Profound Medical Announces Level 1 Post-Market CAPTAIN Trial Comparing TULSA Procedure With Robotic RP Meets Primary Safety Endpoint In Grade Group 2 And 3 Prostate Cancer

– First multicenter, randomized controlled trial directly comparing a new technology to robotic RP for men with localized prostate cancer to successfully recruit to target enrollment –

– TULSA treatment demonstrates a meaningful and statistically significant improvement over robotic RP in the preservation of erectile function together with continence at 6 months –

TORONTO, March 13, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF, TSX:PRN) ("Profound" or the "Company"), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, today announced superiority on the prespecified, primary safety endpoint in the Level 1 post-market CAPTAIN randomized controlled trial comparing the TULSA Procedure™ with robotic radical prostatectomy ("RP") in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer.

CAPTAIN exceeded its enrollment target, treating 211 patients, instead of the initially planned 201 patients, by August 2025 at 20 sites in the United States, two in Canada and one in Europe. Baseline patient characteristics are balanced for the TULSA Procedure vs. robotic RP (all p>0.05): median (IQR) age 63 (58-68) vs. 65 (60-69) years, PSA 6.5 (4.9-9.6) vs. 7.2 (5.6-9.7) ng/mL, prostate volume 41 (31-50) vs. 35 (29-47) cc, proportions of TULSA vs. RP patients with Grade Group 2/3 disease were 76%/24% vs. 77%/23%, and proportions with (IIEF Q2) erectile function and (EPIC) pad-free continence 84% vs. 76%.

Clinical outcomes to 6 months post-treatment were presented earlier today by Laurence Klotz, CM, MD, FRCSC, an esteemed urologist, a professor of surgery at the University of Toronto, the Sunnybrook Chair of Prostate Cancer Research, and one of the investigators for the CAPTAIN trial, during the Late-Breaking and High-Impact session at the 41st Annual European Association of Urology ("EAU 2026") Congress in London, UK.