Vivos Inc (RDGL)

[lovethatgreen]

This was from Oct 11 update and they specify this is for period ending Sept 30 2023.

If the rabbits tests were going to be Jan 2024 I think they would have specified. Like someone else said, no reason could be found to wait 3 months
Also, Cameron remarking about the mayo preping for real time Indicates we're getting close



Medical Business Sector

Submittal of the IDE - (Q211938/S001)
Our next IDE application will be an amendment to the previous submittal. We are systematically preparing the answers to the 60 previous FDA comments. And as we near completion we felt it was worth the investment to redo a few studies to ensure that the FDA comments are fully addressed. This includes the polymer and hydrogel shelf-lives, the effect of radiation on the hydrogel, and the effect of polymer freeze-thaw cycles on the hydrogel properties. These tests will be completed next quarter (Q4).



Important content is the VX2 Tumor Animal Study report and executing the Genotox protocol:

VX-2/Rabbit Animal Study - Dr. Rebecca Krimins has treated 12 rabbits. Next quarter she will treat the last nine rabbits, submit the data to Pearl Pathways for independent review, and write the report.
Genotoxicity – Based on the FDA recommendation; on September 29th we participated in the Pre-Sub meeting to discuss the Genotoxicty Chemical Characterization Protocol (GCCP). We now feel sufficiently confident to initiate the genotox testing next month (October–November 2023).