Edap Tms SA · NASDAQ:FOCL
Edap Tms SA — FocalTherics — Investor Day (June 2026)
113 slides from Edap Tms SA's investor day presentation, Jun 1, 2026
Slide 1: 2026 Investor Day
2026 Investor Day Nasdaq (FOCL) June 1, 2026 1
Slide 2: Forward-Looking Statements & Disclaimer
FORWARD-LOOKING STATEMENTS & DISCLAIMER This presentation is being furnished for informational purposes only and may be given in conjunction with an oral presentation. It should not be taken out of context. Unless the context requires otherwise, references to "FocalTherics," "the Company," "we," "us
Slide 3: Agenda
Agenda 1 RYAN RHODES 3 STEVE ANNEN CEO EVP Product Management Transformation of EDAP | Focal One ® Innovation and Advanced Technologies Our Next Chapter as FocalTherics Commercial Leader in Robotic Focal Therapy: Prostate Cancer 4 KEN MOBECK Clinical Expansion of Our Focal CFO Therapy Platform: BPH
Slide 4: Transformation of EDAP | Focal One: Our Next Chapter as FocalTherics
Transformation of EDAP | Focal One ® Our Next Chapter as FocalTherics Ryan Rhodes, CEO 4
Slide 5: Transforming into a High-Growth Pure-Play Robotic Focal Therapy Company
Focal Therapy Therapeutics We are Transforming into a High-Growth Pure-Play, Robotic Focal Therapy Company with a Leading Position in Both Large and Growing Markets 5
Slide 6: Commitment to Focal Therapy: EDAP Revenue
Commitment to Focal Therapy Focusing on Accelerating Our Growth Engine EDAP Revenue ($) 7% 3 yr CAGR 24M Non-Core 33M 43M 44M 42M 52M HIFU 37M 16M 22M 26M CY22 CY23 CY24 CY25 CY26E Moving Non-Core ESWL and Distribution Business to Discontinued Operations as of Q2 CY26 Note: CY26E = Midpoint of CY26
Slide 7: Commitment to Focal Therapy: HIFU Revenue
Commitment to Focal Therapy Focusing on Accelerating Our Growth Engine HIFU Revenue ($) 40% Y/Y Growth 60000 +32% 50000 3 yr CAGR 40000 30000 52M 20000 37M HIFU 10000 22M 26M 16M 0 CY22 CY23 CY24 CY25 CY26E Note: CY26E = Midpoint of CY26 Guidance Range 7 7
Slide 8: Global Leader in Therapeutic Ultrasound
Global Leader in Therapeutic Ultrasound Redefining the Treatment of Cancer and Benign Disease through Organ Sparing, Function Preserving Focal Therapy 8
Slide 9: 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 9 9
Slide 10: Non-Invasive, No Surgery, No Cutting, No Radiation
Non-Invasive No Surgery No Cutting No Radiation 10
Slide 11: Advanced Imaging, HIFU, Precise Robotic Energy Delivery
High-Intensity Focused Precise Robotic Organ Sparing, Advanced Imaging Ultrasound (HIFU) Energy Delivery Function Preserving 11
Slide 12: Defining, Building, and Leading the Category of Robotic Focal Therapy
Defining, Building, and Leading the Category of Robotic Focal Therapy 12
Slide 13: Driving Commercial Success in Current Markets: Prostate Cancer
Driving Commercial Success in Current Markets Prostate Cancer 13
Slide 14: 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 15: 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 15 15
Slide 16: 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 16
Slide 17: 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) 17
Slide 18: From Radical To Organ-Sparing Treatments
From Radical To Organ-Sparing Treatments The Evolution of Breast and Prostate Cancer Surgery Radical Surgery Organ-Sparing Mastectomy = INCISION AREA REMOVED Radical Mastectomy Modified Radical Mastectomy Lumpectomy Prostatectomy NO INCISIONS INCISION AREA INCISION AREAS = INCISION AREA REMOVED Open
Slide 19: 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 20: Focal One HIFU Bridges the Gap
The Large Gap Between No Treatment and Radical Treatment High Risk 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 Focal One HIFU Bridges the Gap 2 Low and Intermediate R
Slide 21: Emerging Paradigm Shift in Treatment Options
Emerging Paradigm Shift in Treatment Focal Therapy Expected to Grow to Surgery Radiation Options ~40% of the Market Focal Therapy Surgery Focal Active Surveillance Therapy Surgery Active Radiation Active Surveillance Surveillance 2 Radiation Future 2 Current 1 Past [1] As of 2013. Chen et al . Natio
Slide 22: Focal One vs Transurethral and Transperineal Approaches
Focal One Transrectal HIFU Offers Superior Access, Precision, and Tissue Preservation × Requires MRI Suite and 2nd Focal One Transrectal HIFU Physician × Non-Focused Energy ✓ Single Urologist × Bleeding from ✓ Precise Focused Urethra and Ultrasound Transurethral Tissue Damage ✓ Targeted Robotic Ener
Slide 23: HIFU: Fastest Growing Focal Therapy Treatment
HIFU HIFU Fastest Growing Cryo Focal Therapy Treatment1 IRE2 #1 Ablation Technology for Prostate Cancer TULSA2 3 2019 2020 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) Final Rul
Slide 24: Clinical Evidence Supports and Favors Focal One Robotic HIFU
Clinical Evidence Supports and Favors Focal One Robotic HIFU 24
Slide 25: Landmark Studies Demonstrate Positive Clinical Outcomes
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 26: HIFI Study: HIFU vs Radical Prostatectomy
1 HIFI Study: HIFU vs Radical Prostatectomy Largest Prospective Comparative Multicenter Study in the Treatment of Prostate Cancer 3,328 Patients 46 Centers 80+ Urologists 1 2 3 Cancer Control Maintain Urinary Control Preserve Erectile Function Primary Endpoint Secondary Endpoint Secondary Endpoint P
Slide 27: FARP: Focal Ablation vs Radical Prostatectomy
FARP: Focal Ablation vs Radical Prostatectomy 1,2 Level 1 Evidence from RCT Validates HIFI Study Outcomes Optimal Trifecta Outcomes 213 Patients 100% Randomized Controlled Trial 80% Equivalent Oncologic Control at 3 years (93.5% TFF vs 91.5%) 60% Ultrasound Focal Ablation Ultrasound Focal Ablation U
Slide 28: Growing Global Adoption of Focal One Robotic HIFU
Growing Global Adoption of Focal One Robotic HIFU 28
Slide 29: Focal One Adoption Accelerating at Major U.S. Hospitals
91 Focal One Systems as of Mar. 31, 2026 F OC AL O NE A DO P TIO N AC CEL ER ATI NG (43 Academic – 48 Community) At Major U.S. Hospitals 29
Slide 30: Strong Adoption by Highest Ranked Prostate Cancer Hospitals
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 30 30 30 30
Slide 31: Focal One Adoption Accelerating: 300+ Sales Pipeline
F OC AL O NE A DO P TIO N AC CEL ER ATI NG 91 Focal One Systems as of Mar. 31, 2026 300+ (43 Hospitals–in Academic 48Sales Pipeline Community) At Major U.S. Hospitals 31
Slide 32: Focal One Adoption at Major European Hospitals
41 Focal One Systems as of Dec. 31, 2025 F OC AL O NE A DO P TIO N AC CEL ER ATI NG 254 Focal One Treatment Clinical Sites At Major European Hospitals FOCAL ONE FIXED SITES FOCAL ONE MOBILE SITES 32
Slide 33: Most Established Global Commercial Adoption of Any Focal Therapy
FocalTherics has the Most Established And Growing Global Commercial Adoption of any Focal Therapy Company Full Spectrum of 175+ Academic Centers, Large Community Hospitals & Installed Base1 Regional Centers FOCAL ONE FIXED SITES FOCAL ONE MOBILE SITES 33 [1] As of March 31, 2026 33
Slide 34: U.S. Market: Consistent Execution Driving Durable Growth
650 100 Consistent Execution 600 90 Driving Durable Growth 550 500 80 70 450 60 400 50 350 40 1Q24 2Q24 3Q24 4Q24 1Q25 2Q25 3Q25 4Q25 1Q26 US Install Base US Procedure Volume U.S. Market 91 53% Installed Base1 Procedure Volume Growth1 • Expanding Installed Base at Community Hospitals and Major Healt
Slide 35: O.U.S Market: Sharpened Commercial Strategy
750 90 Sharpened Commercial 700 85 80 650 Strategy in Key Markets 600 75 70 550 65 500 60 450 55 400 50 1Q24 2Q24 3Q24 4Q24 1Q25 2Q25 3Q25 4Q25 1Q26 O.U.S Market OUS Install Base OUS Procedure Volume 84 30% Installed Base1 Procedure Volume Growth1 • Direct Commercial Model in Select Markets (UK, Nor
Slide 36: Executing Disciplined Commercial Strategy for Scalable Growth
Executing Disciplined Commercial Strategy for Scalable Growth Targeting Building Scaling Account Activation Program Building Program Independence • Expand Installed Base through • Drive Increased Utilization with • Transition Sites to Clinically Sales to Greenfield High-Volume Physician Training, Ed
Slide 37: Saint Alphonsus Medical Center: Boise, ID
Program Launch Excellence Saint Alphonsus Medical Center: Boise, ID Q4 Q3 Q2 Q1 Significant Case Volume Growth in First Year of Program Launch 37
Slide 38: Creates Favorable Environment for Growth
S T RON G REIMBUR SEMEN T Creates Favorable Environment 1. Cat. 1 CPT® Code at APC Level 6 for Growth 2. Favorable Physician Payment 3. Growing Coverage Based on CMS Hospital Outpatient Prospective Payment System Final Rule 38
Slide 39: Hospital Outpatient Medicare Payment
Hospital Outpatient Medicare Payment Procedure CPT® Code 2026 Payment Prostate Brachytherapy 55875 $5,478 Cryo Ablation 55873 $9,671 HIFU 55880 $9,671 +4.3% Laparoscopic/Robotic Prostatectomy 55866 $10,860 Medicare Payment (National Average). From CMS Hospital Outpati ent Prospective Payment System
Slide 40: 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 41: Expanding Patient Access
Expanding Patient Access Medicare Coverage: Automatic for All Patients Nationwide National and Local Plans may Provide Individual Payment According to their Coverage Policies and/or Local Arrangements Existing and Upcoming Positive Clinical Evidence will Provide Broader and Expanded Coverage 41
Slide 42: Clinical Expansion of our Focal One Platform: BPH and Endometriosis
Clinical Expansion of our Focal One Platform BPH and Endometriosis 42
Slide 43: Benign Prostatic Hyperplasia (BPH) Market
Benign Prostatic Hyperplasia (BPH) Market 100+ Million1 Men Living with BPH Globally Normal Prostate 13+ Million1 New Cases Diagnosed Annually, Globally Enlarged Prostate 600,000+2 Compressed New Cases Diagnosed in the U.S. Urethra [1] Chen X, Yang S, He Z, Chen Z, Tang X, Lin Y, Huang Y, Hou J, Wei
Slide 44: BPH Treatment is a Highly Fragmented Market
BPH Treatment is a Highly Fragmented Market 5% 12% Focal One will be the ONLY 13% 54% Non-Invasive, Non-Surgical Focal Therapy Solution 16% TURP Aquablation Urolift HoLEP Rezum Market share calculated as each procedure’s share of 288 ,935 reported US BPH procedures in 2025 across TURP, Aquablation,
Slide 45: 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 45
Slide 46: 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 46
Slide 47: Ideally Suited to Capture Significant Portion of BPH Market
Ideally Suited to Capture Significant Portion of BPH Market Same Focal One Platform Same Installed Base Same Urology Call Point Same Physicians & Staff 47 47
Slide 48: Straightforward Pathway to Additional Prostate Indications
Straightforward Pathway to Additional Prostate Indications Focal One Payment and Coding Freedom to Operate Prostate Cancer BPH CPT Category 3 Code (Transrectal HIFU Treatment, Specifically for BPH) Other Technologies Regulatory Enrolling Parallel BPH Prostate Cancer Studies 14 Patients Treated in La
Slide 49: Deep Infiltrating Endometriosis (DIE)
Deep Infiltrating Endometriosis (DIE) Endometriosis Lesions Infiltrating 38M Rectal Wall Women Living with Deep Infiltrating Endometriosis Globally1,2,3,4 783,000+ Patients Diagnosed with Deep Rectal Endometriosis Globally1,2,3,4 225,000+ Patients Diagnosed with Deep Rectal Endometriosis in U.S.1,2,
Slide 50: Deep Infiltrating Endometriosis (DIE)
Deep Infiltrating Endometriosis (DIE) Characterized by Lesions that Penetrate >5mm Below the Peritoneal Surface, Invading Surrounding Structures like the Bowel, Bladder, and Rectum. Current Treatment Options are Lacking and Limited to Hormonal and/or Surgical Management. When Offered the Choice, 91%
Slide 51: 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 52: Phased Launch Program Establishes Framework for Broad Commercial Rollout
Phased Launch Program Establishes Framework for Broad Commercial Rollout Goal to end 2026 with Several Active Reference Centers with Influential Thought Leaders x3 x5 x2 x1 Phase 1: Phase 2: Phase 3: Phase 4: Training Pipeline Case Observation Initial Cases 3-20 Cases 20+ Cases (Launch & Training) (
Slide 53: Platform Expansion Opportunity: 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.) 1.5M (O.U.S) BPH >4.3M 400K (U.S.) Procedures 1.7 M Procedures (Global) Prostate Cancer [1] Management Estimates; data on fi le. 53
Slide 54: Behfar Ehdaie, MD, MPH
Behfar Ehdaie, MD, MPH Memorial Sloan Kettering Cancer Center 54
Slide 55: Focal Therapy for Prostate Cancer and Urologic Oncology: A Paradigm Shift
Focal Therapy for Prostate Cancer and Urologic Oncology: A Paradigm Shift in Treatment Behfar Ehdaie, MD, MPH Associate Member Urology Service, Department of Surgery Department of Epidemiology and Biostatistics Memorial Sloan Kettering New York, NY
Slide 56: Overall Prostate Cancer Survival in PROTECT Trial
Overall Prostate Cancer Survival In All Men In The PROTECT Trial: 2.7% At 15 Years [Hamdy, 2023]
Slide 57: Active Monitoring Patients Undergoing Radical Treatment Within 5 Years
Approximately 40% Of Men Randomized To Active Monitoring Underwent Radical Prostatectomy Or Radiation Therapy Within 5 Years [Hamdy, 2023]
Slide 58: Sexual Function Recovery After Prostate Cancer Surgery
Has The Probability Of Regaining Sexual Function After Prostate Cancer Surgery Improved Over The Last Decade? [Mulhall, 2018]
Slide 59: Urinary Function Recovery After Surgery
Similarly, We Have Not Observed Improvements In The Probability Of Regaining Urinary Function After Surgery [Ehdaie, 2022]
Slide 60: Tumor Multifocality and the Emergence of Focal Therapy
Overcoming The Problem Of Tumor Multifocality Within The Prostate Has Been Key To The Emergence of Focal Therapy Grade Group 1 (Gleason score 3+3) Grade Group 1 (Gleason score 3+3) Grade Group 2 (Gleason score 3+4) [Arora et al, 2004]
Slide 61: Adverse Pathologic Features Define the Index Lesion
Adverse Pathologic Features, Including Highest Stage, Gleason Score, And Tumor Volume Converge To Define The Index Lesion Tumor Volume 93.5% Highest Gleason Score [Arora, 2004]
Slide 62: Multiparametric MRI Detects the Index Lesion
Multiparametric MRI Is Enabled Physicians To Detect The Index Lesion And Map The Prostate Gland
Slide 63: Patient Selection Criteria
Patient Selection Criteria Preferred Focal Therapy Candidates: • GG 2 or GG 3 prostate cancer in a single lesion visible on MRI • Concomitant GG1 prostate cancer elsewhere in the gland is allowed and observed • PSA ≤20 if prostate gland size <100gm • No evidence of extraprostatic extension (MRI) • H
Slide 64: Who Is A Candidate For Focal Therapy?
Who Is A Candidate For Focal Therapy? Across 3 prospective prostate cancer diagnostic and screening clinical trials in the UK (total accrual >700 patients) • 48-68% of patients suitable for focal therapy
Slide 65: Key Trends in Patient Selection
Key Trends In Patient Selection Expanding Focal Therapy Eligible Patients A. >60% of patients in the United States with low grade prostate cancer are enrolled in active surveillance and approximately 20% of these patients have higher grade cancer detected within 24 months B. MRI targeted prostate bi
Slide 66: Focal Therapy Fills an Important Treatment Gap
Focal Therapy Fills An Important Treatment Gap In Prostate Cancer Low Risk Intermediate Risk High Risk Relapse Metastatic Active Surveillance Radical treatment (Prostatectomy, Radiotherapy, HIFU) Focal treatment (HIFU) Salvage treatment (HIFU) • Advanced imaging and MR-targeted biopsies have improve
Slide 67: Where Is Focal Therapy For Prostate Cancer Today?
Where Is Focal Therapy For Prostate Cancer Today? • Inclusion in guidelines • Rapid increase in scientific publications • Participation in focal therapy instructional courses at national meetings
Slide 68: European Association of Urology Guidelines Include Focal Therapy
European Association Of Urology Has Changed Their Guidelines To Include Offering Focal Therapy (HIFU/Cryo) For Prostate Cancer Outside Of Clinical Trails – Now Within Prospective Registries.
Slide 69: Annual Scientific Publications Have Quadrupled
Annual Scientific Publications Have Quadrupled In The Last 2 Decades 1,609 474
Slide 70: AUA Courses In Focal Therapy Fully Registered
American Urological Association Offered 2 Courses In Focal Therapy For Prostate Cancer And Both Sessions Were Fully Registered
Slide 71: My Experience With Commercial Utilization of the Focal One Device
My Experience With The Commercial Utilization Of The Focal One® Device Advantages • Leading technology among competition in efficiency and decreased treatment time per treatment • The robotic positioning system provides highly reproducible targeting with submillimeter accuracy and automated treatmen
Slide 72: Slide 72
Slide 73: Data: Oncologic Efficacy
Data: Oncologic Efficacy No evidence of clinically significant prostate cancer in the targeted area in 93% of patients at 12 months Table 1: Recurrences identified on 12-month follow up prostate biopsy. Whole gland 12-month biopsy In-field (12-month biopsy) Oncological efficacy No evidence of GG >=2
Slide 74: Data: Quality of Life
Data: Quality of Life • Good or moderate erectile function reported in 90% of patients with or without medications at 12 months. • No incontinence requiring pads reported at 12 months. Characteristic N Baseline N 3-month 6-month 12-month = 76 (2-4 months) N = 56 (4-9 months) N = 44 (9-15 months) N =
Slide 75: Conclusions
Conclusions • Data supports offering focal therapy as a viable treatment option for select (and growing population) of patients with prostate cancer • Rapid adoption in academic hospitals enables a pipeline of residents and medical students exposed to focal therapy • Inclusion of focal therapy in ac
Slide 76: Thank you for your attention
Thank you for your attention
Slide 77: Innovation & Advanced Technologies
Innovation & Advanced Technologies Steve Annen, EVP Product Management 77
Slide 78: The Focal One Robotic HIFU Advantage
The Focal One Robotic HIFU Advantage Validated by Surgeons, Proven in Practice Easy-To-Use Ongoing Commitment Accurate Treatment Precision HIFU Workflow with to Invest in Clinician- Targeting Energy Ablation Treatment Versatility Driven Innovation 78
Slide 79: Purpose Built for Precision Focal Therapy
Purpose Built for Precision Focal Therapy: Seamless Integration of Technologies Mature Dynamic High Precision Software Focusing Resolution Robotics Driven Probe Imaging Workflow 79
Slide 80: Scalable Focal One Platform Enables Simultaneous Innovation
Scalable Focal One Platform Enables Simultaneous Innovation Precision Advanced Focused Imaging Ultrasound Remote Robotics Connectivity AI-Driven Treatment 80
Slide 81: Scalable Focal One Platform Enables Simultaneous Innovation
Scalable Focal One Platform Enables Simultaneous Innovation Precision Advanced Focused Imaging Ultrasound Remote Robotics Connectivity AI Driven Treatment 81
Slide 82: Open Platform for Advanced Imaging Driven Treatment
Open Platform for Advanced Imaging Driven Treatment NEW Launch 2024 2024-2025 2025-2026 2026 AI Treatment Planning PSMA PET TELIX MRI 3D Biopsy PSMA PET Pharmaceuticals Collab 82
Slide 83: Scalable Focal One Platform Enables Simultaneous Innovation
Scalable Focal One Platform Enables Simultaneous Innovation Precision Focused Advanced Ultrasound Imaging Remote Robotics Connectivity AI-Driven Treatment 83
Slide 84: AI Integration Shaped by Clinician Feedback
AI Integration Shaped by Clinician Feedback Mapping of Real-Time Ability to Cancer & Critical Monitoring of Assess Tissue Structures Anatomy Ablation 84
Slide 85: Scalable Focal One Platform Enables Simultaneous Innovation
Scalable Focal One Platform Enables Simultaneous Innovation Precision Advanced Focused Imaging Ultrasound Remote Robotics Connectivity AI Driven Treatment 85
Slide 86: FocalConnect
FocalConnect Focal One Uniquely Designed for High-Fidelity Focal Therapy Telecollaboration Completely Integrated Leveraging Existing Digital Platform Hospital Networks Broadens Patient Access to Focal Therapy 86
Slide 87: World's First Transcontinental Focal One HIFU Telecollaboration
World’s First Transcontinental Focal One HIFU Telecollaboration 7,000+ miles Cleveland Abu Dhabi Dr. Oliveras “After a while I forgot I was doing a remote surgery.” Dr. Hassen “[Dr. Oliveras] was enabled to seamlessly perform the procedure from beginning to end without my intervention.” Leveraged Ho
Slide 88: FocalConnect
FocalConnect Enabling a New Paradigm in Focal Therapy Telecollaboration Dual Console (Operating Room) Across Hospital Campus Regional Hospital Network 88
Slide 89: FocalConnect
FocalConnect Enabling a New Paradigm in Focal Therapy Telecollaboration Dual Console Regional Hospital Across Hospital Campus Network (Operating Room) 89
Slide 90: FocalConnect
FocalConnect Enabling a New Paradigm in Focal Therapy Telecollaboration Dual Console Same Hospital Campus Across Hospital Campus Regional Hospital Networks (Operating Room) Real-Time Consults 90
Slide 91: FocalConnect
FocalConnect Enabling a New Paradigm in Focal Therapy Telecollaboration Operating Room Across Hospital Campus Regional Hospital Networks 91
Slide 92: FocalConnect Accelerates the Sharing of Best Practices
FocalConnect Accelerates the Sharing of Best Practices in Broadening Patient Access to Expert Care Dr. Jihad Kaouk, MD Enterprise Chair of Urology Cleveland London Akron Abu Dhabi Florida “This innovative approach [with Focal One Robotic HIFU] not only allows us to share expertise across Cleveland C
Slide 93: Scalable Focal One Platform Enables Simultaneous Innovation
Scalable Focal One Platform Enables Simultaneous Innovation Precision Advanced Focused Focused Ultrasound Imaging Ultrasound Remote Robotics Connectivity AI Driven Treatment 93
Slide 94: Lithotripsy, Histotripsy and HIFU
Lithotripsy Histotripsy HIFU Pressure Pressure Pressure Time Time Time • Very Short Shock Pulse • Short Pulse Bursts • Long Pulse (Continuous Wave) Mechanism & Tissue Effect: Tissue Effect: Non-Thermal Tissue Effect: Thermal Coagulative Mechanical Stress Causes Cracks and Mechanical Fractionation of
Slide 95: Histotripsy: Leveraging Focal One HIFU Transducer
Histotripsy Leveraging Focal One HIFU Transducer Histotrip sy-related tec hnologies an d applications are u nder development an d may require addition al testing, 95 validation, and regulatory au thorization p rior to commercialization. 95
Slide 96: Histotripsy: Leveraging Focal One Treatment Workflow
Histotripsy Leveraging Focal One Treatment Workflow 96 96
Slide 97: Scalable Focal One Platform Enables Simultaneous Innovation
Scalable Focal One Platform Enables Simultaneous Innovation HIFU & Advanced Histotripsy Imaging Remote Robotics Connectivity AI-Driven Treatment 97
Slide 98: Focal One HIFU and Histotripsy
Focal One HIFU and Histotripsy HIFU 98
Slide 99: Focal One HIFU and Histotripsy
Focal One HIFU and Histotripsy HIFU Histotripsy 99
Slide 100: Focal One HIFU and Histotripsy
Focal One HIFU and Histotripsy HIFU Histotripsy 100
Slide 101: Focal One HIFU and Histotripsy: Novel Intellectual Property
Focal One HIFU and Histotripsy Actively Developing and Filing Novel Intellectual Property Covering The Unique Combination of HIFU and Histotripsy to Strengthen our IP Portfolio HIFU HIFU + Histotripsy Histotripsy 101
Slide 102: Scalable Focal One Platform Enables Simultaneous Innovation
Scalable Focal One Platform Enables Simultaneous Innovation HIFU & Advanced Histotripsy Imaging Remote Robotics Connectivity AI-Driven Treatment 102
Slide 103: Focal One Robotic Focal Therapy Difference
Focal One Robotic Focal Therapy Difference Advanced Imaging with PSMA PET Most Compatible Precise Energy Delivery Training and Telecollaboration via FocalConnect Easiest to Learn, Use & Teach AI-Assisted Treatment & Ablation Assessment Minimal OR Staffing Expanding Focal One to a Single Platform to
Slide 104: Positioned for Growth: A Pure-Play HIFU Company
Positioned for Growth A Pure-Play HIFU Company Ken Mobeck, CFO 104
Slide 105: Commitment to HIFU Portfolio
Commitment to HIFU Portfolio Accelerating Our Growth Engine EDAP Revenue ($M) HIFU Revenue ($M) Strategic Emphasis Away from Non-Core 7% ~40% Y/Y $80 3-Yr CAGR Growth $70 $24 Non-Core $60 $33 +32% $50 $44 3-Yr CAGR $43 $40 $42 $30 HIFU $52 $52 $20 $37 $37 $22 $26 $22 $26 $10 $16 $16 $- CY22 CY23 CY2
Slide 106: CY 2026 Updated Revenue Guidance
CY 2026 Updated Revenue Guidance Reiterating HIFU Only Guidance (Non-Core Classified to Discontinued Operations) Revenue Guidance ($M) Benefits of HIFU Focus Non-Core • Accelerated Revenue Growth $24 $22-$26 • Higher Gross Margins HIFU HIFU • Lower Operating Expenses $50-$54 $52 $50-$54 $52 • Pathwa
Slide 107: Long-Term Target Revenue Growth Model
Long-Term Target Revenue Growth Model Focal One System Placements & Procedure Volumes Remain Primary Catalysts HIFU Revenue ($M) Growth Drivers • Continued Penetration into Core U.S. Markets ~40% • International Expansion into New Markets 3-Yr CAGR • Procedure Volumes Growth +32% 3-Yr CAGR • Continu
Slide 108: Opportunities to Drive Operating Leverage
Opportunities to Drive Operating Leverage Levers to Drive HIFU Target Gross Margin to ~60% HIFU Gross Margin (%) Levers • Bill of Materials Optimization (850 bps) ~ +1200 bps 60% • Continued Strong Capital Unit Growth 50% ~60% • Procedure Volumes Driving Consumables 40% 30% 56.6% 50.9% 51.5% 48.1% •
Slide 109: Disciplined Operating Expense Investment
Disciplined Operating Expense Investment Operating Leverage Driven by Revenue Growth, Efficiency Gains and Platform Extendibility HIFU Operating Expenses ($M) Priorities 67 160% 57 140% • R&D Investments to Expand Indications 120% 47 and Unlock New Markets 100% • BPH 37 80% • Artificial Intelligence
Slide 110: 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 $37M ~ 40%+ 3-Yr CAGR Revenue (+/- 3%) Gross Margin 48.1% ~60% (+/- 200 bps) Operating Income ($21M) Breakeven EBITDA ($19M) Positive I
Slide 111: Closing Remarks
Closing Remarks FocalTherics
Slide 112: 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 112
Slide 113: Thank You
Thank You FocalTherics.com [email protected] 113