other material
confidence high
sentiment positive
materiality 0.80
CAPTAIN trial meets primary safety endpoint: TULSA superior to robotic RP on function preservation
Profound Medical Corp.
- Primary composite endpoint met: 50% of TULSA patients preserved erectile function and continence at 6 months vs 24% for RP (p<0.05, risk ratio 2.1).
- TULSA preserved pad-free continence in 84% and erectile function in 56% of men at 6 months; RP: 49% and 47% respectively.
- Perioperative benefits: zero blood loss (0 mL vs 150 mL), median 0.3-day hospital stay vs 1.1 days, no ICU admissions versus 1.6% for RP.
- Serious complications requiring hospitalization within 90 days: 0.7% for TULSA vs 6.3% for RP (p<0.05).
- Secondary oncologic endpoints for TULSA arm (12-month biopsy and MRI) expected later in 2026.