Vivos Inc Has Reported Positive Results With Its First Ever Human Trial

In what could prove to be a transformational development in cancer treatment, Vivos Inc. RDGL, the maker of the RadioGel® Precision Radionuclide Therapy™, has reported positive results from its first-ever human trial. 

RadioGel®, a pioneering Yttrium-90-based injectable medical device, represents what the company says is a groundbreaking approach to cancer treatment. It is designed for patients with solid tumors, who are either not eligible for surgery or have chosen not to undergo the procedure, particularly those with non-radioiodine-avid disease and limited burden regional nodal disease. The therapy involves directly injecting a hydrogel containing Yttrium-90 phosphate microparticles into the tumor. This method allows for a more localized and potent radiation treatment compared to traditional external-beam radiation therapies.

In December, the company announced it would conduct its first human trial in India. As of February, Vivos Inc. reported that the first eight patients demonstrated the safety of RadioGel® Precision Radionuclide TherapyTM by satisfying the criteria in the Clinical Study Plan, which included confirmation via PET imaging that the Y-90 remained at the point of injection and no adverse events were reported since the initial treatment date.

As of April, every patient in the trial has met the primary safety endpoint, confirmed through PET imaging showing precise retention of the therapeutic Yttrium-90 isotope at the injection site, with no observed adverse events. The patients are reported to be recovering well with no complications. Importantly, two of the ten patients presented with tumors in direct contact with the trachea and carotid artery, anatomical regions often considered inoperable or high-risk for radiation damage. The study showed that RadioGel® achieved successful treatment without injuring adjacent critical tissues, highlighting the therapy's high Therapeutic Ratio and the core rationale behind the FDA's Breakthrough Device designation.

More encouragingly, one of the local patients—a young teacher with a cancerous node near the trachea—revealed an over 80% reduction in both tumor size and metastatic activity. Vivos' treatment prevented the patient from side effects of other treatments that could have included jeopardizing her voice. 

Next Steps And Applications In The United States 

Vivos Inc. expects the lead investigator to request authority to increase the study from 30 to 50 patients after a detailed assessment of the available data is presented to the Ethics Committee. The expanded human trial in India will provide insightful data on a variety of cancers, including the utilization of new deep injection technology being installed and tested in the treatment hospital in Bangalore, India.

Although the IDE submission is not dependent on completing the international trials, as results emerge, they will be shared with the FDA to further support RadioGel®'s safety profile and reinforce their Investigational Device Exemption (IDE) submission and advance expanded indications for use in the United States.

The company has ensured that its initial trial in India closely aligns with the protocols designed for its planned study at the Mayo Clinic in the United States. Previously, the company received the Breakthrough Devices designation from the FDA, a program designed to accelerate the development and review of innovative technologies that show potential for more effective treatment options. The program’s support is instrumental in hastening patient access to promising medical advancements like RadioGel®. The company is hopeful its dual-track international strategy will accelerate the global introduction of this cutting-edge cancer therapy.

"At Vivos, our policy is to communicate results—not just promises. The initiation of this clinical trial marks a historic moment in the evolution of cancer treatment. It is the result of meticulous preparation, strategic execution, and our unwavering commitment to innovation. We are making history by advancing RadioGel® Precision Radionuclide Therapy™ into its first human trials. This international trial represents not just a milestone for Vivos Inc., but a pivotal moment for the entire field of oncology. We eagerly anticipate sharing preliminary results soon and comprehensive findings upon trial completion," shared CEO Mike Korenko.

Featured photo by National Cancer Institute on Unsplash.

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