AUSTIN, Texas, April 22, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that Focal One will have its largest presence ever at the upcoming 120th American Urological Association (AUA) Annual Meeting. "This year's AUA meeting promises to be the most significant scientific meeting to date highlighting the growing acceptance and utilization of the Focal One Robotic HIFU platform by the global urology community," said Ryan Rhodes, Chief Executive Officer o ...

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]

Core Insights - EDAP TMS SA has appointed Glen French to its Board of Directors, enhancing its leadership with his extensive experience in medical devices and technology [1][2][4] - Glen French emphasizes the transformative potential of EDAP's Focal One technology in treating prostate cancer and its applicability to other medical conditions [2][3] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [5] - The Focal One platform is recognized as a leading prostate focal therapy, with potential expansion into other therapeutic areas [5] Leadership Background - Glen French has over 25 years of experience in the medical device industry, having co-founded and sold three companies and taken another public [2][3] - He served as CEO of Pulmonx Corporation, achieving over 20% compound annual revenue growth and successfully executing an IPO that raised $218.5 million [2][3] Strategic Direction - The addition of Glen French to the Board is expected to guide EDAP's strategic decision-making as it aims to establish Focal One as the premier robotic HIFU technology platform [2] - French believes that the technology can address significant unmet medical needs across various patient populations, indicating a broad market potential [2][3]

Core Insights - Cortechs.ai and EDAP TMS SA have successfully completed the world's first OnQ Prostate-assisted Focal One® Robotic HIFU procedure at UCSF, marking a significant milestone in prostate cancer treatment [1][6] - OnQ Prostate is the only FDA-cleared solution for RSI-MRI, providing detailed tissue microstructure information to help urologists identify suitable candidates for focal therapy [2][6] - The integration of OnQ Prostate with Focal One enhances lesion localization and targeting, improving the precision of prostate cancer treatments [3][6] Company Overview - Cortechs.ai specializes in AI applications in radiology, focusing on advanced medical imaging technologies to enhance disease screening and early detection [5] - The company develops innovative medical device software for tracking neurodegeneration and prostate cancer, offering cost-effective solutions for assessing prostate health [5] - EDAP TMS SA is recognized for its robotic energy-based therapies, developing minimally invasive medical devices using ultrasound technology, with Focal One being a leading platform for prostate focal therapy [7] Industry Context - Focal therapy is an emerging approach in prostate cancer care aimed at ablating significant disease while preserving healthy tissue, thus reducing side effects associated with whole-gland treatments [3][4] - The ability to precisely localize lesions is critical for urologists to achieve successful oncologic control while minimizing damage to surrounding healthy tissue [3][4] - As focal therapy becomes more integrated into prostate cancer care, companies like Cortechs.ai are at the forefront of developing solutions that support effective, evidence-based, and minimally invasive treatment strategies [4]