TriAgenics developed the Zero3 System, a first-of-its-kind medical device for third molar tooth bud ablation in pediatric patients. After a failed attempt with a CRO in Australia where two ethics committees spent months without resolution, TriAgenics partnered with bioaccess® to pursue a parallel regulatory strategy across Panama and El Salvador — accelerating their path to first-in-human data with pre-submission ethics committee engagement built into the process from day one.
TriAgenics had extensive preclinical data from porcine studies and bench testing demonstrating 100% efficacy, but needed first-in-human data to support their FDA IDE submission. Their previous attempt with George Clinical in Australia resulted in months of delays — one ethics committee took six weeks only to say they had never seen anything like it, and a second committee took another six weeks before raising the same vulnerable population concerns the FDA had. The company wasted valuable time and resources with no path forward.
bioaccess® designed a parallel two-country strategy across Panama and El Salvador, with pre-submission meetings built into the process to get early ethics committee feedback before formal submission — exactly the approach that was missing in Australia. The scope covers site search and selection, parallel regulatory submissions in both countries, pre-submission ethics committee meetings, trial set-up and start-up, clinical trial insurance coordination, and certified document translation into Spanish. bioaccess®'s specialization in first-in-human medical device trials in Latin America meant TriAgenics got a team that understood the unique challenges of novel devices in pediatric populations, unlike generalist CROs.