Vivos Nears FDA Gate for Targeted RadioGel Cancer Therapy

KENNEWICK, WA – February 10, 2026 – Vivos Inc., a medical device company, is on the verge of a critical milestone in its quest to bring a novel cancer treatment to human patients. The company announced significant progress toward submitting its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel®, an innovative therapy designed to deliver precise, localized radiation directly into solid tumors.

The submission, planned for the end of the first quarter or April, represents the culmination of years of development and extensive dialogue with regulators. If the IDE is approved, Vivos will be cleared to begin human clinical trials in the United States, a pivotal step in moving its Precision Radionuclide Therapy™ from the laboratory and veterinary clinic into human oncology.

Navigating the FDA Labyrinth with an Expert Guide

Gaining FDA approval for any new medical device is a formidable challenge, but the path is particularly rigorous for Class III "significant risk" devices like RadioGel®. These products, which include implants and life-sustaining technologies, are subject to the highest level of regulatory scrutiny. The FDA’s Center for Devices and Radiological Health (CDRH) requires a comprehensive IDE application demonstrating that the device is safe enough to be tested in human subjects.

Vivos has been engaged in this process for several years, addressing feedback from over 40 different FDA reviewers—a challenge compounded by frequent changes within the agency's review teams. To navigate this complex landscape, the company has made a key strategic move: retaining the services of Dr. John J. Smith and his team at the global regulatory group Hogan Lovells. Dr. Smith is a highly respected figure in the field, with a background as a board-certified radiologist and a former senior official within the FDA's Office of Device Evaluation.

His expertise is considered invaluable, as he possesses a proven track record of guiding Class III implantable radiation devices through the very same FDA branch now overseeing RadioGel®. This firsthand experience with the agency's expectations and review patterns is being leveraged to fortify the IDE submission. The entire application is being reformatted and structured to align with formats that have proven successful for similar devices, ensuring all outstanding FDA concerns are addressed with maximum clarity and effectiveness.

From Paws to Patients: A Unique Path to Approval

One of the most compelling aspects of the Vivos IDE submission is its reliance on a rich dataset from the veterinary world. The company's IsoPet® division has been commercially marketing a version of the same technology for use in animals, providing a wealth of real-world evidence on its safety and efficacy.

To date, IsoPet® has been used in over 100 therapeutic procedures across a diverse range of species and tumor types. Crucially, the company reports zero serious adverse events attributable to the product in these cases. This extensive safety record provides powerful supporting evidence for the therapy's favorable risk profile. The data from these animal patients is being systematically integrated into the human IDE application, offering a unique bridge of translational medicine that is rare for new device submissions.

The submission highlights particularly challenging cases, such as the successful treatment of ocular squamous cell carcinoma in horses. In these procedures, RadioGel® was injected near or directly into the cornea—a highly sensitive and critical anatomical location. The fact that these treatments were conducted without causing major side effects to adjacent structures like the lens or optic nerve serves as a powerful testament to the therapy's precision and minimal invasiveness. This veterinary data bolsters the argument that RadioGel® can safely target tumors even when they are located near vital, healthy tissue.

A Precision Strike Against Solid Tumors

RadioGel® represents a new approach in the rapidly evolving field of targeted radionuclide therapy. The technology consists of a hydrogel containing yttrium-90, a radionuclide that emits beta radiation. When injected directly into a solid tumor, the gel remains localized, delivering a potent, targeted dose of radiation to cancer cells while minimizing exposure to surrounding healthy tissue and preventing the radioactive agent from migrating systemically through the body.

This method positions RadioGel® as a distinct alternative to existing cancer treatments. It is less invasive than traditional brachytherapy, which often requires the surgical implantation of radioactive seeds. Compared to other systemic radiopharmaceuticals, which are injected into the bloodstream to seek out cancer cells, RadioGel®'s direct intratumoral injection is designed to overcome challenges related to uneven drug distribution within solid tumors, a known limitation of some targeted therapies.

The potential benefits for patients are significant. By concentrating the radiation dose precisely where it is needed, RadioGel® aims to improve treatment efficacy while reducing the debilitating side effects often associated with conventional external beam radiation or chemotherapy, which can damage healthy organs and tissues. The FDA previously acknowledged the therapy's potential by granting it a "Breakthrough Device" designation in December 2023, a program intended to expedite the review of technologies that could provide more effective treatment for life-threatening diseases.

The Road Ahead: Financial and Clinical Hurdles

As a clinical-stage company, Vivos Inc., which trades on the OTCQB market under the ticker RDGL, relies on investor capital to fund its extensive research and development activities. The company's financial filings show it has operated at a net loss while advancing its technology, a common scenario for biotech and medtech firms in the pre-commercialization phase. However, recent developments have provided positive signals for investors. Beyond the upcoming IDE submission, insider sentiment appears strong, highlighted by a significant open-market purchase of company stock by CEO Michael K. Korenko in late 2025.

Once the IDE is submitted, the FDA will have 30 days to render a decision. Approval would trigger the start of human clinical trials, a multi-phase process that will further evaluate the safety and effectiveness of RadioGel® in treating human cancers.

“We are encouraged by the constructive dialogue with the FDA and the substantial progress we have made in fortifying our submission,” said Michael K. Korenko, CEO of Vivos Inc., in a recent statement. “With guidance from one of the field’s leading regulatory experts, combined with our incorporation of newly available human clinical data and a refined presentation of pre-clinical information, we are strongly positioned to achieve IDE approval and bring this innovative therapy to patients in need.”

The company's fortified application, combining expert regulatory strategy, novel human data, and an extensive safety record from the veterinary field, represents its most robust effort yet to cross the threshold into human clinical studies and unlock the potential of its precision therapy platform.