EDAP TMS (FOCL) H.C. Wainwright 28th Annual Global Investment Conference summary

Company Positioning, Technology, and Market Opportunity

• Positioned as a global leader in therapeutic ultrasound, focusing on organ-sparing, function-preserving treatments using robotic HIFU for cancer and benign diseases, with over 30 years in sound-based therapy and ongoing innovation in histotripsy.

• Platform integrates advanced imaging, robotics, remote connectivity, and AI-driven treatment, supporting precise and versatile procedures.

• Focal therapy is an emerging market expected to reach 40% of the prostate cancer treatment market, with HIFU as the fastest-growing ablation technology.

• Expansion opportunities include benign prostatic hyperplasia and deep infiltrating endometriosis, representing a total addressable market of over 4.3 million procedures and $10B+ in revenue.

• Prostate cancer market is large and growing, expected to double by 2040, with 1.4 million new cases annually worldwide.

Clinical Data, Patient Value, and Adoption

• HIFI study (2024) with 3,200+ men showed non-inferiority to surgery and superior functional outcomes, with favorable continence and erectile function compared to surgery and radiation.

• Focal One Robotic HIFU addresses the treatment gap for intermediate-risk prostate cancer patients and is written into NCCN guidelines as salvage therapy for failed radiation.

• Demonstrates high cancer control, quality-of-life preservation, and reduced patient burden compared to radical treatments.

• Strong reimbursement environment, with Medicare payment for HIFU procedures at $10,797 and favorable physician payment rates.

Commercial Growth and Expansion

• 96 Focal One systems installed in the U.S. as of June 30, 2026, with over 300 hospitals in the sales pipeline and major adoption at leading academic and community hospitals.

• 88 Focal One systems installed internationally, with 254 clinical sites using the technology and new placements in India, the U.K., Scandinavia, Latin America, and France.

• Multi-indication platform with ongoing clinical studies in BPH and endometriosis, and CE mark for women's health.