EDAP TMS (FOCL) investor relations material

Platform and growth

• Therapeutic ultrasound platform uses HIFU to target disease while preserving organs and functional outcomes; Focal One combines advanced imaging, AI, remote connectivity and five-axis robotics.

• Remote treatment demonstrated between Cleveland Clinic in Ohio and Cleveland Clinic Abu Dhabi, 7,000 miles apart; branded Focal Connect launch planned.

• Revenue grew from EUR 16m to EUR 26m through 2024; stated target was 38% YoY growth and approximately EUR 55m revenue for the year.

• Histotripsy development is underway, with proprietary patents filed and potential future use on the Focal One platform.

Prostate cancer opportunity and evidence

• More than 1.4m men are diagnosed with prostate cancer annually, including 300,000+ in the U.S.; 3.5m men live with the disease, and the market is projected to double by 2040.

• Intermediate-risk cases represent ~50% of newly diagnosed patients; Focal One HIFU is positioned as an option between surveillance for low-risk disease and surgery or radiation for high-risk disease.

• HIFI prospective study covered 3,200 men across 46 centers and 80 urologists; management cited its results as evidence of efficacy and quality-of-life benefits. FARP randomized trial results expected in coming months.

• Management said published data show HIFU is not inferior to surgery and radiation on efficacy endpoints, with better functional outcomes; outpatient procedure typically takes 40–60 minutes.

• HIFU is included in NCCN guidance as salvage treatment after failed primary radiation; cited radiation failure rates are 15%–30%.

Reimbursement and commercial adoption

• Medicare data through 2025 showed HIFU as the fastest-growing focal therapy and the leading prostate cancer ablation technology; CMS final rule raised HIFU reimbursement 10.5%, effective Jan. 1.

• National average hospital payment cited at $10,688, with payments of $14,000–$15,000 in some major metropolitan markets; physician reimbursement is 17.29 work RVUs.

• Installed base reached 192; 16 IDNs had at least two systems, with deployments at Mayo Clinic, Cleveland Clinic, Kaiser and major academic centers. More than 300 qualified U.S. hospital leads are being pursued.

• 94 systems were deployed outside the U.S. across 316 clinical treatment sites; France received reimbursement in January, and Brazil added HIFU to treatment guidelines this year.