# EDGAR Filing Document

**Accession Number:** 0001041934
**File Stem:** 0001171843-25-005786
**Filing Date:** 2025-9
**Character Count:** 18338
**Document Hash:** c5454894977419ea0a48aae1c422fa6e
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001171843-25-005786.hdr.sgml**: 20250909

**ACCESSION NUMBER**: 0001171843-25-005786

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 42

**CONFORMED PERIOD OF REPORT**: 20250909

**FILED AS OF DATE**: 20250909

**DATE AS OF CHANGE**: 20250909

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** EDAP TMS SA
- **CENTRAL INDEX KEY:** 0001041934
- **STANDARD INDUSTRIAL CLASSIFICATION:** ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 000000000
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-29374
- **FILM NUMBER:** 251301627

**BUSINESS ADDRESS:**
- **STREET 1:** PARC D'ACTIVITES LA POUDRETTE LAMARTINE
- **STREET 2:** 4 RUE DU DAUPHINE
- **CITY:** 69120 VAULX EN VELIN
- **STATE:** I0
- **ZIP:** 69120
- **BUSINESS PHONE:** 33672643508

**MAIL ADDRESS:**
- **STREET 1:** PARC D'ACTIVITES LA POUDRETTE LAMARTINE
- **STREET 2:** 4 RUE DU DAUPHINE
- **CITY:** 69120 VAULX EN VELIN
- **STATE:** I0
- **ZIP:** 69120

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION<br> Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16<br> UNDER THE SECURITIES EXCHANGE ACT OF 1934

September 9, 2025

Commission File Number: 0-29374

EDAP TMS S.A.<br> Parc Activite La Poudrette Lamartine<br> 4/6 Rue du Dauphine<br> 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 [ ]

**SIGNATURES**

Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: September 9, 2025

EDAP TMS S.A.

<u>/s/ KEN MOBECK</u><br> KEN MOBECK<br> CHIEF FINANCIAL OFFICER

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The Global Leader in Therapeutic Ultrasound 1

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Statements & Disclaimer F O R W A R D - L O O K I N G 2

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Company Overview 3

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Strategic Company Focus 4 Shift from Legacy Technologies and Distributor Model and Transform into the Global Market Leader in Robotic HIFU Focal Therapy

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Investment Thesis: Strong Growth Opportunity 5 x Large and Growing Market Opportunity: Urology and Prostate Cancer x Solves an Important Unmet Clinical Need in Cancer x Proven Compelling Clinical Evidence x Increasing Patient and Physician Demand x Strong Hospital and Physician Reimbursement x Leverages Current Advancements in Imaging, AI, and Robotics x Growing Worldwide Install Base x Ideally Positioned for Expanded Indications (BPH, Endometriosis, Other)

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350+ Focal One Robotic HIFU Clinical Sites

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Large and Growing Market Opportunity In Urology and Prostate Cancer 7

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3.3 Million American Men Living with Prostate Cancer in the U.S. (1) 313,780 New Cases Diagnosed in the U.S. (1) 35,770 U.S. Deaths from Prostate Cancer (1) U . S . P R O S T A T E C A N C E R M A R K E T Prostate Cancer is the Most Common Cancer Amongst Men In the U.S. Prostate (1) 2025 estimates from the American Cancer Society (www.cancer.org) 8 Lung & Bronchus Colorectum Skin Urinary Bladder New Cases Deaths

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Prostate Cancer Market Opportunity Number of New Prostate Cancer Cases Region 473,011 Europe 386,424 Asia 255,782 North America 225,985 Latin America 103,050 Africa 23,602 Oceania 1,467,854 Total L A R G E G L O B A L M A R K E T 1.5 Million New Prostate Cancer Cases Per Year 9 Data Source: Cases refers to Diagnosed Cases per year From World Health Organization – Globocan 2022

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Focal One Answers an Unmet Need for a Large Underserved Patient Population P R O S TA TE C A N C E R Focal One HIFU Focal One HIFU 10 First - Line Treatment Progression from Active Surveillance Salvage Treatment

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470,000 Focal One HIFU Prostate Cancer Annual Procedure Opportunity

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12 D R I V I N G A P A R A D I G M S HI F T I N P R O S T A T E C A N C E R Focal Therapy \| The New Emerging Market (1) As of 2013. Chen et al. National trends in the management of localized prostate cancer: A population - based analysis 2004 - 2013. Prostate. (2) Internal market estimate Active Surveillance Radical Prostatectomy (Surgery) Radiation Therapy Active Surveillance Radical Prostatectomy (Surgery) Radiation Therapy Focal Therapy (HIFU) Traditional Market (1) Emerging Market (2) Future Market (2) Focal Therapy (HIFU) Active Surveillance Radical Prostatectomy (Surgery) Radiation Therapy

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D R I V I N G A P A R A D I G M S HI F T I N P R O S T A T E C A N C E R HIFU \| The Fastest Growing Treatment Option Based on Medicare Claims reported by CMS on HOPPS Proposed Rule for FY24, FY25 and FY26 13 HIFU Cryo Brachytherapy Radical Prostatectomy

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Strong Supporting Clinical Evidence 14

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15 Proven Clinical Evidence Supporting Focal One Robotic HIFU 3. Preserve Sexual Function 2. Maintain Urinary Control 1. Cancer Control 1000+ Peer - Reviewed Publications Supporting HIFU in the Treatment of Prostate Cancer (1) Optimizing Trifecta Outcomes for Prostate Cancer Functional Outcomes (1) PubMed Database search of "HIFU Prostate Cancer" 15

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16 HIFI - Prospective Multicentric Comparative Study Focal One HIFU vs Radical Prostatectomy Prospective, Comparative, Multicentric , non - inferiority clinical trial comparing HIFU to Radical Prostatectomy (RP) 3,328 patients treated (1,967 HIFU - 1,361 RP) across 46 centers 90% of HIFU patients treated with Focal One Comparable Cancer Control (Primary Endpoint): 90% STFS for HIFU vs 86% for RP; p = 0.008 Superior functional outcomes for HIFU (Secondary Endpoint): • Urinary Continence significantly better after HIFU • Significantly lower stress incontinence after HIFU • Erectile Function less impaired Published in European Urology – December 2024 Ploussard et al. "Whole - gland or Subtotal High - intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial." European urology vol. 87,5 (2025): 526 - 533. doi:10.1016/j.eururo.2 024.11.006

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17 17 HIFI Study Demonstrates Optimal Trifecta Outcomes 1. Cancer Control 3. Preserve Sexual Function 2. Maintain Urinary Control Δ 11% Urinary Continence Pad - Free Continence at 12 months HIFU Provides Superior Functional Outcomes Δ 6 HIFU SURGERY Erectile Function Decrease from baseline at 12 months HIFU SURGERY Comparable Oncologic Outcomes Patients Free from Salvage Treatment at 30 months HIFU RADICAL PROSTATECTOMY 90% 86% Ploussard et al. "Whole - gland or Subtotal High - intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial." European urology vol. 87,5 (2025): 526 - 533. doi:10.1016/j.eururo.2 024.11.006

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18 FARP - Randomized Controlled Trial Focal Ablation vs Radical Prostatectomy Randomized Controlled, Non - inferiority Clinical Trial comparing Focal Ablation (FA) to Robot - Assisted Radical Prostatectomy (RP) Equivalent Oncologic Control at 3 years (93.5% TFF vs 91.5%) Superior Functional Outcomes after Focal Ablation 213 Patients included in the Clinical Trial 25% of Patients refused radical surgery after randomized to RP and opted for FA 80+% of Focal Ablation patients treated with Focal One® Baco et al. Final, three - year oncological results of a randomized clinical trial FARP comparing Focal Ablation and Radical Prostatectomy in patients with unilateral clinically - significant prostate cancer. Journal of Urology [Internet]. 2025 May 1;213(5S):e714. Baco et al. Focal Ablation Versus Radical Prostatectomy for Intermediate - Risk Prostate Cancer: Interim Analysis of a Randomized Controlled Trial. The Journal of Urology. Vol. 206, No. 3S, Supplement, Sunday, September 12, 2021 Final Results Presented at AUA 2025 0% 20% 40% 60% 80% 100% Oncologic Control (ITT Treatment Failure Free) Continence (Pad - free) Erectile Function Preservation Surgery Ultrasound Focal Ablation Surgery Ultrasound Focal Ablation Surgery Ultrasound Focal Ablation O P T I M A L T R I F E C T A O U T C O M E S

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19 Strong Hospital and Physician Reimbursement

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20 Environment for Growth S T R O N G R E I M B U R SE M E N T Creates Favorable 1. APC Level 6 Under CMS for CY23 and CY24 (1,3) 2. 90% Increase in Reimbursement in 2023 (1,2) 3. APC Level 6 Maintained by CMS in 2025 (3) (1) CMS Hospital Outpatient Prospective Payment System - 2023 Final rule (2) CMS Hospital Outpatient Prospective Payment System - 2022 Final rule (3) CMS Hospital Outpatient Prospective Payment System – 2025 Final rule

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21 Hospital Outpatient Medicare Payment (Laparoscopic Prostatectomy with or without Robotic Assistance and/or nerve - sparing) (1) Medicare Payment (National Average. From on CMS Hospital Outpatient Prospective Payment System – 2025 Final rule 2025 Site of Service CPT® Code Procedure $5,084 (1) Standard OR 55875 Prostate Brachytherapy $9,247 (1) Standard OR 55873 Cryo Ablation $12,992 (1) Specialized MRI Suite C9734 / 55882 MRI Transurethral Ultrasound Ablation $9,247 (1) Standard OR 55880 HIFU $10,411 (1) Standard OR 55866 Laparoscopic Prostatectomy +5.4%

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22 (Laparoscopic Prostatectomy with or without Robotic Assistance and/or nerve - sparing) (1) CMS Physician Fee Schedule – CY 2 024 Final rule (2) CMS Physician Fee Schedule – CY 2025 Final rule Physician Payment (Medicare - 2025) Work RVU (2025) (2) CPT® Code Procedure $763 13.46 55875 Prostate Brachytherapy $744 13.60 55873 Cryo $579 11.50 55882 MRI Transurethral Ultrasound Ablation $951 17.73 55880 HIFU $1,157 22.46 55866 Laparoscopic Prostatectomy Favorable Physician Payment

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Focal One® Best - in - Class Technology 23

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Precise Robotic Delivered Ablation 24 T HE L E A D I N G F O C A L T HE R A P Y T E C H N O L O G Y Targeting and Imaging Image Guided Treatment Planning

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Robotics HIFU Advanced Imaging Focal One® Core Technologies Artificial Intelligence (AI) Remote Connectivity 25

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26 Integrated Workstation Compatible With Standard OR Beds MRI, PSMA PET Unfold AI\* , OnQ Prostate\* Koelis\* and DynaCAD\* 3D Biopsy HIFUsion® Image - Guided Treatment Planning Dynamic Focusing Probe Precise Robotic Positioning Multi - Axis Sub - millimeter Robotic Movements Auto - Adjusting Pinpoint Delivery of HIFU Energy The Most Advanced Robotic HIFU Platform Controlled by Urologists • Expanded HIFUsion® Capabilities • Streamlined Treatment Workflows • Embedded Video Content Library • Treatment Streaming and Recording\* • Remote Proctoring & Telecollaboration\* • Endometriosis Treatment Ready\* \* Not available in all markets. May require additional purchase

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27 World's First Focal One Robotic HIFU Transcontinental Telecollaboration Cleveland Clinic Cleveland, Ohio Cleveland Clinic Abu Dhabi Cleveland, Ohio Abu Dhabi 7,000 Miles 27

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BPH & Endometriosis Large Market Opportunities For Expansion 28

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29 HIFU Unlocks a Large Market Opportunity (1) Newly Diagnosed Cases per year From World Health Organization – Globocan 2022 (2) From WHO and Habib N et al. Bowel Endometriosis: Current Perspectives on Diagnosis and Treatment. Int J Womens Health. 2020 (3) Xu et al.. Global, Regional, and National Incidence and Year Lived with Disability for Benign Prostatic Hyperplasia from 1990 to 2019. Am J Mens Health. 2021 (4) Based on UN Population Division and Goehring et al. Epidemiology of benign breast disease, with special attention to histologic types. Epidemiol Rev. 1997 (5) Based on UN Population Division and Bomeli et al. Evaluation of a thyroid nodule. Otolaryngol Clin North Am. 2010 20.5 M (2) Rectal Endometriosis 1.5 M Prostate Cancer (1) 11.3 M (3) BPH (Benign Prostatic Hyperplasia) 510,992 (1) Pancreatic Cancer 866,136 (1) Liver Cancer 51.4 M (5) Thyroid Nodules 2.3 M (1) Breast Cancer 8.3 M (4) Breast Fibroadenoma

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94 Million Global cases of BPH in 2019 (1) 15 Million U.S. men are affected by BPH/LUTS (2) 600,000 U.S. men aged 65+ newly diagnosed annually (3) Leveraging Expertise in Robotic HIFU and Prostate for BPH 12.2 Million men actively managed for BPH/LUTS: • 55% under Drug Management (4) • 35% under Watchful Waiting (4) • 300,000+ Active Surgical Treatments (5) Focal One Robotic HIFU technology has the potential to provide a non - invasive option that can safely treat BPH - related symptoms while avoiding the side effects of standard surgical treatments. 10,000s PCa treatments constitute a robust foundation to build upon for a BPH strategy (1) Fentahun et al. The Lancet Healthy Longevity. 2022 (2) Egan K B. Urologic Clinics of North America. 2016 (3) Urologic Diseases in America. 2024. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. 2024 (4) Vuichoud et al. Can J Urol. 2015 (5) Internal market estimate B E N I G N P R O S T A T I C H Y P E R P L A S I A (B P H) M A R K E T 30

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B P H : F O C A L O N E C L I N I C A L S T U D Y P R O G R E SS Building High - Level Evidence in the Treatment of Benign Prostate Hyperplasia Feasibility Study Completed Phase I - II Study Recruiting • Monocentric Feasibility Study (9 patients) • Confirmed Safety and potential for improvement of BPH - related symptoms • First Patients Treated • Phase I: Three - center study HIFU dose escalation • Phase II: Multi - center Study Safety and Efficacy of Final HIFU Parameters as defined in Phase 1 ض ض ض 31 U.S. Study Under IRB Review • Protocol based on previous study findings

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32 6.5 Million US Women Have Endometriosis (1) 1.3 Million 20% of Cases are Deep Infiltrating Endometriosis (DIE) in the U.S. (2) 11% of U.S. Women are Affected by Endometriosis (2) Leveraging Expertise in Robotic HIFU For Endometriosis Common symptoms of Rectal Endometriosis may include various conditions (acute pelvic pain, constipation, diarrhea, rectal bleeding), all of which negatively impact quality of life and ability to become pregnant. Current treatment options are lacking and limited to hormonal and/or surgical management Focal One has the potential of offering a non - invasive option with the ability of Reducing Symptoms and Improving Quality of Life (1) Office of Women's Health (www.womenshealth.gov) (2) D'Alterio MN et al. Management Challenges of Deep Infiltrating Endometriosis. Int J Fertil Steril. 2021 Apr;15(2):88 - 94. doi: 10.22074/IJFS.2020.134689. Epub 2021 Mar 11. PMID: 33687160; PMCID: PMC8052801 U . S . E N D O M E T R I O S I S M A R K E T

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33 E N DO M E TR I O S I S : F O C A L O N E C L I N I C A L S T U D Y P R O G R E SS Building High - Level Evidence in the Treatment of Deep Infiltrating Rectal Endometriosis Phase I Study Completed Phase II Study Completed • Feasibility (20 patients) • Published in the Journal of Ultrasound in Obstetrics and Gynecology in 2020 • Multicenter Safety and Efficacy Study (60 patients) • Completed in March 2022 • Published in Journal of Human Reproduction in 2024 • Multicenter Double - Blind Randomized Controlled Trial (RCT) • Enrollment completed (60 patients) • Follow - up of all patients in progress • 85% of Sham Group patients elected and received HIFU Treatment ض ض ض • Focal One received CE mark certification for the treatment of posterior deep endometriosis infiltrating the rectum Phase III Study CE Mark Completed Enrollment March 25, 2025 ض

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34 Growing Global Install Base

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35 73 Focal One Systems in the U.S. at the end of Q2 2025 (36 Academic – 37 Community) A C C E L E R A TI N G A D O P T I O N At Major Hospitals Hawaii

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Strong Adoption by the Highest Ranked Prostate Cancer Hospitals in the US F O C A L O N E I S T HE L E A D I N G F O C A L T H E R A P Y T E C H N O L O G Y 70% 7 Out of 10 Best Hospitals for Urology National Comprehensive Cancer Network® 48% 16 Out of 33 NCCN Member Institutions 54% 19 Out of 35 SUO Approved Programs 36

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Key Financial Data 37

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T HR E E M O N T HS E N D E D J U N E 3 0 T H 2025 2024 (in $Million USD except per share data) 18.4 17.0 Revenue 7.8 6.4 Gross Profit 42.5% 37.5% Gross Margin (6.6) (6.6) Operating Profit (Loss) (6.4) (6.6) Net Income (Loss) (0.17) (0.18) Earnings (Loss) Per Share HIFU $5.2M ESWL $2.5M Distribution $9.4M HIFU $9.7M +89% ESWL $1.8M - 27% 3 months 2024 3 months 2025 $1 7 . 0 M Distribution $6.9M - 26% NOTE: Translated for convenience of the reader to U.S. dollars at the 2025 average three months' exchange rate of 1 Euro = 1.1489 USD, and 2024 average three months' exchange rate of 1 Euro = 1.0747 USD 38 $1 8 . 4 M Financial Highlights as of June 30, 2025 +29% HIFU Revenue CAGR +50% Focal One US Install Base CAGR +52% US Focal One Procedure CAGR 1 st Half 2022 - 2025 HIFU Business Key Metrics

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39 Balance Sheet Highlights as of June 30, 2025 Balance Sheet As Of: June 30, 2024 June 30, 2025 (in $Million USD) 32.4 19.1 Cash and Cash Equivalents 39.8 41.4 Other Current Assets 15.9 19.8 Fixed and Other Non - Current Assets 88.0 80.4 29.4 40.2 Current Liabilities 7.6 7.5 Non - Current Liabilities 51.0 32.7 Shareholders' Equity 88.0 80.4 Note: Translated for convenience of the reader to U.S. dollars at the exchange rate of 1 Euro = 1.1770 USD, on June 30, 2025 and at the exchange rate of 1 Euro = 1.0711 USD, on June 30, 2024.

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Positioned for Growth S U M M A R Y • Large Addressable Markets in Men's and Women's Health • Growing Install base of Leading Tier 1 Academic and Community Hospitals • Differentiated Non - Invasive Robotic HIFU Technology Solving Unmet Needs for Prostate Cancer, BPH and Endometriosis • Strong Clinical Evidence with Favorable Reimbursement in Place • Proven Management Team from Industry - Leading MedTech Companies 40

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The Global Leader in Therapeutic Ultrasound 41