Kennewick, WA — February 3, 2026 — Leads & Copy — Vivos Inc. (OTCQB: RDGL) has provided shareholders with an update on human therapy demonstrations in India using RadioGel® Precision Radionuclide Therapy™.
A prominent physician in India initiated the demonstrations in December 2024 to assess the safety and efficacy of RadioGel®.
Patients have attended scheduled regulatory follow-up visits, and no serious adverse events have been reported to date. Several patients have completed their one-year follow-up examinations and continue to show no reported adverse effects.
Preliminary observations from 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.
Vivos Inc. is working 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. An update to the IDE submission will be provided soon, incorporating relevant data from these ongoing demonstrations to further support the U.S. regulatory pathway.
The therapist and facility have been selected for the planned larger-scale clinical trial, intended to support potential future regulatory and commercial pathways in India.
Vivos Inc. is committed to submitting the comprehensive results from these India human therapy demonstrations. This key step continues to progress steadily as part of ongoing efforts to share valuable scientific insights with the broader medical community, and the company looks forward to advancing through the standard phases of data finalization, regulatory considerations, and peer-review processes.
Vivos Inc. is focused on the continued development of RadioGel® as a targeted therapy option for solid tumors and appreciates the ongoing support of shareholders as it advances through these regulatory and clinical steps.
Vivos Inc. has developed a 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.
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.
Source: Vivos Inc.
