FDA Pauses Approval of Vivos Inc.’s Radiogel Cancer Therapy

The U.S. Food and Drug Administration (FDA) has halted the approval process for Radiogel, an experimental radiation therapy developed by Vivos Inc. that was being prepared for clinical trials in the United States.

Radiogel is a hydrogel-based treatment designed to target solid tumors. It contains microscopic yttrium-90 phosphate particles (<2.0 µm) suspended in a sterile saline-polymer gel. Injected directly into tumors, the material delivers concentrated radiation to cancerous tissue while sparing healthy cells nearby.

Breakthrough Status, but Setback in Review

The therapy had previously been granted the FDA’s Breakthrough Device Designation due to its potential in treating certain cancers. However, following a recent 30-day review, the agency declined Vivos’ Investigational Device Exemption (IDE) application. The decision delays planned U.S. human trials, which were set to begin at Mayo Clinic.

Vivos submitted its IDE application in July. At the time, CEO Dr. Michael Korenko described it as the company’s “most comprehensive submission,” citing extensive data from both animal and humans. “The strong evidence of Radiogel’s safety and efficacy brings us closer to delivering a transformative therapy to cancer patients in need,” he said in a statement.

Company Plans to Resubmit

Despite the setback, Vivos says it intends to move forward with the FDA. The company will address the agency’s feedback and has scheduled an initial call within 10 days, followed by a pre-submission meeting in the coming weeks. The goal is to revise and resubmit its IDE application. If approved, the IDE application would allow Vivos to launch its first human clinical trials in the United States.

“Radiogel received the FDA Breakthrough Device Designation and has demonstrated an unparalleled therapeutic ratio and strong safety profile,” Korenko said. “Vivos remains committed to pursuing approval for Radiogel in the U.S. market.”