Vivos Inc. is providing an update to shareholders regarding its FDA regulatory pathway for RadioGel®.
The Company continues to make substantial progress towards the submission of its Investigational Device Exemption (IDE) application for human clinical trials. At the direction of our regulatory expert, we determined more time would be beneficial for refining and strengthening the submission package. While we did not meet our previously anticipated April target, we have used this time productively to further enhance the quality and completeness of the application.
This work includes:
- Fully addressing all outstanding FDA concerns and adopting a submission format and structure proven effective by regulatory experts for similar devices.
- Engaging our experienced regulatory consultant, together with the team’s vast experience in successful IDE approvals, to refine and strengthen the overall submission.
- Incorporating additional information from clinical human data that has become available since the Company’s last IDE submission, further strengthening the evidence package.
- Reformatting and summarizing pre-clinical data in a manner that more directly and effectively addresses the remaining FDA concerns.
- Leveraging extensive veterinary clinical data from IsoPet® commercial use: Integrating comprehensive treatment outcomes from over 200 safely administered therapies across diverse tumor types and species, with zero reportable serious adverse events attributable to the product, to provide additional real-world safety and efficacy evidence supporting the Precision Radionuclide Therapy™ platform.
- Highlighting specialized equine ocular applications: Including detailed case data on successful treatments of ocular squamous cell carcinoma in horses (with injections near or into the cornea), showing no major side effects in adjacent critical structures, to further demonstrate the therapy’s precision, minimal invasiveness, and favorable risk profile in challenging anatomical locations.
We remain highly confident in the quality and completeness of our application and anticipate submitting in the near term with no substantial delay expected. This submission represents a critical milestone that significantly de-risks the program and positions RadioGel® strongly for a successful IDE review and advancement into human studies. We will provide a further update promptly upon submission.
We appreciate the continued support of our shareholders as we execute on this transformative opportunity in Precision Radionuclide Therapy™.
About Vivos Inc.
Vivos Inc. is developing Precision Radionuclide Therapy™ (PRnT™) using its innovative RadioGel® and IsoPet® technologies for targeted treatment of solid tumors.
