Profound Medical (PROF) investor relations material

Product innovation and clinical differentiation

• Focused on TULSA, an MRI-guided, incision-free prostate treatment with AI-driven precision and workflow enhancements, offering both whole and partial gland therapy options.

• Technology enables rapid, outpatient procedures with minimal recovery time and reduced side effects compared to robotic surgery.

• Over 70 peer-reviewed publications support efficacy for prostate cancer and BPH, with ongoing expansion into new clinical indications.

• AI-powered software tools, including Contouring Assistant and Thermal Boost, streamline planning and improve outcomes, with performance equivalent to top radiologists.

• Partnerships with Siemens and Cook are driving adoption of interventional MRI, reducing equipment costs and facility requirements.

Market opportunity and commercialization strategy

• Addressable market includes 200,000 prostate cancer and 400,000 BPH surgical candidates annually in the U.S., plus 10,000 cases for radiation or focal therapy failures.

• Razor-and-blade business model: $500,000 capital per system and $5,500 per disposable, with an average $8,000 per patient revenue.

• Hospital reimbursement for TULSA is higher than robotic surgery, with no hospital stay required, improving hospital economics.

• Insurance coverage is expanding, with Medicare already covering the procedure and major insurers expected to follow as CAPTAIN study data matures.

• Utilization rates vary, but projections target at least 50 cases per site per year, with some sites already exceeding 100 cases annually.

Financial performance and outlook

• 2024 revenue reached CAD 10 million, 2025 revenue CAD 16 million, with high double-digit growth expected to continue.

• Gross margins exceed 70% for both hardware and disposables, supported by in-house manufacturing and software-driven value.

• Profitability projected at CAD 80 million revenue run rate, achievable with 200 sites performing 50 cases per year.

• Continued investment in clinical trials for BPH and expansion of indications planned to drive further adoption.

• Marketing of the interventional MRI combination expected to begin in Q4, pending FDA clearance.