Vivos Inc (RDGL)

[Malibew66]

may 2021.
This effort has strengthened our internal proprietary intellectual property. We discovered non-obvious and novel polymer/hydrogel production techniques that are significant and not published or mentioned in any patents. We are 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 our Standard Operating Procedures for Hydrogel and Particle Production. With the essential elements of these enhancements now completed, we will accelerate our 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.