Profound Medical (PROF) Investor presentation summary

Technology platforms and clinical applications

• TULSA-PRO uses MRI-guided, AI-driven ultrasound ablation for precision treatment of prostate cancer (PCa) and benign prostatic hyperplasia (BPH), with over 3,000 patients treated and a growing installed base expected to reach 75 by year-end 2025.

• Sonalleve leverages similar MR imaging and thermography for non-invasive treatment of adenomyosis, uterine fibroids, and is in trials for pancreatic and other solid organ cancers, with over 4,000 women treated and 10 devices operational in Europe and Asia.

• TULSA-PRO's flexibility allows for whole-gland, partial, or focal ablation, addressing a broad spectrum of prostate disease and BPH, with AI software enhancing treatment planning and workflow.

• The CAPTAIN trial is generating Level 1 evidence comparing TULSA to prostatectomy, showing significant reductions in blood loss, hospital stay, and faster recovery.

• Strategic partnerships with Siemens and others aim to integrate TULSA with interventional MRI suites, expanding clinical reach and future applications.

Market opportunity and growth strategy

• U.S. annual total addressable market for TULSA-PRO is estimated at $1.6B for PCa and $3.2B for BPH, with an $8,000 average procedure price.

• Short-term growth targets 200 TULSA programs using existing MRI infrastructure, aiming for $85M annual revenue and 70%+ gross margin.

• Reimbursement for TULSA procedures became effective January 2025, transitioning from a cash-pay model to reimbursement-based revenue growth.

• Marketing focuses on patient and physician education, leveraging digital media, brand ambassadors, and podium presentations at major conferences.

• Long-term vision includes a fully integrated TULSA + iMRI platform for incision-free interventions across multiple specialties.

Clinical evidence and competitive positioning

• Over 70 peer-reviewed publications and 200+ conference presentations support TULSA's safety and efficacy across a variety of prostate indications.

• CAPTAIN trial data show TULSA eliminates blood loss and overnight hospital stays, with patients experiencing faster recovery and better overall health post-treatment compared to robotic prostatectomy.

• TULSA is positioned as more profitable for hospitals and urologists than robotic surgery, with higher Medicare payments and lower operating costs.

• AI-driven treatment planning (TULSA-AI) continues to improve, with the latest version outperforming urologists and matching radiologists in treatment design.

• TULSA's flexibility allows for efficient scheduling and higher patient throughput, enhancing profitability for providers.