Vivos Inc. announced that during the past few months Vivos has made significant enhancements to the manufacturing process for Radiogel™. These enhancements are crucial in aligning with FDA requirements for future clinical trials and licensing to international markets. Hydrogel and Y-90 particle production processes are safe and efficient and are being used to produce IsoPet® for animal therapy. Full FDA pedigreed pre-clinical testing and clinical trials require Good Manufacturing Practice (GMP) protocols described in detail in FDA regulations. The production improvements for Radiogel™ discussed were identified as part of establishing the GMP protocols for the IDE submission to the FDA. This has been a substantial effort, including fifteen polymer runs to bound the design specifications, incorporation of more than fifty new Quality Management System documents, installation of new precision process control equipment, and a newY-90 particle sterilization process. The company is also assessing a contract with an international company that has the potential to produce a substantial amount of GMP RadioGel™ and IsoPet® both domestically and internationally. This effort has strengthened the internal proprietary intellectual property. The company discovered non-obvious and novel polymer/hydrogel production techniques that are significant and not published or mentioned in any patents. The company is currently evaluating whether to keep these discoveries as a proprietary trade secret or to file additional patents. These manufacturing details have been incorporated in revisions to the Standard Operating Procedures for Hydrogel and Particle Production. With the essential elements of these enhancements now completed, it will accelerate the pre-clinical testing and now anticipate filing the IDE with the FDA in the next 90-120 days. Submitting the IDE after these manufacturing process enhancements were completed creates a much stronger submission with FDA and greatly reduces the risk and expense of having to do repeat testing.