Profound Medical (PROF) Status Update summary

Clinical evidence and trial updates

• CAPTAIN Level 1 randomized controlled trial for TULSA in prostate cancer fully enrolled, with 201 patients randomized and treatments nearly complete.

• CAPTAIN trial is the first Level 1 randomized controlled study directly comparing TULSA to robotic prostatectomy in intermediate-risk prostate cancer.

• TULSA procedure showed zero median blood loss, no overnight hospital stay, less post-operative pain, and faster recovery compared to robotic prostatectomy.

• TULSA patients reported statistically significant better overall health for 30 days post-procedure, with most regaining baseline health within two weeks.

• CARE Registry real-world data showed 90% PSA reduction, 75% disease-free at follow-up, 94% pad-free, and 98% leak-free at one year.

CAPTAIN trial design and endpoints

• CAPTAIN is a prospective, multi-center randomized controlled trial comparing TULSA and radical prostatectomy in men with organ-confined, intermediate-risk prostate cancer.

• Primary safety endpoint: preservation of erectile potency and urinary continence at one year post-treatment.

• Primary efficacy endpoint: freedom from additional prostate cancer treatment, metastases, or prostate cancer-related death at three years.

• Secondary endpoints include complication rates, cost effectiveness, and histologic/biochemical failure.

• TULSA aims to demonstrate non-inferior efficacy to RP with superior quality of life outcomes.

Technology and workflow advancements

• TULSA-PRO® uses real-time MRI, AI-enhanced planning, and robotically-driven ultrasound for precise, incision-free ablation of prostate tissue.

• New TULSA-AI modules introduced, including a volume reduction module for BPH and enhanced contouring assistant with 216 million parameters.

• AI-driven features allow for efficient, customizable treatments, reducing procedure time and improving workflow.

• Physicians can now treat both prostate cancer and BPH patients in the same day, increasing efficiency and patient throughput.

• The new software release, including the treatment arc and volume customizer, will be available to the install base within weeks, with a full launch by Q4.