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1 The Global Leader in Therapeutic Ultrasound
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2 Statements & Disclaimer F O R W A R D - L O O K I N G 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,” the “Company,” “we,” “us,” and “our” refer to EDAP TMS S.A. and its consolidated subsidiaries. This presentation may be used in conjunction with an oral presentation and should be considered in that context. The information contained in this presentation speaks only as of the date presented and reflects management’s current expectations as of such date. The Company undertakes no obligation to update or revise any information contained herein, except as required by applicable law. The continued availability of this presentation on the Company’s website or elsewhere does not imply that the information remains accurate as of any date after the date hereof. This presentation is not, and shall not be deemed to be, filed with or incorporated by reference into any filing of the Company with the U.S. Securities and Exchange Commission (the “SEC”). Forward-Looking Statements This presentation contains forward-looking statements within the meaning of applicable U.S. federal securities laws, including Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements include, among others, statements regarding the Company’s business strategy, anticipated growth and expansion, market opportunities, product development and commercialization, clinical and regulatory activities, and expectations regarding future operating and financial performance. Forward-looking statements may be identified by words such as “believe,” “can,” “could,” “contemplate,” “expect,” “estimate,” “forecast,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “will,” and similar expressions, including their negative or other variations. These statements are based on management’s current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially include, among others: market acceptance of the Company’s High Intensity Focused Ultrasound (“HIFU”) systems and therapies; the rate and degree of adoption of the Company’s products; the availability and adequacy of reimbursement and payment policies; competition; the Company’s ability to obtain and maintain required regulatory clearances and approvals, including for additional indications; the development and protection of intellectual property; the successful initiation and completion of clinical studies; the Company’s ability to successfully discontinue and wind down its ESWL and Distribution operating segments, including the potential costs, timing, disputes, and other consequences associated with such activities; and general economic, political, financial, geopolitical, inflationary, climate-related, and public health conditions and their effects on the Company’s business and demand for its products and services. Additional risks and uncertainties are described in the Company’s filings with the SEC, including under the headings “Cautionary Statement on Forward-Looking Information” and “Risk Factors” in the Company’s Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Market and Industry Data This presentation contains estimates and other statistical data relating to market size, market growth, the Company’s industry, and other matters that have been obtained from independent third parties and sources as well as from the Company’s own estimates. Such information involves assumptions and limitations. The Company has not independently verified all third-party information and makes no representation as to its accuracy or completeness. Projections, assumptions, and estimates regarding future performance are inherently subject to significant uncertainties and risks. Clinical Information FocalTherics is a medical device manufacturer and does not recommend specific treatment approaches. Clinical information presented herein is provided for informational purposes only and should not be construed as medical advice or as a recommendation for any particular patient or treatment. Individual patient outcomes may vary. Physicians should use their independent clinical judgment in determining appropriate treatment for individual patients. Trademarks FocalTherics , Focal One®, HIFUsion®, and other marks used herein are trademarks of the Company or its affiliates. All other trademarks are the property of their respective owners.
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3 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
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4 4 Commitment to Focal Therapy $16M $22M $26M $37M $52M 0 10000 20000 30000 40000 50000 60000 CY22 CY23 CY24 CY25 CY26E HIFU Note: CY26E = Midpoint of CY26 Guidance Range Reiterated on August 13, 2026 +32% 3 yr CAGR 40% Y/Y Growth HIFU Revenue ($) F O C U S I N G O N A C C E L E R A T I N G O U R G R O W T H E N G I N E
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5 Scalable Focal One Platform Enables Simultaneous Innovation Advanced Imaging Robotics HIFU & Histotripsy AI-Driven Treatment Remote Connectivity
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6 6 6 Annual Global Prostate Diagnoses Will DOUBLE by 2040 3 2.9M Cases 1.4M Cases 20402020 >3.5 Million Men Living with Prostate Cancer in the U.S. 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. [1] 2026 estimates from the American Cancer Society (www.cancer.org) [2] 2022 estimates from the World Health Organization [www.who.int/ ] [3] James N, Tannock I, N'Dow J et al. The Lancet Commission on prostate cancer: planning for the surge in cases. The Lancet, 2024; 403, 1683-1722
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7 The Large Gap Between No Treatment and Radical Treatment Low Risk ~30% of patients1 Intermediate Risk ~50% of patients High Risk ~20% of patients No Treatment Active Surveillance Radiation or Organ Removal Radical or Salvage Treatment Previously, There Have Been No Options, Other Than Active Surveillance or Radical Treatments, to Address Intermediate Risk Patients [1] Fletcher, Sean A et al. “Contemporary national trends in prostate cancer risk profile at diagnosis.” Prostate cancer and prostatic diseases vol. 23,1 (2020): 81-87. doi:10.1038/s41391-019-0157-y
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8 Prostate Cancer Patient Value Equation F O C A L O N E® R O B O T I C H I F U PROVEN EFFICACY QUALITY OF LIFE PRESERVATION HIGH LOW HIGH Radiation (Urinary and Sexual Function Outcomes) Focal One Robotic HIFU Active Surveillance Surgery (Cancer Control) Radical Treatments
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9 Low - 1 Session, Same Day Outpatient Procedure Focal One® Robotic HIFU 95%(1) ORGAN-PRESERVING STRATEGY WHOLE-GLAND RADICAL TREATMENT STRATEGY CANCER CONTROL QUALITY OF LIFE PATIENT BURDEN Treatment Comparison Focal One HIFU Provides the Optimal Organ-Preserving Patient Treatment FUNCTIONAL OUTCOMES Continence Preservation 96%(3) Erectile Function Preservation 82%(3) Ejaculation Preservation - Risk of Complications Low Typical Complications - Treatment Process - Active Surveillance 10-year Cancer Specific Survival N/A (*) Hospital stay duration for radical prostatectomy may vary ( 1) Yeh, HTet al.10-year oncological outcomes of EBRT versus HIFU for stage II prostate cancer: a multicenter C hang Gung researc h database (CGRD) study with inverse-probability-of-treatment weighting (IPTW) analysis.Int Urol Nephrol(2025). ( 2) Stensland KD et al. National Long-term Survival Esti mates After Radi cal Prostatectomy for Prostate Cancer. Urology. 2024 Feb;184:135-141. ( 3) Donovan JL, et al. Patient-Reported Outcomes after Monitori ng, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13. ( 4) Sull ivan JF et al . Ejaculati on profiles of men followi ng radiation therapy for prostate cancer. J Sex Med. 2013 May;10(5):1410-6. ( 5) Arnouil, N., et al. "Trai tement foc al par HIFU versus prostatectomie radicale robot-assistée pour c ancer de la prostate localisé: résul tats carc inologiques et foncti onnel s à 1 an."Progrès en Urologie28.12 (2 018): 603-610. ( 6) von Hardenberg J et al. Prostate cancer treatment by the latest focal HIFU devi ce with MRI/TR US-fusion control biopsies: A prospec tive evaluation. Urol ogic Onc ol ogy: Seminars and O riginal Investigations, Volume 36, Issue 9, 2 018, Pages 401.e1-401.e9 98%(5) 93%(5) 96%(6) 96%(3) 75%(3) 49%(3) 69%(3) 28%(4) 0% Medium High Radiation Toxicity, Risk of Secondary Cancers Blood Loss and Other Surgical Complications 45 Sessions 45 Visits 1 Session 1-Day Hospital Stay (*) 91%(1) 99%(2) Radiation Surgery Radical Prostatectomy
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10 Active Surveillance Focal Therapy | The New Emerging Market D R I V I N G A P A R A D I G M S H I F T I N P R O S T A T E C A N C E R [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 estimates 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) Active Surveillance Radical Prostatectomy (Surgery) Radiation Therapy Focal Therapy (HIFU) Focal Therapy Expected to Grow to ~40% of the Market
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11 [1] Based on Medicare claims utilization data published by CMS in connection with the Hospital Outpatient Prospective Payment System (HOPPS) Proposed Rules for CY 2023–CY 2027. [2] IRE and TULSA treatment volumes may include procedures other than prostate treatment, as applicable billing codes are not historically prostate-specific. HIFU Fastest Growing Focal Therapy Treatment1 #1 Ablation Technology for Prostate Cancer HIFU Cryo TULSA2 2021 2022 2023 2024 2025 IRE (all organs)2
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12 Hospital Outpatient Medicare Payment Medicare Payment (National Average). From CMS Hospital Outpatient Prospective Payment System – CY27 Proposed Rule and CY26 Final rule Procedure CPT® Code 2027 Payment (Proposed) Prostate Brachytherapy 55875 $6,292 Cryo Ablation 55873 $10,797 HIFU 55880 $10,797 Laparoscopic/Robotic Prostatectomy 55866 $12,300 +11.6%
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13 Favorable Physician Payment Based on CMS Physician Fee Schedule – CY 2026 Final rule Procedure CPT® Code Work RVU (2026) Physician Payment (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/Robotic Prostatectomy 55866 21.90 $1,087
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F O C A L O N E A D O P T I O N A C C E L E R A T I N G At Major U.S. Hospitals 96 Focal One Systems as of Jun. 30, 2026 (44 Academic – 52 Community) 14
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F O C A L O N E A D O P T I O N A C C E L E R A T I N G At Major U.S. Hospitals 96 Focal One Systems as of Jun. 30, 2026 (44 Academic – 52 Community) 15 96 Focal One Systems as of Jun. 30, 2026 300+ Hospitals in Sales Pipeline
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FOCAL ONE MOBILE SITES FOCAL ONE FIXED SITES F O C A L O N E A D O P T I O N A C C E L E R A T I N G At Major International Hospitals 88 Focal One Systems as of Jun. 30, 2026 254 Focal One Treatment Clinical Sites 16
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17 S I N G L E P L A T F O R M , M U L T I P L E I N D I C A T I O N S Benign Prostatic Hyperplasia (BPH) Deep Infiltrating Endometriosis 38M Women Living with Deep Infiltrating Endometriosis Globally2,3,4,5 783,000+ Patients Diagnosed with Deep Rectal Endometriosis Globally 2,3,4,5 100+ Million1 Men Living with BPH Globally 13+ Million1 New Cases Diagnosed Annually, Globally [1] Chen X, Yang S, He Z, Chen Z, Tang X, Lin Y, Huang Y, Hou J, Wei X. Comprehensive analysis of the global, regional, and national burden of benign prostatic hyperplasia from 1990 to 2021. Sci Rep. 2025 Feb 15;15(1):5644. doi: 10.1038/s41598-025-90229-3. PMID: 39955408; PMCID: PMC11830103. [2] Abrão MS, Petraglia F, Falcone T, Keckstein J, Osuga Y, Chapron C. Deep endometriosis infiltrating the recto-sigmoid: critical factors to consider before management. Human Reproduction Update, 2015; 21(3):329-339. [3] Wenwei Li, Huiyan Feng, Qingjian Ye. Factors contributing to the delayed diagnosis of endometriosis — a systematic review and meta-analysis. Frontiers in Medicine, 2025; doi: 10.3389/fmed.2025.1576490. [4] Agarwal SK, Chapron C, Giudice LC, et al. Clinical diagnosis of endometriosis: a call to action; underdiagnosis estimated at up to 60%. Della Corte L et al, 2020; cited in scoping review 2024. [5] United Nations, Department of Economic and Social Affairs, Population Division. World Population Prospects 2024. Women aged 15-49 by country, 2024 mid-year estimates. Expanded Indications of Focal One
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18 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 1.7 M (Global) Prostate Cancer BPH Endometriosis > 4.3M [1] Management Estimates; data on file. Procedures
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19 19 Q2 2026 Financial Highlights $13.2M HIFU Revenue 39% Y/Y Growth 44% Y/Y Growth 13 Focal One System Sales 184 Global Installed Base E S W L & D I S T R I B U T I O N N O W C L A S S I F I E D U N D E R D I S C O N T I N U E D O P E R A T I O N S 47% Y/Y Procedure Volume Growth 55.6% Gross Margin +444 bps Y/Y
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20 20 Supported by Recent $43M+ Equity Raise (Aug. 2026) to Fund Execution CY25 Actual CY28E Target Range $37M ~ 40%+ 3-Yr CAGR (+/- 3%) 48.1% ~60% (+/- 200 bps) ($21M) Breakeven ($19M) Positive 166 ~ 30%+ 3-Yr CAGR (+/- 5%) Revenue Gross Margin Operating Income EBITDA Installed Base 2028E Target Model Financial Framework Focused on Driving Positive EBITDA and Breakeven Operating Income to Deliver Shareholder Value Note: E = Estimate
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21 The Global Leader in Therapeutic Ultrasound