September 01, 2022
In our previous meeting this past May with the FDA, it was recommended that we perform additional animal testing to confirm RadioGel™ remained at the point of injection. The FDA suggested before we initiate any testing, we send them a copy of the proposed animal test plan to review in our next IDE Pre-Submission meeting.
May 24, 2022
The Vivos team felt that our meeting with the US FDA on 5/20/22 was a significant positive turning point in the FDA review process. We proposed an additional short-term animal test to prove beyond any doubt that RadioGel™ can deliver a precise dose of therapeutic radiation and does not migrate from the tumor site. We now have a clear path forward with the review team toward obtaining the IDE needed for the first in human clinical trials.