Vivos Inc Board Authorizes Vivios Inc to Establish a Corporate Entity in India
Rhea-AI Summary
Vivos Inc (OTCQB:RDGL) has received board authorization to establish a wholly-owned subsidiary, Vivos Scientific India LLP, marking a significant expansion into the Indian market. This strategic move follows the company's initiation of first-in-human trials announced in December 2024.
The company is actively pursuing DCGI approval for expanded human trials in India, which will support their IDE process with the FDA. The new protocol will include post-treatment PET full-body scans to validate RadioGel's safety profile. This expansion aligns with Vivos's long-term strategy to establish their first international manufacturing center for RadioGel and IsoPet products, expand developmental animal testing, and provide commercial treatments for both humans and animals in India.
[ "Establishment of wholly-owned subsidiary in India demonstrates international expansion", "Progress in human trials with potential FDA IDE application support", "Plans for first international manufacturing center for RadioGel and IsoPet", "Strategic expansion of both human and animal treatment capabilities" ]Positive
- None.
Negative
- Pending regulatory approvals from Indian government still required
- Additional clinical validation needed through PET scans for safety profile
News Market Reaction – RDGL
In the Sep 29 session, RDGL gained 1.01%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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Kennewick, WA, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL)
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.
Michael K. Korenko, Sc.D.
CEO, Vivos Inc.
Email: MKorenko@RadioGel.com
Follow Vivos Inc. on X (Twitter): @VivosIncUSA
Learn more about RadioGel® and IsoPet® at www.VivosInc.com
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, identified by terms such as “will,” “expects,” “plans,” “anticipates,” and “intends.” These statements involve risks and uncertainties that may cause actual results to differ materially, including challenges in executing business strategies, economic conditions, competition, regulatory changes, delays in clinic certifications, and other factors beyond Vivos Inc.’s control. For a detailed discussion of these risks, refer to the company’s filings with the Securities and Exchange Commission.
