Vivos Inc Updates Human Therapy Progress in India

Rhea-AI Summary

Vivos Inc (OTCQB: RDGL) provided an update on human therapy demonstrations in India using RadioGel® Precision Radionuclide Therapy. Initiated December 2024, treated patients have completed follow-ups with no reported serious adverse events and several one-year exams showing no adverse effects. Preliminary tumor size reductions and no damage to adjacent critical organs were observed. The company expects DCGI regulatory clearance later this quarter to expand the trial and will update an IDE submission with demonstration data to support the U.S. regulatory pathway.

Positive

• No serious adverse events reported to date
• Several patients reached one-year follow-up with no adverse effects
• Preliminary tumor size reductions observed in treated patients
• No reported damage to adjacent critical organs in evaluated cases
• Therapist and facility selected for planned larger-scale clinical trial

Negative

• DCGI regulatory clearance not yet obtained; anticipated later this quarter
• Current results are preliminary and not yet submitted as comprehensive final data
• IDE submission update pending to incorporate India demonstration data

Kennewick, WA, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) is pleased to provide shareholders with a positive update on the ongoing human therapy demonstrations in India using RadioGel^® Precision Radionuclide Therapy^™.

Initiated in December 2024, a prominent physician in India began treating patients to demonstrate safety and measure efficacy with RadioGel^®.

Patients have continued to attend their scheduled regulatory follow-up visits in accordance with the protocol. To date, no reports of serious adverse events have been received. Several patients have now completed their one-year follow-up examinations and continue to show no reported adverse effects at these timepoints.

Preliminary observations from the treated patients have included instances of tumor size reduction observed over short intervals, with no recurrence noted in those specific cases during the available follow-up period. The protocol has also allowed evaluation of RadioGel^® in cases involving tumors near critical structures, with no reported damage to those adjacent organs observed to date.

We continue to work toward anticipated DCGI regulatory clearance later this quarter to proceed with an expanded phase of therapy. This next stage would incorporate an enhanced protocol that includes elements suggested during prior FDA interactions, such as whole-body PET examinations, and would focus on treatment of cancerous lymph nodes throughout the body. We will provide an update to our IDE submission soon, incorporating relevant data from these ongoing demonstrations to further support our U.S. regulatory pathway.

The therapist and facility have been selected for the planned larger-scale clinical trial, which is intended to support potential future regulatory and commercial pathways in India.

Vivos Inc. remains excited and fully committed to submitting the comprehensive results from these India human therapy demonstrations. This key step continues to progress steadily as part of our ongoing efforts to share valuable scientific insights with the broader medical community, and we look forward to advancing through the standard phases of data finalization, regulatory considerations, and peer-review processes that are typical in high-quality clinical research.

Vivos Inc. remains focused on the continued development of RadioGel^® as a targeted therapy option for solid tumors. We appreciate the ongoing support of our shareholders as we advance through these regulatory and clinical steps.

CONTACTS:
Mike Korenko, ScD	Brad Weeks
CEO, Vivos Inc	President, Vivos Inc
mkorenko@radiogel.com	Brad.Weeks@vivosinc.com

Follow Vivos Inc. on X (Twitter): @VivosIncUSA

Learn more about RadioGel^® and IsoPet^® at www.VivosInc.com

About Vivos Inc.
Vivos Inc. has developed an innovative proprietary precision radionuclide therapy device to deliver targeted radiation for solid tumor treatment. RadioGel^® is an FDA-designated "Breakthrough Device" based on its potential to treat a wide range of solid tumors. The company is focused on advancing clinical applications while pursuing regulatory pathways in the U.S. and international markets.

Safe Harbor Statement
Important Note: RadioGel^® is currently not commercially available in the United States or elsewhere and is being used in these demonstrations solely under investigational protocols. All results described are preliminary, from a limited investigational setting in India, and are not intended to represent or predict final safety or efficacy outcomes. These observations have not been reviewed or approved by the U.S. FDA or other global regulatory authorities for marketing purposes.

This release contains forward-looking statements that are based on Vivos Inc.'s current expectations and assumptions. These statements involve risks and uncertainties, and actual results may differ materially. Vivos Inc. undertakes no obligation to update forward-looking statements except as required by law.

FAQ

What safety results has Vivos (RDGL) reported from the India RadioGel human therapy demonstrations?

Preliminary safety results show no reported serious adverse events to date. According to the company, patients continued scheduled follow-ups and several one-year exams reported no adverse effects, supporting initial tolerability during the available follow-up period.

Has Vivos (RDGL) observed tumor responses in the RadioGel India demonstrations?

Yes; preliminary observations include instances of tumor size reduction over short intervals. According to the company, those specific cases showed no recurrence during available follow-up, though results are described as early and limited to treated patients so far.

When does Vivos (RDGL) expect regulatory progress in India for RadioGel?

Vivos expects DCGI regulatory clearance later this quarter to proceed with an expanded phase. According to the company, the next stage would adopt an enhanced protocol and support broader treatment of cancerous lymph nodes throughout the body.

Will Vivos (RDGL) use India data to support its U.S. regulatory pathway?

Yes; Vivos plans to update its IDE submission using demonstration data from India. According to the company, the update will incorporate relevant findings to further support the U.S. regulatory pathway and reflect prior FDA interaction suggestions.

What clinical measures will be added in the expanded RadioGel protocol planned by Vivos (RDGL)?

The enhanced protocol would include whole-body PET examinations and broader lymph node treatment focus. According to the company, these elements were suggested during prior FDA interactions and aim to strengthen the expanded-phase evaluation and data collection.