Market Opportunity & Growth - The company is a global leader in therapeutic ultrasound for cancer and benign diseases, with a strong growth opportunity in urology and prostate cancer[4,6] - Prostate cancer is the most common cancer among men in the US, with 33 million American men living with it in 2025, and 313780 new cases diagnosed[14,15] - Globally, there are approximately 15 million new prostate cancer cases per year as of 2022, with Europe accounting for 473011 cases, Asia for 386424 cases, and North America for 255782 cases[19,20] - The annual procedure opportunity for Focal One HIFU in prostate cancer is estimated at 470000 globally, including 165000 in Europe, 130000 in Asia, and 100000 in North America[25] Clinical Evidence & Technology - Over 1000 peer-reviewed publications support HIFU in the treatment of prostate cancer[36] - A comparative study (HIFI) showed comparable cancer control with HIFU (90% STFS) versus radical prostatectomy (86% STFS), with superior functional outcomes for HIFU[41,45] - A randomized controlled trial (FARP) demonstrated equivalent oncologic control at 3 years (935% TFF for Focal Ablation vs 915% for Radical Prostatectomy) and superior functional outcomes after focal ablation[54] - The company's Focal One system has 11 systems in the NY/NJ MSA at the end of 2024 and 67 systems in the US at the end of Q1 2025[104,107] Reimbursement & Expansion - Medicare reimbursement for HIFU is $9247 in 2025, a 54% increase, and physician payment is $951[70,73] - The company is targeting large incidence cancer and benign conditions, including 15 million prostate cancer cases, 113 million BPH cases, and 205 million rectal endometriosis cases[89]
EDAP TMS (EDAP) Earnings Call Presentation