Vivos Inc (RDGL)

[User-499230]

A Vivos IDE resubmit is possible shortly after the initiation of DCGI approved human clinical trials. The FDA requested immediate post treatment PET full-body scans from DCGI approved clinical trials could be added to Vivos' IDE package about two weeks to a month from said trial's initiation date. It took Vivos about a month and a half (23 December 2024 - 4 February 2025) to acquire and provide an update on the India based academic safety study's 30-day PET/F-18 imaging results--the Y-90 remained at the point of injection.

Vivos has NOT stated that DCGI approved human clinical trials will be impacted by Vivos' lack of a RadioGel and IsoPet manufacturing center outside of the US. Vivos HAS stated that Vivos intends to establish its first international RadioGel and IsoPet manufacturing center to support COMMERCIAL treatments for humans and animals in India and in other global markets.

The Vivos 29 September 2025 press release states the following: "...our [Vivos'] 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."

A timeline for when Vivos decides to resubmit the IDE package to the FDA depends on three things:

1.) DCGI approving Vivos to begin human clinical trials towards commercialization in India
2.) The initiation date for the human clinical trials towards commercialization in India
3.) If Vivos decides to resubmit the IDE package right after acquiring the FDA requested immediate post treatment PET full- body scans of patients from a DCGI approved human clinical trials and not waiting until after said trial concludes whichis possible

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A Vivos update on DCGI's decision to allow Vivos to conduct human clinical trials towards commercialization in India is likely to be released between mid October 2025 to mid November 2025 or ANY (WITHIN 90 working days of receipt of application which likely occurred around 30 June 2025, according to Vivos' 2025 Q2 Form 10Q) DAY now!

India is the Global Pathway

GO VIVOS INDIA GO!!