Edap Tms SA · NASDAQ:FOCL
Edap Tms SA — Investor Presentation (August 2026)
43 slides from Edap Tms SA's investor presentation, August 2026
Slide 1: The Global Leader in Therapeutic Ultrasound
The Global Leader in Therapeutic Ultrasound 1
Slide 2: Forward-Looking Statements & Disclaimer
F OR W ARD -L OOKI NG Statements & Disclaimer This presentation has been prepared by EDAP TMS S.A., operating under the corporate name FocalTherics (Nasdaq: FOCL) (the “Company”), and is furnished for informational purposes only. Unless the context requires otherwise, references to “FocalTherics,” t
Slide 3: Global Leader in Therapeutic Ultrasound for the Treatment of Cancer and Benign Disease
Global Leader in Therapeutic Ultrasound for the Treatment of Cancer and Benign Disease Redefining the Treatment of Cancer and Benign Disease through Organ Sparing, Function Preserving Focal Therapy 3
Slide 4: Commitment to Focal Therapy
FOC US ING ON AC CELERA TI NG OUR GR OWT H EN GIN E Commitment to Focal Therapy HIFU Revenue ($) 40% Y/Y 60000 Growth 50000 HIFU +32% 3 yr $52M 40000 CAGR 30000 $37M 20000 $26M $22M 10000 $16M 0 CY22 CY23 CY24 CY25 CY26E Note: CY26E = Midpoint of CY26 Guidance Range Rei terated on August 13, 2026 4
Slide 5: Driving Growth Across Three Strategic Pillars
Driving Growth Across Three Strategic Pillars Expanding our Market Advancing Scaling Commercial Opportunity with Added Technological Execution in Innovation in HIFU Indications on the Prostate Cancer and Beyond Focal One Platform 5 5
Slide 6: Large and Growing Market Opportunity in Prostate Cancer
Large and Growing Market Opportunity in Prostate Cancer 6
Slide 7: Prostate Cancer is the Most Common Cancer Among Men
Prostate Cancer is the Most Common Cancer Among Men1 >1.4 Million 2 New Cases Diagnosed Annually, Globally >330,000 New Cases Diagnosed Annually in the U.S. Annual Global Prostate 2.9M Diagnoses Will >3.5 Million Cases Men Living with Prostate Cancer in the U.S. DOUBLE 3 1.4M Cases by 2040 2020 2040
Slide 8: The Prostate Cancer Patient's Dilemma
The Prostate Cancer Patient’s Dilemma Treatment A Diagnosis that Demands a Outcomes Difficult Choice Active Surveillance Treatment Effectiveness Complications & Surgery Recovery Loss of Urinary Control Radiation Loss of Sexual Function 8
Slide 9: The Shift from Radical Treatment to Focal Therapy
The Shift from Radical Treatment to Focal Therapy Surgery is Still Surgery… Open Surgery Laparoscopic Surgery Robotic Surgery Radiation is still Radiation… XRT Radiation IMRT Radiation SBRT Radiation Robotic Focal HIFU Ablation 9 9
Slide 10: Prostate Cancer Patient Value Equation
FOC AL O NE® RO BOTIC HIFU Prostate Cancer Patient Value Equation Surgery HIGH Focal One Robotic HIFU Radiation Radical Treatments PROVEN EFFICACY (Cancer Control) Active Surveillance LOW HIGH QUALITY OF LIFE PRESERVATION (Urinary and Sexual Function Outcomes) 10
Slide 11: The Large Gap Between No Treatment and Radical Treatment
The Large Gap Between No Treatment and Radical Treatment Low Risk Intermediate Risk High Risk ~30% of patients1 ~50% of patients ~20% of patients No Treatment Radiation or Organ Removal Active Surveillance Radical or Salvage Treatment Previously, There Have Been No Options, Other Than Active Surveil
Slide 12: Focal Therapy | The New Emerging Market
DRIVING A PA RADIGM SHIF T IN PROSTATE C ANC ER Focal Therapy | The New Emerging Market Future Market(2) Emerging Market(2) Focal Therapy Expected to Grow to Traditional Market(1) Focal Therapy (HIFU) Active ~40% Active Surveillance Surveillance of the Market Focal Active Therapy Surveillance Radica
Slide 13: HIFU | The Fastest Growing Treatment Option
DRIVING A PA RADIGM SHIF T IN PROSTATE C ANC ER HIFU | The Fastest Growing Treatment Option HIFU Radical Cryo Brachytherapy Prostatectomy Based on Medicare Claims reported by CMS on HOPPS Final Rule for FY24, FY25 an d FY26 13
Slide 14: HIFU
HIFU HIFU Fastest Growing Focal Therapy Treatment1 Cryo #1 Ablation Technology for Prostate Cancer IRE (all organs)2 TULSA2 2021 2022 2023 2024 2025 [1] Based on Medicare clai ms utilization data publi shed by CMS in connection with the Hospital Outpatient Prospective Payment System (HOPPS) Proposed
Slide 15: Favorable Facility & Physician Reimbursement
Favorable Facility & Physician Reimbursement 15
Slide 16: Hospital Outpatient Medicare Payment
Hospital Outpatient Medicare Payment Procedure CPT® Code 2027 Payment (Proposed) Prostate Brachytherapy 55875 $6,292 Cryo Ablation 55873 $10,797 HIFU 55880 $10,797 +11.6% Laparoscopic/Robotic Prostatectomy 55866 $12,300 Medicare Payment (National Average). From CMS Hospital Outpati ent Prospective P
Slide 17: Favorable Physician Payment
Favorable Physician Payment Procedure CPT® Code Work RVU Physician Payment (2026) (Medicare - 2026) MRI Transurethral Ultrasound Ablation 55882 11.21 $530 Prostate Brachytherapy 55875 13.12 $693 Cryo 55873 13.26 $692 Irreversible Electroporation 55877 13.50 $675 HIFU 55880 17.29 $884 Laparoscopic/Ro
Slide 18: Technology Leadership & Innovation on the Focal One Platform
Technology Leadership & Innovation on the Focal One Platform 18
Slide 19: Non-Invasive, No Surgery, No Cutting, No Radiation
Non-Invasive No Surgery No Cutting No Radiation 19
Slide 20: Advanced Imaging, HIFU, Precise Robotic Energy Delivery
High-Intensity Focused Precise Robotic Organ Sparing, Advanced Imaging Ultrasound (HIFU) Energy Delivery Function Preserving 20
Slide 21: The Most Advanced Robotic HIFU Platform Controlled by Urologists
HIFUsion® The Most Advanced Robotic HIFU Image-Guided Treatment Planning Platform Controlled by Urologists MRI, PSMA PET Unfold AI* , OnQ Prostate* Koelis* and DynaCAD* 3D Biopsy Precise Robotic Positioning Multi-Axis Sub-millimeter Robotic Movements • Expanded HIFUsion® Capabilities Dynamic Focusin
Slide 22: Scalable Focal One Platform Enables Simultaneous Innovation
Scalable Focal One Platform Enables Simultaneous Innovation HIFU & Advanced Histotripsy Imaging Remote Robotics Connectivity AI-Driven Treatment 22
Slide 23: Strong Supporting Clinical Evidence
Strong Supporting Clinical Evidence 23
Slide 24: Landmark Studies Demonstrate Positive Clinical Outcomes Supporting Focal One HIFU Therapy
Landmark Studies Demonstrate Positive Clinical Outcomes Supporting Focal One HIFU Therapy Prospective Prospective Long-Term Comparative Salvage Retrospective HIFI1 HIFI-22 CGRD3 European Urology European Urology Oncology Int. Urology and Nephrology HIFU vs Radical Prostatectomy HIFU in Salvage Post
Slide 25: HIFI - Prospective Multicentric Comparative Study Focal One HIFU vs Radical Prostatectomy
HIFI - Prospective Multicentric Comparative Study Focal One® HIFU vs Radical Prostatectomy Published in European Urology – December 2024 Prospective, Comparative, Multicentric, non-inferiority clinical trial comparing HIFU to Radical Prostatectomy (RP) 3,328 patients treated (1,967 HIFU - 1,361 RP)
Slide 26: Growing Global Install Base
Growing Global Install Base 26
Slide 27: Focal One Adoption Accelerating at Major U.S. Hospitals
96 Focal One Systems as of Jun. 30, 2026 F OC AL O NE A DO P TIO N AC CEL ER ATI NG (44 Academic – 52 Community) At Major U.S. Hospitals 27
Slide 28: Strong Adoption by the Highest Ranked Prostate Cancer Hospitals in the US
Focal One is the Leading Focal Therapy Technology Strong Adoption by the Highest Ranked Prostate Cancer Hospitals in the US National Comprehe nsive Cancer Networ k® Best Hospitals SUO Approved NCCN Member for Urology Programs Institutions 70% 66% 58% 7 Out of 10 23 Out of 35 19 Out of 33 28 28 28 28
Slide 29: 300+ Hospitals in Sales Pipeline
96 Focal One Systems as of Jun. 30, 2026 F OC AL O NE A DO P TIO N AC CEL ER ATI NG (44 Academic 300+ Hospitals –in52 Sales Community) Pipeline At Major U.S. Hospitals 29
Slide 30: 254 Focal One Treatment Clinical Sites at Major International Hospitals
88 Focal One Systems as of Jun. 30, 2026 F OC AL O NE A DO P TIO N AC CEL ER ATI NG 254 Focal One Treatment Clinical Sites At Major International Hospitals FOCAL ONE FIXED SITES FOCAL ONE MOBILE SITES 30
Slide 31: Expanding Clinical Indications
Expanding Clinical Indications 31
Slide 32: Expanded Indications of Focal One
S IN GLE PLAT FOR M, MULT IPL E IN DI CAT ION S Expanded Indications of Focal One Benign Prostatic Deep Infiltrating Hyperplasia (BPH) Endometriosis 38M 100+ Million1 Women Living with Deep Men Living with BPH Globally Infiltrating Endometriosis Globally2,3,4,5 13+ Million1 New Cases Diagnosed Annua
Slide 33: Benign Prostatic Hyperplasia (BPH) Market
BE NIG N PR OSTATI C HY PER PL ASI A Leveraging Expertise in Robotic HIFU (BP H) MAR KET and Prostate for BPH 100+ Million 12.2 Million men actively managed for BPH/LUTS: • 55% under Drug Management (3) • 35% under Watchful Waiting (3) Men Living with BPH Globally (1) • 300,000+ Active Surgical Trea
Slide 34: A BPH Solution Designed to Meet Patient Priorities
A BPH Solution Designed to Meet Patient Priorities Non-Invasive No Bleeding No Foreign Body Particularly Compelling for the Growing Number of No Quality-of-Life Tradeoffs BPH Patients on Anti-Coagulation Medication who are at Risk of Bleeding Complications 34
Slide 35: BPH Indication Expansion Pipeline
BPH Indication Expansion Pipeline U.S. IRB Approved as part of U.S. – Chile Collaboration Next Key Catalyst BPH Parallel Studies Feasibility Data Readout Launch of Pivotal 2026 O.U.S. 2026 Study 2027 Phase I-II Multi-Center Study 35
Slide 36: U.S. Endometriosis Market
U.S . END OME TRI OSIS MA RKE T Leveraging Expertise in Robotic HIFU For Endometriosis 6.5 Million Common symptoms of Rectal Endometriosis may include various conditions (acute pelvic US Women Have Endometriosis (1) pain, constipation, diarrhea, rectal bleeding), all of which negatively impact quali
Slide 37: Endometriosis Indication Expansion Pipeline
Endometriosis Indication Expansion Pipeline Next Key Catalyst O.U.S. Ongoing Endometriosis Phase I Feasibility Phase II Pivotal Phase III RCT Limited Full Commercial 2020 2024 European Launch Roll Out 2026 Next Key Catalyst U.S. Endometriosis Initial Data from Breakthrough Long-Term Data Finalize St
Slide 38: Focal One Platform Expansion Opportunity Represents a TAM of 4.3M+ Procedures and $10B+ Revenue
Focal One Platform Expansion Opportunity Represents a TAM of 4.3M+1 Procedures and $10B+ Revenue 480K (O.U.S) Endometriosis 235K (U.S.) BPH 1.5M (O.U.S) 400K (U.S.) > 4.3M Procedures 1.7 M (Global) Prostate Cancer [1] Management Estimates; data on fi le. 38
Slide 39: Key Business Trends & Financial Highlights
Key Business Trends & Financial Highlights 39
Slide 40: Q2 2026 Financial Highlights
Q2 2026 Financial Highlights $13.2M 44% 184 HIFU Revenue Y/Y Growth Global Installed Base 39% Y/Y Growth 13 Focal One System Sales 47% 55.6% Y/Y Procedure Gross Margin Volume Growth +444 bps Y/Y ESWL & DISTRI BUTION NOW C LASSIFIED UN DER D IS CON T INUED OPERAT IO NS 40 40
Slide 41: 2028E Target Model Financial Framework
2028E Target Model Financial Framework Focused on Driving Positive EBITDA and Breakeven Operating Income to Deliver Shareholder Value CY25 Actual CY28E Target Range Revenue $37M ~ 40%+ 3-Yr CAGR (+/- 3%) Gross Margin 48.1% ~60% (+/- 200 bps) Operating Income ($21M) Breakeven EBITDA ($19M) Positive I
Slide 42: FocalTherics: Positioned For Strong Growth
FocalTherics: Positioned For Strong Growth Large, Underserved Differentiated Technology Expanding Favorable Growing Market Leading the Category of Reimbursement Robotic Focal Therapy Robust Clinical Evidence Accelerated Global Growing Revenue and Commercial Execution Pathway To Profitability 42
Slide 43: The Global Leader in Therapeutic Ultrasound
The Global Leader in Therapeutic Ultrasound 43
EDAP TMS SA (FocalTherics) — Investor Presentation (August 2026) on 6ix