Profound Medical's TULSA Procedure Achieves Superior Safety & Functional Outcomes Over Robotic Prostatectomy in CAPTAIN Trial

summarizeSummary

Profound Medical announced that its CAPTAIN trial met its primary safety endpoint, showing the TULSA Procedure is statistically superior to robotic radical prostatectomy in preserving erectile function and urinary continence.

check_boxKey Events

• CAPTAIN Trial Met Primary Safety Endpoint

  The CAPTAIN trial, comparing the TULSA Procedure to robotic radical prostatectomy (RP), successfully met its primary safety endpoint, demonstrating statistical superiority for TULSA.

• Superior Functional Outcomes

  At 6 months, 50% of TULSA patients preserved both erectile function and urinary continence, compared to 24% for RP (p<0.05). TULSA also showed superior preservation of pad-free continence (84% vs 49% for RP) and erectile function (56% vs 47% for RP).

• Reduced Complications and Faster Recovery

  The TULSA Procedure resulted in zero blood loss, no overnight hospital stay, reduced pain, and significantly fewer serious complications (0.7% vs 6.3% for RP) within 90 days, leading to faster return to work.

• Oncologic Outcomes Pending

  Secondary oncologic outcomes, including histology and imaging, are expected to be reported later this year following 12-month biopsy and MRI results.

auto_awesomeAnalysis

This filing announces highly positive clinical trial results for Profound Medical's TULSA Procedure, demonstrating statistical superiority over robotic radical prostatectomy (RP) in preserving erectile function and urinary continence. The CAPTAIN trial, a Level 1 randomized controlled study, also showed significantly fewer complications and faster recovery times for TULSA. This direct comparison against the current standard of care provides strong validation for TULSA-PRO, potentially accelerating its adoption and paving the way for inclusion in prostate cancer treatment guidelines. While secondary oncologic outcomes are still pending, the established safety and quality-of-life benefits are a major competitive advantage.