Vivos Inc. (OTCQB: RDGL) submits Early Feasibility

§ 01 Executive Snapshot

• What: Vivos Inc. submits Early Feasibility IDE application for RadioGel® to the FDA.
• Who: Vivos Inc., Dr. Michael Korenko (CEO), FDA.
• Why it matters: This submission marks a critical step in advancing innovative cancer treatment technology aimed at improving patient outcomes.

§ 02 Key Developments

• The IDE application includes strengthened technical and manufacturing data confirming precise delivery of RadioGel®.
• Over 200 IsoPet® veterinary patients provided real-world safety data showcasing a favorable safety profile.
• Vivos expects FDA feedback or decision within the standard 30-day review period.

§ 03 Strategic Context

• Vivos Inc. is pioneering Precision Radionuclide Therapy™ (PRnT) with its RadioGel® technology, which targets solid tumors while minimizing damage to healthy tissue.
• The submission follows substantial progress from earlier 2026 updates and highlights the company's iterative engagement with the FDA regarding regulatory pathways.

§ 04 Strategic Implications

• Immediate implications include potential acceleration of human clinical trials for RadioGel®, enhancing its market readiness.
• Long-term implications involve expanding Vivos’ commercial opportunities and establishing a foothold in both human and veterinary oncology markets.

§ 05 Risks & Constraints

• Potential regulatory challenges may arise during the FDA review process, impacting timelines for clinical studies.
• Competition from other oncology therapies and emerging technologies could affect market positioning and adoption rates.

§ 06 Watchlist / Forward Signals

• The upcoming FDA feedback within 30 days will be a critical indicator of the application's success.
• Future developments in international clinical research and commercialization opportunities will signal Vivos’ growth trajectory in the oncology sector.