Edap Tms SA · NASDAQ:FOCL
Edap Tms SA — Investor Presentation (March 2026)
33 slides from Edap Tms SA's investor presentation, Mar 18, 2026
Slide 1: The Global Leader in Therapeutic Ultrasound
The Global Leader in Therapeutic Ultrasound 1
Slide 2: Statements & Disclaimer: Forward-Looking
Statements & Disclaimer F O R W A R D - L O O K I N G 2
Slide 3: Strategic Company Focus
Strategic Company Focus 3 Global Leader in Therapeutic Ultrasound for the Treatment of Cancer and Benign Disease
Slide 4: Large and Growing Market Opportunity in Urology and Prostate Cancer
Large and Growing Market Opportunity In Urology and Prostate Cancer 4
Slide 5: Prostate Cancer Market Opportunity
Prostate Cancer Market Opportunity Number of New Prostate Cancer Cases Region Europe Asia North America Latin America Africa Oceania Total 473,011 386,424 255,782 225,985 103,050 23,602 1,467,854 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 Data Source: Cases refe
Slide 6: Focal One Answers an Unmet Need for a Large Underserved Patient Population
Focal One Answers an Unmet Need for a Large Underserved Patient Population PR O S T A T E C A N C ER Focal One HIFU Focal One HIFU 6 First - Line Treatment Progression from Active Surveillance Salvage Treatment
Slide 7: Focal One Robotic HIFU Prostate Cancer Patient Value Equation
FO C A L O N E ® RO B O T I C HI FU Prostate Cancer Patient Value Equation HIGH LOW HIGH Radiation QUALITY OF LIFE PRESERVATION (Urinary and Sexual Function Outcomes) Focal One Robotic HIFU Active Surveillance Surgery PROVEN EFFICACY (Cancer Control) 7
Slide 8: Driving a Paradigm Shift in Prostate Cancer: Focal Therapy
8 DR I V I N G A P A R A DI G M S H I 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) Source: Internal company management e
Slide 9: HIFU: The Fastest Growing Treatment Option
9 0% 20% 40% 60% 80% CAGR (2022 - 2024) DR I V I N G A P A R A DI G M S H I 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 data reported by CMS in the HOPPS Final Rules for FY2024 – FY2026.. As CMS publishes claims data on a retrospective bas
Slide 10: Focal One Best-in-Class Technology
10 Focal One ® Best - in - Class Technology
Slide 11: The Most Advanced Robotic HIFU Platform Controlled by Urologists
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 De
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Slide 13: Focal One Core Technologies
Robotics HIFU Advanced Imaging Focal One ® Core Technologies Artificial Intelligence (AI) Remote Connectivity 13
Slide 14: Strong Supporting Clinical Evidence
Strong Supporting Clinical Evidence 14
Slide 15: Proven Clinical Evidence Supporting Focal One Robotic HIFU
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 (1) PubMed Database search
Slide 16: Treatment Comparison: Focal One HIFU Provides the Optimal Organ-Preserving Treatment
16 CANCER CONTROL PATIENT BURDEN Treatment Comparison Focal One HIFU Provides the Optimal Organ - Preserving Patient Treatment ORGAN - PRESERVING STRATEGY WHOLE - GLAND RADICAL TREATMENT STRATEGY QUALITY OF LIFE FUNCTIONAL OUTCOMES 96% (3) Continence Preservation 82% (3) Erectile Function Preservati
Slide 17: HIFI Prospective Multicentric Comparative Study
17 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
Slide 18: FARP Randomized Controlled Trial
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
Slide 19: HIFU Demonstrates Equivalent Survival to Radiation Therapy
19 HIFU Demonstrates Equivalent 10 - year Survival to Radiation Therapy 10 - year Oncological Outcomes of HIFU vs EBRT (1) • Lower Mortality at 10 years post HIFU (9.2%) compared to EBRT (16.7%) • Lower Cancer - Specific Mortality after HIFU (5.4%) compared to EBRT (9.2%) Radiation HIFU HIFU Radiati
Slide 20: Strong Hospital and Physician Reimbursement
Strong Hospital and Physician Reimbursement 20
Slide 21: Strong Reimbursement Creates Favorable Environment for Growth
Environment for Growth ST R O N G R E I MBU R SE ME N T Creates Favorable 1. APC Level 6 Under CMS for CY23, CY24 and CY25 2. 90% Increase in Reimbursement in 2023 3. APC Level 6 Maintained by CMS in 2026 Based on CMS Hospital Outpatient Prospective Payment System Final rule 21
Slide 22: Hospital Outpatient Medicare Payment 2026
Hospital Outpatient Medicare Payment 2026 Payment CPT ® Code Procedure $5,478 55875 Prostate Brachytherapy $9,671 55873 Cryo Ablation +4.3% $9,671 55880 HIFU $10,860 55866 Laparoscopic/Robotic Prostatectomy (Medicare Payment (National Average). From CMS Hospital Outpatient Prospective Payment System
Slide 23: Favorable Physician Payment
Favorable Physician Payment Physician Payment (Medicare - 2026) Work RVU (2026) CPT ® Code Procedure $693 13.12 55875 Prostate Brachytherapy $692 13.26 55873 Cryo $530 11.21 55882 MRI Transurethral Ultrasound Ablation $884 17.29 55880 HIFU Laparoscopic/Robotic Prostatectomy 55866 21.90 $1,087 Based
Slide 24: Growing Global Install Base
Growing Global Install Base 24
Slide 25: Focal One Adoption Accelerating at Major U.S. Hospitals
FO CA L O NE A D O P T I O N A CCE L E R A T I NG At Major U.S. Hospitals 87 Focal One Systems as of Dec. 31, 2025 (42 Academic – 45 Community)
Slide 26: Strong Adoption by the Highest Ranked Prostate Cancer Hospitals in the US
Strong Adoption by the Highest Ranked Prostate Cancer Hospitals in the US FO C A L O N E I S T H E L E A D I N G FO C A L T H E RA 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® 55% 18 Out of 33 NCCN Member Institutions 63% 22 Out of 35 SUO
Slide 27: Focal One Adoption Accelerating at Major European Hospitals
FOCAL ONE FIXED SITES FOCAL ONE MOBILE SITES 41 Focal One Systems as of Dec. 31, 2025 254 Focal One Treatment Clinical Sites FO CA L O NE A D O P T I O N A CCE L E R A T I NG At Major European Hospitals
Slide 28: Key Business Trends
dap | Focal‘One Key Business Trends
Slide 29: Focal One U.S. Momentum 2021-2025
29 2021 2022 2023 2024 2025 Focal One U.S. Momentum 2021 - 2025 (Compounded Annual Growth Rates) Focal One Procedures CAGR 29 Focal One Installations CAGR 44% 52% Focal One Procedures Focal One Installations
Slide 30: Focal One HIFU Accelerated Revenue Growth
30 30 2021 2022 2023 2024 Focal One HIFU Accelerated Revenue Growth Capital Sale + Recurring Revenue Capital Sales Disposables & Treatment - Driven Revenue Service (1) 2025 ANNUAL HIFU REVENUE (1) Based on preliminary, unaudited Company results for 2025 (2) Source: 2026 financial guidance as disclos
Slide 31: HIFU Unlocks a Large Market Opportunity
31 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 I
Slide 32: Positioned for Growth: Summary
Positioned for Growth SU MMA R Y • Large Addressable Markets in Men’s and Women’s Health • Growing Global 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 Cl
Slide 33: The Global Leader in Therapeutic Ultrasound
The Global Leader in Therapeutic Ultrasound 33