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]

Summary of EDAP Focal One Conference Call Company Overview - **Company**: EDAP Focal One - **Industry**: Medical Devices, specifically in therapeutic ultrasound for cancer treatment - **Key Technology**: Focal One robotic High-Intensity Focused Ultrasound (HIFU) Core Points and Arguments 1. **Market Opportunity**: EDAP Focal One identifies a significant growth opportunity in the urology and prostate cancer markets, with prostate cancer being the most commonly diagnosed cancer among men, with over 313,000 new cases expected in 2025 in the US alone [3][6][41] 2. **Clinical Need**: The company addresses an unmet clinical need in cancer treatment, particularly for patients with intermediate-risk prostate cancer who have limited options after radiation therapy failure [4][9] 3. **Patient Demographics**: There are approximately 3.3 million men living with prostate cancer in the US, with a potential market of over 470,000 patients globally who could benefit from Focal One's technology [6][9] 4. **Emerging Market Shift**: The market is shifting from traditional treatments (surgery, radiation) to emerging focal therapy driven by HIFU, which is expected to grow significantly [10][12] 5. **Clinical Evidence**: Strong clinical evidence supports HIFU's effectiveness, with studies showing superior functional outcomes compared to traditional surgery, particularly in preserving urinary control and sexual function [15][18][50] 6. **Reimbursement Landscape**: The company benefits from favorable reimbursement conditions, with a 90% increase in CMS reimbursement rates for HIFU treatments in 2023 [24][27] 7. **Technological Advancements**: Focal One's technology leverages advanced imaging, robotics, and AI, allowing for precise treatment delivery and integration with various imaging modalities [27][28] 8. **Expansion into New Indications**: EDAP is exploring new indications for its technology, including benign prostatic hyperplasia (BPH) and endometriosis, with significant market potential [32][34] 9. **Global Presence**: The company has a growing global footprint with over 350 clinical sites and is expanding its market presence in key regions such as the US, Germany, and Japan [5][41] Additional Important Insights 1. **Strategic Shift**: The company is transitioning from a legacy business focused on kidney stone treatments to a concentrated focus on HIFU technology, aiming to become a market leader in this domain [44][45] 2. **Impact of Tariffs**: EDAP anticipates a 10% impact from tariffs on goods entering the US but believes its manufacturing base in France will help mitigate costs [56][57] 3. **Capital Equipment Market**: The Focal One I platform was well-received at major conferences, indicating strong interest from hospitals in investing in advanced cancer treatment technologies [59][61] 4. **Guideline Changes**: There is potential for changes in treatment guidelines as more data becomes available, which could accelerate the adoption of HIFU therapies [55] This summary encapsulates the key points discussed during the conference call, highlighting EDAP Focal One's strategic positioning, market opportunities, and technological advancements in the medical device industry.