Funding to Support Continued Growth of Focal One® Robotic HIFU AUSTIN, Texas, August 26, 2025 - EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced execution of a letter of intent for EUR 36 million credit facility with the European Investment Bank (EIB). Proceeds from this financing will support the continued expansion of Focal One® Robotic HIFU in Focal Therapy, the fastest-growing treatment category for early-stage prostate cancer whi ...

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]

Core Insights - EDAP TMS SA announced positive final results from the Focal Ablation Versus Radical Prostatectomy (FARP) Study, demonstrating non-inferiority of focal ablation compared to robotic prostatectomy in treating localized prostate cancer [1][6] Study Results - The FARP study achieved its primary endpoint, showing a treatment failure rate of 5.6% in the Focal Ablation (FA) group versus 7.9% in the Radical Prostatectomy (RP) group, indicating a statistical difference of 2.3% in favor of Focal Ablation [7] - A total of 213 patients were enrolled, with 107 randomized to FA and 106 to RP, and 25% of RP patients crossed over to FA [7] Clinical Implications - The study provides significant evidence supporting the use of ultrasound energy-based focal ablation for organ-localized prostate cancer, particularly High-Intensity Focused Ultrasound (HIFU) [2][4] - The positive results from the FARP trial, along with the HIFI Study, are expected to accelerate the adoption of Focal One Robotic HIFU in clinical practice [4] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing minimally invasive medical devices utilizing ultrasound technology for various conditions [5] - The Focal One® system is positioned as a leading prostate focal therapy, with potential applications beyond prostate cancer [5]

Financial Data and Key Metrics Changes - The company reported total revenue for the full year 2024 of EUR64.1 million, an increase of 6.1% compared to EUR60.4 million in 2023 [51] - Fourth quarter revenue for 2024 was EUR20.3 million, a 3.6% increase from EUR19.6 million in the same period in 2023 [53] - HIFU revenue for the full year 2024 was EUR23.8 million, reflecting a year-over-year growth of 15.7% [52] - Gross profit for Q4 2024 was EUR9.1 million, with a gross profit margin of 44.8%, up from 43.7% in the previous year [56] Business Line Data and Key Metrics Changes - HIFU business revenue for Q4 2024 was EUR8.8 million, compared to EUR7.5 million in Q4 2023, driven by 11 Focal One systems sold [54] - Disposable revenues in the HIFU segment grew by 28.5% year-over-year [54] - The ESWL division reported revenue of EUR2.4 million for Q4 2024, a slight increase from EUR2.3 million in Q4 2023, while distribution revenue decreased to EUR9.1 million from EUR9.9 million [55] Market Data and Key Metrics Changes - The company placed its first Focal One systems in Arkansas, Idaho, and Georgia, expanding its presence to over half of all U.S. states [13] - Focal One procedures in the U.S. grew approximately 31% year-over-year in Q4 2024, with total procedures growing about 51% over 2023 [15] Company Strategy and Development Direction - The company aims to focus on high-growth market opportunities, particularly in the HIFU segment, while reducing investments in lower-growth, low-margin businesses [45] - The recent CE Mark for Focal One for treating deep infiltrating endometriosis is seen as a significant regulatory milestone, allowing for controlled market entry [7][9] - The company plans to phase down its non-core ESWL and distribution business to concentrate on the HIFU growth strategy [63] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, projecting revenue growth of 16% to 25% year-over-year for 2025 [62] - The positive reception of the landmark HIFI study is expected to drive demand for Focal One in 2025 and beyond [64] - The company is committed to expanding its HIFU technology into new indications, including BPH and pancreatic tumors [24][44] Other Important Information - The company reported a net loss of EUR1.9 million for Q4 2024, an improvement from a net loss of EUR5 million in the same period in 2023 [58] - Total cash and cash equivalents at the end of Q4 were EUR29.8 million, up from EUR25.5 million at the end of Q3 2024 [59] Q&A Session Summary Question: Guidance on HIFU sales growth - Management expects continued demand for Focal One, with a strong pipeline and recurring revenue from procedures and service revenue contributing to projected growth [67][69] Question: Non-core ESWL and distribution business phase down - The company is transitioning away from non-core distribution products, focusing on high-growth HIFU business, but cannot project if it will phase down to zero [70][72] Question: Capital equipment purchase patterns from hospitals - The sales cycle remains elongated, but the company has adapted its strategy to close deals more effectively, emphasizing the clinical necessity of its offerings [79][81] Question: Impact of increased reimbursement on hospital interest - The recent increase in CMS reimbursement is expected to enhance interest from hospitals in adopting Focal One, as it allows more patients access to the technology [84][86] Question: Strategy on endometriosis commercialization - The company is in the early stages of expanding clinical development efforts following the CE Mark for treating deep infiltrating endometriosis [93][95] Question: Data from the pancreatic tumor study - The PULS trial is in its early stages, being conducted locally in France, with patient recruitment ongoing [97][99] Question: Revenue growth expectations related to reimbursement - The revenue growth guidance is primarily based on the core business of prostate cancer treatment, with additional potential from new indications not factored in [102][105]