RadioGel® is not FDA-approved for commercial use in the United States.
RadioGel® is not FDA-approved for commercial use in the United States.
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Vivos Inc Updates Human Therapy Progress in India
We want to provide a brief update regarding our anticipated DCGI (Drugs Controller General of India) approval for the expansion of our human therapy trials with RadioGel® Precision Radionuclide Therapy™ in India.
As previously communicated, we had anticipated receiving this regulatory clearance by the end of March 2026 to proceed with the next phase of the trial. While we have made significant progress and continue to work closely with the relevant authorities, the approval has experienced a delay beyond our original target timeframe.
Regulatory review processes, particularly for innovative medical therapies, are complex and involve multiple layers of evaluation to ensure patient safety and efficacy. Timeframes provided by regulatory bodies are estimates only and can be difficult to predict precisely due to factors such as additional data requests, internal reviews, or procedural steps that may extend the timeline.
We remain confident in the strength of our application and the promising early data from our ongoing work in India. Our team is actively engaged with the DCGI to address any outstanding items and facilitate a timely resolution. We will keep you informed as soon as we receive any meaningful updates on the approval status.
In the meantime, we are advancing other key initiatives, including preparations for our U.S. IDE submission and further development of our IsoPet® veterinary platform, to drive long-term value for the company and its shareholders.
Thank you for your continued support and confidence in Vivos Inc. as we work toward bringing this innovative cancer treatment technology to patients.
Bangalore, India