UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

~~September~~October 920, 2025

Commission File Number: 0-29374

EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F [ x ] Form 40-F [ ]

Finance Contract

On October 17, 2025 (the “Effective Date”), EDAP TMS S.A. (the “Company”) entered into a €36.0 million credit facility agreement (the “Finance Contract”) with the European Investment Bank (“EIB”).

The Company plans to use the proceeds from the facility to further its research and development projects relating to its robotic medical technology using high-intensity focused ultrasound to treat various medical conditions such as prostate cancer and endometriosis (the “Project”).

The €36.0 million credit facility is comprised of three tranches: €11.0 million for the first tranche (“Tranche A”), €12.0 million for the second tranche (“Tranche B”), and €13.0 million for the third tranche (“Tranche C”, and collectively, the “Tranches”). Each Tranche will have a maturity date of five years following disbursement of borrowings. The disbursement of borrowings for each Tranche, including the disbursement of borrowings for Tranche A, is subject to certain conditions.

The Company is entitled to, and may request, disbursement of Tranche A borrowings at any time in the nine months following the Effective Date upon the occurrence of certain conditions, including, among other things:

the Company’s issuance of the Tranche A Warrants (defined below);

the Company’s achievement of certain revenue thresholds;

the Company (including through its subsidiaries) maintaining a direct presence in certain countries; and

the Company’s achievement of certain regulatory and clinical milestones.

The Company is entitled to, and may request, disbursement of Tranche B borrowings at any time in the 18 months following the Effective Date upon the occurrence of certain conditions, including, among other things:

the Company’s issuance of the Tranche B Warrants (defined below);

the Company’s achievement of certain revenue and EBITDA thresholds; and

the Company’s achievement of certain manufacturing and clinical milestones.

The Company is entitled to, and may request, disbursement of Tranche C borrowings at any time in the 30 months following the Effective Date upon the occurrence of certain conditions, including, among other things:

the Company’s issuance of the Tranche C Warrants (defined below);

the Company’s achievement of certain revenue and EBITDA thresholds; and

the Company’s achievement of certain manufacturing and commercialization milestones.

Interest will accrue on Tranche A and Tranche B borrowings at a fixed rate of 8% per annum and 7% per annum, respectively, payable on an annual basis; however, such interest is permitted to be deferred, such that it is payable at the maturity date of each such Tranche. Interest will accrue on Tranche C borrowings at a fixed rate of 6% per annum, payable on an annual basis until the Tranche C maturity date.

Subject to certain terms and conditions, EIB may demand immediate repayment by the Company of all or part of the outstanding borrowings, depending on the specific event, together with accrued interest, and all other accrued or outstanding amounts payable to EIB under the Finance Contract and/or cancel any undisbursed Tranches upon the occurrence of certain events, including: (i) a reduction in the projected total cost of the Project, (ii) any occurrence or likely occurrence of a voluntary prepayment, in whole or in part, by the Company or its subsidiaries of any indebtedness or other repayment obligation to a counterparty other than EIB, (iii) any change of control of the Company, (iv) the Chief Executive Officer having ceased to be actively involved in the management of the Company without the prior written consent of EIB (such consent not being required in certain cases), (v) any change in law or regulation which would materially impair the Company’s or its subsidiaries’ ability to perform their obligations under the Finance Contract, the guarantee agreements, the Warrant Agreement (as defined below), the fee letter by and between the Company and EIB, dated as of July 15, 2025, or the effective global rate letter (together the “Finance Documents”), (vi) any disposal of assets, or shares in subsidiaries holding assets, related to the Project, (vii) any events where it would become unlawful for EIB to perform any of its obligations as contemplated in the Finance Contract or fund or maintain the credit facility, (viii) the occurrence of a lawsuit for the revocation or declaration of nullity of any of the corporate resolutions taken for purposes of issuance of the warrants, and (ix) any events of default.

Events of default under the Finance Contract include, among other things: (i) default of payment obligations under the Finance Documents, (ii) default by the Company or any of its subsidiaries in the performance of its obligations under the Finance Documents, (iii) defaults arising from incorrect, incomplete or misleading representations to EIB, (iv) cross defaults resulting in acceleration or cancellation of any other loan or obligation, (v) defaults in the performance of any obligation in respect of any other loan or financial instrument granted by EIB or the European Union, (vi) the occurrence of a material adverse change, (vii) any warrants ceasing to be in full force and effect (other than as a result of exercise), and (viii) certain bankruptcy and insolvency events.

On the Effective Date, the Company received from EIB a “TEG letter” setting out an indicative calculation of the effective global rate applicable to borrowings under Tranche A, Tranche B and Tranche C based upon certain assumptions as required under French law.

As a condition precedent to the disbursement of Tranche A, the Company is to provide to EIB guarantee agreements of certain of its subsidiaries wherein such subsidiaries provide guarantees with respect to the Company’s obligations towards EIB under the Finance Contract.

Warrant Agreement

Concurrent with the execution of the Finance Contract, the Company entered into a warrant agreement (the “Warrant Agreement”) with EIB, which establishes the terms of certain warrants (the “Warrants”) to be issued by the Company to EIB prior to the receipt of borrowings under each Tranche. The Warrant Agreement contains certain customary representations and warranties by the Company and is governed by French law.

The number of Warrants to be issued at each Tranche as follows:

(i)

with respect to Tranche A, a number “X” of Warrants to be issued by the Company (the “Tranche A Warrants”) determined according to the following formula:

X = 11,000,000 / (an amount equal to (y) the euro (“EUR”) equivalent, calculated based on the last EUR/USD currency exchange rate published by the European Central Bank on its website (“EIC Exchange Rate”) on the date immediately preceding the issuance date of the Tranche A Warrants, of the average closing price (in USD) per American Depositary Share (defined below) as reported by NASDAQ over the 90 days preceding, but not including, the date of issuance of the Tranche A Warrants by the Company, multiplied by (z) 2.5);

(ii)

with respect Tranche B, a number “X” of Warrants to be issued by the Company (the “Tranche B Warrants”) determined according to the following formula:

X = 12,000,000 / (an amount equal to (y) the EUR equivalent, calculated based on the last EIC Exchange Rate published on the date immediately preceding the issuance date of the Tranche B Warrants, of the average closing price (in USD) per American Depositary Share as reported by NASDAQ over the 90 days preceding, but not including, the date of issuance of the Tranche B Warrants by the Company, multiplied by (z) 3); and

(iii)

with respect to Tranche C, a number “X” of Warrants to be issued by the Company (the “Tranche C Warrants”) determined according to the following formula:

X = 13,000,000 / (an amount equal to (y) the EUR equivalent, calculated based on the last EIC Exchange Rate published on the date immediately preceding the issuance date of the Tranche C Warrants, of the average closing price (in USD) per American Depositary Share as reported by NASDAQ over the 90 days preceding, but not including, the date of issuance of the Tranche C Warrants by the Company, multiplied by (z) 4.2).

“American Depositary Shares” refers to the Company’s American Depositary Shares, each representing one ordinary share of the Company.

Each Warrant shall be exercisable for one ordinary share of the Company, subject to possible adjustments below. To the extent the Company issues a class of shares senior to its ordinary shares after the date of issuance of the Warrants, the Warrants shall be exercisable into shares of such senior class.

Each Warrant shall be exercisable at an exercise price determined as follows:

(i)

with respect to Tranche A Warrants, an amount “Sa” in euro (EUR) determined according to the following formula:

Sa = amount equal to (y) the EUR equivalent, calculated based on the last EIC Exchange Rate published on the date immediately preceding the issuance date of the Tranche A Warrants, of the average closing price (in USD) per American Depositary Share as reported by NASDAQ over the 90 days preceding, but not including, the date of issuance of the Tranche A Warrants by the Company, multiplied by (z) 0.90;

(ii)

with respect to Tranche B Warrants, an amount “Sb” in euro (EUR) determined according to the following formula:

Sb = amount equal to (y) the EUR equivalent, calculated based on the last EIC Exchange Rate published on the date immediately preceding the issuance date of the Tranche B Warrants, of the average closing price (in USD) per American Depositary Share as reported by NASDAQ over the 90 days preceding, but not including, the date of issuance of the Tranche B Warrants by the Company, multiplied by (z) 0.90; and

(iii)

with respect to Tranche C Warrants, an amount “Sc” in euro (EUR) determined according to the following formula:

Sc = amount equal to (y) the EUR equivalent, calculated based on the last EIC Exchange Rate published on the date immediately preceding the issuance date of the Tranche C Warrants, of the average closing price (in USD) per American Depositary Share as reported by NASDAQ over the 90 days preceding, but not including, the date of issuance of the Tranche C Warrants by the Company, multiplied by (z) 0.90.

The Warrants expire on the twentieth anniversary of their issuance date. Any outstanding Warrants will become exercisable upon the earliest to occur of (i) the maturity date of the applicable Tranche, and (ii) the occurrence of certain events (each an “Exercise Event”), including: (a) the disposal of assets, or shares of subsidiaries holding assets, related to the Project, (b) a change of control of the Company, (c) the maturity date of the last Tranche disbursed under the Finance Contract, (d) the prepayment of any principal amount due under the Finance Contract, or (e) an event of default.

Following any Exercise Event and until expiration of the applicable Warrants, EIB may exercise a put option pursuant to which EIB may require the Company to repurchase all or part of such then-exercisable Warrants at the fair market value, up to a number of Warrants that would result in the put option price being no higher than €20 million in respect of all then-exercisable Warrants.

The Company has a right of first refusal to repurchase Warrants that are offered for sale a third parties on the same terms and conditions of such offer.

The Warrants may be transferred following an Exercise Event to certain affiliates of EIB, promotional banks or finance agencies set up by one or more member states of the European Union or any transferees of the credit facility, or otherwise with the prior written approval of the Company.

The Warrant Agreement provides for anti-dilution adjustments triggered by the occurrence of certain events, including: (i) a financial transaction that includes the issuance of new instruments with or without preferential subscription rights of the shareholders (other than issuance of Tranche B Warrants and Tranche C Warrants), (ii) a free distribution of shares to shareholders, share split or reverse share split, (iii) an increase of the par value of the shares, (iv) a distribution of reserves or premiums in cash or in kind, (v) a free distribution to the Company’s shareholders of any instrument other than the Company’s shares, (vi) a repurchase by the Company of its own shares at a price higher than the market price (other than a repurchase of its own shares from EIB or its affiliates), (vii) a change in profit distribution, including through the creation of preferred shares, (viii) a reduction or redemption of the Company’s share capital, (ix) a dividend distribution, (x) the issuance of any instrument (with or without preferential subscription rights), including by way of dividend distribution or capitalization of profits or reserves (including share premium account and any capital redemption reserve), or (xi) a merger, demerger of the Company with or into another entity or other similar operation as a result of which the Company does not survive, or a spin-off. Such anti-dilution adjustments are subject to certain carve-outs, including (y) the issuance of shares at a price higher than Sa, Sb and Sc or equity-linked securities with conversion or exercise prices higher than Sa, Sb and Sc, and (z) the grant of equity incentive instruments following the date of the Warrant Agreement in an amount not to exceed 10% of the fully diluted capitalization of the Company.

In connection with the Warrant Agreement, the Company agreed to certain customary covenants, including: refraining from taking any action that may result in any Warrants not being exercisable or the ordinary shares issuable upon exercise of the Warrants not being issuable, refraining from creating or issuing a new class of shares with preferential treatment to the Company’s ordinary shares, and refraining from converting the Company into an entity of another form under any jurisdiction.

In connection with the Warrant Agreement, the Company committed to, among other things, use its commercially reasonable efforts to file a registration statement (the “Registration Statement”) with the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended, covering the resale of the Warrants and the ordinary shares, represented by American Depositary Shares, issuable upon exercise of the Warrants, within five calendar days of the filing of its Annual Report on Form 10-K for the fiscal year ended June 30, 2025, but in no event earlier than April 1, 2026 (the “Required Filing Date”). The Company is required to use commercially reasonable efforts to have such Registration Statement filed as soon as practicable after the filing thereof, but in any event no later than 60 calendar days after the Required Filing Date (or 90 calendar days in the event of a “full review” by the Commission).

Tranche A

On October 17, 2025, the Company requested the Tranche A borrowings and issued 2,624,421 Tranche A Warrants to EIB.

The Tranche A borrowings are expected to be disbursed by EIB early November 2025.

The Tranche A borrowings will mature five years from the disbursement date and interest on the Tranche A borrowings shall be payable on the maturity date of Tranche A, and shall capitalized annually by increasing the principal amount of Tranche A.

The descriptions of the terms and conditions of the Finance Contract and the Warrant Agreement herein do not purport to be complete and are qualified by reference in its entirety by reference to the terms of the Finance Contract and the Warrant Agreement, copies of which are filed as exhibits 99.1 and 99.2, respectively, to this Current Report on Form 6-K.

The full text of the press release issued in connection with the entry into the credit facility is furnished as Exhibit 99.3 to this Current Report on Form 6-K.

This Current Report on Form 6-K and exhibits 99.1 and 99.2 hereto shall be deemed to be incorporated by reference in the Company’s registration statement on Form F-3 (File No. 333-278526).

EXHIBIT INDEX

Exhibit	Title
99.1	Finance Contract, dated as of October 17, 2025, between the Company and the European Investment Bank
99.2	Warrant Agreement, dated as of October 17, 2025, between the Company and the European Investment Bank
99.3	Press Release issued by the Company on October 20, 2025

SIGNATURES

Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: September 9, 2025

	EDAP TMS S.A


Date: October 20, 2025	By /s/ Ken Mobeck
	Ken Mobeck
	Chief Financial Officer

EDAP TMS S.A.

/s/ KEN MOBECK KEN MOBECK CHIEF FINANCIAL OFFICER

The Global Leader in Therapeutic Ultrasound 1

Statements & Disclaimer F O R W A R D - L O O K I N G 2

Company Overview 3

Strategic Company Focus 4 Shift from Legacy Technologies and Distributor Model and Transform into the Global Market Leader in Robotic HIFU Focal Therapy

Investment Thesis: Strong Growth Opportunity 5 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)

350+ Focal One Robotic HIFU Clinical Sites

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 . P R O S T A T E C A N C E R M A R K E T Prostate Cancer is the Most Common Cancer Amongst Men In the U.S. Prostate (1) 2025 estimates from the American Cancer Society ( www.cancer.org ) 8 Lung & Bronchus Colorectum Skin Urinary Bladder New Cases Deaths

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 L A R G E G L O B A L M A R K E T 1.5 Million New Prostate Cancer Cases Per Year 9 Data Source: Cases refers to Diagnosed Cases per year From World Health Organization – Globocan 2022

Focal One Answers an Unmet Need for a Large Underserved Patient Population P R O S TA TE C A N C E R Focal One HIFU Focal One HIFU 10 First - Line Treatment Progression from Active Surveillance Salvage Treatment

470,000 Focal One HIFU Prostate Cancer Annual Procedure Opportunity

12 D R I V I N G A P A R A D I G M S HI F T I N P R O S T A T E C A N C E R Focal Therapy | The New Emerging Market (1) As of 2013. Chen et al. National trends in the management of localized prostate cancer: A population - based analysis 2004 - 2013. Prostate. (2) Internal market estimate 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) Focal Therapy (HIFU) Active Surveillance Radical Prostatectomy (Surgery) Radiation Therapy

D R I V I N G A P A R A D I G M S HI F T I N P R O S T A T E C A N C E R HIFU | The Fastest Growing Treatment Option Based on Medicare Claims reported by CMS on HOPPS Proposed Rule for FY24, FY25 and FY26 13 HIFU Cryo Brachytherapy Radical Prostatectomy

Strong Supporting Clinical Evidence 14

15 Proven Clinical Evidence Supporting Focal One Robotic HIFU 3. Preserve Sexual Function 2. Maintain Urinary Control 1. Cancer Control 1000+ Peer - Reviewed Publications Supporting HIFU in the Treatment of Prostate Cancer (1) Optimizing Trifecta Outcomes for Prostate Cancer Functional Outcomes (1) PubMed Database search of “HIFU Prostate Cancer” 15

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 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.2 024.11.006

17 17 HIFI Study Demonstrates Optimal Trifecta Outcomes 1. Cancer Control 3. Preserve Sexual Function 2. Maintain Urinary Control Δ 11% Urinary Continence Pad - Free Continence at 12 months HIFU Provides Superior Functional Outcomes Δ 6 HIFU SURGERY Erectile Function Decrease from baseline at 12 months HIFU SURGERY Comparable Oncologic Outcomes 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.2 024.11.006

18 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 Focal 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 Prostatectomy 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 O P T I M A L T R I F E C T A O U T C O M E S

19 Strong Hospital and Physician Reimbursement

20 Environment for Growth S T R O N G R E I M B U R SE M E N T Creates Favorable 1. APC Level 6 Under CMS for CY23 and CY24 (1,3) 2. 90% Increase in Reimbursement in 2023 (1,2) 3. APC Level 6 Maintained by CMS in 2025 (3) (1) CMS Hospital Outpatient Prospective Payment System - 2023 Final rule (2) CMS Hospital Outpatient Prospective Payment System - 2022 Final rule (3) CMS Hospital Outpatient Prospective Payment System – 2025 Final rule

21 Hospital Outpatient Medicare Payment (Laparoscopic Prostatectomy with or without Robotic Assistance and/or nerve - sparing) ( 1) Medicare Payment (National Average. From on CMS Hospital Outpatient Prospective Payment System – 2025 Final rule 2025 Site of Service CPT ® Code Procedure $5,084 (1) Standard OR 55875 Prostate Brachytherapy $9,247 (1) Standard OR 55873 Cryo Ablation $12,992 (1) Specialized MRI Suite C9734 / 55882 MRI Transurethral Ultrasound Ablation $9,247 (1) Standard OR 55880 HIFU $10,411 (1) Standard OR 55866 Laparoscopic Prostatectomy +5.4%

22 (Laparoscopic Prostatectomy with or without Robotic Assistance and/or nerve - sparing) (1) CMS Physician Fee Schedule – CY 2 024 Final rule (2) CMS Physician Fee Schedule – CY 2025 Final rule Physician Payment (Medicare - 2025) Work RVU (2025) (2) CPT ® Code Procedure $763 13.46 55875 Prostate Brachytherapy $744 13.60 55873 Cryo $579 11.50 55882 MRI Transurethral Ultrasound Ablation $951 17.73 55880 HIFU $1,157 22.46 55866 Laparoscopic Prostatectomy Favorable Physician Payment

Focal One ® Best - in - Class Technology 23

Precise Robotic Delivered Ablation 24 T HE L E A D I N G F O C A L T HE R A P Y T E C H N O L O G Y Targeting and Imaging Image Guided Treatment Planning

Robotics HIFU Advanced Imaging Focal One ® Core Technologies Artificial Intelligence (AI) Remote Connectivity 25

26 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 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* * Not available in all markets. May require additional purchase

27 World’s First Focal One Robotic HIFU Transcontinental Telecollaboration Cleveland Clinic Cleveland, Ohio Cleveland Clinic Abu Dhabi Cleveland, Ohio Abu Dhabi 7,000 Miles 27

BPH & Endometriosis Large Market Opportunities For Expansion 28

29 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 (2) Rectal Endometriosis 1.5 M Prostate Cancer (1) 11.3 M (3) BPH (Benign Prostatic Hyperplasia) 510,992 (1) Pancreatic Cancer 866,136 (1) Liver Cancer 51.4 M (5) Thyroid Nodules 2.3 M (1) Breast Cancer 8.3 M (4) Breast Fibroadenoma

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) Internal market estimate B E N I G N P R O S T A T I C H Y P E R P L A S I A ( B P H ) M A R K E T 30

B P H : F O C A L O N E C L I N I C A L S T U D Y P R O G R E SS Building High - Level Evidence in the Treatment of Benign Prostate Hyperplasia 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 31 U.S. Study Under IRB Review • Protocol based on previous study findings

32 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 . E N D O M E T R I O S I S M A R K E T

33 E N DO M E TR I O S I S : F O C A L O N E C L I N I C A L S T U D Y P R O G R E SS Building High - Level Evidence in the Treatment of Deep Infiltrating Rectal Endometriosis Phase I Study Completed Phase II Study Completed • Feasibility (20 patients) • Published in the Journal of Ultrasound in Obstetrics and Gynecology in 2020 • Multicenter Safety and Efficacy 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 Sham 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 Phase III Study CE Mark Completed Enrollment March 25, 2025 ض

34 Growing Global Install Base

35 73 Focal One Systems in the U.S. at the end of Q2 2025 (36 Academic – 37 Community) A C C E L E R A TI N G A D O P T I O N At Major Hospitals Hawaii

Strong Adoption by the Highest Ranked Prostate Cancer Hospitals in the US F O C A L O N E I S T HE L E A D I N G F O C A L T H E R A P Y T E C H N O L O G Y 70% 7 Out of 10 Best Hospitals for Urology National Comprehensive Cancer Network® 48% 16 Out of 33 NCCN Member Institutions 54% 19 Out of 35 SUO Approved Programs 36

Key Financial Data 37

T HR E E M O N T HS E N D E D J U N E 3 0 T H 2025 2024 (in $Million USD except per share data) 18.4 17.0 Revenue 7.8 6.4 Gross Profit 42.5% 37.5% Gross Margin (6.6) (6.6) Operating Profit (Loss) (6.4) (6.6) Net Income (Loss) (0.17) (0.18) Earnings (Loss) Per Share HIFU $5.2M ESWL $2.5M Distribution $9.4M HIFU $9.7M +89% ESWL $1.8M - 27% 3 months 2024 3 months 2025 $ 1 7 . 0 M Distribution $6.9M - 26% NOTE: Translated for convenience of the reader to U.S. dollars at the 2025 average three months’ exchange rate of 1 Euro = 1.1489 USD, and 2024 average three months’ exchange rate of 1 Euro = 1.0747 USD 38 $ 1 8 . 4 M Financial Highlights as of June 30, 2025 +29% HIFU Revenue CAGR +50% Focal One US Install Base CAGR +52% US Focal One Procedure CAGR 1 st Half 2022 - 2025 HIFU Business Key Metrics

39 Balance Sheet Highlights as of June 30, 2025 Balance Sheet As Of: June 30, 2024 June 30, 2025 (in $Million USD) 32.4 19.1 Cash and Cash Equivalents 39.8 41.4 Other Current Assets 15.9 19.8 Fixed and Other Non - Current Assets 88.0 80.4 29.4 40.2 Current Liabilities 7.6 7.5 Non - Current Liabilities 51.0 32.7 Shareholders’ Equity 88.0 80.4 Note: Translated for convenience of the reader to U.S. dollars at the exchange rate of 1 Euro = 1.1770 USD, on June 30, 2025 and at the exchange rate of 1 Euro = 1.0711 USD, on June 30, 2024.

Positioned for Growth S U M M A R Y • 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 40

The Global Leader in Therapeutic Ultrasound 41

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