Vivos Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application to begin a first-in-human feasibility study for RadioGel. This approval allows the company to initiate a US-based study using RadioGel, an innovative yttrium-90-based injectable hydrogel for the targeted treatment of cancerous tumors. The study aims to evaluate the safety and feasibility of the therapy in patients with non-resectable papillary thyroid carcinoma.

The clinical trial will be conducted at Mayo Clinic in Jacksonville, FL. The protocol is expected to initially enroll five patients, and the results will help shape subsequent pivotal trials. The FDA determined that the company provided sufficient data to support the initiation of the investigation, with the conditions of approval incorporated into the protocol for Mayo Institutional Review Board (IRB) review.

Study Details and Objectives

The feasibility study focuses on assessing the safety profile of RadioGel in human patients. Preclinical studies in veterinary patients and laboratory animals demonstrated the safety and effectiveness of Yttrium-90 RadioGel precision radionuclide therapy (PRnT) in cancer treatment. Histopathology across multiple studies confirmed no radiation-associated adverse effects in any normal organs or tissues.

Management Commentary

Brad Weeks, President of Vivos Inc., stated that the IDE approval is a major milestone validating the strength of the company's preclinical and clinical data. He emphasized that advancing RadioGel into human studies brings the company closer to delivering a precise, minimally invasive cancer therapy.

Mike Korenko, CEO of Vivos Inc., added that receiving FDA IDE approval represents the culmination of years of dedicated work. He expressed confidence in RadioGel as a breakthrough approach in precision radionuclide therapy and highlighted the partnership with Mayo Clinic as a critical step toward bringing the therapy to patients.

Strategic Focus

Vivos continues to advance its multi-track strategy, which includes expanding commercial adoption of IsoPet for veterinary oncology and advancing non-U.S. clinical research and commercialization opportunities for RadioGel. The company is also pursuing international licensing and monetization opportunities for the PrecisionGel platform while progressing RadioGel through the U.S. regulatory pathway for human cancer therapy.

Vivos Therapeutics, Inc. announced compelling clinical data showing that treatment with its FDA-cleared Vida oral appliance led to statistically significant improvement in insomnia severity in 100% of study participants. The company believes this finding underscores a major new commercial opportunity in the large and underserved global insomnia market.

Vivos focuses on the treatment of breathing-related sleep disorders such as obstructive sleep apnea (OSA), insomnia, and associated chronic health conditions. The Vida oral appliance is a central component of the company's medical device and healthcare service offerings.

The clinical trial results indicate a complete response rate among participants regarding the reduction of insomnia severity. This data highlights the potential efficacy of the Vida device in addressing sleep-related conditions beyond its primary applications.

Clinical Trial Outcomes

The study evaluated the impact of the Vida oral appliance on patients suffering from insomnia. The results demonstrated a consistent positive response across the entire participant pool.

The company positions these results as a validation for expanding the commercial application of its Vida device. Vivos aims to leverage this data to capture a share of the global insomnia market.