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]

About EDAP TMS SA AUSTIN, Texas, April 24, 2025 - EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy- based therapies, announced the launch of the new Focal One i system at the upcoming 120th American Urological Association (AUA) Annual Meeting being held in Las Vegas, Nevada from April 26-29, 2025. The Focal One i system incorporates important new features and enhanced capabilities including: "The new features and design of the Focal One i system are based directly on the feedback from our cust ...

Core Insights - EDAP TMS SA will have its largest presence at the 120th American Urological Association (AUA) Annual Meeting, showcasing the Focal One Robotic HIFU platform [1][2] - The meeting will highlight the growing acceptance of robotic HIFU technology in the urology community, with numerous hands-on simulations and live demonstrations planned [2][5] Company Activities - The Focal One Robotic HIFU Masterclass will take place at the Keck School of Medicine of USC on April 24-25, featuring lectures and live procedures [5][6] - Expert-led demonstrations and semi-live procedures will be part of the AUA activities, emphasizing the advanced capabilities of the Focal One technology [5][9] Scientific Presentations - The AUA meeting will include the final results of the FARP study, the first randomized controlled trial comparing ultrasound-based focal ablation to robotic prostatectomy for early-stage prostate cancer [3][6] - A notable increase in scientific presentations on focal therapy and ablation for prostate cancer management is expected, indicating a growing interest in this area [5][9] Notable Presentations - Dr. Ruben Olivares will present the first remote transatlantic Focal One Robotic HIFU procedure, showcasing the technology's remote capabilities [3][6] - The FARP study results will be presented by Eduard Baco, providing level-1 evidence to support the use of focal ablation with Focal One [6]

Table of Contents As filed with the Securities and Exchange Commission on March 27, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(B) OR (G) OF THE SECURITIES EXCHANGE ACT OF 1934, OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMP ...

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]

Financial Data and Key Metrics Changes - The company reported fourth quarter HIFU revenues of $9.3 million, a 15% increase year over year, reflecting strong adoption of Focal One technology [7] - Total worldwide revenue for the fourth quarter was $21.5 million, representing a 1.1% growth year over year [7] - Full year 2024 global HIFU revenue increased by 15.3% over 2023, while total worldwide revenues for 2024 were $69.2 million, a growth of 5.7% over 2023 [8][9] Business Line Data and Key Metrics Changes - The HIFU segment reported revenues of €23.8 million for the full year 2024, a growth of 15.7% year over year, driven by increased placements and procedure volumes [38] - In the fourth quarter, the Hycean business generated €8.8 million, up from €7.5 million in the same period last year, with disposable revenues growing by 28.5% [39] - The ESWL division saw nominal growth, with revenues of €2.4 million compared to €2.3 million in the previous year [40] Market Data and Key Metrics Changes - The number of Focal One procedures grew approximately 51% in 2024 compared to 2023, with U.S. procedures increasing by about 31% year over year [13] - The company placed its first Focal One systems in Arkansas, Idaho, and Georgia, expanding its presence to over half of all U.S. states [11] 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 [34] - The recent CE mark for Focal One for treating deep infiltrating endometriosis is seen as a significant regulatory milestone, allowing for controlled market entry and further clinical development [6][25] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, projecting revenue growth of 16-25% year over year for 2025 [46] - The company anticipates that the landmark Hi Fi study will drive demand for Focal One, positioning it as a mainstream treatment option for prostate cancer [47] Other Important Information - The company has entered into clinical studies for the treatment of BPH and pancreatic tumors, indicating a commitment to expanding its HIFU technology into new indications [20][21] - The Centers for Medicare and Medicaid Services finalized a 5.4% increase in the Medicare hospital outpatient payment rate for HIFU procedures, effective January 1, 2025 [17] Q&A Session Summary Question: Can you provide more detail on HIFU sales growth guidance? - Management expects continued demand for Focal One, with a strong pipeline and recurring revenue from procedures and service revenue contributing to projected growth [49][50] Question: What is the intent for the non-core ESWL and distribution business? - 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 [51][52] Question: How is the capital equipment purchase pattern from hospitals in 2025? - The sales cycle remains consistent, but the company has adapted its strategy to close deals more effectively, expecting notable growth throughout 2025 [58][60] Question: Has there been an uptick in interest from hospitals since the reimbursement increase? - The reimbursement increase has positively impacted hospital interest in adopting Focal One, as it enhances the financial analysis for adding this treatment to their services [62][64] Question: What is the strategy for endometriosis commercialization? - The company is working with experts to refine clinical development efforts following the CE mark, with plans for a Phase one launch in CE mark countries [71][72] Question: When can we expect data from the pancreatic tumors study? - The PULSE trial is early in patient recruitment, being conducted locally in France, with no specific data timeline provided yet [73][74]

Financial Data and Key Metrics Changes - The company reported fourth quarter HIFU revenues of $9.3 million, a 15% increase year over year, reflecting strong adoption of Focal One technology [7] - Total worldwide revenue for the fourth quarter was $21.5 million, representing a 1.1% growth year over year [7] - Full year 2024 global HIFU revenue increased by 15.3% over 2023, with total worldwide revenues of $69.2 million, a growth of 5.7% over 2023 [8][9] Business Line Data and Key Metrics Changes - The HIFU segment reported revenues of €23.8 million for the full year 2024, a growth of 15.7% year over year, driven by increased placements and procedure volumes [38] - In the fourth quarter, the Hycean business generated €8.8 million, up from €7.5 million in the same period last year, driven by 11 Focal One systems sold [39][40] - The ESWL division saw nominal growth with revenues of €2.4 million in the fourth quarter, while the distribution business revenue decreased to €9.1 million from €9.9 million [41][42] Market Data and Key Metrics Changes - Focal One procedures grew approximately 51% in 2024 compared to 2023, with U.S. procedures increasing by about 31% year over year in the fourth quarter [13] - The company placed its first Focal One systems in Arkansas, Idaho, and Georgia, expanding its presence to over half of all U.S. states [11] - Notable sales were made in international markets, including Germany, Portugal, and Turkey [12] Company Strategy and Development Direction - The company aims to focus on high growth market opportunities, particularly in prostate cancer, endometriosis, and BPH, leveraging the Focal One platform [32] - Plans to reduce investments in lower growth, low margin businesses, including the discontinuation of the ZONALIB iMOVE lithotripsy product line [33][34] - The company is committed to transforming into a more agile organization, with new board members bringing expertise in medical device commercialization [34][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, projecting revenue growth of 16-25% year over year for 2025 [47] - The recent CE mark for Focal One for treating deep infiltrating endometriosis is seen as a significant milestone, allowing for controlled market entry [6] - The company anticipates that the Hi Fi study publication will drive further adoption of Focal One as a treatment option for prostate cancer [15][48] Other Important Information - The Centers for Medicare and Medicaid Services finalized a 5.4% increase in the Medicare hospital outpatient payment rate for HIFU procedures, effective January 1, 2025 [17] - The company is actively working on clinical studies for BPH and pancreatic tumors, demonstrating its commitment to expanding the applications of HIFU technology [19][20] Q&A Session Summary Question: Can you provide more detail on the HIFU sales growth guidance? - Management expects continued demand for Focal One, with a strong pipeline and recurring revenue from procedures and service revenue contributing to projected growth [50][52] Question: Is the intent to phase down the non-core ESWL and distribution business to zero? - Management indicated that while they are winding down some non-core businesses, they cannot project if it will go to zero, but focus will shift to high growth HIFU business [53][54] Question: How is the capital equipment purchase pattern from hospitals in 2025? - Management noted that the sales cycle remains consistent, but they have adjusted strategies to close deals more effectively, with a growing active pipeline [60][62] Question: Has there been an uptick in interest from hospitals since the reimbursement increase? - Management confirmed that the reimbursement increase has positively impacted hospital interest in adopting Focal One technology [64][66] Question: What is the strategy for commercializing the endometriosis treatment? - The company is in the early stages of expanding clinical development efforts following the CE mark approval for treating deep infiltrating endometriosis [73][74] Question: When can we expect data from the pancreatic tumors study? - The PULSE trial is in the early recruitment phase, with the study being conducted in France [75][76]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 March 27, 2025 Commission File Number: 0-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [x] Form 40-F [ ] 1 SIGNATURES Pursuant to th ...

Core Insights - EDAP TMS SA reported strong financial results for Q4 and full-year 2024, highlighting significant growth in its Focal One Robotic HIFU business, particularly in the prostate cancer treatment market [1][5][20]. Business Performance - Full-year 2024 HIFU revenue reached USD 25.7 million, a 15.3% increase from 2023 [5]. - Q4 2024 HIFU revenue was USD 9.3 million, reflecting a 15.0% increase compared to Q4 2023 [5]. - The number of Focal One HIFU procedures in the U.S. grew by 51% year-over-year in 2024 [5]. Clinical Developments - The Focal One system received CE Mark certification for treating deep infiltrating endometriosis [5][6]. - The landmark HIFI study published in European Urology demonstrated positive outcomes for Focal One Robotic HIFU compared to surgery for prostate cancer management [2][7]. - The first patients were treated in a Phase I/II study evaluating Focal One Robotic HIFU for Benign Prostatic Hyperplasia (BPH) [5][10]. Financial Overview - Total worldwide revenue for Q4 2024 was EUR 20.3 million (USD 21.5 million), a 3.6% increase from Q4 2023 [13]. - Gross profit for Q4 2024 was EUR 9.1 million (USD 9.6 million), with a gross profit margin of 44.8% [17]. - The net loss for Q4 2024 was EUR 1.9 million (USD 2.1 million), an improvement from a net loss of EUR 5.0 million (USD 5.5 million) in Q4 2023 [19]. Strategic Focus - The company aims to expand its core Focal One business while reducing investments in non-core products, targeting high-growth opportunities in therapeutic HIFU [3]. - EDAP TMS is positioned to create significant value for patients and shareholders as it advances clinical development programs in various conditions beyond prostate cancer [3]. Upcoming Events - EDAP TMS will have a significant presence at the American Urology Association (AUA) Meeting from April 26-29, 2025, in Las Vegas, Nevada [11].

Group 1 - The company, EDAP TMS SA, will release its financial results for Q4 and the full year ended December 31, 2024, on March 27, 2025, before market opening [1] - A conference call and webcast will be hosted by key executives including the CEO, CFO, and Chief Accounting Officer [2] - The conference call is scheduled for March 27 at 8:30 am EDT, with specific dial-in information provided for domestic and international participants [3] Group 2 - EDAP TMS SA is recognized as a leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [4] - The company has introduced the Focal One® system, which is a leading prostate focal therapy controlled by urologists, with potential applications beyond prostate cancer [4]