Ictero Medical

Executive Summary

Ictero Medical is a private medical device company developing the CholeSafe System, the first minimally invasive gallbladder ablation technology for gallstone disease. Founded in 2018 by a team from the Texas Medical Center Biodesign fellowship, the company aims to offer the definitive benefits of surgical cholecystectomy—complete elimination of gallstone recurrence—without the associated risks, invasiveness, and long recovery times. The system addresses a large, underserved market: over 20 million Americans suffer from gallstone disease, with approximately 700,000 cholecystectomies performed annually in the US alone. Current non-surgical treatments like oral dissolution or shock wave lithotripsy have low efficacy and high recurrence rates. While the CholeSafe System holds potential to disrupt standard of care, it is still in early development stages, with no publicly disclosed funding rounds, clinical data, or regulatory milestones. The technology faces significant technical hurdles in achieving consistent, safe gallbladder ablation and must navigate stringent FDA clearance pathways for novel devices. As an early-stage venture without a clear commercialization timeline, the risk profile is high, but success could yield a transformative product with substantial market demand.

Upcoming Catalysts (preview)

• Q4 2026First-in-human clinical trial initiation or results35% success
• Q2 2027Series A funding round or strategic partnership40% success
• Q3 2027FDA Investigational Device Exemption (IDE) submission or clearance30% success