Kennewick, Wash. — September 15, 2026 – Vivos Inc. (OTCQB: RDGL) (“Vivos” or the “Company”) is pleased to provide shareholders with an update on the continued advancement of its U.S. first-in-human feasibility study of RadioGel®, the Company’s innovative yttrium-90 injectable hydrogel designed for the targeted treatment of cancerous tumors.
The Company continues to build on the significant regulatory milestone announced on July 6, 2026, when the U.S. Food and Drug Administration approved Vivos’ Investigational Device Exemption (IDE) for its RadioGel® feasibility study. That approval authorized Vivos to initiate its first U.S. human clinical study, which is planned to be conducted in collaboration with Mayo Clinic in Jacksonville, Florida and is designed to initially evaluate RadioGel® in five patients with non-resectable papillary thyroid carcinoma. Data from this feasibility study are expected to help inform the design of subsequent pivotal clinical trials.
Another Important Milestone at Mayo Clinic
RadioGel® reached another important institutional milestone as Vivos continues executing its U.S. clinical strategy. The first-in-human study in the U.S is moving closer to IRB submission.
The Mayo Clinic clinical team has reviewed the protocol, expressed support for the study and voted to proceed. This is a critical institutional step and allows the program to advance into the next phase of research-unit activities leading toward Institutional Review Board (IRB) submission. As part of this process, the protocol has been finalized to incorporate the FDA’s conditional recommendations in preparation for IRB review.
This represents continued forward movement through Mayo Clinic’s established institutional process and brings the Company another step closer to IRB review, final study activation, patient enrollment and ultimately the first U.S. patient treatment with RadioGel®.
Mayo Clinic collaborators have confirmed that the study is progressing through the institution’s established process as quickly as reasonably possible. Following IRB approval and final study activation, the Mayo Clinic clinical team will be responsible for identifying, evaluating, consenting and enrolling eligible patients under the approved protocol.
Building on a Transformational Regulatory Milestone
The July 6, 2026 IDE approval established the regulatory pathway for RadioGel® to move from extensive preclinical and international development into a formal U.S. investigational feasibility study. RadioGel® remains investigational and is not approved for commercial human use in the United States.
The planned feasibility study is designed to evaluate the safety and feasibility of RadioGel®, Vivos’ Precision Radionuclide Therapy™ (PRnT) platform, in patients with non-resectable papillary thyroid carcinoma. RadioGel® is designed to deliver therapeutic radiation directly within a tumor while limiting radiation exposure to surrounding healthy tissue.
The Company believes the progression from FDA IDE approval into Mayo Clinic’s institutional review and study-activation process reflects continued execution of its U.S. clinical development strategy. IRB review and final study activation remain required before patient enrollment and first U.S. treatment.
Vivos Continues to Build for the Future
The RadioGel® clinical program represents one component of a broader strategy to establish Vivos as a leader in Precision Radionuclide Therapy™ for both human and veterinary oncology.
Through its proprietary technology platforms, RadioGel® for human applications, IsoPet® for veterinary oncology, and PrecisionGel™ as its polymer platform,Vivos is developing targeted, minimally invasive technologies designed to improve treatment precision while limiting radiation exposure to surrounding healthy tissue.
Each milestone is part of a larger progression. FDA IDE approval opened the door to U.S. human clinical investigation. Recent Mayo Clinic’s insitutional review and support have allowed the program to advance to the next phase of research-unit preparation for IRB submission.
Vivos is encouraged by this progress and remains focused on disciplined execution of the remaining institutional and regulatory steps required before first U.S. patient treatment.
The Company will provide updates as appropriate milestones are achieved.
About Vivos Inc.
Vivos Inc. is advancing next-generation Precision Radionuclide Therapy™ (PRnT) platforms designed to deliver highly targeted cancer treatment directly to tumors and surgical margins while minimizing exposure to surrounding healthy tissue. Through RadioGel®, IsoPet® and its proprietary polymer technologies, Vivos is working to expand the potential applications of localized radionuclide therapy across both human and veterinary oncology.
RadioGel® is currently not approved for human commercial use in the United States and is being studied under an FDA-approved Investigational Device Exemption.
Forward-Looking Statements
This press release contains forward-looking statements regarding future development, regulatory activities, commercialization opportunities, and potential therapeutic applications of Vivos’ technologies. Actual results may differ materially from those projected due to various risks and uncertainties. Vivos undertakes no obligation to update forward-looking statements except as required by law.
Contact: Vivos Inc Investors Relations
investors@vivosinc.com
