Initial Perioperative Data from CAPTAIN Randomized Trial Demonstrate MRI-Guided TULSA Provides Statistically Significant Improvement of Post-Operative Experience Vs. Robotic Radical Prostatectomy

Core Insights - The CAPTAIN trial is the first Level 1 study comparing the TULSA procedure with radical prostatectomy (RP) in men with intermediate-risk prostate cancer, showing TULSA's advantages in safety and patient experience [1][4][7] - Initial perioperative data indicates TULSA has no blood loss, shorter hospital stays, and reduced post-procedure pain compared to RP, leading to quicker recovery [1][5][6] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing AI-powered, incision-free therapies for tissue ablation [1][8] - The TULSA-PRO system combines real-time MRI, AI-enhanced planning, and ultrasound technology for precise treatment of prostate conditions [9] Clinical Trial Details - The CAPTAIN trial recruited 201 patients across 20 sites in the U.S., Canada, and Europe, with 69% receiving TULSA and 31% RP [3][7] - The primary endpoints include preservation of erectile potency and urinary continence at one year, and freedom from additional treatment or cancer-related death by three years [7] Key Findings - TULSA showed a median blood loss of 0 mL compared to 100 mL for RP, and a median length of stay of 0.29 days versus 1.24 days for RP [5] - Patient-reported outcomes indicated significantly lower pain levels and better quality of life for TULSA patients compared to those undergoing RP [5][6] Market Implications - The positive outcomes from the CAPTAIN trial are expected to drive patient demand and influence insurance coverage policies, as Level 1 trials are considered the gold standard in evidence-based research [6]