FocalTherics (NASDAQ: EDAP) details HIFU focus, 2026 guidance and CY28 goals
Rhea-AI Filing Summary
EDAP TMS, operating as FocalTherics, used its 2026 Investor Day to lay out a pure‑play HIFU strategy and updated financial framework. The company is moving its ESWL and Distribution businesses to discontinued operations from Q2 2026 and focusing on its Focal One robotic focal therapy platform.
HIFU revenue grew from $16M in 2022 to $37M in 2025, and guidance for calendar 2026 is $50–$54M, implying about 40% year‑over‑year growth and a 32% three‑year CAGR. Management targets HIFU gross margin of roughly 60% and a pathway to breakeven operating income and positive EBITDA in 2028, driven by installed‑base expansion and procedure growth.
The presentation highlights accelerating adoption of Focal One in prostate cancer, with 91 systems in the U.S. and 41 in Europe, reimbursement support including a Cat. 1 CPT code and 2026 Medicare outpatient payment of $9,671 for HIFU, and indication expansion opportunities in benign prostatic hyperplasia and deep infiltrating endometriosis that together contribute to a stated total addressable opportunity of more than four million annual procedures and over $10B in potential revenue.
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Insights
FocalTherics is repositioning as a focused HIFU growth story with 2026 guidance and 2028 profitability targets.
FocalTherics is concentrating on High Intensity Focused Ultrasound by classifying ESWL and Distribution as discontinued operations from Q2 2026. HIFU revenue increased from $16M in 2022 to $37M in 2025, with $50–$54M guidance for 2026, implying about 40% year‑over‑year growth and a 32% three‑year CAGR.
Management’s model targets HIFU gross margin of roughly 60% versus 48.1% in 2025, relying on mix shift to capital and consumables, pricing discipline, and utilization. They also outline a path to breakeven operating income and positive EBITDA in 2028, contingent on continued system placements, procedure growth, and operating‑expense leverage.
Strategically, the company is leaning on clinical data, reimbursement support (including a Cat. 1 CPT code and $9,671 2026 Medicare outpatient payment for HIFU), and expansion into BPH and deep infiltrating endometriosis. Execution on indication clearances, clinical evidence, and adoption at high‑volume centers will determine whether the projected growth and margin trajectory are achieved.
8-K Event Classification
Key Figures
Key Terms
High Intensity Focused Ultrasound medical
Cat. 1 CPT Code regulatory
deep infiltrating endometriosis medical
Histotripsy medical
FocalConnect technical
ESWL medical
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| Item 7.01 | Regulation FD Disclosure. |
As previously announced, spokespersons of EDAP TMS S.A. (the "Company") presented the information in the presentation attached hereto as Exhibit 99.1 at the FocalTherics Investor Day on June 1, 2026, which commenced at 8:00 a.m. ET and was open to all participants via live webcast through the Events and Presentations section of the Company's Investor Relations website. A replay of the webcast and associated slide presentation is available on the Company's website.
The information in this item and item 9.01 of this Form 8-K, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | FocalTherics Investor Day Presentation dated June 1, 2026 | |
| 104 | Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EDAP TMS S.A. | |||
| Date: June 1, 2026 | By: | /s/ Sanket Shah | |
| Sanket Shah | |||
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General Counsel and Corporate Secretary
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Exhibit 99.1
2026 Investor Day Nasdaq (FOCL) June 1, 2026 1
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," and "our" refer to EDAP TMS S.A., operating under the corporate name FocalTherics (Nasdaq: FOCL). The information contained in this presentation speaks only as of the date this presentation is made, is preliminary, subjectto change, and reflects management's current expectations as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this presentation,to conform these statements to actual results, or to make changes in the Company’s expectations, except as required by applicable law. In addition to historical information, this presentation contains forward - looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S. Securities Exchange Act of 1934. These include statements regarding the Company’s business strategy, expected progress, expectations related to the Company’s product candidates to treat various conditions, growth and expansion plans. Forward - looking statements may be identified by words such as "believe," "can," "contemplate," "could," "plan," "intend," "may," "might," "potential," "objective," "target," "project," "predict," "forecast," "guideline," "should," "will," "estimate," "expect," and "anticipate," or their negative or similar expressions. These statements reflect management's current expectations regarding future events andfinancial performance. Forward - looking statements are subject to inherent risks and uncertainties, including matters not yet known to us or not currently considered material by us, that could cause actual results to differ materially from those expressed or implied. Important factors that could cause actual results to differ materially include, among others, the clinical status and market acceptance of the Company's High Intensity Focused Ultrasound (“HIFU”) devices; risks associated with the intended discontinuation of the Company's Extracorporeal Shock Wave Lithotripsy (“ESWL”) and Distribution operating segments, including that the discontinuation may take longer or cost more than expected, may result in disputes with customers, distributors, employees or other counterparties, and may not produce the strategic benefits anticipated; the rate and degree of market acceptance of the Company's products and therapies; the establishment and maintenance of favorable reimbursement and payment policies; the effects of increased competition; the ability to obtain required regulatory approvals; the development and protection of intellectual property; the successful completion of clinical trials; and risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services. Additional risks are described in the Company's filings with the Securities and Exchange Commission, 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. This presentation and the accompanying oral presentation also contain estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. The Company has not independently verified the accuracy or completeness of the data contained in these industry publications and other publicly available information. The Company makes no representations as to the accuracy or completeness of that data. In addition, projections, assumptions, and estimates of ourfuture performance and the future performance of the markets in which we compete are necessarily subject to a high degree of uncertainty and risk. FocalTherics is a medical device manufacturer and cannot and does not recommend specific treatment approaches. The clinical data presented herein is intended for informational purposes only. Individual patient results may vary. Patients should consult their physician to determine the appropriate treatment for their individual circumstances. Certain physicians referenced in this presentation may have received consulting fees, research grants, or other compensationfrom FocalTherics. 2
Agenda Transformation of EDAP | Focal One ® Our Next Chapter as FocalTherics Commercial Leader in Robotic Focal Therapy: Prostate Cancer Clinical Expansion of Our Focal Therapy Platform: BPH and Endometriosis Clinical Experience with Focal One Robotic HIFU Innovation and Advanced Technologies Financials: Positioned for Growth Closing and Q&A RYAN RHODES CEO BEHFAR EHDAIE, MD, MPH Memorial Sloan Kettering Cancer Center STEVE ANNEN EVP Product Management KEN MOBECK CFO ALL 1 2 3 4 5 3
Transformation of EDAP | Focal One ® Ryan Rhodes, CEO Our Next Chapter as FocalTherics 4
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
16M 22M 26M 37M 52M 42M 43M 44M 33M 24M CY22 CY23 CY24 CY25 CY26E Commitment to Focal Therapy Focusing on Accelerating Our Growth Engine Moving Non - Core ESWL and Distribution Business to Discontinued Operations as of Q2 CY26 EDAP Revenue ($) 7% 3 yr CAGR HIFU Note: CY 26E = Midpoint o f CY26 Guidance Range 6 Non - Core
16M 22M 26M 37M 52M CY22 CY23 CY24 CY25 CY26E HIFU HIFU Revenue ($) 40% Y/Y Growth +32% 3 yr CAGR Commitment to Focal Therapy Focusing on Accelerating Our Growth Engine Note: CY 26E = Midpoint o f CY26 Guidance Range 7
Global Leader in Therapeutic Ultrasound Redefining the Treatment of Cancer and Benign Disease through Organ Sparing, Function Preserving Focal Therapy 8
Driving Growth Across Three Strategic Pillars 9 Scaling Commercial Execution in Prostate Cancer Expanding our Market Opportunity with Added Indications on the Focal One Platform Advancing Technological Innovation in HIFU and Beyond
10 Non - Invasive No Surgery No Cutting No Radiation
11 High - Intensity Focused Ultrasound (HIFU) Advanced Imaging Precise Robotic Energy Delivery Organ Sparing, Function Preserving
Defining, Building, and Leading the Category of Robotic Focal Therapy 12
Driving Commercial Success in Current Markets 13 Prostate Cancer
14 14 14 Annual Global Prostate Diagnoses Will DOUBLE by 2040 3 2.9M Cases 1.4M Cases 2020 2040 >3.5 Million Men Living with Prostate Cancer in the U.S. Prostate Cancer is the Most Common Cancer Among Men 1 >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.o rg ) 2 2022 estimates from the W orld Health Organization [ www.who .int / ] 3 James N, Tannock I, N'Do w J et al. The Lancet Commissio n on prostate cancer: planning for the surge in case s . The Lancet, 2024; 403, 1683 - 1722
The Shift from Radical Treatment to Focal Therapy Open Surgery Laparoscopic Surgery Robotic Surgery Robotic Focal HIFU Ablation Surgery is Still Surgery… Radiation is still Radiation… XRT Radiation IMRT Radiation SBRT Radiation 15 15
Loss of Urinary Control Treatment Complications & Recovery Treatment Effectiveness The Prostate Cancer Patient’s Dilemma A Diagnosis that Demands a Difficult Choice Active Surveillance Surgery Outcomes Radiation 16 Loss of Sexual Function
Prostate Cancer Patient Value Equation F O C A L O N E ® R O B O TI C HI F U HIGH LOW HIGH Radiation QUALITY OF LIFE PRESERVATION (Urinary and Sexual Function Outcomes) Focal One Robotic HIFU Active Surveillance Surgery PROVEN EFFICACY (Cancer Control) 17 Radical Treatments
Radical Surgery Organ - Sparing Radical Mastectomy Modified Radical Mastectomy Lumpectomy Open Radical Prostatectomy Robotic Radical Prostatectomy INCISION AREA INCISION AREAS Mastectomy = INCISION AREA REMOVED Prostatectomy = INCISION AREA REMOVED NO INCISIONS Robotic Focal HIFU Ablation 18 From Radical To Organ - Sparing Treatments The Evolution of Breast and Prostate Cancer Surgery
The Large Gap Between No Treatment and Radical Treatment Low Risk ~30% of patients 1 Intermediate Risk ~50% of patients High Risk ~20% of patients No Treatment Active Surveillance Radiation or Organ Removal Radical or Salve Treatment Previously, There Have Been No Options , Other Than Active Surveillance or Radical Treatments, to Address Intermediate Risk Patients 19 [1] Fletcher, Sean A et al. “Contempo rary national trends in prostate cancer risk pro fi le at diagnosis.” Pro state cancer and prostatic diseases vo l. 23,1 (2020): 81 - 87. doi:10.1038/s41391 - 019 - 0157 - y
The Large Gap Between No Treatment and Radical Treatment Low Risk ~30% of patients 1 Intermediate Risk ~50% of patients High Risk ~20% of patients Focal One HIFU Bridges the Gap Low and Intermediate Risk Patients Represent a >$4B TAM 2 No Treatment Active Surveillance Radiation or Organ Removal Radical or Salve Treatment [1] Fletcher, Sean A et al. “Contempo rary national trends in prostate cancer risk pro fi le at diagnosis.” Pro state cancer and prostatic diseases vo l. 23,1 (2020): 81 - 87. doi:10.1038/s41391 - 019 - 0157 - y [2] Company Data o n File 20
Focal Therapy Emerging Paradigm Shift in Treatment Options Past 1 Current 2 Future 2 Focal Therapy Focal Therapy Expected to Grow to ~ 40% of the Market Active Surveillance [1] As of 2013. Chen et al. Natio nal trends in the management of lo calized prostate cancer: A popul ation - based analysis 2004 - 2013. Prostate. [2] Company Data on File 21 Radiation Surgery Active Surveillance Radiation Surgery Active Surveillance Radiation Surgery
22 Transurethral Transperineal (Needle - Based) x Single Urologist x Precise Focused Ultrasound x Targeted Robotic Energy Delivery x Closest Proximity To Target Tissue x Urethra Sparing x No Bleeding î Requires MRI Suite and 2 nd Physician î Non - Focused Energy î Bleeding from Urethra and Tissue Damage î Punctures Through Perineum î Manual Placement and Positioning î Bleeding from Tissue Damage Focal One Transrectal HIFU Offers Superior Access, Precision, and Tissue Preservation Focal One Transrectal HIFU
23 1 Based on Medicare claims utilization data published by CMS in connecti on with the Hospital Outpatient Pro spective Payment System (HOPPS) Final Rules fo r CY 2021 – CY 2026. 2 IRE and TULSA treatment volumes may include procedures other than prostate cancer treatment, as applicable billing co des are not histo rically prostate - specific. 3 Company Data on File HIFU Fastest Growing Focal Therapy Treatment 1 #1 Ablation Technology for Prostate Cancer 2019 2020 2021 2022 2023 2024 HIFU Cryo IRE 2 TULSA 2 2025 3
24 Clinical Evidence Supports and Favors Focal One Robotic HIFU
25 Landmark Studies Demonstrate Positive Clinical Outcomes Supporting Focal One HIFU Therapy HIFU Demonstrated Superior Progression - Free Survival compared to Active Surveillance HIFI 1 European Urology HIFU vs Radical Prostatectomy HIFU Demonstrated High Cancer Control and Superior Continence and Erectile Function Preservation HIFI - 2 2 European Urology Oncology HIFU in Salvage Post Radiation HIFU Demonstrated High Cancer Control. 71% ADT - free Survival at 30 Months Int. Urology and Nephrology HIFU Demonstrated Higher Survival at 10 Years versus Radiation FARP 4 Presented at AUA 2025 Focal Ablation Demonstrated Equivalent Cancer Control HIFUSA 5 Presented at AFU 2025 Long - Term Retrospective CGRD 3 Prospective Comparative Prospective Salvage HIFU vs Radiation RCT Focal Ablation vs Radical Prostatectomy HIFU vs Active Surveillance RCT [ 1 ] Ploussard G et al . "W hol e - gland o r Subtotal High - intensity Focused Ultrasound Versus Radical Pro statectomy : The Pr ospective, Noninfe riortiy, Nonrandomized, HIFI Trial . " European Urology , Nove mber 2024 . DOI : 10 . 1016 /j . eurur o . 2024 . 11 . 006 , [ 2 ] Ploussard G et al . "HIFI - 2 : Prospective nationwide study acro ss 32 centers in France, 531 patients . ADT - free survival 71 % at 30 months . " European Uro logy Oncology, 2025 . , [ 3 ] Yeh HT et al . " 10 - year onco logical outcomes of EBRT versus HIFU for stage II prostate cancer : a multicenter Chang Gung Research Database (CGRD) study with inve rse - probability - of - treatment weighting (IPTW) analysis . " International Urology and Nephrol ogy , 2025 . DOI : 10 . 1007 /s 11255 - 025 - 04805 - 7 , [ 4 ] Baco E et al . "Final 3 - year outcome of F ocal Ablation versus Radical Prostatectomy (FARP) Randomiz ed Control led Trial . " Presented at 120 th AUA Annual Meeting, April 27 , 2025 . NCT 03668652 . , [ 5 ] S . Crouz et et al . Résultat préliminaire de l’étude randomisée HIFUSA, Progrès en Urologie - FMC, Volume 35 , Issue 7 , Supple ment, 2025 , Pages S 114 - S 115 , ISSN 1761 - 676 X,
26 Patients Free from Salvage Treatment at 30 Months 90% 86% Radical HIFU Prostatectomy 1 Cancer Control 2 Maintain Urinary Control 3 Preserve Erectile Function Pad - Free Continence at 12 Months Δ 11% HIFU SURGERY Δ 6 Decrease from Baseline at 12 Months HIFU SURGERY HIFI Study: HIFU vs Radical Prostatectomy 1 Largest Prospective Comparative Multicenter Study in the Treatment of Prostate Cancer [1] Ploussard et al. “Whole - gland o r Subtotal High - intensity Focused Ultrasound Versus Radical Pro statectomy: The Prospective, Noninfe rior ity , Nonrandomized HIFI Trial.” European urology vol. 87,5 (2025): 526 - 533. doi:10.1016/j.e ururo.2024.11.006 Primary Endpoint Secondary Endpoint Secondary Endpoint 3,328 Patients 46 Centers 80+ Urologists
27 0% 20% 40% 60% 80% 100% Optimal Trifecta Outcomes Surgery Ultrasound Focal Ablation Surgery Ultrasound Focal Ablation Surgery Ultrasound Focal Ablation Oncologic Control (ITT Treatment Failure Free) Continence (Pad Free) Erectile Function Preservation [1] Baco et al. Final, three - year onco logical results of a randomized clinical trial FARP comparing Focal Ablation and Radical P ro statectomy in patients with unilateral clinically - significant prostate cancer. Journal of Urol ogy [Internet]. 2025 May 1;213(5S):e714. [2] Baco et al. Focal Ablati on Versus Radical Prostatectomy for Intermediate - Risk Prostate Cancer: Interim Analysis of a Rando mized Contro lled Trial. The J ournal of Urology. Vo l. 206, No. 3S, Supplement, Sunday, September 12, 2021 213 Patients Randomized Controlled Trial Equivalent Oncologic Control at 3 years (93.5% TFF vs 91.5%) Superior Functional Outcomes 25% of Patients Refused Radical Prostatectomy after Randomization and Chose Focal Ablation FARP: Focal Ablation vs Radical Prostatectomy Level 1 Evidence from RCT Validates HIFI Study Outcomes 1,2
Growing Global Adoption of Focal One Robotic HIFU 28
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 91 Focal One Systems as of Mar. 31, 2026 (43 Academic – 48 Community) 29
30 Focal One is the Leading Focal Therapy Technology Strong Adoption by the Highest Ranked Prostate Cancer Hospitals in the US Best Hospitals for Urology 70% 7 Out of 10 SUO Approved Programs 66% 23 Out of 35 NCCN Member Institutions 58% 19 Out of 33 National Comprehensive Cancer Network ® 3 3 0 0
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 91 Focal One Systems as of Mar. 31, 2026 300+ Hospitals in Sales Pipeline 91 Focal One Systems as of Mar. 31, 2026 (43 Academic – 48 Community) 31
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 European Hospitals 41 Focal One Systems as of Dec. 31, 2025 254 Focal One Treatment Clinical Sites FOCAL ONE FIXED SITES FOCAL ONE MOBILE SITES 32
Full Spectrum of Academic Centers, Large Community Hospitals & Regional Centers 175+ Installed Base 1 FocalTherics has the Most Established And Growing Global Commercial Adoption of any Focal Therapy Company FOCAL ONE FIXED SITES FOCAL ONE MOBILE SITES 33 [1] As of March 31, 2026
Consistent Execution Driving Durable Growth U.S. Market 1Q24 2Q24 3Q24 4Q24 1Q25 2Q25 3Q25 4Q25 1Q26 US Install Base US Procedure Volume 34 [1] As of March 31, 2026 91 Installed Base 1 53% Procedure Volume Growth 1 • Expanding Installed Base at Community Hospitals and Major Health Systems, Including Opportunities for Multi - System Sites • Growing Physician Adoption Through Education, Training, and Clinical Evidence • Driving Patient Demand for a Non - Invasive, Effective, Function Preserving Treatment Option
Sharpened Commercial Strategy in Key Markets O.U.S Market 84 Installed Base 1 30% Procedure Volume Growth 1 • Direct Commercial Model in Select Markets (UK, Nordic Countries, etc.) • Reimbursement Established in France from HIFI Study • Converting a Legacy Mobile System Service Model to Capital Sales • Initial Entry into India and LatAm Countries • Early Launch in Endometriosis Driving Multi - Specialty Sales 1Q24 2Q24 3Q24 4Q24 1Q25 2Q25 3Q25 4Q25 1Q26 OUS Install Base OUS Procedure Volume 35 [1] As of March 31, 2026
Executing Disciplined Commercial Strategy for Scalable Growth • Transition Sites to Clinically Autonomous Programs Targeting Account Activation Building Program Building Scaling Program Independence <10% 36 Penetration into Initial Target Market Leaves Substantial Runway 53% YoY Procedure Growth in Q1 2026 70% U.S. Procedures YTD Required No Clinical Application Support • Drive Increased Utilization with Physician Training, Education & Clinical Evidence • Develop Robust Patient Pipeline through Dedicated Hospital Marketing and Program Support • Reduce Reliance on Clinical Staffing as Programs Mature • Expand Installed Base through Sales to Greenfield High - Volume Centers • Prioritize Accounts with Multi - System and Multi - Urologist Opportunities
Saint Alphonsus Medical Center: Boise, ID Program Launch Excellence Q1 Q4 Q2 Q3 Significant Case Volume Growth in First Year of Program Launch 37
Creates Favorable Environment for Growth S TR O N G R E I M B U R S E M E N T 1. Cat. 1 CPT ® Code at APC Level 6 2. Favorable Physician Payment 3. Growing Coverage 38 Based on CMS Ho spital Outpatient Prospe ctive Payment System Final Rule
Hospital Outpatient Medicare Payment 2026 Payment CPT ® Code Procedure $5,478 55875 Prostate Brachytherapy $9,671 55873 Cryo Ablation $9,671 55880 HIFU $10,860 55866 Laparoscopic/Robotic Prostatectomy +4.3% 39 Medicare Payment (Natio nal Average). From C MS Hospital Outpatient Prospective Payment System – CY25 and CY 26 Final rule
Favorable Physician Payment Physician Payment (Medicare - 2026) Work RVU (2026) CPT ® Code Procedure $530 11.21 55882 MRI Transurethral Ultrasound Ablation $693 13.12 55875 Prostate Brachytherapy $692 13.26 55873 Cryo $675 13.50 55877 Irreversible Electroporation $884 17.29 55880 HIFU $1,087 21.90 55866 Laparoscopic/Robotic Prostatectomy 40 Based on CMS Physician Fee Schedule – CY 2026 Final rule
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 Expanding Patient Access 41
Clinical Expansion of our Focal One Platform 42 BPH and Endometriosis
Benign Prostatic Hyperplasia (BPH) Market 43 Normal Prostate Compressed Urethra Enlarged Prostate 100+ Million 1 Men Living with BPH Globally 13+ Million 1 New Cases Diagnosed Annually, Globally 600,000+ 2 New Cases Diagnosed in the U.S. 1 Chen X, Yang S, He Z, C hen Z, Tang X, Lin Y, Huang Y, Hou J, Wei X. Comprehensive analysis of the glo bal, regional, and n ational burden of benign prostatic hyperplasia from 1990 to 2021. Sci R ep. 2025 Feb 15;15(1):5644. doi: 10.1038 /s41598 - 025 - 90229 - 3. PMID: 39955408 ; PMCID: PMC11830103. 2 Urologic Diseases in America. 2024. National Institutes of Health, National Institute of Diabetes and Digestive and Kidne y Diseases. 2024
44 Focal One will be the ONLY Non - Invasive, Non - Surgical Focal Therapy Solution BPH Treatment is a Highly Fragmented Market 54% 16% 13% 5% 12% TURP Aquablation Urolift HoLEP Rezum Market share calculated as each procedure’s share of 288,935 repo rted US BPH pro cedures in 2025 across TURP, Aquablatio n, UroLift, HoLEP, and Rezūm. Source: proudP analysis of 2025 US BPH procedure vol umes. Procedure - volume proxy only; do es no t represent total BPH care, as ~95.9% of diagnosed US BPH patients were manage d without proc edural intervention in 2025.
BPH Indication Expansion Pipeline Feasibility 2026 Next Key Catalyst Launch of Pivotal Study 2027 Parallel Studies O.U.S. Phase I - II Multi - Center Study Data Readout 2026 U.S. IRB Approved as part of U.S. – Chile Collaboration BPH 45
A BPH Solution Designed to Meet Patient Priorities Non - Invasive No Bleeding No Foreign Body No Quality - of - Life Tradeoffs Particularly Compelling for the Growing Number of BPH Patients on Anti - Coagulation Medication who are at Risk of Bleeding Complications 46
Ideally Suited to Capture Significant Portion of BPH Market Same Focal One Platform Same Installed Base Same Urology Call Point Same Physicians & Staff 47
Prostate Cancer BPH Straightforward Pathway to Additional Prostate Indications BPH Prostate Cancer Payment and Coding Freedom to Operate CPT Category 3 Code (Transrectal HIFU Treatment, S pecifically for BPH) Regulatory Enrolling Parallel Studies 14 Patients Treated in Latin America Focal One 48 Other Technologies
49 Deep Infiltrating Endometriosis (DIE) Endometriosis Lesions Infiltrating Rectal Wall 38M Women Living with Deep Infiltrating Endometriosis Globally 1,2,3,4 783,000+ Patients Diagnosed with Deep Rectal Endometriosis Globally 1,2,3,4 225,000+ Patients Diagnosed with Deep Rectal Endometriosis in U.S. 1,2,3,4 [ 1 ] Abrão MS, Petraglia F, Falcone T, Keckstein J, Osuga Y, Chapron C . Deep endo metrio sis infiltrating the recto - sigmoid : critical facto rs to consi der before management . Human Reproduction Update, 2015 ; 21 ( 3 ) : 329 - 339 . [ 2 ] Wenwei Li, Huiyan Feng, Qingjian Ye . Factors contributing to the delayed diagnosis of endo metrio sis — a systematic review and meta - analysis . Frontiers in Medicine, 2025 ; doi : 10 . 3389 /fmed . 2025 . 1576490 . [ 3 ] Agarwal SK, Chapron C, Giudice LC, et al . Clinical diagno sis of endometri osis : a call to actio n ; underdiagno sis estimated at up to 60 % . Della C orte L et al, 2020 ; cited in scoping review 2024 . [ 4 ] United Nations, Department of Economic and Social Affairs, Populatio n Division . Wor ld Popul ation Prospects 2024 . Women aged 15 - 49 by country, 2024 mid - year estimates . [ 5 ] Vercellini P, et al . Surgery versus hormonal therapy fo r deep endo metriosis : hormonal treatment is ineffective or not tolerated in ~ 30 % of women . Minerva Ginecol, 2016 ; PMID 27544308 .
50 Deep Infiltrating Endometriosis (DIE) [1] Vercellini P, et al. Surgery versus hormonal therapy fo r deep endo metriosi s: hor monal treatment is ineffective or not tolerated in ~30% o f women. Minerva Ginecol, 2016; PMID 27544308 . 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% of Women Prefer Non - Surgical Options 1
Endometriosis Indication Expansion Pipeline Next Key Catalyst Phase I Feasibility 2020 Full Commercial Roll Out U.S. Endometriosis Finalize Strategy for Regulatory Pathway by End of 2026 51 Long - Term Data Readout from European Studies Breakthrough Designation Awarded 2024 Initial Data from European Phase I & II O.U.S. Endometriosis Phase II Pivotal 2024 Phase III RCT Limited European Launch 2026 Ongoing Next Key Catalyst
Phased Launch Program Establishes Framework for Broad Commercial Rollout Training Pipeline Phase 1: Case Observation (Launch & Training) Phase 2: Initial Cases (Proctored Case Series) Phase 3: 3 - 20 Cases (Review of Case Series & Initial Patient Outcomes) Phase 4: 20+ Cases (Advanced Program Development) Goal to end 2026 with Several Active Reference Centers with Influential Thought Leaders x 3 x 5 x 2 x 1 52
480K (O.U.S) 235K (U.S.) 1.5M (O.U.S) 400K (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) Endometriosis BPH Prostate Cancer 53 [1] Management Estimates; data on fi le.
Behfar Ehdaie, MD, MPH Memorial Sloan Kettering Cancer Center 54
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
Overall Prostate Cancer Survival In All Men In The PROTECT Trial: 2.7% At 15 Years [Hamdy, 2023]
Approximately 40% Of Men Randomized To Active Monitoring Underwent Radical Prostatectomy Or Radiation Therapy Within 5 Years [Hamdy, 2023]
Has The Probability Of Regaining Sexual Function After Prostate Cancer Surgery Improved Over The Last Decade? [Mulhall, 2018]
Similarly, We Have Not Observed Improvements In The Probability Of Regaining Urinary Function After Surgery [Ehdaie, 2022]
Overcoming The Problem Of Tumor Multifocality Within The Prostate Has Been Key To The Emergence of Focal Therapy Grade Group 2 (Gleason score 3+4) Grade Group 1 (Gleason score 3+3) Grade Group 1 (Gleason score 3+3) [Arora et al, 2004]
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]
Multiparametric MRI Is Enabled Physicians To Detect The Index Lesion And Map The Prostate Gland
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) • HIFU: • Anterior margin of treatment ≤4cm from the rectal wall • No treatment plans crossing midline anterior to the urethra
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
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 biopsies have enabled detection of low volume ‘high risk’ prostate cancer in a single lesion visible on MRI C. Utilization of MRI in post radiation patients have enabled detection of recurrence earlier and localized stage making them candidates for salvage focal treatment
• Advanced imaging and MR - targeted biopsies have improved the ability to localize disease and risk stratify prostate cancer • Patients are seeking an option between active surveillance and radical therapy • Patients are more accepting of less invasive treatments to optimize quality of life as they seek to expand their own interests instead of seeing prostate cancer as only a life or death decision Low Risk Relapse Metastatic Intermediate Risk High Risk Active Surveillance Focal treatment (HIFU) Salvage treatment (HIFU) Radical treatment (Prostatectomy, Radiotherapy, HIFU) Focal Therapy Fills An Important Treatment Gap In Prostate Cancer
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
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.
Annual Scientific Publications Have Quadrupled In The Last 2 Decades 1,609 474
American Urological Association Offered 2 Courses In Focal Therapy For Prostate Cancer And Both Sessions Were Fully Registered
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 treatment planning thereby reducing operator variability • Ease of workflow: OR device without requirement of the MRI suite • State of the art: 1) Real - time treatment modification to adjust treatment boundaries and update plans if anatomy shifts 2) MRI/ultrasound fusion software to improve identifying and targeting the tumor
Data: Oncologic Efficacy [Fainberg, Ehdaie Unpublished ] No evidence of clinically significant prostate cancer in the targeted area in 93% of patients at 12 months In - field (12 - month biopsy) Whole gland 12 - month biopsy 57 (93%) 54 (89%) Oncological efficacy No evidence of GG >=2 57 (93%) 41 (67%) Biopsy Outcome NED 0 (0%) 13 (21%) GG1 3 (4.9%) 6 (9.8%) GG2 1 (1.6%) 1 (2%) GG3 0 (0%) 0 (0%) GG4 - 5
Data: Quality of Life [Fainberg, Ehdaie Unpublished ] • 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. 12 - month 6 - month 3 - month Baseline N N Characteristic (9 - 15 months) N = 18 (4 - 9 months) N = 44 (2 - 4 months) N = 56 = 76 8 (4, 11) 7 (4, 10) 9 (4, 12) - - 55 MSHQ (Range 1 - 15; Higher Indicates Better Ejaculatory Function) 7 (5, 10) 5 (3, 10) 6 (3, 9) 6 (4, 12) 184 IPSS (Range 0 - 35; Higher Indicates worse urinary symptoms) 21 (8, 29) 24 (7, 28) 20 (6, 26) 26 (19, 30) 180 IIEF (Range 1 - 30; Higher indicates better erectile function)
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 academic meetings (courses, research sessions, panels) will positively influence specialty and national guidelines • Focal therapy has reduced the burden of prostate cancer for patients without compromising oncologic outcomes
Thank you for your attention
Innovation & Advanced Technologies 77 Steve Annen, EVP Product Management
The Focal One Robotic HIFU Advantage Accurate Treatment Targeting Precision HIFU Energy Ablation Easy - To - Use Workflow with Treatment Versatility Ongoing Commitment to Invest in Clinician - Driven Innovation Validated by Surgeons, Proven in Practice 78
Purpose Built for Precision Focal Therapy: Seamless Integration of Technologies Precision Robotics Dynamic Focusing Probe High Resolution Imaging Mature Software Driven Workflow 79
Scalable Focal One Platform Enables Simultaneous Innovation Robotics Precision Focused Ultrasound AI - Driven Treatment Remote Connectivity Advanced Imaging 80
Precision Focused Ultrasound Robotics Remote Connectivity AI Driven Treatment Advanced Imaging Scalable Focal One Platform Enables Simultaneous Innovation 81
Launch MRI NEW 2024 3D Biopsy 2024 - 2025 AI Treatment Planning 2025 - 2026 PSMA PET 2026 PSMA PET TELIX Pharmaceuticals Collab Open Platform for Advanced Imaging Driven Treatment 82
Precision Advanced Focused Imaging Ultrasound Robotics Remote Connectivity AI - Driven Treatment Scalable Focal One Platform Enables Simultaneous Innovation 83
Mapping of Cancer & Critical Structures Real - Time Monitoring of Anatomy Ability to Assess Tissue Ablation AI Integration Shaped by Clinician Feedback 84
Precision Advanced Focused Imaging Ultrasound Robotics AI Driven Treatment Remote Connectivity Scalable Focal One Platform Enables Simultaneous Innovation 85
Completely I ntegrated Digital Platform Leveraging Existing Hospital Networks Broadens Patient Access to Focal Therapy FocalConnect Focal One Uniquely Designed for High - Fidelity Focal Therapy Telecollaboration 86
87 Abu Dhabi Cleveland 7,000+ miles 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.” World’s First Transcontinental Focal One HIFU Telecollaboration Leveraged Hospital Network with No Delays or Interruptions
Dual Console (Operating Room) Regional Hospital Network Across Hospital Campus FocalConnect Enabling a New Paradigm in Focal Therapy Telecollaboration 88
Dual Console (Operating Room) Across Hospital Campus Regional Hospital Network 89 FocalConnect Enabling a New Paradigm in Focal Therapy Telecollaboration
Regional Hospital Networks Dual Console (Operating Room) 90 Across Hospital Campus FocalConnect Enabling a New Paradigm in Focal Therapy Telecollaboration
Operating Room Across Hospital Campus Regional Hospital Networks FocalConnect Enabling a New Paradigm in Focal Therapy Telecollaboration 91
Abu Dhabi Cleveland Akron Florida London “This innovative approach [with Focal One Robotic HIFU] not only allows us to share expertise across Cleveland Clinic’s locations but also expands access to specialized care for patients , no matter where they are.” FocalConnect Accelerates the Sharing of Best Practices in Broadening Patient Access to Expert Care Dr. Jihad Kaouk, MD Enterprise Chair of Urology FocalConnect 92
Focused Advanced Ultrasound Imaging Robotics Remote Connectivity AI Driven Treatment Precision Focused Ultrasound 93 Scalable Focal One Platform Enables Simultaneous Innovation
Histotripsy HIFU Lithotripsy Pressure Time • Short Pulse Bursts Tissue Effect: Non - Thermal Mechanical Fractionation of Tissue into Microparticles, Tissue is Liquified Pressure Time • Long Pulse (Continuous Wave) Tissue Effect: Thermal Coagulative Necrosis in the Focal Zone; Surrounding Tissue Largely Spared Pressure Time • Very Short Shock Pulse Mechanism & Tissue Effect: Mechanical Stress Causes Cracks and Fragmentations of Calcified Structures 94
95 Histotripsy Leveraging Focal One HIFU Transducer Histotripsy - related technologies and applications are under development and may require additional testing, validation, and regulatory authorization prior to commercialization.
Histotripsy Leveraging Focal One Treatment Workflow 96
Scalable Focal One Platform Enables Simultaneous Innovation Robotics AI - Driven Treatment Remote Connectivity Advanced Imaging HIFU & Histotripsy 97
Focal One HIFU and Histotripsy 98 HIFU
Focal One HIFU and Histotripsy HIFU Histotripsy 99
Focal One HIFU and Histotripsy HIFU Histotripsy 100
Focal One HIFU and Histotripsy HIFU Histotripsy HIFU + Histotripsy 101 Actively Developing and Filing Novel Intellectual Property Covering The Unique Combination of HIFU and Histotripsy to Strengthen our IP Portfolio
Scalable Focal One Platform Enables Simultaneous Innovation Robotics HIFU & Histotripsy AI - Driven Treatment Remote Connectivity Advanced Imaging 102
Expanding Focal One to a Single Platform to Treat Multiple Indications with a Combination of HIFU and Histotripsy Advanced Imaging with PSMA PET AI - Assisted Treatment & Ablation Assessment Training and Telecollaboration via FocalConnect Most Compatible Precise Energy Delivery Easiest to Learn, Use & Teach Minimal OR Staffing Shortest Treatment Times 103 Focal One Robotic Focal Therapy Difference
Positioned for Growth A Pure - Play HIFU Company Ken Mobeck, CFO 104
HIFU Revenue ($M) $16 $22 $26 $37 $52 CY22 CY23 CY24 CY25 CY26E ~40% Y/Y Growth Commitment to HIFU Portfolio Accelerating Our Growth Engine +32% 3 - Yr CAGR EDAP Revenue ($M) Strategic Emphasis Away from Non - Core 7% 3 - Yr CAGR $24 $33 $43 $44 $42 $52 $37 $16 $22 $26 CY22 CY23 CY24 CY25 CY26E Moving Non - Core ESWL and Distribution Business to Discontinued Operations as of Q2 CY26 Non - Core HIFU 105 Note: CY 26E = Midpoint o f CY26 Guidance Range
CY 2026 Updated Revenue Guidance Reiterating HIFU Only Guidance (Non - Core Classified to Discontinued Operations) • Accelerated Revenue Growth • Higher Gross Margins • Lower Operating Expenses • Pathway to Operating Income Breakeven in CY28 Benefits of HIFU Focus Revenue Guidance ($M) Previous CY26 Guidance 106 New CY26 Guidance Non - Core $22 - $26 HIFU $50 - $54 HIFU $50 - $54
Long - Term Target Revenue Growth Model Focal One System Placements & Procedure Volumes Remain Primary Catalysts $16 $22 $26 $37 CY22 CY23 CY24 CY25 CY26E CY27E CY28E +32% 3 - Yr CAGR • Continued Penetration into Core U.S. Markets • International Expansion into New Markets • Procedure Volumes Growth • Continued Marketing Program Development • New Indications will Boost Procedures • Installed Base Growth ~40% 3 - Yr CAGR Growth Drivers HIFU Revenue ($M) 107
56.6% 50.9% 51.5% 48.1% ~60% CY22 CY23 CY24 CY25 CY26E CY27E CY28E • Bill of Materials Optimization • Continued Strong Capital Unit Growth • Procedure Volumes Driving Consumables • Maintain Pricing Discipline • Enhanced Capacity Utilization Levers HIFU Gross Margin (%) (850 bps) ~ +1200 bps Opportunities to Drive Operating Leverage Levers to Drive HIFU Target Gross Margin to ~60%
• R&D Investments to Expand Indications and Unlock New Markets • BPH • Artificial Intelligence • Histotripsy • High Evidence Clinical Studies • SG&A Investment to Complete Global Commercialization Build - Out Disciplined Operating Expense Investment Operating Leverage Driven by Revenue Growth, Efficiency Gains and Platform Extendibility Priorities HIFU Operating Expenses ($M) $4 $6 $7 $9 $13 $26 $29 $35 $ CY22 CY23 R&D SG&A CY24 CY25 OpEx % of Rev CY26E CY27E CY28E SGA % of Rev R&D % of Rev 109
CY28E Target Range CY25 Actual ~ 40%+ 3 - Yr CAGR (+/ - 3%) $37M ~60% (+/ - 200 bps) 48.1% Breakeven ($21M) Positive ($19M) ~ 30%+ 3 - Yr CAGR (+/ - 5%) 166 Revenue Gross Margin Operating Income EBITDA Installed Base 2028E Target Model Financial Framework 110 Note: E = Estimate Focused on Driving Positive EBITDA and Breakeven Operating Income to Deliver Shareholder Value
Closing Remarks 111
FocalTherics: Positioned For Strong Growth 112 Large, Underserved Growing Market Differentiated Technology Leading the Category of Robotic Focal Therapy Expanding Favorable Reimbursement Robust Clinical Evidence Accelerated Global Commercial Execution Growing Revenue and Pathway To Profitability
Thank You FocalTherics.com Investor.relations@focalone.com 113