soft tissue sarcomas. The company believes this classification may extend to a broader range of veterinary cancers, including most solid tumors in animals. As veterinary medical devices do not require premarket approval or notification for commercial distribution in the United States, IsoPet® is authorized for marketing and commercial distribution following this classification, provided it is safe, effective, properly labeled, and compliant with applicable laws and regulations.