Vivos Inc. provided an update on its human clinical trial in India for RadioGel Precision Radionuclide Therapy, an FDA-designated Breakthrough Device. Ten patients with cancerous nodes have now been successfully treated, further establishing a strong safety profile and generating promising early evidence of efficacy. All patients met the primary safety endpoint, with PET imaging confirming precise retention of the Yttrium-90 isotope at the injection site and no observed adverse events.
Notably, two patients with tumors in direct contact with the trachea and carotid artery were successfully treated without injuring adjacent critical tissues. This outcome highlights RadioGel's high Therapeutic Ratio and its potential for treating high-risk anatomical regions. Patients continue to recover well with no complications under disciplined clinical follow-up.
The study in India is approved to treat 30 patients, with a formal request being prepared for the Ethics Committee to approve up to 50 patients to evaluate RadioGel in a broader range of tumor types. Vivos is also laying groundwork for a permanent operational footprint in India, including a corporate office and a regional manufacturing facility, to support clinical rollout and commercial availability in a market valued at approximately USD 4.21 billion in 2023, projected to reach USD 5.89 billion by 2030.
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