Focal One® Prostate Cancer Awareness Month Campaign Shines Spotlight on Robotic HIFU Treatment Option Focal One Robotic HIFU Patient Story Featured on Health Uncensored with Dr. Drew on Lifetime Network AUSTIN, Texas – September 30, 2025 – EDAP TMS SA (Nasdaq: EDAP), a global leader in robotic energy-based therapies, announced that its non-invasive, nonsurgical treatment option, Focal One Robotic HIFU, was featured on national television on Friday, September 26, reaching millions of viewers nationwide. The ...

Focal One® HIFU Receives Prestigious Innovation Award AUSTIN, Texas, September 16, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that the company has been honored with the 2025 Industry Award for Innovations in Endourological Instrumentation by the Endourological Society in recognition of its groundbreaking work with the Focal One High-Intensity Focused Ultrasound (HIFU) platform. Focal One is the first Focal Therapy technology to receive this dist ...

Summary of EDAP TMS FY Conference Call Company Overview - **Company**: EDAP TMS - **Industry**: Medical Devices, specifically focused on HIFU (High-Intensity Focused Ultrasound) technology for treating prostate cancer - **Key Product**: FocalOne platform, with the latest version being FocalOne-i launched in April 2025 [1][3] Strategic Shift - Management has shifted focus entirely to the HIFU business, de-emphasizing lithotripsy and distribution businesses [1][3] - Plans to expand HIFU applications to include endometriosis treatment and benign prostatic hyperplasia (BPH) [1][12] Market Opportunity - Prostate cancer is the most diagnosed cancer in men globally, with nearly 1.5 million cases annually, projected to double by 2040 [4] - The market for prostate cancer treatment is expected to grow significantly, with an increase in mortality rates [4] - FocalOne addresses a gap in treatment options between active surveillance and radical treatments, providing a less invasive alternative [5][6] Product Features and Clinical Data - FocalOne-i features a five-axis robotic positioning system and is compatible with various imaging technologies, including AI [3][4] - HIFU is showing exponential growth, while traditional treatments like cryoablation and surgery are stagnating [8] - The HiFi study, involving 3,328 patients, demonstrated superior functional outcomes for HIFU compared to traditional surgery [10][11] - A randomized controlled trial (FARP) showed that 25% of patients opted for FocalOne HIFU over surgery, indicating strong patient preference [11] Financial Performance - Reported a 77% increase in HIFU revenues year-over-year for Q2 2025 [15] - Increased guidance for HIFU revenue growth, indicating confidence in the strategic shift [17] Reimbursement and Market Access - Anticipated 5.6% increase in facility payment levels from CMS starting January 1, 2026, which is expected to enhance hospital investment in HIFU [18][19] - Hospitals are recognizing the ROI of investing in FocalOne due to its efficacy and quality of life outcomes for patients [18] Future Developments - Clinical studies for BPH are expected to begin in early 2026, with a potential labeling change following [21] - CE Mark received for endometriosis treatment, with limited launch currently underway [22] Financial Strategy - Agreement with the European Investment Bank for a €36 million credit facility to support investments in HIFU [23][24] - Transitioning to a domestic filer on NASDAQ effective January 1, 2026, to enhance market presence [26] Conclusion - EDAP TMS is positioned for significant growth in the HIFU market, with a clear strategy focused on expanding treatment applications and improving patient outcomes through innovative technology and clinical validation [1][12][15]

Focal One Robotic HIFU procedure now covered under France’s national universal health systemReimbursement milestone allows increased patient access to Focal One Robotic HIFU AUSTIN, Texas, September 8, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that the French Ministry of Health has awarded reimbursement for High Intensity Focused Ultrasound (HIFU) procedure for the treatment of prostate cancer in France. Reimbursement in France will specifically ...

Financial Data and Key Metrics Changes - Global HIFU revenues reached $9.7 million, an increase of 89% year over year, driven by the placement of 12 Focal One systems, representing a 140% growth compared to Q2 2024 [4][5] - Total revenue for Q2 2025 was €16 million, a 1.6% increase from €15.8 million in Q2 2024, with HIFU revenue growing 76.8% year over year [21][22] - Gross profit for Q2 2025 was €6.8 million, with a gross margin of 42.5%, up from 37.5% in the same period last year [24] Business Line Data and Key Metrics Changes - HIFU business revenue for Q2 2025 was €8.5 million, compared to €4.8 million in Q2 2024, driven by nine capital sales versus three in the prior year [22][23] - Non-core distribution and ESWL businesses declined by 31.2% in Q2 2025 compared to Q2 2024 [21] Market Data and Key Metrics Changes - U.S. procedures grew approximately 4.8% year over year, despite challenges with Medicare Advantage plans impacting growth in certain markets [10][11] - The proposed hospital payment for the Focal One HIFU procedure in 2026 is set at $9,765, a 5.6% increase from 2025 [12] Company Strategy and Development Direction - The company is focusing on expanding its Focal One Endometriosis application, having received CE marking for HIFU in treating rectal endometriosis [14][15] - A strategic financing facility with the European Investment Bank for €36 million is expected to enhance the balance sheet and support the expansion of Focal One robotic HIFU [17][19] - Transitioning to a U.S. domestic filer starting January 1, 2026, to comply with SEC reporting rules and attract new institutional investors [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerating growth of Focal One, driven by strong clinical data and increasing awareness among patients and physicians [30] - The company updated its 2025 financial guidance, expecting core HIFU business revenue to grow between 26% to 34% year over year [29] Other Important Information - Inventory decreased to $15.5 million in Q2 2025 from €18 million at the end of Q1 2025, attributed to efficient inventory management [26] - The company is actively working with market access partners to improve pre-authorizations for Focal One procedures [11] Q&A Session Summary Question: Can you provide details on the payer issues and reimbursement situation? - Management noted improvements in reimbursement efforts, with strong collaboration with market access partners to accelerate pre-authorizations for Focal One procedures [33][34] Question: What factors does CMS consider for higher reimbursement rates? - CMS evaluates average payments, cost of service, volume of procedures, and clinical value when determining reimbursement rates [43][44] Question: Can you provide an update on the endometriosis trial? - The phase three study showed over 80% of sham arm patients opted for Focal One treatment post-unblinding, with a limited European launch currently underway [53][54] Question: How is the €36 million from the EIB intended to be used? - The funds are earmarked for accelerated commercial growth in the HIFU business and investment in clinical indications and new technologies [56][59]

Financial Data and Key Metrics Changes - Global HIFU revenues reached $9.7 million, an increase of 89% year over year, driven by the placement of 12 Focal One systems, representing a 140% growth compared to Q2 2024 [3][4] - Total revenue for Q2 2025 was €16 million, a 1.6% increase from €15.8 million in Q2 2024, with HIFU revenue growing 76.8% year over year to €8.5 million [21][22] - Gross profit for Q2 2025 was €6.8 million, with a gross margin of 42.5%, up from 37.5% in the same period last year [23] Business Line Data and Key Metrics Changes - The HIFU business saw a 76.8% increase in revenue, driven by nine capital sales compared to three in the prior year, and a 16.1% increase in treatment-driven revenue [21][22] - Non-core distribution and ESWL businesses declined by 31.2% in Q2 2025 compared to Q2 2024 [21] Market Data and Key Metrics Changes - U.S. procedures grew approximately 4.8% year over year, despite challenges with Medicare Advantage plans impacting growth in certain markets [9][10] - The proposed hospital payment for the Focal One HIFU procedure in 2026 is set at $9,765, a 5.6% increase from 2025 [11] Company Strategy and Development Direction - The company is expanding its Focal One Endometriosis application, having received CE marking for HIFU in treating rectal endometriosis, which is expected to drive incremental sales growth [13][15] - A strategic financing facility with the European Investment Bank for €36 million is expected to enhance the balance sheet and support the expansion of Focal One robotic HIFU [17][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerating growth of Focal One, driven by strong clinical data and increasing awareness among patients and physicians [5][29] - The company updated its 2025 financial guidance, expecting core HIFU business revenue to grow between 26% to 34% year over year [28] Other Important Information - The company will transition to a U.S. domestic filer starting January 1, 2026, which is expected to enhance transparency and attract new institutional investors [18][20] - Inventory decreased to $15.5 million in Q2 2025, reflecting efficient inventory management and higher turnover due to increased demand for Focal One [25][26] Q&A Session Summary Question: Can you provide details on the payer issues and improvements? - Management noted solid growth in the HIFU business despite challenges with Medicare Advantage plans, with early signs of improvement in procedure approvals [32][34] Question: What factors does CMS consider for reimbursement rate increases? - CMS considers service value, clinical value ratios, procedure volume, and costs associated with services when determining reimbursement rates [43][45] Question: How much effort is placed on multi-unit purchases? - Significant effort is placed on every sale, with recent sales indicating strong validation of the technology's value [48][50] Question: Update on the endometriosis trial? - The phase three study is ongoing, with over 80% of sham arm patients opting for Focal One treatment post-unblinding, and a limited European launch is underway [55][56] Question: Status of the €36 million financing? - No funds have been received yet, as the company is finalizing terms with the European Investment Bank [58][59]

Core Insights - EDAP TMS SA reported its strongest second quarter performance in company history, with a net total of 12 Focal One Robotic HIFU Systems placed, driven by increased customer demand from both U.S. and international markets [2][6] - The company executed a letter of intent with the European Investment Bank for a credit facility of 36 million Euros to support the expansion of its Focal One platform and focused ultrasound technologies [2][8] - The company anticipates continued growth in demand for Focal One treatments as more prostate cancer patients recognize its advantages, supported by recent clinical studies [2][6] Financial Performance - Total revenue in the HIFU business for Q2 2025 was EUR 8.5 million (USD 9.7 million), a 76.8% increase from EUR 4.8 million (USD 5.2 million) in Q2 2024 [6][9] - The company recorded a 23.9% year-over-year growth in worldwide disposable revenue, with Focal One procedures growing 4.8% in the U.S. [6][9] - Total worldwide revenue for Q2 2025 was EUR 16.0 million (USD 18.4 million), a slight increase of 1.6% compared to EUR 15.8 million (USD 17.0 million) in Q2 2024 [9] Business Segments - The non-core business (ESWL and Distribution) revenue for Q2 2025 was EUR 7.6 million (USD 8.7 million), down from EUR 11.0 million (USD 11.8 million) in Q2 2024, reflecting a strategic focus on the high-growth HIFU opportunity [7][9] - For the first half of 2025, total revenue in the HIFU business was EUR 14.7 million (USD 16.1 million), a 38.5% increase from EUR 10.6 million (USD 11.4 million) in the same period of 2024 [13] - The non-core business revenue for the first half of 2025 was EUR 15.0 million (USD 16.5 million), a 25.7% decrease compared to EUR 20.1 million (USD 21.7 million) in the first half of 2024 [14] Profitability Metrics - Gross profit for Q2 2025 was EUR 6.8 million (USD 7.8 million), with a gross profit margin of 42.5%, up from 37.5% in Q2 2024 [10] - Operating loss for Q2 2025 was EUR 5.8 million (USD 6.6 million), an improvement from an operating loss of EUR 6.1 million (USD 6.6 million) in Q2 2024 [11] - Net loss for Q2 2025 was EUR 5.6 million (USD 6.4 million), or EUR (0.15) per share, compared to a net loss of EUR 6.1 million (USD 6.6 million), or EUR (0.16) per share in Q2 2024 [12] Future Outlook - The company updated its 2025 financial guidance, expecting core HIFU business revenue growth to be between 26% and 34% year-over-year, up from the previous range of 16% to 25% [5][7] - The combined non-core ESWL and Distribution business revenue is expected to decline between 25% and 30% year-over-year [5][7] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference in New York City from September 8-10, 2025 [4]

Core Insights - EDAP TMS SA has announced a letter of intent for a EUR 36 million credit facility with the European Investment Bank (EIB) to support the growth of Focal One Robotic HIFU in the treatment of early-stage prostate cancer [1][2] - The financing will enhance the company's balance sheet and provide low-interest funding accessible in tranches as needed [2] - The credit facility is expected to close by the end of Calendar Year 2025, pending final legal documentation [1] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [3] - The company introduced Focal One as a leading prostate focal therapy, with potential applications beyond prostate cancer [3]

Company Overview - EDAP TMS SA is a global leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [2] - The company has developed the Focal One system, which is recognized as a leading prostate focal therapy controlled by urologists, with potential applications beyond prostate cancer [2] Upcoming Events - Ryan Rhodes, the CEO of EDAP TMS, will participate in a fireside chat and host one-on-one investor meetings at the H.C. Wainwright 27th Annual Global Investment Conference [1] - The conference is scheduled for September 8-10, 2025, in New York City, with Rhodes' presentation set for September 9 from 8:30-9:00 AM ET [1]

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]