EDAP TMS (FOCL) investor relations material

Strategic positioning and market overview

• Rebranded as a high-growth, pure-play robotic focal therapy company, focusing on large and expanding markets in urology, prostate cancer, BPH, and women's health.

• Identifies as a global leader in therapeutic ultrasound, emphasizing organ-sparing, function-preserving focal therapy.

• Prostate cancer incidence is rising, with nearly 3 million new cases projected globally by 2040; current treatments often compromise quality of life.

• Robotic focal HIFU addresses the gap between active surveillance and radical treatments, targeting low and intermediate risk patients with a $4 billion TAM.

• HIFU is the fastest-growing focal therapy for prostate cancer, with Medicare data showing increasing adoption and declining use of traditional treatments.

Technology, clinical evidence, and product innovation

• FocalTherics i platform launched with advanced imaging, proprietary HIFU, robotics, and AI, enabling non-invasive, organ-sparing procedures.

• Shortest treatment times among focal therapies; telecollaboration demonstrated with transatlantic procedures.

• Expanding into histotripsy, aiming to offer both HIFU and histotripsy on a single platform.

• Multiple clinical studies (HI-FI, HIFI-2, C.G.R.D., FARP, HIFU-AS) show HIFU is non-inferior to surgery and superior in preserving quality of life.

• HI-FI study, funded by the French government, demonstrated efficacy and superior functional outcomes exclusive to FocalTherics technology.

Commercial execution, reimbursement, and growth drivers

• Category 1 CPT code for HIFU with increasing reimbursement, now close to $14,000 in some regions; commercial payers often pay 1.5–2x Medicare rates.

• HIFU is the highest-paid focal therapy for urologists; strong adoption in top U.S. cancer centers and academic hospitals.

• 300 qualified deals in the U.S. pipeline; international expansion includes Europe, the U.K., Scandinavia, India, and Latin America.

• BPH and endometriosis represent new indications, with ongoing clinical studies and regulatory pathways underway.

• Targeting 4.3 million procedures and $10 billion revenue potential across prostate cancer, BPH, and endometriosis.