Vivos's Radionuclide Gel: A Precision Strike Against Untreatable Cancer

KENNEWICK, WA – July 06, 2026

In a move that could reshape the treatment landscape for a challenging form of thyroid cancer, medical device company Vivos Inc. has received U.S. Food and Drug Administration (FDA) approval to begin a first-in-human clinical study for its innovative RadioGel®. This Investigational Device Exemption (IDE) clears the way for a partnership with the prestigious Mayo Clinic to test a therapy that promises to deliver targeted radiation directly into tumors, potentially offering a lifeline to patients with few other options.

The FDA's decision marks a pivotal moment for the Kennewick-based firm, validating years of preclinical work and signaling a potential breakthrough in the field of precision oncology. The study will focus on patients with non-resectable papillary thyroid carcinoma, a condition where surgical removal of the tumor is not possible. By injecting a yttrium-90-based hydrogel directly into the cancer, Vivos aims to destroy it from the inside out while minimizing damage to surrounding healthy tissue. This milestone moves a promising technology from the veterinary world, where it is known as IsoPet®, into the critical arena of human cancer therapy.

A New Frontline for a Stubborn Cancer

Papillary thyroid carcinoma (PTC) is the most common form of thyroid cancer, and for most patients, the prognosis is exceptionally good. With 20-year survival rates exceeding 90%, standard treatments like surgery and subsequent radioactive iodine therapy are highly effective. However, a small but significant subset of patients faces a much more difficult journey: their tumors are deemed "non-resectable," meaning they cannot be safely removed with surgery due to their size or location near critical structures.

For this group, the path forward is fraught with challenges. Current treatments often involve systemic therapies like tyrosine kinase inhibitors, which can have debilitating side effects and to which cancers can quickly develop resistance. Another option, external beam radiation, lacks the precision to avoid collateral damage to healthy tissues in the neck. This creates a significant unmet need for a localized, potent, and less toxic treatment.

RadioGel® is designed to fill this void. By providing a minimally invasive, targeted option, it could offer an alternative to therapies that affect the entire body. "For patients with localized but inoperable tumors, the goal is always maximum impact on the cancer with minimum impact on the patient," noted one oncologist not involved with the study. "A technology that can be precisely delivered and contained within the tumor represents a significant step toward that goal." The upcoming trial at Mayo Clinic in Jacksonville, Florida, will be the first test of this principle in humans, initially enrolling five patients whose outcomes will be crucial in shaping the future of this therapy.

The Science of Precision: How RadioGel® Works

At the heart of Vivos's innovation is a clever combination of nuclear medicine and materials science. RadioGel® utilizes yttrium-90 (Y-90), a well-understood radioisotope that emits beta particles. Unlike gamma rays, which can travel through the body, beta particles deposit their energy over a very short distance—just a few millimeters. This physical property makes Y-90 an ideal candidate for destroying tumor cells with pinpoint accuracy while sparing adjacent healthy organs and tissues.

The true innovation, however, lies in the delivery system: an injectable hydrogel. This liquid gel is mixed with the Y-90 immediately before treatment and injected directly into the cancerous mass. Once inside the tumor, the hydrogel solidifies, creating a stable, localized depot of radiation. This prevents the radioisotope from migrating through the bloodstream, a key safety feature that distinguishes it from many other forms of radionuclide therapy.

This approach has been validated extensively in preclinical and veterinary settings. Dr. Darrell R. Fisher, a nuclear medicine physicist with Versant Medical Physics and Radiation Safety, highlighted the extensive safety data. “Over many years, preclinical studies in veterinary patients (cats, dogs, and horses) and laboratory animals (rabbits) demonstrated the safety and effectiveness of Yttrium-90 RadioGel® precision radionuclide therapy (PRnT) in cancer treatment,” he stated. “Across multiple studies, histopathology confirmed no radiation-associated adverse effects in any normal organs or tissues.” This robust animal data was instrumental in securing the FDA's confidence. As Dr. Fisher noted, he is "pleased that the Food and Drug Administration has recognized the safety profile of this device, permitting its use in human patients as part of the Mayo study.”

From Lab to Clinic: A Milestone for Vivos Inc.

For Vivos Inc., a developmental-stage company trading on the OTCQB market, this FDA approval is more than just a regulatory hurdle cleared; it's a fundamental validation of its entire platform and business strategy. Securing an IDE for a first-in-human trial is a massive de-risking event that can attract significant investor interest and partnership opportunities.

“This IDE approval is a major milestone for Vivos and validates the strength of our preclinical and clinical data, along with our regulatory efforts,” said Brad Weeks, President of Vivos Inc. “Advancing RadioGel® into human studies in the U.S. brings us closer to delivering a precise, minimally invasive cancer therapy that can meaningfully improve patient outcomes.”

His sentiment was echoed by CEO Mike Korenko, who added, “Receiving FDA IDE approval represents the culmination of years of dedicated work by our team.” Korenko confirmed that the FDA determined the company provided sufficient data to begin the investigation and that the conditions of approval will be integrated into the protocol for review by Mayo Clinic's Institutional Review Board (IRB).

The company's journey is a case study in strategic development. Vivos has pursued a multi-track strategy, commercializing its technology for animals under the brand IsoPet® to generate early revenue and real-world data. This veterinary application has provided a practical proving ground for the technology while the company navigated the long and expensive path of human clinical trials. This dual-market approach is a savvy way for smaller biotech firms to sustain operations while aiming for the much larger, more lucrative human health market.

The Mayo Clinic Study and the Path Forward

The selection of Mayo Clinic as the clinical trial site lends immense credibility to the undertaking. As a world-renowned medical center with deep expertise in both thyroid cancer and novel therapies, its involvement underscores the potential seen in RadioGel®. The initial feasibility study, while small, is a critical first step. Its primary goal is to establish the safety and procedural viability of administering RadioGel® in human patients.

"A feasibility study is exactly what it sounds like: we are asking if this procedure is safe and doable in the intended patient population," explained a medical device analyst. "Positive results here don't guarantee final approval, but they are the essential ticket to designing and launching the larger, more definitive pivotal trials that the FDA requires for market clearance."

Success in these initial five patients would provide Vivos and its clinical partners at Mayo Clinic with invaluable data on dosimetry, patient response, and potential side effects. This information will be used to refine the treatment protocol and design a subsequent pivotal study with a larger patient cohort, aimed at demonstrating both safety and efficacy. For patients with non-resectable papillary thyroid carcinoma, the initiation of this study represents a tangible source of hope and a critical step toward bringing a potentially transformative, targeted therapy into clinical practice.

The journey for RadioGel® is far from over, but with the FDA's green light and a top-tier clinical partner, Vivos Inc. has officially moved its promising technology into the spotlight of human cancer care.