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 patients had less blood loss, shorter hospital stays, less pain, and faster return to work compared to surgery.

• Continence and erectile function recovery were significantly better with TULSA at six months, with continence expected to improve further by one year.

• TULSA demonstrated high precision and safety, with minimal risk to surrounding organs and customizable treatment plans using AI and MRI guidance.

• Long-term data from the TACT trial and real-world studies support durable outcomes, with continence rates up to 97% and erectile function up to 87% at one year and beyond.

Guideline inclusion and market positioning

• 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.

• Professional societies require a body of evidence; guideline evolution is gradual, moving from experimental to recommended status as more data matures.

• Registry-based use aligns with current guidelines, and insurance payers are beginning to approve coverage for TULSA under these conditions.

• Awareness remains a challenge, but guideline recognition will obligate physicians to present TULSA as an option, driving adoption.

Technology and future directions

• TULSA's flexibility allows treatment of whole gland, partial gland, and BPH, supported by new AI-based software for targeted ablation.

• MRI-guided precision is central to TULSA's effectiveness, with real-time imaging enabling avoidance of critical structures.

• Siemens and other MR companies are developing interventional MR systems, signaling a broader shift toward MR-guided surgery.

• TULSA's platform approach and evidence base position it for expansion into new indications and broader clinical use.

• Upcoming data releases, including oncologic endpoints and long-term safety, are expected to further support adoption and payer coverage.