EDAP TMS (EDAP) Oppenheimer 36th Annual Healthcare MedTech & Services Conference summary

Market opportunity and disease focus

• Therapeutic ultrasound addresses large, growing markets in urology, especially prostate cancer, with cases expected to double to 2.9 million by 2040.

• Focal One robotic HIFU targets an underserved patient group between low and high risk, offering organ-preserving treatment.

• HIFU is gaining market share as surgery and radiation decline, driven by patient demand for high efficacy and quality-of-life outcomes.

• BPH and endometriosis represent additional large addressable markets, with ongoing clinical studies and recent CE mark approval for endometriosis.

Technology, clinical evidence, and outcomes

• Focal One i, launched in April 2025, features expanded imaging fusion, AI integration, and telecollaboration capabilities.

• Over 1,000 peer-reviewed publications support HIFU for prostate cancer, with landmark studies (HIFI, FARP) showing comparable cancer control and superior functional outcomes versus surgery.

• HIFU demonstrates lower 10-year mortality and cancer-specific mortality compared to external beam radiation.

• Focal One preserves urinary continence and sexual function better than radical treatments, filling a gap between active surveillance and whole gland therapies.

Adoption, reimbursement, and business trends

• Focal One is installed in 87 U.S. hospitals (as of Dec 2025), including top academic centers, and is expanding in Europe with 41 systems and 254 clinical sites.

• Medicare reimbursement for HIFU increased in 2025, with physician payments nearly matching those for surgery; commercial payers typically pay more.

• 52% compound annual growth in installations and 44% in procedures from 2021–2025, with revenue from capital sales, disposables, treatments, and service.

• Strong management team with experience from leading med tech companies supports ongoing growth.