The Vivos Board granted authorization to form a wholly owned corporate subsidiary in India. Vivos Inc filed for the name of Vivos Scientific India LLP. Vivos is completing the steps remaining to obtain formal approvals from the Indian government.

“This demonstrates our long-term commitment to doing business in India and supports our long-term plan of establishing our first international manufacturing center for RadioGel and IsoPet, for expanding our developmental animal testing, and for commercially treating humans and animals in India.”

India is an important region for us, having initiated first in human trials, which we announced in December of 2024. We are actively pursuing DCGI (Drug Controller General of India) approval for additional expanded human trials in India. As we have previously stated, we believe our India trials are supportive of our IDE process with the FDA. Based on feedback from the FDA, as part of our IDE application process, our formal protocol for the next phase of human trials in India will include immediate post treatment PET full- body scans to further validate RadioGel’s safety profile.