Zero3™ Animal Trials
TriAgenics has conducted extensive animal testing (live animal and ex vivo bench-level tissue testing) to demonstrate the safety and efficacy of its Zero3 3TBA (3rd molar Tooth Bud Ablation) technology. Phase I live animal testing in 2015 demonstrated the ability to consistently perform the 3TBA procedure. TriAgenics Zero3 technology has been engineered to control all aspects of the Zero3 3TBA process to make the procedure safe, effective and simple. As demonstrated in multiple animal studies, Zero3 3TBA predictably blocks molar agenesis. Additional live animal studies are planned to optimize the thermal ablation process to minimize damage outside the tooth bud. The menu items below provide a representative overview of TriAgenics’ animal testing program. Our animal testing program will result in a request IDE application submission to the FDA in 2019.
The following CT image time series show a sagittal (lateral) view of an unablated maxillary control molar tooth bud (upper left quadrant) and the resulting progression of tooth formation inside the molar tooth bud starting at age 8 weeks (pig animal model) to a nearly fully formed crown at age 24 weeks.
The following CT image time series show a sagittal (lateral) view of an ablated mandibular molar tooth bud (lower left quadrant) at age 8 weeks (pig animal model) and the resulting post operative healing response through to age 24 weeks (16 weeks post op)