Core Insights - Vivos Inc. is advancing its RadioGel technology, a Precision Radionuclide Therapy (PRnT), and is working towards securing FDA Investigational Device Exemption (IDE) approval for human clinical trials [1][6] Company Efforts - The company has engaged extensively with the FDA, addressing feedback from over 40 reviewers and finalizing key technical parameters to demonstrate the precision delivery of RadioGel [3] - Vivos has hired a top regulatory expert in brachytherapy to enhance its IDE submission, leveraging the expert's experience with successful IDE approvals for similar devices [4] - The company plans to submit the IDE by the end of Q1 or in April, indicating a strong commitment to advancing RadioGel towards human clinical trials [6] Submission Enhancements - The IDE submission will include fully addressing FDA concerns, incorporating new clinical human data, and reformatting pre-clinical data to better meet FDA expectations [8] - The submission will leverage extensive veterinary clinical data from IsoPet, showcasing over 100 safely administered therapies with no serious adverse events, to strengthen the evidence for safety and efficacy [8] - Specialized equine ocular applications will be highlighted, including successful treatments of ocular squamous cell carcinoma in horses, demonstrating the therapy's precision and minimal invasiveness [8]

Core Insights - Vivos Inc. has provided a positive update regarding ongoing human therapy demonstrations in India using RadioGel Precision Radionuclide Therapy, initiated in December 2024 [1] Group 1: Patient Outcomes - Patients have been attending regulatory follow-up visits as per protocol, with no serious adverse events reported to date [2] - Some patients have shown tumor size reduction over short intervals, with no recurrence noted during the follow-up period [3] - The therapy has been evaluated in cases involving tumors near critical structures, with no damage to adjacent organs reported [3] Group 2: Regulatory and Clinical Development - The company is working towards obtaining DCGI regulatory clearance later this quarter to expand the therapy phase, which will include enhanced protocols based on prior FDA interactions [4] - A therapist and facility have been selected for a larger-scale clinical trial to support future regulatory and commercial pathways in India [5] - Vivos Inc. is committed to submitting comprehensive results from the India demonstrations as part of its efforts to share scientific insights with the medical community [6] Group 3: Product Development Focus - Vivos Inc. remains focused on the development of RadioGel as a targeted therapy option for solid tumors, with ongoing support from shareholders [7]

Core Insights - Vivos Inc. has submitted an Investigational Device Exemption (IDE) application to the FDA for its innovative RadioGel therapy, aimed at delivering targeted radiation to solid tumors while minimizing damage to healthy tissue [1][2][3] - The IDE application is supported by extensive animal and human data, indicating strong evidence of RadioGel's safety and efficacy, which is crucial for addressing life-threatening conditions with unmet medical needs [2][3] Company Developments - The IDE application represents the most comprehensive submission by Vivos Inc. to date, developed through close collaboration with the FDA under the Breakthrough Device sprint process [2][3] - Dr. Michael Korenko, CEO of Vivos Inc., emphasized that the strong evidence of RadioGel's safety and efficacy brings the company closer to providing transformative therapy for cancer patients [3]

Core Insights - Vivos Inc. is advancing its human clinical trial for RadioGel Precision Radionuclide Therapy in India, which is designated as a Breakthrough Device by the FDA for treating solid tumors [1][10] Clinical Progress - The trial has successfully treated ten patients, confirming a strong safety profile and early evidence of efficacy, building on initial results that confirmed safety in the first five patients [2][3] - All patients have met the primary safety endpoint, with PET imaging showing precise retention of Yttrium-90 isotope at the injection site and no adverse events reported [3] - RadioGel has successfully treated tumors in high-risk anatomical regions without damaging adjacent critical tissues, demonstrating a high Therapeutic Ratio [4] Technical Innovations - The clinical team has implemented new technical refinements, including deep-needle injection techniques and precision image guidance, enhancing dose control and organ protection [6] - Ongoing discussions with Mayo Clinic investigators are aimed at preparing for a parallel clinical study in the U.S. [6] Expansion Plans - The study in India is approved to treat 30 patients, with a request being prepared to increase this to 50 patients to evaluate RadioGel in a broader range of tumor types [7] - Vivos is establishing a permanent operational presence in India, including plans for a corporate office and a regional manufacturing facility for yttrium phosphate microparticles [8] Market Opportunity - The cancer treatment market in India was valued at approximately USD 4.21 billion in 2023 and is projected to reach USD 5.89 billion by 2030, presenting a significant opportunity for innovative therapies like RadioGel [12] - Establishing a presence in India allows Vivos to diversify revenue streams and enhance global recognition of RadioGel as a relevant oncology solution [12] Regulatory Strategy - Vivos is sharing preliminary trial data with the FDA to support an Investigational Device Exemption (IDE) submission within the next 90 days [10] - The company is pursuing a multi-track global strategy to ensure momentum in regulatory progress, particularly in regions with streamlined pathways for innovative cancer therapies [10][11]