RadioGel™ Cancer Therapy

Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of
tumors in animals (IsoPet®) and humans (RadioGel™). Brachytherapy uses highly localized
radiation to destroy cancerous tumors by placing a radioactive isotope directly inside
the treatment area using the company’s proprietary hydrogel technology.

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RadioGel™ – Cancer therapy for humans.

Radiogel™ is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.

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IsoPet® – Cancer therapy for animals

The Isopet® Solutions division utilized university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. Testing on feline sarcoma at the Washington State University was completed in 2018 and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.

IsoPet® Therapy is readily available at The University of Missouri and select Regional Clinics.

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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.

(Dr. Mike Korenko CEO • President | December 2, 2021 Press Release)

Vivos Inc Obtains Feedback from the FDA on Clinical Testing of RadioGel™

Richland WA, Dec. 02, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), on November 30 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.

Full Press Release