EDAP TMS (NasdaqGM:EDAP) 2025 Conference Transcript

Summary of EDAP TMS Conference Call Company Overview - Company: EDAP TMS (NasdaqGM:EDAP) - Industry: MedTech, specifically focused on therapeutic ultrasound for cancer treatment Core Technology and Product - Focal One: A robotic High-Intensity Focused Ultrasound (HIFU) platform designed for urologists to perform focal ablation of prostate tissue, launched in May 2025 as an improvement over the previous platform [2][3] - Key Features: - Combines imaging, robotics, and HIFU technologies for precision [3] - Real-time imaging and dynamic focusing technology for accurate treatment [3][4] - Outpatient procedure with minimal recovery time [5] Market Opportunity - Prostate Cancer Statistics: Nearly 1.5 million patients annually, projected to double to 2.9 million by 2040 [6] - Treatment Gap: Focal One addresses the gap in treatment for favorable intermediate-risk prostate cancer, which is not adequately served by existing therapies [7] - Market Growth: HIFU is experiencing growth while traditional treatments like surgery and radiation are stagnating or declining [9] Clinical Evidence and Studies - HIFY Study: Largest study of its kind, showing positive outcomes in oncologic control and preservation of sexual function and urinary control [11][12] - FARP Study: Randomized control trial comparing HIFU and radical prostatectomy, expected to publish results soon [12] - Comparative Study: HIFU showed lower mortality rates compared to external beam radiation therapy over 10 years [13] Sales and Adoption - Current Install Base: Nearly 80 systems placed in top cancer hospitals and academic institutions [13] - Procedure Growth: 67% CAGR in procedures, with a 15% quarter-over-quarter growth from Q2 to Q3 2025 [14] - Adoption Curve: Currently in the early adoption phase, with increasing sales and reimbursement support [16][17] Expansion into New Indications - BPH (Benign Prostatic Hyperplasia): Initiating studies to treat BPH, leveraging the existing technology [15][21] - Endometriosis: Limited launch in Europe for treating stage four endometriosis, with promising initial results [15][22] Financial Performance - Margin Improvement: Gross margins increased from 39.4% to 43%, focusing on higher-margin HIFU business [27] - Strategic Focus: Transitioning away from non-core businesses to enhance profitability in the HIFU segment [27][28] Conclusion - Future Outlook: Strong potential for continued growth in the HIFU market, with ongoing clinical trials and expanding applications in urology and women's health [20][23]