Core Insights - Profound Medical Corp. announced the superiority of the TULSA Procedure over robotic radical prostatectomy (RP) in terms of primary safety endpoints in the CAPTAIN trial for men with intermediate-risk prostate cancer [1][5] Group 1: CAPTAIN Trial Overview - The CAPTAIN trial exceeded its enrollment target, treating 211 patients across 20 sites in the U.S., two in Canada, and one in Europe by August 2025 [2] - The trial aimed to compare the safety and efficacy of the TULSA Procedure with RP, focusing on preserving erectile function and urinary continence [8] Group 2: Clinical Outcomes - At 6 months post-treatment, 50% of patients preserved both erectile function and urinary continence after TULSA compared to 24% after RP, indicating a statistically significant improvement (p<0.05, risk ratio 2.1) [5] - TULSA preserved pad-free continence in 84% of men, while only 49% achieved this after RP [5] - Patient-reported erectile function was preserved in 56% of TULSA patients compared to 47% after RP [5] Group 3: Perioperative Measures - TULSA demonstrated zero blood loss during the procedure, while RP had an average blood loss of 150 mL (p<0.001) [5] - Patients undergoing TULSA had a shorter recovery time, missing an average of 10 days from work compared to 19 days for RP (p<0.05) [5] - There were significantly fewer serious complications requiring hospitalization after TULSA (0.7%) compared to RP (6.3%) within 90 days (p<0.05) [5] Group 4: Future Implications - The CAPTAIN trial is positioned to potentially establish the TULSA Procedure as a standard of care for prostate cancer treatment, with secondary oncologic outcomes expected later this year [6][8] - The trial's design allows for a rigorous comparison of safety, quality of life, and oncological control between the two treatment modalities [6]

Core Insights - The CAPTAIN trial demonstrates that the TULSA Procedure shows significant improvement over robotic radical prostatectomy (RP) in preserving erectile function and urinary continence at 6 months post-treatment [1][3][5] Group 1: Trial Overview - CAPTAIN trial successfully exceeded its enrollment target, treating 211 patients across 20 sites in the U.S., two in Canada, and one in Europe by August 2025 [2] - The trial aims to compare the safety and efficacy of the TULSA Procedure with RP in men with localized, intermediate-risk prostate cancer [7] Group 2: Clinical Outcomes - At 6 months, 50% of patients preserved both erectile function and urinary continence after TULSA compared to 24% after RP, with a statistically significant p-value of <0.05 [3] - TULSA preserved pad-free continence in 84% of men, while only 49% achieved this after RP [3] - Patient-reported erectile function was preserved in 56% of TULSA patients compared to 47% after RP [3] Group 3: Perioperative Measures - TULSA showed zero blood loss compared to 150 mL after RP, with a significant p-value of <0.001 [3] - Patients undergoing TULSA had a shorter recovery time, missing an average of 10 days from work compared to 19 days for RP [3] Group 4: Complications and Safety - The rate of serious complications within 90 days was significantly lower for TULSA at 0.7% compared to 6.3% for RP [3] - No patients required ICU admission after TULSA, while 1.6% did after RP [3] Group 5: Future Outlook - Secondary oncologic outcomes from the TULSA Procedure are expected to be reported later this year, which will provide further insights into its efficacy [4][5] - The trial positions the TULSA Procedure as a potential standard of care in prostate cancer treatment, pending further results [5][6]

Core Insights - Profound Medical Corp. is set to present the first clinical outcomes from the Level 1 post-market CAPTAIN trial, comparing the TULSA Procedure™ with robotic radical prostatectomy for localized prostate cancer at the EAU 2026 Congress on March 13, 2026 [1][2] Company Overview - Profound Medical Corp. is a commercial-stage medical device company specializing in AI-powered, MRI-guided, incision-free therapies for ablation of diseased tissue [1][5] - The company's flagship platform, TULSA-PRO, allows for precise, incision-free prostate therapy, enabling real-time treatment confirmation and personalized strategies for prostate care [6] - Profound also offers Sonalleve, an MRI-guided therapy for non-surgical treatment of various conditions, including pain palliation for bone metastases and gynecologic issues [7] Upcoming Events - A press release summarizing the CAPTAIN presentation will be issued after the event, followed by an investor webinar at 11:30 a.m. EDT on March 13, 2026, where Dr. Klotz will discuss the clinical relevance of the data [3][4] - Profound management will participate in one-on-one investor meetings at the 38th Annual Roth Conference from March 22-24, 2026 [4] Market Approval - Profound's technologies, including TULSA-PRO and Sonalleve, are approved in major global markets, including the United States, Europe, Canada, and several other countries [8][9]