Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • Jul 15
Vivos Inc. Submitted the Investigational Device Exemption Application for Human Clinical Trials At Mayo Clinic Vivos Inc. announced the submission of its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel®?, a novel hydrogel-based radioactive therapy designed to deliver targeted radiation to solid tumors. This comprehensive submission, supported by extensive animal and human data, marks a significant milestone in Vivos Inc.'s mission to provide innovative cancer treatments. RadioGel®? is a novel medical device that enables precise radiation delivery to tumors, while minimizing damage to surrounding healthy tissue. The IDE application, developed through months of close collaboration with the FDA under the Breakthrough Device sprint process, addresses regulatory concerns with robust evidence of RadioGel's safety and promising efficacy. The Breakthrough Device designation expedites development for devices that address life-threatening conditions with unmet medical needs. Aankondiging • Apr 15
Vivos Inc. Reports Continued Progress in India Human Clinical Trial for RadioGel Precision Radionuclide Therapy Vivos Inc. share new developments in its ongoing human clinical trial in India for RadioGel Precision Radionuclide Therapy, an FDA-designated Breakthrough Device for the treatment of solid tumors. The latest results highlight both technical progress and growing clinical validation. This update builds upon the initial results released in February 2025, which confirmed the safety of RadioGel®? in the first five patients. As of this report, ten patients with cancerous nodes have now been successfully treated, further establishing a strong safety profile while generating promising early evidence of efficacy. Every patient in the trial has met the primary safety endpoint, confirmed through PET imaging showing precise retention of the therapeutic Yttrium-90 isotope at the injection site--with no observed adverse events. Patients continue to recover well with no complications, monitored under disciplined clinical follow-up protocols. Importantly, two of the ten patients presented with tumors in direct contact with the trachea and carotid artery, anatomical regions often considered inoperable or high-risk for radiation damage. Yet, RadioGel®? achieved successful treatment without injured adjacent critical tissues, underscoring the therapy's high Therapeutic Ratio and the core rationale behind the FDA's Breakthrough Device designation. These outcomes affirm the unique advantage of RadioGel®?: internal, highly localized beta radiation delivered directly within the tumor, sparing healthy tissue and enabling outpatient treatment with minimal post-procedure restrictions. Led by a highly experienced principal investigator in India, the clinical team has introduced new technical references to the treatment methodology, including deep-needle injection techniques, precision image guidance, and the use of saline spacers to enhance dose control and organ protection. These protocol advancements are being actively reviewed in discussions with Mayo Clinic investigators who are preparing for a parallel clinical study in the United States. The study in India, has been approved to treat 30 patients. A formal request is being prepared for the Ethics Committee to approve up to 50 patients, enabling evaluation of RadioGel®? In a broader range of tumor types, including those located deeper in the body such as lung and pancreatic cancers. Vivos is concurrently laying the groundwork for a permanent operational footprint in India, including plans to open a corporate office and to establish a regional manufacturing facility for yttrium phosphate microparticles. This infrastructure will support the clinical rollout and eventual commercial availability of RadioGel®®? in India--serving as a strategic hub for future global expansion. The results of the India trial, including comprehensive clinical and imaging data, will be submitted for peer-reviewed publication later this year. This milestone is expected to significantly enhance the therapy's visibility among physicians and oncologists and support regulatory submissions globally. Building on the FDA "Breakthrough Device" status of Radiogel®? Precision Radion Blvdide Therapy™?, Vivos is sharing preliminary India trial data directly with the FDA to support the company's goal to submit an Investigational Device Exemption (IDE) within the next 90 days. While the company is encouraged by its regulatory progress, it also acknowledges the inherent unpredictability of the U.S. regulatory environment, particularly amid shifting priorities and evolving review protocols under the new FDA administration. As such, Vivos continues to pursue a multi-track global strategy to ensure momentum regardless of domestic regulatory timing. Importantly, the clinical and commercial potential for RadioGel®? outside the U.S. is significant, particularly in regions with streamlined regulatory pathways and increasing demand for innovative, minimally invasive cancer therapies. The company are witnessing precise, safe, and promising therapy outcomes in tumors that traditionally pose high treatment risk. These results not onlyforce confidence in the technology, but also validates the FDA's designation of RadioGel®? as a Breakthrough Device. The company are optimistic about what lies ahead in India and globally--as move toward making this therapy accessible to patients in urgent need of new cancer treatment options. The company's Precision Radionuclide Therapy (PRnT™?) platform delivers targeted internal radiation from the U.S. Aankondiging • Feb 04
Vivos Inc. Reports Encouraging Human Clinical Trial Results Vivos Inc. reported that the first five patients demonstrated the safety of RadioGel Precision Radionuclide TherapyTM by satisfying the criteria in the Clinical Study Plan, including confirmation via PET imaging that the Y-90 remained at the point of injection and no adverse events reported by any of the initial five patients since the initial treatment date. Additionally, 30-day PET/F-18 imaging of a local patient—a young teacher with a cancerous node near the trachea—revealed an over 80% reduction in both tumor size and metastatic activity. Other treatment options would have jeopardized her voice, making this outcome particularly meaningful. While the trial’s primary objective is to establish safety, these early signs of efficacy are highly encouraging. Expansion of Clinical Trial: After completing the detailed assessment of the available data from the patients, the results will be presented to the Ethics Committee. The lead investigator intends to request authority to increase the study from 30 patients to 50 patients. The expanded trial will provide valuable data on a variety of cancers and include the utilization of new deep injection technology being installed and tested in the treatment hospital in India. This advanced deep-needle CT-guided precision injection device, designed for use with RadioGel®, will enable precise treatment of deeper-seated tumors, including lung and pancreatic cancer nodules. Under the current timeline, The company anticipates completing the initial 30-patient trial by June 30 and the expanded trial by year-end. Consistent with the previous disclosure, the trial’s comprehensive data will be submitted under the guidance of the lead investigator for publication in leading medical journals. Additionally, as results emerge, they will be shared with the FDA to further support RadioGel®’s safety profile and reinforce the Investigational Device Exemption (IDE) submission and advance expanded indications for use in the United States. 