Financial Data and Key Metrics Changes - The company reported global revenues of $16.1 million for Q3 2025, marking the second consecutive quarter of record overall quarterly revenue [2] - HIFU revenue reached $7.7 million, a 57% increase compared to Q3 2024 [2] - Total revenue for Q3 2025 was EUR 13.9 million, a 6% increase from EUR 13.1 million in Q3 2024 [11] - Gross profit for Q3 2025 was EUR 6 million, with a gross margin of 43%, up from 39.4% in the same period last year [12][14] - Net loss for Q3 2025 was EUR 5 million, an improvement from a net loss of EUR 6.4 million in Q3 2024 [15] Business Line Data and Key Metrics Changes - HIFU business grew 49% year-over-year, driven by six capital sales in Q3 2025 compared to three in the prior year [11][12] - Focal One placements increased by 167% year-over-year, with eight placements in Q3 2025 [3] - Focal One procedures in the US grew more than 15% year-over-year, indicating a return to double-digit growth [3][4] Market Data and Key Metrics Changes - The company is seeing meaningful progress in reimbursement coverage, particularly among Medicare Advantage providers [4] - The latest hospital and physician payment rules from CMS reinforce the use case of HIFU, providing a clear reimbursement pathway [5] Company Strategy and Development Direction - The company aims to make Focal One the standard of care for localized prostate cancer, focusing on expanding clinical adoption and market access [2][18] - Plans to expand into new clinical indications, including benign prostatic hyperplasia (BPH) and endometriosis, are underway [6][8] - The company maintains financial guidance for 2025, expecting core HIFU business revenue growth of 26%-34% [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, supported by strong clinical evidence and expanding market access [18] - The company is focused on accelerating adoption and utilization across its Focal One install base while maintaining a disciplined investment approach [18] Other Important Information - The company received the first tranche of EUR 11 million from the European Investment Bank, aimed at supporting strategic investments in HIFU [16][22] - The company is monitoring the impact of US tariff policies, estimating a full-year impact of EUR 900,000 [17] Q&A Session Summary Question: Details on the EIB deal and its use - Management indicated that proceeds from the EIB deal will be used for product development, clinical development, and commercial growth, primarily focused on the HIFU core business [22] Question: Coverage of US Focal One procedures and expected growth - Management noted that the procedure mix includes Medicare patients, Medicare Advantage plan patients, and commercial patients, with positive trends in Medicare Advantage coverage expected to drive volume growth [23] Question: Expectations for Q4 given typical seasonal softness - Management reiterated guidance for 2025, confident that Q4 numbers will align with year-end targets of $58 million to $62 million [24]

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.