Vivos Inc. Advances RadioGel® Precision Radionuclide Therapy Toward FDA Clinical Trials
Key Insights
Vivos Inc. (search) has made significant progress toward FDA Investigational Device Exemption (IDE) approval for RadioGel® (search), a targeted radiation therapy that delivers precise beta radiation to solid tumors (search) via direct injection.
The company has engaged with over 40 FDA reviewers and enlisted a top regulatory expert in brachytherapy to strengthen their IDE submission with enhanced clinical data and refined pre-clinical presentations.
RadioGel® (search) has demonstrated safety in over 100 veterinary treatments with zero reportable serious adverse events, including successful treatments of ocular squamous cell carcinoma (search) in horses.
Vivos Inc. (search) (OTCQB: RDGL) has announced significant progress toward securing FDA Investigational Device Exemption (IDE) approval for RadioGel® (search), its innovative Precision Radionuclide Therapy™ (PRnT™) technology designed to treat solid tumors (search) through targeted radiation delivery.
RadioGel® (search) represents a targeted radiation therapy approach that delivers precise, localized beta radiation to solid tumors (search) via direct injection, minimizing exposure to surrounding healthy tissue and reducing systemic migration of the radiopharmaceutical agent. The technology aims to address limitations of conventional radiation therapy by providing more precise tumor targeting.
Extensive FDA Engagement and Regulatory Strategy
Over the past several years, Vivos has engaged extensively with the FDA, successfully addressing feedback from more than 40 individual reviewers—many comments stemming from frequent review team changes within the Agency. The company has provided comprehensive data and finalized key technical parameters related to demonstrating precision delivery of RadioGel® (search) to the treatment area and ensuring minimal exposure to non-target tissues.
In a strategic move to strengthen their regulatory pathway, Vivos has engaged one of the top regulatory experts in the field of brachytherapy and combination radiotherapy devices, with deep experience guiding such products through the FDA's Center for Devices and Radiological Health (CDRH). This expert's prior role at the FDA and proven track record of successful IDE approvals for Class III implantable radiation devices, several reviewed by the same branch overseeing RadioGel® (search), have provided invaluable guidance.
Enhanced IDE Submission Strategy
With this expert's analysis of FDA feedback patterns, the company is bolstering its IDE submission through several key enhancements:
The submission will fully address all outstanding FDA concerns and adopt a submission format and structure proven effective by regulatory experts for similar devices. Additionally, Vivos is incorporating additional information from clinical human data that has become available since the company's last IDE submission, further strengthening the evidence package.
The company is also reformatting and summarizing pre-clinical data in a manner that more directly and effectively addresses the remaining FDA concerns, while leveraging extensive veterinary clinical data from IsoPet® (search) commercial use.
Veterinary Clinical Evidence
A significant component of the enhanced submission includes comprehensive treatment outcomes from over 100 safely administered therapies across diverse tumor types and species, with zero reportable serious adverse events attributable to the product. This real-world safety and efficacy evidence supports the Precision Radionuclide Therapy™ platform.
Particularly noteworthy are the specialized equine ocular applications, which include detailed case data on successful treatments of ocular squamous cell carcinoma (search) in horses. These treatments involved injections near or into the cornea, showing no major side effects in adjacent critical structures, further demonstrating the therapy's precision, minimal invasiveness, and favorable risk profile in challenging anatomical locations.
Timeline and Leadership Perspective
Vivos plans to submit the IDE by the end of the first quarter or in April 2026. "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. (search) "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 remains fully committed to advancing RadioGel® (search) toward human clinical trials in the United States and continues its strong collaborations for future indications for use. Vivos Inc. (search) is a clinical-stage medical device company developing RadioGel® as a precision radiotherapy hydrogel for human and veterinary oncology applications, with IsoPet® (search) currently commercially available for veterinary use in certified clinics nationwide.