Profound Medical (PROF) Status update summary

Clinical trial outcomes and evidence base

• CAPTAIN trial compared TULSA to radical prostatectomy in intermediate-risk prostate cancer, showing TULSA outperformed surgery in safety, functional recovery, and perioperative outcomes at six months.

• TULSA demonstrated rapid recovery of continence and erectile function, with continence rates around 80% at six months and expected to improve further, while surgery showed higher rates of incontinence and slower recovery.

• Minimal blood loss, shorter hospital stays, less pain, and faster return to work were observed with TULSA compared to surgery.

• CAPTAIN is the first large-scale, multi-center, randomized trial to successfully compare surgery to an energy-based intervention in prostate cancer.

• TULSA's outcomes are consistent across multiple studies, supported by over 70 peer-reviewed publications and extensive real-world data.

Technology and treatment flexibility

• TULSA uses MRI-guided transurethral ultrasound ablation, offering high precision and real-time thermal mapping for targeted treatment.

• AI-based contouring and live MRI enable customized, accurate treatment planning and execution, improving outcomes and reducing errors.

• The technology allows for whole gland, partial gland, and focal treatments, as well as use in large prostates and BPH, expanding its clinical utility.

• TULSA achieves significant prostate volume reduction, translating to symptom relief for BPH and supporting long-term durability.

• New AI-based software enables efficient, targeted ablation for BPH, further broadening TULSA's application.

Guideline inclusion and commercial outlook

• TULSA is now named in the 2025 NCCN prostate cancer guidelines, marking a significant step toward broader adoption.

• CAPTAIN provides Level I evidence, strengthening the case for guideline inclusion and insurance coverage.

• Guideline evolution is a process; registry-based use is already consistent with current recommendations, and payer engagement is increasing.

• Full guideline inclusion and broader reimbursement are expected as more oncologic and long-term safety data mature, with key milestones anticipated by year-end and 2028.

• Increased awareness and guideline embedding are expected to drive adoption, as physicians will be obligated to present TULSA as an option.