Announcement • Feb 10
Vivos Inc. Announces Significant Progress Toward FDA Investigational Device Exemption Submission for RadioGel Precision Radionuclide Therapy Vivos Inc. provided an update on its ongoing efforts to secure FDA Investigational Device Exemption (IDE) approval for human clinical trials of RadioGel® in advanced human therapy applications. RadioGel®? is a targeted radiation therapy designed to deliver precise, localized beta radiation to solid tumors via direct injection, minimizing exposure to surrounding healthy tissue and reducing systemic migration of the radiopharmaceutical agent. Over the past several years, the Company 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. Vivos has provided comprehensive data and finalized the key technical parameters related to demonstrating precision delivery of RadioGel®? to the treatment area and ensuring minimal exposure to non-target tissues. In a key strategic move, 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 device, several reviewed by the same branch overseeing RadioGel®?, have provided invaluable guidance. With this expert's analysis of FDA feedback patterns, the Company is bolstering its IDE submission by: Fully addressing all outstanding FDA concerns and adopting a submission format and structure proven effective by regulatory experts for similar devices. 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 100 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 effectiveness, and favorable risk profile in challenging anatomical locations. These enhancements maintain the intended use while maximizing the submission's clarity, completeness, and alignment with Agency expectations. These recommendations required substantial effort to incorporate into next submission. Vivos remains fully committed to advancing RadioGel®? toward human clinical trials in the United States and continues its strong collaborations for future indications for use. The Company has plans to submit the IDE by the end of the first quarter or in April. Announcement • Feb 04
Vivos Inc. Updates Human Therapy Progress in India Vivos Inc. provided shareholders with a positive update on the ongoing human therapy demonstrations in India using RadioGel®? Precision Radionuclide Therapy™?. Initiated in December 2024, a prominent physician in India began treating patients to demonstrate safety and measure efficacy with RadioGel®?. Patients have continued to attend their scheduled regulatory follow-up visits in accordance with the protocol. To date, no reports of serious adverse events have been received. Several patients have now completed their one-year follow-up examinations and continue to show no reported adverse effects at these timepoints. Preliminary observations from the treated patients have included instances of tumor size reduction observed over short intervals, with no recurrence noted in those specific cases during the available follow-up period. The protocol has also allowed evaluation of RadioGel®? in cases involving tumors near critical structures, with no reported damage to those adjacent organs observed to date. The therapist and facility have been selected for the planned larger-scale clinical trial, which is intended to support potential future regulatory and commercial pathways in India. Vivos Inc. remains excited and fully committed to submitting the comprehensive results from these India human therapy demonstrations. This key step continues to progress steadily as part of ongoing efforts to share valuable scientific insights with the broader medical community, and look forward to advancing through the standard phases of data finalization, regulatory considerations, and peer-review processes that are typical in high-quality clinical research. Announcement • Aug 14
Vivos Inc. Announces Investigational Device Exemption (Ide) Application for Human Clinical Trials At Mayo Declined by FDA Vivos Inc. Following the 30-day review period, the FDA declined approval of the Radiogel®? IDE submission. Vivos remains committed to pursuing approval for Radiogel®? in the US market. 
