other material
confidence high
sentiment positive
materiality 0.55
Vivos 2021 recap: first equine IsoPet therapy, FDA pre-sub for RadioGel IDE, production improved 3x
VIVOS INC
- University of Missouri performed first equine IsoPet therapy; excellent outcome confirmed after monitoring.
- Pre-submission meeting with FDA for RadioGel IDE; used rapid breakthrough review; revised IDE to be submitted after biocompatibility tests.
- Polymer production time reduced and output increased by factor of three; contaminants reduced below FDA guidelines.
- New provisional patent filed covering improved hydrogel, other isotopes, and anti-circumvention techniques.
- Capital structure in excellent shape: no toxic debt or derivatives; all SEC filings timely.