CAPTAIN Trial Comparing Profound's MRI-Guided TULSA Procedure(TM) to Robotic Radical Prostatectomy Successfully Meets Primary Safety Endpoint, Preservation of Erectile Function and Urinary Continence

Executive Summary

• Profound Medical announced that the Level 1 post‑market CAPTAIN trial met its prespecified primary safety endpoint, showing statistically superior preservation of erectile function and urinary continence at 6 months for TULSA Procedure patients versus robotic RP (50% vs. 24%; p < 0.05).
• Peri‑operative advantages were demonstrated: zero blood loss and virtually no overnight hospital stay for TULSA, compared with median 150 mL blood loss and >1 day stay for RP; serious complications within 90 days were markedly lower (0.7% vs. 6.3%).
• Secondary oncologic outcomes are pending, but early surgical pathology from the RP arm shows a 33% positive‑margin rate and 35% upstaging, underscoring the need for further efficacy data on TULSA.

Key Details

• Trial enrollment & sites: 211 patients treated (exceeding target of 201) across 20 U.S., 2 Canadian, and 1 European site by August 2025.
• Baseline balance (p > 0.05): Median age 63 vs. 65 y; PSA 6.5 vs. 7.2 ng/mL; prostate volume 41 vs. 35 cc; Grade Group 2/3 distribution ~76%/24% vs. 77%/23%.
• Primary safety endpoint (functional outcomes):
• 50% of TULSA patients preserved both erectile potency and pad‑free continence at 6 months vs. 24% for RP (risk ratio 2.1, p < 0.05).
• Quality‑of‑life metrics:
• Pad‑free continence: 84% (TULSA) vs. 49% (RP).
• Erectile function sufficient for intercourse: 56% (TULSA) vs. 47% (RP).
• Peri‑operative measures (30 days):
• Blood loss: 0 mL (IQR 0‑0) TULSA vs. 150 mL (100‑200) RP, p < 0.001.
• Hospital stay: 0.3 days (0.2‑0.3) TULSA vs. 1.1 days (1.1‑1.3) RP, p < 0.001.
• Time off paid work: median 10 days (4‑15) TULSA vs. 19 days (10‑41) RP, p < 0.05.
• Serious complications (≤90 days): 0.7% for TULSA vs. 6.3% for RP (p < 0.05); ICU admission 0% vs. 1.6%.
• Oncologic interim data (RP arm only, 6 months): Positive surgical margin in 33%; upstaging in 35%. TULSA histology and imaging pending 12‑month biopsy/MRI; results expected later 2026.
• Investors’ webinar: Profound will host a live webcast on the same day (11:30 a.m. EDT) where Dr. Klotz will review CAPTAIN data and management will discuss commercial implications.

Notable Quotes

• Dr. Laurence Klotz, MD: “CAPTAIN is a first‑of‑its‑kind study… establishing these outcomes would facilitate moving the TULSA Procedure into the standard of care.”
• Arun Menawat, CEO & Chairman: “The trial now positions us to demonstrate with statistical rigor the TULSA Procedure’s superior quality‑of‑life profile while delivering whole‑gland treatment efficacy comparable to robotic RP.”