Vivos Inc. Receives FDA IDE Approval to Initiate First-in-Human Study of RadioGel® for Papillary Thyroid Carcinoma
核心洞察
Vivos Inc. (搜索) received FDA approval for its Feasibility IDE application, enabling the first U.S.-based human clinical study of RadioGel® (搜索) at Mayo Clinic in Jacksonville, FL.
The study will evaluate the safety and feasibility of the yttrium-90-based injectable hydrogel in patients with non-resectable papillary thyroid carcinoma (搜索), initially enrolling five patients.
Preclinical and veterinary data from over 200 IsoPet® patients demonstrated a favorable safety profile with no radiation-associated adverse effects in normal organs or tissues.
Vivos Inc. (搜索) (OTCQB: RDGL) has received U.S. Food and Drug Administration (FDA) approval for its Feasibility Investigational Device Exemption (IDE) application, clearing the way for the first-in-human clinical study of RadioGel® (搜索) in the United States. The study will be conducted at Mayo Clinic in Jacksonville, Florida, and will evaluate the safety and feasibility of the company's yttrium-90-based injectable hydrogel in patients with non-resectable papillary thyroid carcinoma (搜索).
"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. (搜索) "Advancing RadioGel® (搜索) into human studies in the U.S. brings us closer to delivering a precise, minimally invasive cancer therapy that can meaningfully improve patient outcomes."
Regulatory Pathway and Study Design
The IDE approval follows the submission of an Early Feasibility IDE application, which was developed with expert regulatory guidance and reflected iterative engagement with the FDA. The submission included strengthened technical and manufacturing data confirming precise delivery and highly localized retention, additional clinical insights from an ongoing international human trial, updated preclinical evidence addressing prior Agency questions, and compelling real-world safety data from over 200 IsoPet® veterinary patients across a wide range of tumor types.
The feasibility study protocol is expected to initially enroll five patients. Results from this study will help shape subsequent pivotal trials. Mike Korenko, CEO of Vivos Inc. (搜索), noted that the conditions of the FDA approval will be incorporated into the protocol for Mayo Institutional Review Board (IRB) review.
RadioGel® (搜索) Technology and Preclinical Evidence
RadioGel® (搜索) is an innovative yttrium-90-based injectable hydrogel designed to deliver precise, localized beta radiation to solid tumors while minimizing exposure to surrounding healthy tissue. This targeted approach, termed Precision Radionuclide Therapy™ (PRnT), offers significant potential as a new treatment option for patients with difficult-to-treat tumors, including those with metastatic disease.
Dr. Darrell R. Fisher, nuclear medicine physicist with Versant Medical Physics and Radiation Safety, commented on the technology's development: "Yttrium-90 RadioGel® (搜索) is designed to efficiently deliver targeted radiation to cancerous tumors while minimizing treatment-related side effects. 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."
Dr. Fisher further emphasized that across multiple studies, histopathology confirmed no radiation-associated adverse effects in any normal organs or tissues, adding: "I am 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."
Multi-Track Strategy and Broader Momentum
The IDE approval represents one component of Vivos Inc. (搜索)'s broader multi-track strategy. The company continues to expand commercial adoption of IsoPet® in veterinary oncology, advance non-U.S. clinical research and commercialization opportunities for RadioGel® (搜索) through Vivos Scientific India LLP, pursue international licensing and monetization opportunities for RadioGel®, PrecisionGel®, and related technologies, and progress RadioGel® through the U.S. regulatory pathway for human use.
The company also recently participated in the SNMMI 2026 Annual Meeting in Los Angeles, where it engaged with key leaders in nuclear medicine and molecular imaging, resulting in productive discussions and new contacts that further indicate significant clinical interest in RadioGel® (搜索).
"Receiving FDA IDE approval represents the culmination of years of dedicated work by our team," said Korenko. "FDA has determined that we have provided sufficient data to support initiation of the investigation. We are excited to partner with Mayo Clinic and take this important step toward bringing RadioGel® (搜索) to patients who need better treatment options. This clearance reinforces our confidence in RadioGel® as a Breakthrough approach in precision radionuclide therapy."