Edap Tms SA · NASDAQ:FOCL
Edap Tms SA — Q2 2026 Earnings Presentation
45 slides from Edap Tms SA's earnings presentation, Aug 11, 2026
Slide 1: Global Leader in Therapeutic Ultrasound
1 Global Leader in Therapeutic Ultrasound
Slide 2: Statements & Disclaimer
Statements & Disclaimer This presentation has been prepared by EDAP TMS S.A, ("EDAP,” “EDAP TMS," the “Company,” “we" or “us” or "our’). This presentation, and its contents and the accompanying discussion with management are confidential and may not be further copied, distributed or passed on, direc
Slide 3: Rebrand to FocalTherics, Investor Day and core focus
3 • Rebranded to FocalTherics (NASDAQ: FOCL) • Executed Successful NASDAQ MarketSite Investor Day on June 1 • Announced Core Focus on High -Growth Robotic Focal Therapy • Shift of Reporting Legacy Non -Core ESWL and Distribution Financials To Discontinued Operations Effective Q2'26
Slide 4: Global Leader in Therapeutic Ultrasound
4 Global Leader in Therapeutic Ultrasound Redefining the Treatment of Cancer and Benign Disease through Organ Sparing, Function Preserving Focal Therapy
Slide 5: Preliminary Q2'26 Financial Results & Key Business Updates
5 Preliminary Q2’26 Financial Results & Key Business Updates Growing Commercial Momentum: ✓ Strong commercial execution with record second quarter HIFU Revenue ✓ Accelerated adoption across leading hospital networks with four additional health systems purchasing a second or subsequent system during
Slide 6: Large and Growing Market Opportunities In Prostate Cancer, BPH and Endometriosis
6 Large and Growing Market Opportunities In Prostate Cancer, BPH and Endometriosis
Slide 7: Focal One Platform Expansion Opportunity Represents a TAM of 4.3M+ Procedures
7 1.5M (O.U.S) 400K (U.S.) 235K (U.S.) 480K (O.U.S) Focal One Platform Expansion Opportunity Represents a TAM of 4.3M+ (1) Procedures and $10B+ Revenue >4.3M Procedures 1.7 M Procedures (Global) Prostate Cancer BPH Endometriosis [1] Management Estimates; data on file.
Slide 8: Focal One Answers an Unmet Need for a Large Underserved Patient Population
8 8 Focal One Answers an Unmet Need for a Large Underserved Patient Population PROSTATE CANCER Focal One HIFU Focal One HIFU
Slide 9: Prostate Cancer Patient Value Equation
9 Prostate Cancer Patient Value Equation FOCAL ONE ® ROBOTIC HIFU PROVEN EFFICACY QUALITY OF LIFE PRESERVATION HIGH LOW HIGH Radiation (Urinary and Sexual Function Outcomes) Focal One Robotic HIFU Active Surveillance Surgery (Cancer Control)
Slide 10: Focal Therapy | The New Emerging Market
10 10 Focal Therapy |The New Emerging Market DRIVING A PARADIGM SHIFT IN PROSTATE CANCER (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 estimates Active Surveillanc
Slide 11: HIFU | The Fastest Growing Treatment Option
11 HIFU |The Fastest Growing Treatment Option DRIVING A PARADIGM SHIFT IN PROSTATE CANCER Based on Medicare claims data reported by CMS in the HOPPS Final Rules for FY2024 –FY2026.. As CMS publishes claims data on a retrospective basis, the CAGR shown reflects growth over the 2022 –2024 claims perio
Slide 12: Prostate Cancer Treatment Modalities
12 [1] Based on Medicare claims utilization data published by CMS in connection with the Hospital Outpatient Prospective Payment Sy stem (HOPPS) Proposed Rules for CY 2023 –CY 2027. [2] IRE and TULSA treatment volumes may include procedures other than prostate cancer treatment, as applicable billing
Slide 13: Strong Supporting Clinical Evidence
13 Strong Supporting Clinical Evidence
Slide 14: Proven Clinical Evidence Supporting Focal One Robotic HIFU
14 14 Proven Clinical Evidence Supporting Focal One Robotic HIFU 1000+ Peer -Reviewed Publications Supporting HIFU in the Treatment of Prostate Cancer (1) 3. Preserve Sexual Function 2. Maintain Urinary Control 1. Cancer Control Optimizing Trifecta Outcomes for Prostate Cancer (1) PubMed Database se
Slide 15: Prostate Cancer Treatment Comparison
15 Low - 1 Session, Same Day Outpatient Procedure Focal One ® Robotic HIFU 95% (2) ORGAN -PRESERVING STRATEGY WHOLE -GLAND RADICAL TREATMENT STRATEGY CANCER CONTROL QUALITY OF LIFE PATIENT BURDEN Prostate Cancer Treatment Comparison (1) Focal One HIFU Provides an Optimal Organ -Preserving Patient Tr
Slide 16: HIFI - Prospective Multicentric Comparative Study
16 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 patient
Slide 17: FARP - Randomized Controlled Trial
17 17 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 Outcome
Slide 18: HIFU Demonstrates Equivalent Survival to Radiation Therapy
18 18 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%) (1) Yeh, HT., Liu, YY., Chan
Slide 19: Strong Hospital and Physician Reimbursement
19 Strong Hospital and Physician Reimbursement
Slide 20: Strong And Growing HIFU Facility Payment
20 20 Strong And Growing HIFU Facility Payment (Medicare Payment (National Average). From CMS Hospital Outpatient Prospective Payment System – CY27 Proposed Rule and CY26 Fina l rule Procedure CPT ® Code 2027 Payment (Proposed) Prostate Brachytherapy 55875 $6,292 Cryoablation 55873 $10,797 HIFU 5588
Slide 21: Favorable HIFU Physician Payment
21 21 Favorable HIFU Physician Payment Based on CMS Physician Fee Schedule – CY 2026 Final rule Procedure CPT ® Code Work RVU (2026) Physician Payment (Medicare - 2026) Prostate Brachytherapy 55875 13.12 $693 Cryoablation 55873 13.26 $692 MRI Transurethral Ultrasound Ablation (TULSA) 55882 11.21 $53
Slide 22: Expanding Clinical Indications
22 Expanding Clinical Indications
Slide 23: Single Platform, Multiple Indications
23 23 Single Platform, Multiple Indications • Prostate Cancer • Benign Prostatic Hyperplasia (BPH) • Deep Infiltrating Endometriosis Focal One is currently being evaluated in a clinical study for treatment of benign prostatic hyperplasia (BPH). Not Available for Sale in U.S. Focal One has received C
Slide 24: Benign Prostatic Hyperplasia
24 Benign Prostatic Hyperplasia 24 Normal Prostate Compressed Urethra Enlarged Prostate 100M+ Men Living with BPH Globally 13M+ New Cases Diagnosed Annually, Globally 600,000+ New Cases Diagnosed in the U.S. [1] Chen X, Yang S, He Z, Chen Z, Tang X, Lin Y, Huang Y, Hou J, Wei X. Comprehensive analys
Slide 25: BPH Clinical Advantages and Regulatory Pathway
25 25 • Non -Invasive, Urethra -sparing • No Bleeding • No Foreign Body • No Impairment of Sexual or Ejaculatory Function Promising Clinical Advantages • Leverages Existing Prostate Tissue Ablation Indication • New CPT Category 3 Code Specific to Transrectal HIFU for BPH Potential For a Straightforw
Slide 26: Deep Infiltrating Endometriosis
26 Deep Infiltrating Endometriosis Endometriosis Lesions Infiltrating the Rectal Wall 38M Women Living with Deep Infiltrating Endometriosis Globally 1,2,3,4,5 783,000+ Patients Diagnosed with Deep Rectal Endometriosis Globally 1,2,3,4,5 225,000+ Patients Diagnosed with Deep Rectal Endometriosis in U
Slide 27: Focal One Solves an Unmet Need in Women's Health
27 27 • No Surgery • No Incision • No Blood Loss • Quick Return to Normal Activities Promising Clinical Advantages • Active CE Mark • Commercial Launch initiated in 5 countries • FDA -Granted Breakthrough Device Designation Key Regulatory Milestones • Expands Use of Focal One into Women’s Health • S
Slide 28: Focal One Adoption Accelerating At Major European Hospitals
FOCAL ONE ADOPTION ACCELERATING At Major European Hospitals 28 European Clinical Sites in Endometriosis Training Pathway
Slide 29: Technology Leadership & Innovation
29 Technology Leadership & Innovation
Slide 30: Non-Invasive: No Surgery, No Cutting, No Radiation
30 Non -Invasive No Surgery No Cutting No Radiation
Slide 31: HIFU, Advanced Imaging, Precise Robotic Energy Delivery
31 High -Intensity Focused Ultrasound (HIFU) Advanced Imaging Precise Robotic Energy Delivery Organ Sparing, Function Preserving
Slide 32: Focal One Proprietary Integrated Technologies
32 32 Focal One Proprietary Integrated Technologies Robotics Advanced Imaging Artificial Intelligence (AI) Tele - Collaboration
Slide 33: Leading in Therapeutic Ultrasound
33 33 Leading in Therapeutic Ultrasound
Slide 34: HIFU + Histotripsy on a Single Platform
34 34 Leading in Therapeutic Ultrasound HIFU + Histotripsy Ideally Positioned to Combine HIFU and Histotripsy on a Single Platform with an Established, Non -Invasive Treatment Workflow
Slide 35: Focal One Proprietary Integrated Technologies with Histotripsy
35 35 Focal One Proprietary Integrated Technologies Robotics HIFU Advanced Imaging Artificial Intelligence (AI) Tele - Collaboration HIFU + Histotripsy
Slide 36: Accelerating Global Focal One Adoption
36 Accelerating Global Focal One Adoption
Slide 37: Adopted by Major U.S. Hospitals: 96 Systems
37 37 LEADING FOCAL THERAPY Adopted by Major U.S. Hospitals 96 Focal One Systems as of June 30, 2026 (44 Academic – 52 Community)
Slide 38: 96 Systems and 300+ Hospitals in Sales Pipeline
38 38 LEADING FOCAL THERAPY Adopted by Major U.S. Hospitals 96 Focal One Systems as of June 30, 2026 300+ Hospitals in Sales Pipeline
Slide 39: Focal One Adoption Accelerating at Major European Hospitals
FOCAL ONE MOBILE SITES FOCAL ONE FIXED SITES FOCAL ONE ADOPTION ACCELERATING At Major European Hospitals 39 41 Focal One Systems as of Dec. 31, 2025 254 Focal One Treatment Clinical Sites
Slide 40: Company Highlights
Focal Company Highlights
Slide 41: Company Highlights
41 • An Established and Growing Commercial Foundation With Expanding Adoption In Prostate Cancer and A Clear Path to Deeper Market Penetration Across Global Markets • Differentiated Technology Leadership in HIFU Supported by Continued Innovation to Include Robotic Histotripsy, With Clinical Differen
Slide 42: Annex
Focal Annex
Slide 43: Preliminary Unaudited Estimated Financial Results, Six Months Ended June 30, 2026
43 Preliminary Unaudited Estimated Financial Results as of and for the Six Months Ended June 30, 2026
Slide 44: Preliminary unaudited estimated financial results tables
44 44 The following tables provide detail on our preliminary unaudited estimated financial results as of and for the six months ended June 30, 2026 :
Slide 45: Global Leader in Therapeutic Ultrasound
45 Global Leader in Therapeutic Ultrasound