EDAP TMS (EDAP) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Company overview and business divisions

• Global leader in advanced ultrasound technologies for diagnosis and treatment of disease.

• Three revenue streams: proprietary HIFU (Focal One), advanced imaging (ExactVu), and extracorporeal shockwave lithotripsy.

• Operates seven global subsidiaries with offices in the US, Europe, and Asia.

Key milestones and regulatory progress

• Focal One received FDA clearance in 2018 and a Category 1 CPT code three years later.

• Achieved a 90% increase in Medicare reimbursement with APC 6 payment in 2023.

• Completed phase III trial for endometriosis in January 2024 and received FDA Breakthrough Device Designation in March 2024.

Market opportunities and clinical focus

• HIFU technology addresses prostate cancer, BPH, benign thyroid nodules, liver and pancreatic tumors, breast fibroadenoma, and rectal endometriosis.

• Prostate cancer is a major focus, with 300,000 new US cases annually and 1.5 million globally.

• Focal One targets intermediate-risk prostate cancer patients and salvage treatment post-radiation.