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Profound Medical presents CAPTAIN RCT: TULSA-PRO eliminates blood loss, overnight stay; launches TULSA-AI for BPH
Profound Medical Corp.
- CAPTAIN RCT peri-operative data: median blood loss 0 vs 100 mL and length of stay 0.29 vs 1.24 days for TULSA vs robotic prostatectomy (p<0.001).
- Patients reported significantly less pain and better overall health (EQ-5D-5L VAS) in first month after TULSA vs robotic prostatectomy (p<0.05).
- Real-world CARE registry (n=223): PSA decreased 90% at 1 year; 94% pad-free continence; 77% preserved erectile function; 6.3% retreatment rate.
- New TULSA-AI Volume Reduction module and Treatment ARC FDA cleared for BPH, expanding TULSA addressable market.
- CAPTAIN is first RCT in localized prostate cancer to reach target enrollment (201 patients randomized 2:1 TULSA vs radical prostatectomy).