FOCL 8-K
Edap Tms SA (FOCL)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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CURRENT REPORT
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On January 12, 2026, EDAP TMS S.A. (“EDAP” or the “Company”) issued a press release announcing select preliminary unaudited financial and operational results for the fourth quarter and full fiscal year ended December 31, 2025 and disclosing select guidance for 2026. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
On January 12, 2026, the Company plans to present the presentation attached hereto as Exhibit 99.2 (the “Presentation”) to analysts and investors.
The furnishing of the Presentation is not an admission as to the materiality of any information therein. The information contained in the Presentation is summary information that is intended to be considered in the context of more complete information included in EDAP’s filings with the U.S. Securities and Exchange Commission (the “SEC”) and other public announcements that EDAP has made and may make from time to time by press release or otherwise. EDAP undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. For important information about forward looking statements, see the slide titled “Forward-Looking Statements & Disclaimer” in the Presentation.
The information in Item 2.02 and Item 7.01 of this Current Report on Form 8-K and Exhibits 99.1 and 99.2 attached hereto 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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), or incorporated by reference in any filing of EDAP under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
(d) Exhibits
| 99.1 | Press Release dated January 12, 2026 | |
| 99.2 | EDAP Investor Presentation | |
| 104 | Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document |
Signature
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: January 12, 2026 | By: | /s/ Sanket Shah |
| Sanket Shah | ||
| General Counsel and Corporate Secretary | ||
Exhibit 99.1
EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance
36% to 38% Annual YoY HIFU Revenue Growth, Record Performance Driven by Increased Focal One® System Sales and Growth in Number of U.S. Focal One Procedures
69% Annual YoY Growth in Focal One System Placements
28% Q4 YoY Growth in U.S. Procedures Highlights Accelerating Quarterly Procedure Growth
AUSTIN, Texas, January 12, 2026 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company” or “EDAP”), the global leader in robotic energy-based therapies, today announced select preliminary unaudited financial and operational results highlighting record fourth quarter and full-year 2025 HIFU revenue, driven by strong system placements and accelerating procedure growth. The Company also issued initial worldwide revenue guidance for 2026.
For the fourth quarter ended December 31, 2025, the Company’s worldwide HIFU revenue is expected to range between $12.9 million and $13.3 million (€11.2 million and €11.6 million), which would represent the highest quarterly HIFU revenue in its history. Annual 2025 worldwide HIFU revenue is expected to range between $36.7 million and $37.2 million (€32.5 million and €32.9 million), which would represent the highest annual HIFU revenue in the Company’s history. Performance was driven by a record 15 Focal One system placements during the fourth quarter, reflecting strong global demand from hospitals and urology centers. In the United States, the number of Focal One HIFU procedures increased approximately 28% year over year in the fourth quarter, demonstrating growing utilization across both newly placed and existing systems.
EDAP’s non-core (Distribution and ESWL) preliminary unaudited fourth quarter revenue is expected to range between $7.9 million and $8.3 million (€6.8 million and €7.1 million) and annual 2025 non-core revenue is expected to range between $32.7 million to $33.1 million (€29.0 million and €29.3 million).
“Our preliminary results reflect a strong finish to 2025 and accelerating demand for Focal One across global markets,” said Ryan Rhodes, Chief Executive Officer. “System placements reached a quarterly record, and procedure growth in the U.S. continues to scale, which we believe reinforces the strength and durability of our recurring revenue model. For the first time in the Company’s history, the expected growth in HIFU revenue represents more than half of our expected annual revenue, validating our execution strategy.”
Mr. Rhodes added, “We believe increasing clinical validation, including data from key trials such as the landmark HIFI study and FARP Randomized Controlled Trial, is driving broader clinical adoption of focal therapy for prostate cancer. As a result, more large hospital networks are recognizing Focal One as both a strategic and necessary investment in a comprehensive prostate cancer management program.”
“Entering 2026, our global pipeline is expanding, customer engagement remains strong, and procedure utilization continues to grow. Based on this momentum, we are confident in our ability to deliver continued revenue growth and shareholder value creation in the year ahead.”
2026 Financial Guidance
The Company is issuing its initial 2026 financial guidance. In 2026, the Company’s core HIFU business revenue is expected to be in the range of $50.0 million to $54.0 million (€43.0 million to €46.0 million) and combined non-core (Distribution and ESWL) business revenue is expected to be in the range of $22.0 million to $26.0 million (€19.0 million to €22.0 million).
The above information is preliminary and subject to completion of quarter-end financial reporting processes and reviews. The preliminary financial and operational results and 2026 financial guidance included in this press release have been prepared by, and are the responsibility of, our management. During the course of the preparation of our financial statements and related notes as of for the fiscal year ended December 31, 2025, we may identify items that would require us to make material adjustments to the preliminary financial and operational results presented herein. As a result, investors should exercise caution in relying on this information and should not draw any inferences from this information. Our independent registered public accounting firm has not audited, reviewed, examined, compiled, or performed any procedures with respect to these preliminary unaudited financial and operational results and 2026 financial guidance, nor has our independent registered public accounting firm expressed any opinion or any other form of assurance on these preliminary unaudited financial and operational results and 2026 financial guidance. This preliminary financial and operational information should not be viewed as a substitute for full financial statements prepared in accordance with U.S. GAAP and reviewed by our independent registered public accounting firm. EDAP expects to release completed 2025 annual financial results in March 2026.
Currency Translation
Euro-denominated amounts have been translated into U.S. dollars for convenience using an average exchange rate of $1.15 = €1.00 for the fourth quarter of 2025, $1.13 = €1.00 for the full year 2025, and $1.17 = €1.00 for 2026 financial guidance for illustrative purposes.
About EDAP TMS SA
A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP introduced the Focal One® in Europe and in the U.S. as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com/.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements include those related to the demand and growing adoption of our products, the drivers thereof, and our future financial results. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, 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. Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.
Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.
Investor Contacts
Investor Relations
EDAP TMS SA
[email protected]
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
[email protected]
Exhibit 99.2
1 The Global Leader in Therapeutic Ultrasound
2 Statements & Disclaimer FORWARD - LOOKING
3 Company Overview
4 Strategic Company Focus Global Leader in Therapeutic Ultrasound for the Treatment of Cancer and Benign Disease
5 5 Investment Thesis: Strong Growth Opportunity x Large and Growing Market Opportunity: Urology and Prostate Cancer x Solves an Important Unmet Clinical Need in Cancer x Proven Compelling Clinical Evidence x Increasing Patient and Physician Demand x Strong Hospital and Physician Reimbursement x Leverages Current Advancements in Imaging, AI, and Robotics x Growing Worldwide Install Base x Ideally Positioned for Expanded Indications (BPH, Endometriosis, Other)
6 Large and Growing Market Opportunity In Urology and Prostate Cancer
7 3.3 Million American Men Living with Prostate Cancer in the U.S. (1) 313,780 New Cases Diagnosed in the U.S. (1) 35,770 U.S. Deaths from Prostate Cancer (1) U.S. PROSTATE CANCER MARKET Prostate Cancer is the Most Common Cancer Amongst Men In the U.S. (1) 2025 estimates from the American Cancer Society ( www.cancer.org ) Prostate Lung & Bronchus Colorectum Skin Urinary Bladder New Cases Deaths
8 8 Prostate Cancer Market Opportunity Number of New Prostate Cancer Cases Region 473,011 Europe 386,424 Asia 255,782 North America 225,985 Latin America 103,050 Africa 23,602 Oceania 1,467,854 Total LARGE GLOBAL MARKET 1.5 Million New Prostate Cancer Cases Per Year Data Source: Cases refers to Diagnosed Cases per year From World Health Organization – Globocan 2022
9 9 Focal One Answers an Unmet Need for a Large Underserved Patient Population PROSTATE CANCER Focal One HIFU Focal One HIFU First - Line Treatment Progression from Active Surveillance Salvage Treatment
10 10 470,000 Based on 2023 Internal Company Estimates 165,000 130,000 100,000 75,000 Europe Asia North America South America Focal One HIFU Prostate Cancer Annual Procedure Opportunity Global Addressable Market FOCAL ONE ROBOTIC HIFU
11 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)
12 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 96% (3) Continence Preservation 82% (3) Erectile Function Preservation - Ejaculation Preservation Low Risk of Complications - Typical Complications - Treatment Process Active Surveillance N/A 10 - year Cancer Specific Survival (*) Hospital stay duration for radical prostatectomy may vary (1) Yeh, HT et al. 10 - year oncological outcomes of EBRT versus HIFU for stage II prostate cancer: a multicenter Chang Gung research database (CGRD) study with inverse - probability - of - treatment weighting (IPTW) analysis. Int Urol Nephrol (2025). (2) Stensland KD et al. National Long - term Survival Estimates After Radical Prostatectomy for Prostate Cancer. Urology. 2024 Feb;18 4:135 - 141. (3) Donovan JL, et al. Patient - Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13. (4) Sullivan JF et al. Ejaculation profiles of men following radiation therapy for prostate cancer. J Sex Med. 2013 May;10(5):141 0 - 6. (5) Arnouil , N., et al. " Traitement focal par HIFU versus prostatectomie radicale robot - assistée pour cancer de la prostate localisé : résultats carcinologiques et fonctionnels à 1 an." Progrès en Urologie 28.12 (2018): 603 - 610. (6) von Hardenberg J et al. Prostate cancer treatment by the latest focal HIFU device with MRI/TRUS - fusion control biopsies: A pros pective evaluation. Urologic Oncology: Seminars and Original Investigations, Volume 36, Issue 9, 2018, Pages 401.e1 - 401.e9 98% (5) 93% (5) 96% (6) 75% (3) 96% (3) 69% (3) 49% (3) 0% 28% (4) High Medium Blood Loss and Other Surgical Complications Radiation Toxicity, Risk of Secondary Cancers 1 Session 1 - Day Hospital Stay (*) 45 Sessions 45 Visits 99% (2) 91% (1) Surgery Radical Prostatectomy Radiation
13 13 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 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)
14 HIFU | The Fastest Growing Treatment Option DRIVING A PARADIGM SHIFT IN PROSTATE CANCER Based on Medicare Claims reported by CMS on HOPPS Final Rule for FY24, FY25 and FY26 HIFU Cryo Brachytherapy Radical Prostatectomy
15 Strong Supporting Clinical Evidence
16 16 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 search of “HIFU Prostate Cancer” Functional Outcomes
17 17 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 patients treated with Focal One Comparable Cancer Control (Primary Endpoint): 90% STFS for HIFU vs 86% for RP; p = 0.008 Superior functional outcomes for HIFU (Secondary Endpoint): • Urinary Continence significantly better after HIFU • Significantly lower stress incontinence after HIFU • Erectile Function less impaired Published in European Urology – December 2024 Ploussard et al. “Whole - gland or Subtotal High - intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial.” European urology vol. 87,5 (2025): 526 - 533. doi:10.1016/j.eururo.2024.11.006
18 18 HIFI Study Demonstrates Optimal Trifecta Outcomes 1. Cancer Control Comparable Oncologic Outcomes 3. Preserve Sexual Function 2. Maintain Urinary Control Δ 11% Urinary Continence Erectile Function Pad - Free Continence at 12 months Decrease from baseline at 12 months HIFU Provides Superior Functional Outcomes Δ 6 HIFU SURGERY HIFU SURGERY Patients Free from Salvage Treatment at 30 months HIFU RADICAL PROSTATECTOMY 90 % 86 % Ploussard et al. “Whole - gland or Subtotal High - intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial.” European urology vol. 87,5 (2025): 526 - 533. doi:10.1016/j.eururo.2024.11.006
19 19 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 Outcomes after F ocal Ablation 213 Patients included in the Clinical Trial 25% of Patients refused radical surgery after randomized to RP and opted for FA 80+% of Focal Ablation patients treated with Focal One ® Baco et al. Final, three - year oncological results of a randomized clinical trial FARP comparing Focal Ablation and Radical Prost atectomy in patients with unilateral clinically - significant prostate cancer. Journal of Urology [Internet]. 2025 May 1;213(5S):e714. Baco et al. Focal Ablation Versus Radical Prostatectomy for Intermediate - Risk Prostate Cancer: Interim Analysis of a Randomized Controlled Trial. The Journal of Urology. Vol. 206, No. 3S, Supplement, Sunday, September 12, 2021 Final Results Presented at AUA 2025 0% 20% 40% 60% 80% 100% Oncologic Control (ITT Treatment Failure Free) Continence (Pad-free) Erectile Function Preservation Surgery Ultrasound Focal Ablation Surgery Ultrasound Focal Ablation Surgery Ultrasound Focal Ablation OPTIMAL TRIFECTA OUTCOMES
20 20 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%) Yeh, HT., Liu, YY., Chang, Y.L. et al. 10 - year oncological outcomes of EBRT versus HIFU for stage II prostate cancer: a multicen ter Chang Gung research database (CGRD) study with inverse - probability - of - treatment weighting (IPTW) analysis. Int Urol Nephrol (2025). https:// doi.org /10.1007/s11255 - 025 - 04805 - 7 Radiation HIFU HIFU Radiation
21 Strong Hospital and Physician Reimbursement
22 Creates Favorable Environment for Growth STRONG REIMBURSEMENT 1. APC Level 6 Under CMS for CY23, CY24 and CY25 2. 90% Increase in Reimbursement in 2023 3. APC Level 6 Maintained by CMS in 2026 Based on CMS Hospital Outpatient Prospective Payment System Final rule
23 23 Hospital Outpatient Medicare Payment (Medicare Payment (National Average). From CMS Hospital Outpatient Prospective Payment System – CY25 and CY26 Final rule 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%
24 24 Favorable Physician Payment Based on CMS Physician Fee Schedule – CY 2026 Final rule Physician Payment (Medicare - 2026) Work RVU (2026) CPT ® Code Procedure $693 13.12 55875 Prostate Brachytherapy $692 13.26 55873 Cryo $530 11.21 55882 MRI Transurethral Ultrasound Ablation $884 17.29 55880 HIFU $1,087 21.90 55866 Laparoscopic/Robotic Prostatectomy
25 Focal One ® Best - in - Class Technology
26 Targeting and Imaging Precise Robotic Delivered Ablation THE LEADING FOCAL THERAPY TECHNOLOGY Image Guided Treatment Planning
27 27 Robotics HIFU Advanced Imaging Focal One ® Core Technologies Artificial Intelligence (AI) Remote Connectivity
28 Integrated Workstation Compatible With Standard OR Beds MRI, PSMA PET Unfold AI* , OnQ Prostate* Koelis * and DynaCAD * 3D Biopsy HIFUsion ® Image - Guided Treatment Planning Dynamic Focusing Probe Precise Robotic Positioning Multi - Axis Sub - millimeter Robotic Movements Auto - Adjusting Pinpoint Delivery of HIFU Energy * Not available in all markets. May require additional purchase The Most Advanced Robotic HIFU Platform Controlled by Urologists • Expanded HIFUsion ® Capabilities • Streamlined Treatment Workflows • Embedded Video Content Library • Treatment Streaming and Recording* • Remote Proctoring & Telecollaboration* • Endometriosis Treatment Ready*
29 29 World’s First Focal One Robotic HIFU Transcontinental Telecollaboration Cleveland, Ohio Abu Dhabi Cleveland, Ohio Abu Dhabi
30 BPH & Endometriosis Large Market Opportunities For Expansion
31 31 HIFU Unlocks a Large Market Opportunity (1) Newly Diagnosed Cases per year From World Health Organization – Globocan 2022 (2) From WHO and Habib N et al. Bowel Endometriosis: Current Perspectives on Diagnosis and Treatment. Int J Womens Health. 2020 (3) Xu et al.. Global, Regional, and National Incidence and Year Lived with Disability for Benign Prostatic Hyperplasia from 1990 to 2019. Am J Mens Health. 2021 (4) Based on UN Population Division and Goehring et al. Epidemiology of benign breast disease, with special attention to histologic types. Epidemiol Rev. 1997 (5) Based on UN Population Division and Bomeli et al. Evaluation of a thyroid nodule. Otolaryngol Clin North Am. 2010 20.5 M Rectal Endometriosis (2) 1.5 M Prostate Cancer (1) 11.3 M BPH (Benign Prostatic Hyperplasia) (3) 8.3 M Breast Fibroadenoma 510 ,992 Pancreatic Cancer (1) 866,136 Liver Cancer (1) 51.4 M Thyroid Nodules (5) 2.3 M Breast Cancer (1) (4)
32 94 Million Global cases of BPH in 2019 (1) 15 Million U.S. men are affected by BPH/LUTS (2) 600,000 U.S. men aged 65+ newly diagnosed annually (3) Leveraging Expertise in Robotic HIFU and Prostate for BPH 12.2 Million men actively managed for BPH/LUTS: • 55% under Drug Management (4) • 35% under Watchful Waiting (4) • 300,000+ Active Surgical Treatments (5) Focal One Robotic HIFU technology has the potential to provide a non - invasive option that can safely treat BPH - related symptoms while avoiding the side effects of standard surgical treatments. 10,000s PCa treatments constitute a robust foundation to build upon for a BPH strategy (1) Fentahun et al. The Lancet Healthy Longevity . 2022 (2) Egan K B. Urologic Clinics of North America. 2016 (3) Urologic Diseases in America. 2024. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. 2024 (4) Vuichoud et al. Can J Urol. 2015 (5) Source: Internal company estimates BENIGN PROSTATIC HYPERPLASIA (BPH) MARKET
33 Building High - Level Evidence in the Treatment of Benign Prostate Hyperplasia BPH: FOCAL ONE CLINICAL STUDY PROGRESS Feasibility Study Completed Phase I - II Study Recruiting • Monocentric Feasibility Study (9 patients) • Confirmed Safety and potential for improvement of BPH - related symptoms • First Patients Treated • Phase I: Three - center study HIFU dose escalation • Phase II: Multi - center Study Safety and Efficacy of Final HIFU Parameters as defined in Phase 1 ض ض ض U.S. Study IRB - Approved • Protocol based on previous study findings
34 6.5 Million US Women Have Endometriosis (1) 1.3 Million 20% of Cases are Deep Infiltrating Endometriosis (DIE) in the U.S. (2) 11% of U.S. Women are Affected by Endometriosis (2) Leveraging Expertise in Robotic HIFU For Endometriosis Common symptoms of Rectal Endometriosis may include various conditions (acute pelvic pain, constipation, diarrhea, rectal bleeding), all of which negatively impact quality of life and ability to become pregnant. Current treatment options are lacking and limited to hormonal and/or surgical management Focal One has the potential of offering a non - invasive option with the ability of Reducing Symptoms and Improving Quality of Life (1) Office of Women’s Health ( www.womenshealth.gov ) (2) D'Alterio MN et al. Management Challenges of Deep Infiltrating Endometriosis. Int J Fertil Steril . 2021 Apr;15(2):88 - 94. doi : 10.22074/IJFS.2020.134689. Epub 2021 Mar 11. PMID: 33687160; PMCID: PMC8052801 U.S. ENDOMETRIOSIS MARKET
35 Building High - Level Evidence in the Treatment of Deep Infiltrating Rectal Endometriosis ENDOMETRIOSIS: FOCAL ONE CLINICAL STUDY PROGRESS Phase I Study Completed Phase II Study Completed Phase III Study Completed Enrollment • Feasibility (20 patients) • Published in the Journal of Ultrasound in Obstetrics and Gynecology in 2020 • Multicenter Safety and Ef ficacy Study (60 patients) • Completed in March 2022 • Published in Journal of Human Reproduction in 2024 • Multicenter Double - Blind Randomized Controlled Trial (RCT) • Enrollment completed (60 patients) • Follow - up of all patients in progress • 85% of S ham Group patients elected and received HIFU Treatment ض ض ض • Focal One received CE mark certification for the treatment of posterior deep endometriosis infiltrating the rectum CE Mark March 25, 2025 ض
36 Growing Global Install Base
FOCAL ONE ADOPTION ACCELERATING At Major U.S. Hospitals 87 Focal One Systems as of Dec. 31, 2025 (42 Academic – 45 Community)
38 38 Strong Adoption by the Highest Ranked Prostate Cancer Hospitals in the US FOCAL ONE IS THE LEADING FOCAL THERAPY TECHNOLOGY 70% Best Hospitals for Urology 7 Out of 10 NCCN Member Institutions 55% 18 Out of 33 National Comprehensive Cancer Network® 63% SUO Approved Programs 22 Out of 35
FOCAL ONE MOBILE SITES FOCAL ONE FIXED SITES 41 Focal One Systems as of Dec. 31, 2025 254 Focal One Treatment Clinical Sites FOCAL ONE ADOPTION ACCELERATING At Major European Hospitals
40 Key Business Trends
41 41 Focal One U.S. Momentum 2021 - 2025 (Compounded Annual Growth Rates) Focal One Procedures CAGR Focal One Installations CAGR 44% 52% Focal One Procedures Focal One Installations (1) (1) Based on 2025 Preliminary, Unaudited Company Results
42 42 2021 2022 2023 2024 2025 Focal One HIFU Accelerated Revenue Growth Capital Sale + Recurring Revenue Capital Sales Service Disposables & Treatment - Driven Revenue 2026 (1) ANNUAL HIFU REVENUE (1) Based on 2025 Preliminary, Unaudited Company Results (2) Source: Internal company estimates (2)
43 43 Positioned for Growth SUMMARY • Large Addressable Markets in Men’s and Women’s Health • Growing Install base of Leading Tier 1 Academic and Community Hospitals • Differentiated Non - Invasive Robotic HIFU Technology Solving Unmet Needs for Prostate Cancer, BPH and Endometriosis • Strong Clinical Evidence with Favorable Reimbursement in Place • Proven Management Team from Industry - Leading MedTech Companies
44 Appendix
45 45 THREE MONTHS ENDED SEPTEMBER 30TH 2025 2024 (in $Million USD except per share data) 16.1 14.4 Revenue 6.9 5.7 Gross Profit 43.0% 39.4% Gross Margin (5.7) (6.4) Operating Profit (Loss) (5.8) (7.0) Net Income (Loss) (0.16) (0.19) Earnings (Loss) Per Share NOTE: Translated for convenience of the reader to U.S. dollars at the 2025 average three months’ exchange rate of 1 Euro = 1.1620 USD, and 2024 average three months’ exchange rate of 1 Euro = 1.1010 USD HIFU $4.9M ESWL $2.2M Distribution $7.3M HIFU $7.7M + 57 % ESWL $2.1M - 4 % Distribution $6.3M - 14% 3 months 2024 3 months 2025 $14.4M $16.1M Financial Highlights as of September 30, 2025
46 46 NINE MONTHS ENDED SEPTEMBER 30TH 2025 2024 (in $Million USD except per share data) 48.8 47.6 Revenue 20.7 19.0 Gross Profit 42.5% 39.9% Gross Margin (18.7) (18.2) Operating Profit (Loss) (19.8) (18.5) Net Income (Loss) (0.53) (0.50) Earnings (Loss) Per Share NOTE: Translated for convenience of the reader to U.S. dollars at the 2025 average nine months’ exchange rate of 1 Euro = 1.1 213 USD, and 2024 average nine months’ exchange rate of 1 Euro = 1.0858 USD HIFU $16.3M ESWL $7.1M Distribution $24.1M HIFU $ 23.9 M +46% ESWL $5.7M - 20% Distribution $19.1M - 21 % 9 months 2024 9 months 2025 $47.6M $48.8M Financial Highlights as of September 30, 2025
47 47 Balance Sheet Highlights as of September 30, 2025 Balance Sheet As Of: September 30 , 2024 September 30 , 2025 (in $Million USD) 28.4 12.4 Cash and Cash Equivalents 42.9 39.6 Other Current Assets 16.8 20.1 Fixed and Other N on - Current Assets 88.1 72.1 32.7 36.9 Current Liabilities 7.8 7.9 Non - Current Liabilities 47.5 27.4 Shareholders’ Equity 88.1 72.1 Note: Translated for convenience of the reader to U.S. dollars at the exchange rate of 1 Euro = 1.1734 USD, on September 30, 202 5 and at the exchange rate of 1 Euro = 1.1145 USD, on September 30, 2024.
49 The Global Leader in Therapeutic Ultrasound