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Item 3. Key Information ​ Risk Factors ​ In addition to the other information contained in this annual report, the following risk factors should be carefully considered in evaluating us and our business.

These statements are intended to highlight the material risk factors that may cause actual financial, business, research or operating results to differ materially from expectations disclosed in this annual report.

See also factors disclosed under “Cautionary statement on forward-looking information.” Summary of Key Risks Our business and our industry are subject to numerous risks described in the following risk factors and elsewhere in this annual report, Investors should carefully consider these risks before making a decision to invest in our securities.

The main risk factors relating to the Company and its business operations are grouped into the seven categories listed below.

The most important risk factors have been identified and assessed considering the likelihood of occurrence and the possible negative effect on the Company, in each case also taking into account corrective actions and risk management measures that have been put in place.

The occurrence of new events, whether internal or external to the Company, is therefore likely to modify this ranking in the future. ​ 6 Table of Contents Risks Relating to our Business, Financial Position and Capital Needs ● Our history of losses and our expectation of continuing negative cash flows may raise substantial doubt about our ability to continue as a going concern and may hinder our ability to access the debt and equity capital markets to help meet our cash needs . ● Our future revenue and income growth depends, among other things, on implementing our business strategy, which largely depends on the success of our HIFU technology. ● Our cash flow is highly dependent on cyclical demand for our products. ● Our results of operations have fluctuated significantly from quarter to quarter in the past and may continue to do so in the future.

Risks Related to our Product Candidates and the Industry in which we Operate ● If we do not optimize our sales channels and maintain high product quality , our operating results may be negatively impacted. ● New device developments and introductions may adversely impact our financial results. ● Our future success depends on obtaining and maintaining government regulatory approval of our products. ● Our business depends on the success of our clinical trials related to products using HIFU technology. ● The commercial success of our products depends on whether our products are eligible for reimbursement by national health authorities and third party payers. ● HIFU technology may not be widely adopted by the medical community and may never become a standard of care. ● There is a substantial risk our products or service offerings could become obsolete or uncompetitive.

Risks Related to our Organization and Operations ● Our revenue may be disrupted due to our strategic shift to focus on HIFU activities away from our legacy non-HIFU activities. ● We may face a significant risk of exposure to product liability claims linked to the misuse of our products. ● We depend on a single site to manufacture our products, and any interruption of operations could impact our business. ● We depend on a small number of suppliers who may fail to deliver sufficient supplies to us or increase the cost of items supplied, which would interrupt our production processes or negatively impact our results of operations. ● We utilize distributors for our sales abroad, which subjects us to a number of risks that could harm our business . ● We are a relatively small company and sales fluctuations and employee turnover may adversely affect our business. ● The loss of key members of our executive management team could adversely affect our business. ● We may have difficulties in attracting and recruiting highly qualified experts in hardware, software, artificial intelligence, design and development of high technology devices. ● We have identified material weaknesses in our internal control over financial reporting with respect to our U.S. subsidiary.

If we fail to remediate these material weaknesses or if we experience additional material weaknesses in the future or otherwise fail to achieve an effective system of internal controls, we may not be able to report our financial results accurately or timely.

In addition, the trading price of our securities may be adversely affected ● We are exposed to risks related to cybersecurity threats and incidents. ● The expansion of social media platforms and new technologies present risks and challenges for our business and reputation. ​ Risks Related to Intellectual Property Rights ● Our success largely depends on our ability to establish and protect the intellectual property rights related to our medical devices. ● We may encounter disruption in our Intellectual Property protections due to expiring patents and lack of updated filings. ● U.S. laws relating to the patentability of certain inventions in medical technology industry are uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain patents in the future. ● We may not be able to protect or enforce our intellectual property rights throughout the world. ● Our use of “open source” software could negatively affect our ability to sell our products and subject us to possible litigation.

Risks Relating to our Status as a Foreign Private Issuer or a French Company ● Our French and international operations expose us to additional costs, legal and regulatory risks, which could have a material adverse effect on our business, financial condition and results of operations. ● We sell our products in many parts of the world, as a result, our business is affected by fluctuations in currency exchange rates. ● Our by-laws and French corporate law contain provisions that may delay or discourage a takeover attempt. ● The rights of shareholders in companies subject to French corporate law differ in material respects from the rights of shareholders of corporations incorporated in the United States or other countries. ● French law may limit the amount of dividends we are able to distribute, and we do not currently intend to pay dividends. 7 Table of Contents ● We expect to lose our foreign private issuer status in 2026, which will likely result in significant additional costs and expenses. ● Judgments of U.S. courts, including those predicated on the civil liability provisions of the federal securities laws of the United States, may not be enforceable in French courts. ​ Risks Related to Ownership of our Ordinary Shares and the ADSs ● Our securities may be affected by volume fluctuations, and may fluctuate significantly in price, causing investors to lose some or all of their investment. ● Holders of ADSs have fewer rights than direct shareholders and must act through the Depositary to exercise those rights. ● If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our market or business, our ADS price and trading volume could decline. ● We are subject to different corporate disclosure standards that may limit the information available to holders of our ADSs. ● Preferential subscription rights may not be available for U.S. persons. ​ ​ General Risk Factors ● Our results of operations and financial condition could be adversely affected by adverse economic changes, political, social and geopolitical developments, financial changes, and the impact of climate change. ● Global potential inflation may have a material adverse effect on our business, results of operations and financial condition. ● We may issue additional securities that may be dilutive to our existing shareholders, in view of funding our new developments and accelerating our business expansion . ● We may in the future be the target of securities class action or other litigation, which could be costly and time consuming to defend. ​ Risks Relating to Our Business, Financial Position and Capital Needs ​ We may in the future face substantial doubt about our ability to continue as a going concern as a result of our history of operating losses and our expectation of continuing negative cash flows, which could hinder our ability to access the debt and equity capital markets to help meet our cash needs.

We have a history of operating losses and expect such losses to continue in the foreseeable future. As of December 31, 2024, we had €29.8 million in cash and cash equivalents, a decrease of €13.6 million from December 31, 2023.

We believe we have sufficient funds to support our operations for at least a period of twelve months from the date of issue of our consolidated financial statements. However, we will need to raise substantial additional financing in order to meet our cash flow needs in the subsequent period and until we achieve profitability.

We may not be able to raise additional financing on acceptable terms or at all and this condition may in the future raise uncertainty regarding our ability to continue as a going concern.

Management is actively exploring various alternatives, including seeking additional funding through the debt and equity capital markets, cost-cutting measures, and restructuring opportunities, but there is no assurance that these efforts will be successful or sufficient to address these liquidity concerns.

If we are unable to raise capital when needed on acceptable terms, or at all, we may be forced to restructure our business or delay, reduce, or terminate our research and product development programs, future commercialization efforts or other operations.

See Note 1-2 to our consolidated financial statements. ​ Our future revenue and income growth depends, among other things, on implementing our business strategy, which largely depends on the success of our HIFU technology, and our capacity to scale our operations to manage and sustain our future growth.

Our business strategy depends on the success of our HIFU technology for future revenue growth and net profit generation. We are dependent on the successful development and commercialization of other product lines, such as devices based on HIFU but not limited to the Focal One System, to generate significant additional revenues and to achieve and sustain profitability in the future.

To implement our business strategy, we need (among other things) to develop new applications for our HIFU technology, to improve our products and service offerings, and to educate physicians and patients about the clinical and cost benefits of our products, all of which we believe could increase patients’ wellbeing and acceptance of our products.

Our focus is to primarily expand our HIFU business in the U.S. as HIFU is FDA approved for ablation of prostate tissue and reimbursed at an acceptable level.

Although we are particularly dependent on the success of our HIFU technology to grow our business through our HIFU division, other revenues, generated by our Extracorporeal ShockWave Lithotripsy (“ESWL”) division and our Distribution (“Distribution”) division directly linked to the distribution of other complementary products on behalf of third-party medical companies, contributed to our global revenue in 2024.

In 2025, we will 8 Table of Contents discontinue system sales in our ESWL business, but we will continue to service our existing installed base. This will result in a decline in revenue related to ESWL in 2025 and subsequent periods.

In addition, some distribution agreements with third parties expired in December 2024 and were not renewed; the termination of these commitments from such third parties will have a material adverse effect on our revenue, financial condition and results of operations.

See Item 4, “Information on the Company—ESWL Division” and “Information on the Company—Distribution Division.” ​ In addition, there can be no assurance that we will be able to manage our future growth efficiently or profitably, and revenue may be less than expected.

If we are unable to scale our production capabilities efficiently or maintain pricing, we may fail to achieve expected operating margins, which would have a material and adverse effect on our operating results. Growth may also stress our ability to adequately manage our operations, quality of products, safety, and regulatory compliance.

Failure to implement necessary internal quality controls, procedures, equipment, or processes or to hire the necessary personnel in a timely and effective manner could result in higher costs or an inability to meet market demand and could have a material adverse impact on our business, results of operations, financial condition, and prospects.

Additionally, our future growth will increase the demands placed on our third-party suppliers, and there is no guarantee that our suppliers will be able to support our anticipated growth. If growth significantly changes, it can negatively impact our cash reserves, and we may be required to obtain additional financing, which may increase indebtedness or result in dilution to shareholders.

Further, there can be no assurance that we would be able to obtain additional financing on acceptable terms, if at all. Although we achieved operating income in 2020, we incurred operating losses in 2021, 2022, 2023 and 2024.

We expect that our marketing, selling and research and development expenses will increase as we attempt to further develop and commercialize our HIFU devices and particularly with the planned acceleration of our U.S. HIFU expansion plan.

In this respect, we may not generate a sufficient level of revenue to offset these expenses and may not be able to adjust spending in a timely manner to respond to any unanticipated decline in revenue. We cannot guarantee that we will realize sufficient revenue to achieve profitability in the future.

See Item 5, “ Operating and Financial Review and Prospects. ” Our operating cash flow is highly dependent on cyclical demand for our products.

Our operating cash flow has historically been subject to significant fluctuations over the course of any given fiscal year due to cyclical demand for medical devices, in particular with hospital budgets being mostly spent at year-end, and the resulting annual and quarterly fluctuations in trade and other receivables and inventories.

This has in the past resulted in significant variations in working capital requirements and operating cash flows.

Since, in addition to raising additional funding, we anticipate relying on cash flow from operating activities to meet our liquidity requirements, a decrease in the demand for our products, or the inability of our customers or distributors to meet their financial obligations to us, would reduce the funds available to us.

In the future, our liquidity may be constrained, and our cash flows may be uncertain, negative or significantly different from period to period. Our cash flow is affected by increased expenses in clinical trials, sales efforts and other market costs related to implementing our expanded U.S. and global strategy, which require significant additional resources.

However, there is no assurance that this will result in an increase in the demand for our products and services.

Our results of operations have fluctuated significantly from quarter to quarter in the past and may continue to do so in the future as we experience long and variable product sales cycles, which are long and seasonal and are partly dependent on access to sufficient financing.

Our results of operations have fluctuated in the past and may continue to fluctuate from quarter to quarter depending upon numerous factors, including, but not limited to, the timing and results of clinical trials, changes in healthcare reimbursement policies, cyclicality of demand for our products, changes in pricing policies by us or our competitors, new product announcements by us or our competitors, customer order deferrals in anticipation of new or enhanced products offered by us or our competitors, product quality problems and exchange rate fluctuations.

Furthermore, because our main products have relatively high unit prices, the amount and timing of individual orders can have a substantial effect on our results of operations in any given quarter.

The sales cycle of our products is lengthy as our products are high value capital items for our customers to purchase and often require the approval of multiple levels of management or Boards of hospitals, purchasing groups and, in some cases, government authorities.

In addition, some sales are subject to a public tender offer process with many approvals which could be lengthy to obtain, and, as a result, hospitals may delay their purchase orders according to their timelines and budget allocations. It is difficult to predict the exact timing for closing product sales directly linked to the length of capital expenditure cycles.

In addition, our customers may rely on the credit market to secure dedicated lease financing to purchase or lease our equipment. Due to the limited availability of lending, we may be unable to access sufficient lease financing to support these transactions.

Without lease financing, we may be unable to continue the development of our revenue-per-procedure (“RPP”) model, or we may need to fund such activity out of our existing working capital. Similarly, some of our clients rely on lease financing to finance their purchases of 9 Table of Contents equipment.

Limited availability of lease financing facilities may also affect their purchasing decisions and may adversely impact our equipment sales.

In addition, the current macro-economic environment with elevated or increasing interest rates as compared to prior years, may make lease financing less attractive and more difficult to implement for our customers. ​ Risks Related to our Product Candidates and the Industry in which we Operate If we do not successfully optimize our sales, marketing, and potential future distribution channels or do not effectively expand and update our infrastructure, or maintain high product quality and reliability, our operating results may be negatively impacted. ​ If we do not adequately predict market demand or otherwise optimize and operate our sales, marketing and potential future distribution channels successfully, it could result in excess or insufficient inventory or fulfillment capacity, increased costs, or immediate shortages in product or component supply, or harm our business in other ways.

In addition, if we do not maintain adequate infrastructure to enable us to, among other things, manage our purchasing and inventory levels, it could negatively impact our cash flow and operating results. ​ Moreover, our future success will depend largely on our ability to continue to hire, train, retain and motivate skilled sales representatives or distributors with significant technical and clinical knowledge about our products.

New hires require training, supervision and take time to achieve full productivity. If we fail to train and supervise new hires adequately, or if we experience a high turnover in our sales force or trained professionals in the future, we cannot be certain that we will maintain or increase our sales.

If we are unable to expand our sales and marketing capabilities, we may not be able to effectively commercialize our HIFU devices or our other products and service offerings in development, which would adversely affect our business, results of operations, and financial condition. ​ Our success depends on the quality and reliability of our products.

While we subject our devices to stringent quality specifications and processes, our products incorporate mechanical parts, electrical components and computer software, any of which may contain errors or exhibit failures, especially when devices are first introduced.

Component failures, manufacturing flaws, design defects, or inadequate disclosure of product-related risks with respect to our products could result in an unsafe condition or injury to, or death of, the patient. In addition, new devices or developments may contain undetected errors or performance problems that, despite testing, are discovered only after commercial placement.

Any of the foregoing would adversely affect our business, results of operations, and financial condition. ​ ​ New device developments and introductions may adversely impact our financial results. From time to time, we may develop and introduce new devices, hardware and software, with enhanced features, including artificial intelligence (“AI”).

These developments may extend a product’s capabilities, targeting new clinical applications or improving existing approaches.

The success of new device introductions depends on a number of factors including, but not limited to, timely and successful research and development, receipt of regulatory clearances or approvals, pricing, competition, market and consumer acceptance, manufacturing and supply costs, and the risk that new devices may have quality or other defects.

We invest in various research and development projects to expand our product offerings. Our research and development efforts are critical to our success, and our research and development projects may not be successful.

We may be unable to develop and market new products successfully, and the products we invest in and develop may not be well received by customers or meet our expectations.

Our research and development investments may not generate significant operating income or contribute to our future operating results for several years, and such contributions may not meet our expectations or even cover the costs of such investments.

If we fail to effectively develop new products, obtain regulatory clearances or approvals and manage new product introductions in the future, our business, financial condition, results of operations, or cash flows could be materially and adversely impacted.

We operate in a highly regulated industry and our future success depends on obtaining and maintaining government regulatory approval of our products, which we may not receive or be able to maintain or which may be delayed for a significant period of time.

Government regulation significantly impacts the development and marketing of our products, particularly in the United States, European Union and Japan. We are regulated in each of our major markets with respect to preclinical and clinical testing, manufacturing, labeling, distribution, sale, marketing, advertising and promotion of our products.

To market and sell products, we are required to obtain approval or clearance from the relevant regulatory agencies, including the U.S. Food and Drug Administration (“FDA”) with respect to the United States. The process of applying for regulatory approval or clearance is often lengthy and requires the expenditure of substantial resources.

Further, there can be no assurance that we will receive the required approvals or clearance for our products from 10 Table of Contents the required regulatory authorities or, if we do receive the required approvals, that we will receive them on a timely basis, on the conditions and for the indications we seek, or that we will otherwise be able to satisfy the conditions of such approval, if any.

The regulatory agencies may not act favorably or quickly in their review of our submissions, or we may encounter significant difficulties in our efforts to obtain their clearance or approval, or to maintain our existing approvals, all of which could delay or preclude the sale of new or existing products in the related territories.

Our manufacturing operations must comply with regulations established by regulatory agencies in the United States, the European Union and other countries, and in particular with the Current Good Manufacturing Practices (“CGMP”) and other standards for quality assurance and manufacturing process control under applicable regulatory authorities. Such standards may change or evolve, requiring that we change or evolve our manufacturing operations.

We may not always comply with all applicable standards and, as a result, would be unable to manufacture our products for commercial sale or for clinical trial supply. Our manufacturing facilities are subject to inspection by regulatory authorities at any time.

If any inspection by the regulatory authorities reveals deficiencies in manufacturing, we could be required to take immediate corrective or remedial actions, suspend production or close the current and future production facilities, which would disrupt our manufacturing processes. Accordingly, failure to comply with these regulations could have a material adverse effect on our business, financial condition and results of operations.

In the European Union, the regulation of medical devices is being updated by the European Medical Device Regulation (“MDR”) imposing stricter requirements on the conformity assessment and the commercialization of our products. A transition period to conform to MDR requirement has been adopted based on MDR classification of devices with an application date of December 31, 2028, at the latest.

The extension of the period during which the devices can be placed on the market is subject to certain conditions. To benefit from the new provisions, we were required to, and did, implement a Quality Management System (“QMS”) that complies with the MDR requirements .

An MDR compliance action plan has been put in place in preparation of MDR enforcement within the expected timelines. We are implementing operational actions and internal audits to ensure our devices may be distributed on the European and international market and conform to MDR requirements, where applicable.

However, the uncertainty of continuing healthcare changes, regulations, and our ability to maintain MDR compliance of our products may negatively affect our business. Even if regulatory approval to market a product is granted, it may include limitations on the indicated uses for which the product may be marketed.

Failure to comply with regulatory requirements can result in fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecutions. Regulatory policy may change, and additional government regulations may be established that could prevent or delay regulatory approval of our products.

Any delay, failure to receive regulatory approval or the loss of previously received approvals could have a material adverse effect on our business, financial condition and results of operations.

For more information on the regulation of our business, see Item 4, “ Information on the Company—Government Regulation ” and “ Information on the Company—HIFU Division—HIFU Clinical and Regulatory Status. ” Our clinical trials related to products using HIFU technology may not be successful, and we may not be able to obtain regulatory approvals necessary for commercialization of all of our HIFU products.

Before obtaining regulatory approvals or clearance for the commercial sale of any of our devices under development, we must demonstrate through preclinical testing and clinical trials that the device is safe and effective in each intended use.

Product development, including pre-clinical studies and clinical trials, is a long, expensive and uncertain process, and is subject to delays and failures at any stage. We or the relevant regulatory authorities may suspend or terminate clinical trials at any time and regulating agencies may even refuse to grant exemptions to pursue clinical trials.

The results from preclinical testing and early clinical trials may not predict the results that will be obtained in large-scale clinical trials. We could suffer significant setbacks in later-stage clinical trials, even after promising results in earlier trials. Furthermore, data obtained from a trial might be insufficient to demonstrate that our products are safe, and effective.

The commencement, continuation or completion of any of our clinical trials may be delayed or halted, or inadequate to support approval of an application to regulatory authorities for numerous reasons including, but not limited to: · that regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold, discussions with regulatory authorities to improve our clinical protocols may prove difficult and lengthy; see Item 4, “ Information on the Company—HIFU Division—HIFU Clinical and Regulatory Status ;” · slower than expected rates of patient recruitment and enrollment; · inability to adequately monitor patients during or after treatment; · failure of patients to complete the clinical trial; · prevalence and severity of adverse events and other unforeseen safety issues; · third-party organizations not performing data collection and analysis in a timely and accurate manner; · governmental and regulatory delays or changes in regulatory requirements, policies or guidelines; · that regulatory authorities conclude that our trial design is inadequate to demonstrate safety and efficacy. 11 Table of Contents ​ The data we collect from our preclinical studies, current clinical trials, and other clinical trials may not be sufficient to support requested regulatory approval.

Additionally, certain regulatory authorities may disagree with our interpretation of the data from our preclinical studies and clinical trials, or may find the clinical trial design, conduct or results inadequate to prove safety or efficacy, and may require us to pursue additional preclinical studies or clinical trials, which would increase costs and could further delay the approval of our products.

If we are unable to demonstrate the safety and/or efficacy of our products in our clinical trials, we will be unable to obtain regulatory approval to market our products.

Operating and Financial Review and Prospects The following discussion of our results of operations, liquidity and capital resources for the fiscal years ended December 31, 2024, and 2023 is based on, and should be read in conjunction with, our consolidated financial statements and the notes thereto included in Item 18, “ Financial Statements. ” The consolidated financial statements have been prepared in accordance with U.S.

GAAP. The following discussion contains certain forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those contained in such forward-looking statements.

See “Cautionary Statement on Forward-Looking Information” at the beginning of this annual report. 40 Table of Contents Critical Accounting Estimates Management has not identified any estimates made in accordance with generally accepted accounting principles that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on the financial condition or results of operations of the registrant.

Operating Results Overview Our activities are organized into three divisions: HIFU, ESWL and Distribution. Recently, we have shifted to a growth strategy focused on developing our core proprietary HIFU activities and placing less emphasis on our non-HIFU distribution and ESWL business activities. We expect this new strategy to impact our accounts. See Item 3.

“ Risk Factors— Risks Related to our Organization and Operations. ” Total revenues of the Company include sales of our medical devices and sales of disposables (“sales of goods”), sales of RPPs and leases, and sales of spare parts and services, all net of third-party distributor and agent commissions, as well as other revenues.

Sales of goods have historically been comprised of net sales of medical devices (HIFU devices, ESWL lithotripters and other third-parties’ devices) and net sales of disposables (mostly Focalpaks in the HIFU division, electrodes in the ESWL division and disposables from third parties’ devices sold by the Distribution division).

The sale price of our medical devices is subject to variation based on a number of factors, including market competition, warranties and payment terms.

Consequently, a particular sale of a medical device may, depending on its terms, result in significant fluctuations in the average unit sale price of the product for a given period, which may not be indicative of a market trend.

Sales of RPP and leases mainly include the revenues recorded in the HIFU division from the sale of Focal One treatment procedures and from leasing Focal One devices or treatment probes. We provide Focal One systems to clinics and hospitals at no charge for a limited period, rather than selling the systems.

These hospitals and clinics perform treatments using the systems and usually pay us based on the number of individual treatments provided. With this business model, the hospital or clinic does not make an initial investment until the increase in patient demand justifies the purchase of a HIFU device.

Consequently, we are able to make Focal One treatments available to a larger number of hospitals and clinics, which we believe should serve to create more long-term interest in the product.

Compared to the sale of systems, this business model initially generates a smaller, although more predictable stream of revenue and, if successful, should lead to more purchases of Focal One systems by hospitals and clinics in the long term.

Regarding the ESWL division, and in line with our growth strategy, we have made the decision to stop selling the Sonolith i-move lithotripsy product line. Final system sales are currently scheduled to conclude in the second half of calendar year 2025.

Going forward, we will continue to service our installed base of ESWL systems by providing consumable electrodes, spare parts and repair services to customers on active service agreements as well as customers purchasing electrodes, parts and services outside of standard service agreements. This will result in a decline in revenue related to ESWL in 2025 and subsequent periods.

Revenues recorded in our Distribution division include sales of complementary products such as lasers, micro-ultrasound systems and other products from third parties, including the associated disposables and maintenance contracts.

Some distribution agreements with third parties expired in December 2024 and were not renewed; the termination of these commitments from such third parties will have a material adverse effect on our revenue, financial condition and result of operations.

Sales of spare parts and services include revenues arising from maintenance services furnished by us for the installed base of ESWL lithotripters, HIFU systems and complementary products from third parties.

We derive a significant portion of both net sales of medical devices and disposables and net sales of spare parts and services from our operations in Asia, through our wholly-owned subsidiaries or representative offices in Japan (Edap Technomed Co. Ltd), Malaysia (Edap Technomed Sdh Bhd) and South Korea (Edap Technomed Korea).

Net sales derived from our operations in Asia represented 30% of our total consolidated net sales in 2024. Net sales of goods in Asia represented 34% of such sales in 2024 and consisted mainly of sales of urology devices and disposables.

Net sales of spare parts, supplies and services in Asia represented 29% of such sales in 2024 and related primarily to ESWL lithotripters. We also derive a significant portion of net sales of medical devices and disposables from our operations in the U.S., through our wholly owned subsidiary (Edap Technomed. Inc).

Net sales derived from our operations in the U.S. represented 28% of our total consolidated net sales in 2024. Net sales of goods in the U.S. represented 28% of such sales in 2024 and consisted mainly of sales of urology devices and disposables. See Note 18 of our consolidated financial statements.

We sell our products in many parts of the world and, as a result, our business is affected by fluctuations in currency exchange 41 Table of Contents rates. We are exposed to foreign currency exchange rate risk because the mix of currencies in which our costs are denominated is different from the mix of currencies in which we earn revenues.

In 2024, 59% of our costs of sales and research and development, selling, marketing and general and administrative expenses were denominated in euro, while 55% of our sales were denominated in currencies other than euros (primarily the U.S. Dollar and Japanese yen).

Our operating profitability could be materially affected by large fluctuations in the rate of exchange between the euro and such other currencies. To minimize our exposure to exchange rate risks, we sometimes use certain financial instruments for hedging purposes.

See Item 3, “ Risk Factors—We sell our products in many parts of the world and, as a result, our business is affected by fluctuations in currency exchange rates ” and Item 11, “ Quantitative and Qualitative Disclosures About Market Risk ” for a description of the impact of foreign currency fluctuations on our business and results of operations.

Reserves for slow-moving and obsolete inventory are determined based upon quarterly reviews of all inventory items.

Items that are not expected to be sold or used in production, based on management’s analysis, are written down to their net realizable value, which is their fair market value or zero in the case of spare parts or disposable parts for systems that are no longer in commercial production.

Consolidated research and development expenses include all costs related to the development of new technologies and products and the enhancement of existing products, including the costs of organizing clinical trials and of obtaining patents and regulatory approvals.

We do not capitalize any of our research and development expenses, except for the expenses relating to the production of machines to be used in clinical trials and that have alternative future uses as equipment or components for future research projects.

Consolidated research and development expenses, as described above, amounted to €7.7 million and €7.0 million in 2024 and 2023, respectively, representing 12.1% and 11.5% of total revenues in 2024 and 2023, respectively. This increase was mainly driven by our HIFU development programs and clinical studies.

Research and development government grants and tax credits are deducted from our consolidated research and development expenses for amounts of €0.7 million and €0.6 million in 2024 and 2023, respectively.

Beginning in 2025, management expects the budget for research and development expenses to increase to 15% of total revenues, which we expect will allow us to maintain our strategy to launch new clinical studies (thus strengthening our clinical credibility), to continue to focus our efforts on obtaining regulatory approvals in Japan in particular, and to build reimbursement coverage in key countries and particularly in the U.S., to continue to develop our HIFU product range and to fund projects to expand the use of HIFU beyond the treatment of prostate cancer.

Consolidated selling and marketing expenses amounted to €25.3 million in 2024 and €22.6 million in 2023. The €2.7 million or 11.9% increase in selling and marketing expenses from 2023 to 2024 was primarily a result of the implementation of the HIFU expansion plan in the U.S.

Beginning in 2025, management expects selling and marketing expenses to increase in connection with the acceleration of HIFU adoption in the U.S. ​ Consolidated general and administrative expenses decreased €0.6 million or 3.7% to €14.1 million in 2024, reflecting the impact of the HIFU expansion plan in the U.S., which includes the impact of share-based compensation plans for €1.7 million in 2024 and for €2.9 million in 2023 and non-recurring expenses linked to the leadership succession plan for €3.4 million in 2023, which includes the impact of share-based compensation plan for €1.3 million.

Beginning in 2025, management expects general and administrative expenses to increase in connection with the development of the U.S. activity. ​ 42 Table of Contents Fiscal Year Ended December 31, 2024 Compared to Fiscal Year Ended December 31, 2023 We report our segment information on a “net contribution” basis.

See Note 29 to our consolidated financial statements. ​ ​ ​ ​ ​ ​ ​ (in millions of euros) 2024 2023 Total revenues 64.1 60.4 ​ Total net sales 64.1 60.4 ​ HIFU 23.8 20.6 ​ ESWL 9.0 9.9 ​ DISTRIBUTION 31.3 29.9 ​ Total cost of sales (37.6) (36.0) ​ Gross profit 26.6 24.4 ​ Gross profit as a percentage of total net sales 41.42 % 40.40 % Total operating expenses (47.1) (44.2) ​ Loss from operations (20.5) (19.8) ​ HIFU ​ (17.5) ​ (14.8) ​ ESWL ​ 1.2 ​ (0.2) ​ DISTRIBUTION ​ (0.6) ​ (0.2) ​ Net loss (19.0) (21.2) ​ ​ Total revenues Our total revenues increased 6.1% from €60.4 million in 2023 to €64.1 million in 2024.

HIFU division . The HIFU division’s total revenues increased by 15.7% from €20.6 million in 2023 to €23.8 million in 2024, reflecting growth of equipment sales and treatment-driven revenue in the U.S.

The HIFU division’s net sales of medical devices were stable with €9.7 million in 2024, with 22 Focal One units sold (including 12 in the U.S.), as compared to €9.8 million in 2023, with 21 Focal One units sold (including 15 in the U.S.).

Treatment-driven revenue, which includes net sales of RPP & leases, net sales of disposables and treatments related services, increased by 31.4% to €11.9 million in 2024. Net sales of HIFU maintenance services increased by 25.2% to €2.2 million in 2024. ESWL division.

The ESWL division’s total revenues decreased 9.3% from €9.9 million in 2023 to €9.0 million in 2024, primarily due to the decrease in sales of equipment and maintenance services, consistent with our strategic shift to de-emphasize our ESWL division.

The ESWL division’s net sales of medical devices decreased 9.2% from €2.8 million in 2023 to €2.5 million in 2024 with 13 ESWL devices sold in 2024 compared to 16 ESWL units sold in 2023. Net sales of ESWL-related consumables, spare parts, supplies, RPP, leasing and services decreased 8.8% from €7.1 million in 2023 to €6.5 million in 2024.

Distribution division. The Distribution division’s total revenues increased 4.6% from €29.9 million in 2023 to €31.3 million in 2024, primarily due to the increase of consumables and maintenance revenues linked to the development of the installed base.

The Distribution division’s net sales of medical devices decreased 3.8% from €15.6 million in 2023 to €15.0 million in 2024, consistent with our strategy to de-emphasize our Distribution division.

Net sales of Distribution-related consumables, spare parts, supplies, leasing and services increased 13.7% from €14.4 million in 2023 to €16.3 million in 2024, reflecting the growth of the installed base. 43 Table of Contents Cost of sales.

Cost of sales increased 4.3% from €36.0 million in 2023 to €37.6 million in 2024 and represented 58.6% as a percentage of net sales in 2024, down from 59.6% as a percentage of net sales in 2023.

This effect was primarily due to segment mix and a better absorption of our fixed costs mainly due to the growth of the HIFU revenues, which carry a lower cost of sales as a percentage of revenue. Operating expenses. Operating expenses increased 6.5%, or €2.9 million, from €44.2 million in 2023 to €47.1 million in 2024.

Marketing and sales expenses increased €2.7 million, or 11.9% to €25.3 million in 2024, reflecting the impact of the HIFU expansion plan in the U.S. Research and development (“R&D”) expenses increased 11.0% to €7.7 million in 2024 from €7.0 million in 2023.

R&D expenses are net of R&D grants and tax credits of €0.7 million in 2024 and €0.6 million in 2023. This increase was mainly driven by the increase in research and development activities associated with our HIFU development programs and clinical studies. G eneral and administrative expenses decreased €0.6 million or 3.7% to €14.1 million in 2024.

This reduction reflects the impact of non-recurring expenses linked to the leadership succession plan for €3.4 million in 2023, which includes the impact of share-based compensation plan for €1.3 million. This is offset by the HIFU expansion plan in the U.S., which includes the impact of share-based compensation plans for €1.7 million in 2024 and for €2.9 million in 2023.

Operating profit (loss). As a result of the factors discussed above, particularly the expansion of our activities in the U.S. to accelerate HIFU adoption, we recorded a consolidated operating loss of €20.5 million in 2024, as compared to a consolidated operating loss of €19.8 million in 2023.

We recorded an operating loss in the HIFU division of €17.5 million in 2024, as compared with an operating loss of €14.8 million in 2023, an operating profit in the ESWL division of €1.2 million in 2024, as compared to an operating loss of €0.2 million in 2023, and an operating loss in the Distribution division of €0.6 million in 2024, as compared to an operating loss of €0.2 million in 2023.

Interest (expense) income, net. Net interest income was €0.6 million in 2024, compared with a net interest income of €1.1 million in 2023. The interest income was mainly generated by short-term deposits net of interest expenses generated by long-term debt and short-term borrowings. Foreign currency exchange gain (loss), net.

In 2024, we recorded a net foreign currency exchange gain of €1.2 million, mainly due to the variation of the Euro against the U.S. Dollar, compared to a loss of €1.8 million in 2023. Income taxes.

Income tax expenses in the consolidated statement of operations was an expense of €0.3 million in 2024, compared to an expense of €0.6 million in 2023. Net loss. As a result of the above, we realized a consolidated net loss of €19.0 million in 2024 compared with a consolidated net loss of €21.2 million in 2023.

For comparison between the fiscal year ended December 31, 2023 and the fiscal year ended December 31, 2022, please refer to our annual report on Form 20-F filed with the SEC on March 28, 2024. ​ 44 Table of Contents Effect of Inflation In 2023 and 2024, geopolitical instability and other factors have led to higher worldwide inflation leading to a global increase in costs.

We are constantly addressing this cost increase by mitigating the impact on our margins, in particular by adjusting our prices, reducing our costs or implementing counter measures to ensure the minimum residual impact. ​ Liquidity and Capital Resources Our cash flow has historically been subject to significant fluctuations over the course of any given financial year due to cyclical demand for medical devices.

Cyclical demand has historically resulted in significant annual and quarterly fluctuations in trade, other receivables and inventories, and therefore led to significant variations in working capital requirements and operating cash flows that were not necessarily indicative of changes in our business. We have a history of operating losses and expect such losses to continue in the foreseeable future.

As of December 31, 2024, we had €29.8 million in cash and cash equivalents, a decrease of €13.6 million from December 31, 2023. We believe we have sufficient funds to support our operations for at least a period of twelve months from the date of issue of our consolidated financial statements.

However, we will need to raise substantial additional financing in order to meet our cash flow needs in the subsequent period and until we achieve profitability. We may not be able to raise additional financing on acceptable terms or at all and this condition may in the future raise uncertainty regarding our ability to continue as a going concern.

Management is actively exploring various alternatives, including seeking additional funding through the debt and equity capital markets, cost-cutting measures, and restructuring opportunities, but there is no assurance that these efforts will be successful or sufficient to address these liquidity concerns.

If we are unable to raise capital when needed on acceptable terms, or at all, we may be forced to restructure our business or delay, reduce, or terminate our research and product development programs, future commercialization efforts or other operations. See Note 1-2 to our consolidated financial statements.

Material Cash Requirements The following table discloses aggregate information about material contractual obligations and periods in which payments were due as of December 31, 2024. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Payments Due by Period ​ Total Less than 1 year 1-3 years 4-5 years More than 5 years Short-Term Debt ​ 6,243 6,243 — — — Long-Term Debt 4,571 2,409 2,152 10 — Financing Lease Obligations 519 168 258 78 15 Operating Leases Obligations 2,588 999 1,374 215 — ​ The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, excluding interest on long-term debt.

Future events could cause actual payments to differ from these estimates.

Long term debts represent a €4.2 million cash requirement as of December 31, 2024 and are mainly related to the two loans taken out from French banks, in the form of the loans guaranteed by the French State for a total amount of €4.0 million at inception in the context of the Covid-19 pandemic, and a new loan taken out from a French bank in December 2024, for a total amount of €2.2 million at inception, to finance the purchase of ultrasound technology.

This loan will reach maturity in December 2026. The first two loans taken out in August 2020 with initial maturity in August 2021 have been extended until August 2026. The amendments provide for reimbursements to be made over four years, beginning in August 2022.

Operating and financing leases represent a €3.1 million cash requirement as of December 31, 2024, with a repayment horizon up to 2030. Cash Flows We anticipate that cash flow in future periods will be derived mainly from ongoing operations. However, as noted above, we will need to raise additional substantial financing to meet our future cash needs.

As of the date of this annual report, we do not employ any off-balance sheet financing.

An inability to raise additional financing, a decrease in the demand for our products, or the inability of 45 Table of Contents our customers to meet their financial obligations to us due to operating difficulties or adverse market conditions, would reduce the availability of funds to us to meet our cash needs. ​ ​ ​ ​ ​ ​ (in thousands of euros) 2024 2023 Net cash generated by/(used in) in operating activities (13,584) (14,678) Net cash generated by/(used in) in investing activities (4,120) (4,344) Net cash generated by/(used in) in financing activities 4,635 (911) Net effect of exchange rate changes (566) 268 Net increase/(decrease) in cash and cash equivalents (13,635) (19,665) Cash and cash equivalents at the beginning of the year 43,471 63,136 Cash and cash equivalents at the end of the year 29,836 43,471 ​ Our cash position as of December 31, 2024, and 2023 was €29.8 million (with no short-term treasury investments) and €43.5 million (with no short-term treasury investments), respectively.

We experienced a decrease in cash and cash equivalents of €13.6 million in 2024 and a decrease of €19.7 million in 2023. In 2024, our negative net cash flow was primarily due to net cash used in operating activities of €13.6 million and in investing activities of €4.1 million.

In 2023, our negative net cash flow was primarily due to net cash used in operating activities of €14.7 million and in investing activities of €4.3 million. In 2024, net cash used in operating activities was €13.6 million compared with net cash used in operating activities of €14.7 million in 2023.

In 2024, net cash used in operating activities reflected principally: - a net loss of €19.0 million; - elimination of €7.4 million of net loss without effects on cash, including €2.6 million of depreciation and amortization, €1.0 million of change in allowances for doubtful accounts & slow-moving inventories, which includes €0.6 million of allowances for inventories related to the termination agreement for the Lumenis Lasers activity , €0.2 million of change in long term provisions, €0.5 million of net capital loss on disposals of assets and €3.3 million of non-cash compensation linked to stock-based compensation plans and free shares; and - an increase in working capital of €2.0 million primarily reflecting the increase in inventory linked to the advanced purchasing related to ultrasound technology. ​ In 2023, net cash used in operating activities was €14.7 million compared with net cash used in operating activities of €3.0 million in 2022.

In 2023, net cash used in operating activities reflected principally: - a net loss of €21.2 million; - elimination of €9.4 million of net loss without effects on cash, including €1.9 million of depreciation and amortization, €0.4 million of change in allowances for doubtful accounts & slow-moving inventories and €0.2 million of change in long term provisions ; and €6.9 million of non-cash compensation linked to stock-based compensation plans and free shares; and - an increase in working capital of €2.9 million primarily reflecting the increase in inventory and trade receivables linked to the higher level of sales. ​ In 2024, net cash used in investing activities was €4.1 million compared with net cash used in investing activities of €4.3 million in 2023. 46 Table of Contents Net cash used in investing activities of €4.1 million in 2024 reflected mainly: - investments of €2.6 million in capitalized assets produced by the Company including devices for RPP and lease activities (€0.7 million), HIFU treatments probes (€1.8 million) and R&D programs (€0.2 million); - investment of €1.3 million in property and equipment (including €0.6 million of laser and ExactVu equipment for demo, €0.7 million for IT, offices and industrial equipment); and - investment of €0.2 million in intangible assets (licences and development of IT softwares). ​ Net cash used in investing activities of €4.3 million in 2023 reflected mainly: - investments of €2.6 million in capitalized assets produced by the Company including devices for RPP and lease activities (€0.8 million), HIFU treatments probes (€1.5 million) and R&D programs (€0.4 million) ; - investment of €1.2 million in property and equipment (including €0.3 million of laser and ExactVu equipment for demo, €0.7 million for IT, offices and industrial equipment and €0.1 million for vehicles); and - investment of €0.5 million in intangible assets (licences and development of IT softwares). ​ In 2024, net cash generated by financing activities was €4.6 million compared with net cash used in financing activities of €0.9 million in 2023.

Item 6. Directors, Senior Management and Employees Senior Management The following table sets forth the name, age and position of each of our senior executive officers as of March 15, 2025 (the “Senior Management”). The Senior Management listed below have entered into employment agreements with us or our subsidiaries (which permit the employee to resign subject to varying notice periods).

In addition, in case of a change of control of the Company, or of a termination of their employment agreement by the Company without cause, the members of Senior Management are entitled to receive severance packages totaling €1.7 million. 48 Table of Contents Name ​ ​ Position ​ ​ ​ ​ Ryan Rhodes Age: 63 ​ ​ Chief Executive Officer of EDAP TMS S.A.

Member of the Board of Directors Chief Executive Officer of EDAP Technomed Inc. Mr. Ryan Rhodes was appointed as Chief Executive Officer of the Company in May 2023. Mr. Rhodes was appointed as a member of the Board of Directors in August 2023. Mr.

Rhodes has over 30 years of leadership experience in market development in the medical device industry, including 20 years dedicated to medical robotics. Prior to joining EDAP, Mr. Rhodes served as the Chief Executive Officer of Restoration Robotics, a global leader in robotic aesthetic medicine, where he led the company to a successful merger with Venus Concept Inc. in 2019.

Prior to Restoration Robotics, Mr. Rhodes spent over 13 years at Intuitive Surgical, the global leader in medical robotics, where he was a key architect of the company’s multi-procedure market focus and development efforts, including the successful launch of the global Urology franchise.

Prior to Intuitive Surgical, he spent over 11 years in various management positions in sales, marketing, professional education, and market development at Ethicon Inc., a Johnson & Johnson Company. Mr. Rhodes holds a B.A. in Public Administration from San Diego State University. ​ ​ Ken Mobeck Age: 54 ​ ​ Chief Financial Officer of EDAP TMS S.A.

Ken Mobeck was appointed as the Company’s Chief Financial Officer in January 2024. Prior to that position, Mr. Mobeck held the position of Chief Financial Officer of EDAP’s U.S. subsidiary since joining the company in December 2022. Prior to joining EDAP, Mr.

Mobeck served as Vice President of Finance and Investor Relations at medical device manufacturer Accuray Inc., a leading global radiation therapy company. Prior to joining Accuray, Mr. Mobeck served as Vice President, Finance with an optical networking leader, Lumentum.

Before Lumentum, he spent over two decades in positions with increasing levels of responsibility at some of Silicon Valley’s most innovative companies including Silicon Graphics, Hewlett Packard, KLA and Intel Corporation. Mr.

Mobeck holds an MBA and a BSC in Finance from the Leavey School of Business at Santa Clara University. ​ ​ François Dietsch Age: 49 ​ ​ Chief Accounting Officer of EDAP TMS S.A. François Dietsch was appointed as the Company’s Chief Accounting Officer in January 2024. Prior to that position, Mr.

Dietsch held the position of Chief Financial Officer of the Company since July 2015. Mr. Dietsch joined EDAP in 2005 as Internal Audit and Consolidation Manager and in 2012 was promoted to Group Financial Control Manager and Finance Manager of EDAP's French subsidiary.

Prior to joining EDAP he held finance positions at Valeo, a leading global supplier of components and systems to the automotive industry. He holds master’s degrees in management and Corporate Finance from University of Paris Dauphine. ​ ​ 49 Table of Contents Frédéric Pech Age: 56 ​ ​ President of EDAP TMS France S.A.S.

Frédéric Pech joined EDAP TMS France S.A.S. in January 2021, as Chief Operating Officer and was appointed as President of EDAP TMS France on May 1, 2023.

Prior to joining EDAP TMS France, he served as Chief Operating Officer at Metal Global Concept, a company specialized in the design and manufacturing of medical instrumentation containers for operating rooms, from 2018 to 2021.

Prior to this position, he served as Human Resources Director, mainly in the medical devices industry at companies including Stryker, Tornier and Wright Medical, from 2000 to 2018.

Frédéric holds a master's degree in accounting, a master's degree in organization from the CNAM (Conservatoire National des Arts et Métiers), an MBA from IGS Paris (Institut de Gestion Social) and a double degree from EM Lyon business school (Certificate in Business Management and Executive Advanced Management program). ​ ​ ​ ​ ​ ​ Jean-François Bachelard Age: 61 ​ ​ President and Chief Executive Officer of Edap Technomed Co.

Ltd. (Japan) Jean-François Bachelard was appointed President & Chief Executive Officer of Edap Technomed Co., Ltd. (Japan) in 2009. Jean-François Bachelard started his career at EDAP TMS Group in 1987 as Service Engineer. In 1989, he became Service Manager for Asia Pacific (APAC) area based in Tokyo.

From 1993 to 1998, he worked for Inamed Corp. as Product Manager France (Bioenterics, gastric implants). In 1999, he reintegrated EDAP TMS Group as Area Manager Northen Europe and General Manager of EDAP TMS Moscow office.

He graduated from Grenoble University with a degree in Electrotechnics and Robotics. ​ ​ ​ Board of Directors The following table sets forth the names and backgrounds of the members of the Board of Directors as of March 15, 2025.

Since May 1, 2023, we have separated the offices of Chairman of the Board and Chief Executive Officer. ​ None of the directors have service contracts with the Company or any of its subsidiaries providing for benefits upon termination of employment (except for those related to Mr. Rhodes’s current position as Chief Executive Officer, as provided under his employment agreement).

Five of the six Board members are independent within the meaning of Nasdaq Marketplace Rule 5605(2). The mandate of our directors, was reduced to a period of two years at the General Meeting of Shareholders held on June 28, 2024.

The directors’ mandates will expire at the end of the ordinary general meeting of shareholders, which will approve the accounts for the financial year ended December 31, 2025, to be held in 2026. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 50 Table of Contents Lance Willsey Age: 63 Mandate: 2 years Appointment: December 6, 2023 Expiration: 2026 ​ ​ ​ ​ ​ ​ ​ ​ Marie Meynadier Age: 63 Mandate: 2 years Appointment: June 30, 2020 Expiration: 2026 ​ ​ ​ ​ ​ ​ ​ Fran Schulz Age: 61 Mandate: 2 years Appointment: June 28, 2024 Expiration: 2026 ​ ​ ​ ​ ​ ​ Josh Levine Age: 64 Mandate: 2 years Appointment: December 19, 2024 Expiration: 2026 ​ Interim Chairman of the Board Dr.

Lance Willsey, M.S., M.D. joined the Board of Directors in December 2023 and was appointed Interim Chairman of the Board in September 2024. Dr. Willsey is a urologist who has 36 years of private and public board experience focused in the area of cancer diagnostics and therapeutics.

He completed his surgical and urology training at the Massachusetts General Hospital and additional postgraduate training in the Steele Lab, Harvard University and the Dana Farber Cancer Institute. Dr. Willsey is a founding Partner of the healthcare fund DCF Capital.

He also actively participated on boards of directors as a director of Exact Sciences from 1999 to 2009 and of Exelixis from 1997 to 2023. He also has extensive experience in corporate governance, having served on audit, compensation, finance and scientific advisory committees. Dr.

Lance Willsey holds an MS and MD from Wayne State University. ​ Marie Meynadier joined the Board of Directors in June 2020. Ms. Meynadier currently serves on the boards of directors of several medical technology companies in Europe and North America. Ms.

Meynadier has been serving as a director of Pixium Vision since 2019 and as a director of Alphatec Spine since 2021. From 1999 through 2018, she served at EOS Imaging as its Chief Executive Officer and led the company through a period of rapid worldwide sales growth prior to its sale to Alphatec Holdings in 2021.

Prior to EOS Imaging, Ms. Meynadier served as the Chief Executive Officer of Biospace Lab, a preclinical imaging company she developed and turned to profitability. Ms. Meynadier received a degree in electrical engineering from Sup Télécom, Paris, and her Ph.D. in physics from Ecole Normale Supérieure Ulm, Paris.

Marie Meynadier informed the Board of her resignation from the Board of Directors effective March 31, 2025 ​ Fran Schulz joined the Board of Directors in June 2024. Ms. Schulz is a seasoned executive with over 35 years of experience with EY who has spent her career working with large public and emerging private companies in the life sciences industry.

Ms. Schulz also has significant experience working on U.S. SEC and International Financial Reporting Standards (“IFRS”) matters. She is qualified to serve as a financial expert under SEC, NYSE and NASDAQ rules. Ms. Schulz currently also serves as a Board Member of Senti Biosciences and Menlo College.

Previously, she served as a Board Member for the National Board of Women in Bio (2013 – 2023) and for the California Life Sciences Industry Association. Ms. Schulz is a licensed certified public accountant (CPA) licensed in California. Ms. Schulz received her B.S. in Business Administration from Menlo College. ​ Josh Levine joined the Board of Directors in December 2024.

From 2012 to 2022, Mr. Levine served as President, Chief Executive Officer, and Director of Accuray Incorporated. Concurrent with his Accuray roles, Mr. Levine served as an independent director from 2018-2022 and later as Non-Executive Chairman of the board of Natus Medical from 2022-2023. Prior to that Mr.

Levine served as President, Chief Executive Officer, and Board Member of Immucor, Inc. in 2011. From 2004 to 2010, Mr. Levine served as President, Chief Executive Officer and Board Member of Mentor Corporation, where he played an instrumental role in repositioning the company by executing a strategic transformation. Mr.

Levine has completed executive management programs at UCLA Anderson School of Business, Stanford University, and University of Pennsylvania, and he received his bachelor’s degree in communications from the University of Arizona. ​ ​ ​ 51 Table of Contents ​ ​ Glen French Age: 62 Mandate: 2 years Appointment: February 27, 2025 Expiration: 2026 ​ Glen French joined the Board of Directors in February 2025.

Mr. French has been a member of the Pulmonx Corporation board of directors since December 2014. Mr. French serves or has served on many private medical device company boards. He served as President and CEO of Pulmonx Corporation from December 2014 to March 2024. From January 2014 to November 2014, Mr.

French served as President, CEO and Director of ApniCure, a medical device company. From October 2010 to December 2012, Mr. French served as President, Pulmonary Endoscopy for Boston Scientific Corporation, a medical device company. From December 2003 to October 2010, Mr. French served as President, CEO, Co-Founder and Director of Asthmatx, Inc., a medical device company.

From March 1997 to December 2003, he served as President, CEO, Co-Founder, and Director of Broncus Technologies. Mr. French served as the Executive Chairman of the board of directors of Levita Magnetics, a medical device company, from August 2013 to January 2022. Mr.

French holds a B.A. in History from Dartmouth College and an M.B.A. from the Wharton School at the University of Pennsylvania. ​ ​ ​ ​ ​ ​ ​ ​ Ryan Rhodes Age: 62 Mandate: 6 years Appointment: August 23, 2023 Expiration: 2026 ​ Chief Executive Officer.

See Ryan Rhodes’ biography above. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Compensation Aggregate compensation paid or accrued for services in all capacities by the Company and its subsidiaries to senior management and to the Board of Directors as a group (for those individuals in office during the course of the year) for the fiscal year 2024 was €2,227 thousand including performance bonuses of €322 thousand and benefits in kind of €49 thousand (benefits in kind comprise car allowances for senior management).

No amount was set aside or accrued by us to provide pension, retirement or similar benefits for senior management and to the Board of Directors as a group (for those individuals in office during the course of the year) for the fiscal year 2024 other that the legal retirement indemnity for French senior executives.

On November 8, 2023, the Board of Directors adopted the Company’s Clawback Policy which is filed as exhibit 97.1 to this annual report.

For information regarding compensation paid in the form of stock options or free shares, see “—Share Ownership ” and “ Options to Purchase or Subscribe for Securities—Free shares .” Compensation Committee The Compensation Committee is comprised of the following independent members: Dr. Lance Willsey, Mr. Glen French, Mr. Josh Levine, Ms. Marie Meynadier and Ms. Fran Schulz. Ms.

Marie Meynadier, resigning from the Board of Directors as of March 31, 2025, will no longer be a member of the Compensation Committee from this date. The Compensation Committee gathers at least once a year to review the compensation of our Chief Executive Officer and to propose to the Board of Directors any changes to the Chief Executive Officer’s compensation.

The Chief Executive Officer is not present when the Compensation Committee reviews his compensation. The Compensation Committee operates pursuant to a charter.

The principal duties and responsibilities of our Compensation Committee include, but are not limited to: - Make recommendations and proposals to the Board of Directors regarding compensation programs, including benefits in kind and equity compensation, for the Chief Executive Officer and members of the Board of Directors; - Define methods used to calculate variable compensation and set objectives and assist the Board of Directors in determining whether the objectives have been met for bonuses and other types of equity or non-equity compensation plans; and - Formulate general policies on the granting of equity compensation and recommend to the Board of Directors the granting of options and other stock awards thereunder. ​ 52 Table of Contents Audit Committee The Board of Directors’ Audit Committee is comprised of the following independent members of the Board: Ms.

Fran Schulz, acting as Chairperson of the Audit Committee and financial expert, Mr. Glen French, Mr. Josh Levine, Ms. Marie Meynadier and Dr. Lance Willsey. Ms. Marie Meynadier, resigning from the Board as of March 31, 2025, will no longer be a member of the Audit Committee from this date. The Audit Committee operates pursuant to a charter.

The principal duties and responsibilities of our Audit Committee include, but are not limited to: ​ - Provide assistance to the Board of Directors in fulfilling their oversight responsibility to the shareholders, potential shareholders, the investment community and others relating to: the integrity of our financial statements, our compliance with legal and regulatory requirements, our accounting practices and financial reporting processes, the effectiveness of our disclosure controls and procedures and internal control over financial reporting; - Review the independent auditor’s qualifications, compensation and independence, and the performance of our internal audit function and independent auditors; - Approve all services provided by the independent auditors; - Recommend the appointment of the independent auditors for consideration and approval by the Company’s shareholders in accordance with French law; - Review and discuss annual financial statements with management and the independent auditors and prepare the Audit Committee report, prior to SEC filings, as well as review related press releases; and - Request any officer or employee of the Company or our outside counsel or independent auditor to attend a meeting of the Audit Committee or to meet with any members of, or consultants to, the Audit Committee. ​ Nomination Committee The Nomination Committee is comprised of the following independent members: Mr.

Glen French, Mr. Josh Levine, Ms. Marie Meynadier, Ms. Fran Schulz and Dr. Lance Willsey. Ms. Marie Meynadier, resigning from the Board as of March 31, 2025, will no longer be a member of the Nomination Committee from this date. The Nomination Committee recommends director nominees to the Board, which then submits its nominees to the shareholders for election.

In addition, under specified circumstances and in accordance with French law, shareholders may also submit resolutions to the general meeting to appoint directors. The Company’s nominations practice is formalized in a Board resolution.

The Nomination Committee operates pursuant to a charter, the terms of which apply to the Board of Directors when considering director nominees, including in the evaluation of potential candidates and in recommendations to the Board of Directors prior to submitting the candidates to the vote of shareholders.

The principal duties and responsibilities of our Nomination Committee include, but are not limited to: - Develop and recommend to the Board of Directors appropriate criteria for the selection of individual director candidates (such as, independence, industry knowledge, fields of expertise, ability to serve as “financial expert,” leadership, diversity, etc.) and executive officers; - Evaluate candidates in light of appropriate criteria and conduct all necessary and appropriate inquiries into the backgrounds and qualifications of potential candidates; - Assist the Board of Directors in evaluating director independence, conflicts of interest and re-election of current directors; - Make recommendations to the Board of Directors concerning the size and composition of the Board of Directors in order to ensure it has the necessary expertise and diversity; - Make recommendations to the Board of Directors concerning appointees to be selected by the Board of Directors for service on its committees or removal of any member of any committee; and - Assist the Board of Directors in ensuring adequate succession planning for our executive bodies, in particular, through the establishment of a succession plan for the chairman and Chief Executive Officer. ​ ​ ​ 53 Table of Contents Employees As of December 31, 2024, we employed 310 individuals on a full-time basis, as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Sales & ​ Manufac- ​ ​ ​ Research ​ Regula- ​ Clinical ​ Adminis- ​ ​ ​ Marketing turing Service & Dvpt tory Affairs trative Total France 25 31 26 34 8 15 22 161 Germany 7 — 4 — — — 2 13 Japan 22 — 21 — 3 — 7 53 Malaysia 2 — 4 — — — 2 8 South Korea 2 — 5 — — — 2 9 Switzerland 1 — — — — — 1 2 USA 35 — 17 — — — 12 64 Total 94 31 77 34 11 15 48 310 ​ ​ As of December 31, 2023, we employed 307 individuals on a full-time basis, as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Sales & ​ Manufac- ​ ​ ​ Research ​ Regula- ​ Clinical ​ Adminis ​ ​ ​ Marketing turing Service & Dvpt tory Affairs trative Total France 25 35 24 33 11 15 21 164 Germany 6 — 3 — — — 2 11 Japan 21 — 23 — 3 — 8 55 Malaysia 2 — 3 — — — 2 7 South Korea 2 — 5 — — — 2 9 Switzerland — — — — — — — — USA 36 — 17 — — — 8 61 Total 92 35 75 33 14 15 43 307 ​ As of December 31, 2022, we employed 264 individuals on a full-time basis, as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Sales & Manufac- ​ Research Regula- Clinical Adminis- ​ ​ Marketing ​ turing Service & Dvpt tory Affairs ​ trative Total France 24 29 26 26 9 12 21 147 Germany 5 — 4 — — — 2 11 Japan 27 — 20 — 3 — 9 59 Malaysia 1 — 3 — — — 2 6 South Korea 2 — 4 — — — 2 8 Switzerland ​ — — — — — — — — USA 18 — 11 — — — 4 33 Total 77 29 68 26 12 12 40 264 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Management considers labor relations to be good.

Employee benefits are in line with those specified by applicable government regulations. Share Ownership As of March 15, 2025, the total number of shares issued was 37,661,619 with 269,533 shares held as treasury shares, thus bringing the total number of shares outstanding to 37,392,086.

As of March 15, 2025, the Board of Directors and members of the Company’s administrative, supervisory and management bodies during 2024 held a total of 1,072,713 shares.

The Board of Directors and members of the Company’s administrative, supervisory and management bodies during 2024 beneficially own, in the aggregate less than 3% of the Company’s outstanding shares. 54 Table of Contents As of March 15, 2025, the members of the Company’s administrative, supervisory and management bodies during 2024 held a total of 33,333 free shares and an aggregate of 1,707,500 options to purchase or to subscribe to a total of 1,707,500 ordinary shares, with a weighted average exercise price of €5.66 per share.

Of these options, 40,000 will expire on April 26, 2026; 20,000 expire on April 25, 2027; 20,000 expire on August 29, 2028; 15,000 expire on April 4, 2029; 837,500 expire on June 11, 2031; 375,000 expire on December 15, 2032; 200,000 expire on May 2, 2033, 100,000 expire on January 18, 2034, and 100,000 expire on March 26, 2034.

Options to Purchase or Subscribe for Securities – Free Shares Options On June 28, 2024, the shareholders authorized the Board of Directors to grant up to 2,000,000 options to subscribe to 2,000,000 new shares at a fixed price to be set by the Board of Directors and 600,000 free shares.

These new resolutions superseded the June 30, 2021 and 2022 resolutions, cancelling the unused portion of the 2021 and 2022 resolutions. As of March 15, 2025, we had sponsored four stock purchase and subscription option plans open to employees of EDAP TMS group and two free share plans.

On December 31, 2024, the expiration of our stock options contracts was as follows: ​ ​ ​ ​ ​ Number of Date of expiration Options April 25, 2026 152,500 April 26, 2027 81,080 August 25, 2028 57,500 April 4, 2029 70,000 June 11, 2031 954,533 November 17, 2031 83,300 May 17, 2032 76,000 November 2, 2032 20,000 December 15, 2032 395,000 April 5, 2033 ​ 69,000 May 2, 2033 200,000 May 31, 2033 ​ 50,000 August 23, 2033 ​ 150,000 September 20, 2033 ​ 53,000 November 8, 2033 ​ 10,000 December 6, 2033 ​ 34,000 January 18, 2034 ​ 142,000 February 28, 2034 ​ 12,000 March 26, 2034 ​ 160,000 June 3, 2034 ​ 167,000 August 21, 2034 ​ 34,000 November 6, 2034 ​ 60,000 ​ ​ 55 Table of Contents As of December 31, 2024, a summary of stock option activity to purchase or to subscribe to shares under these plans is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2024 ​ 2023 ​ 2022 ​ ​ ​ ​ Weighted ​ ​ ​ Weighted ​ ​ ​ Weighted ​ ​ ​ average ​ ​ average ​ ​ average ​ ​ ​ exercise ​ ​ exercise ​ ​ exercise ​ ​ ​ price ​ ​ price ​ ​ price ​ Options (€) Options (€) Options (€) Outstanding on January 1, ​ 3,198,913 ​ 6.26 ​ 2,613,886 ​ 5.66 ​ 2,408,508 ​ 4.38 Granted 599,000 5.34 686,000 8.53 571,000 9 Exercised (24,584) 4.71 (55,973) 4.66 (320,622) 2 Forfeited (742,416) 4.92 (45,000) 7.99 (45,000) 5.34 Expired — — — — — — Outstanding on December 31, 3,030,913 6.42 3,198,913 6.26 2,613,886 5.66 Exercisable on December 31, 2,130,107 6.17 1,997,666 5.23 1,362,205 4.35 Share purchase options available for grant on December 31, 25,000 25,000 20,000 ​ As of December 31, 2024, 1,894,000 options to subscribe for new shares are available for future grants. ​ The following table summarizes information about options to purchase existing shares held by the Company, or to subscribe to new shares, as of December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Outstanding options ​ Fully vested options (1) ​ ​ ​ ​ Weighted ​ Weighted ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ ​ average average Aggregate ​ ​ average Aggregate ​ ​ ​ remaining exercise Intrinsic ​ ​ exercise Intrinsic ​ ​ ​ contractual price Value ​ ​ price Value Exercise price (€) Options life (€) (2) Options (€) -2 10.32 ​ 20,000 ​ 7.8 ​ 10.32 ​ — ​ 13,889 ​ 10.32 ​ — 10.10 ​ 200,000 ​ 8.3 ​ 10.10 ​ — ​ 105,556 ​ 10.10 ​ — 9.96 ​ 69,000 ​ 8.3 ​ 9.96 ​ — ​ 38,333 ​ 9.96 ​ — 9.94 ​ 395,000 ​ 8.0 ​ 9.94 ​ — ​ 263,333 ​ 9.94 ​ — 9.32 ​ 50,000 ​ 8.4 ​ 9.32 ​ — ​ 26,389 ​ 9.32 ​ — 7.53 ​ 150,000 ​ 8.7 ​ 7.53 ​ — ​ 66,667 ​ 7.53 ​ — 6.83 ​ 160,000 ​ 9.3 ​ 6.83 ​ — ​ 40,000 ​ 6.83 ​ — 6.64 ​ 10,000 ​ 8.8 ​ 6.64 ​ — ​ 3,611 ​ 6.64 ​ — 6.41 ​ 76,000 ​ 7.3 ​ 6.41 ​ — ​ 65,444 ​ 6.41 ​ — 6.08 ​ 53,000 ​ 8.8 ​ 6.08 ​ — ​ 22,083 ​ 6.08 ​ — 5.59 ​ 954,533 ​ 6.4 ​ 5.59 ​ — ​ 954,533 ​ 5.59 ​ — 5.48 ​ 167,000 ​ 9.5 ​ 5.48 ​ — ​ 27,833 ​ 5.48 ​ — 5.46 ​ 12,000 ​ 9.2 ​ 5.46 ​ — ​ 3,333 ​ 5.46 ​ — 5.29 ​ 142,000 ​ 9.1 ​ 5.29 ​ — ​ 43,389 ​ 5.29 ​ — 5.18 ​ 83,300 ​ 6.8 ​ 5.18 ​ — ​ 83,300 ​ 5.18 ​ — 4.98 ​ 34,000 ​ 8.9 ​ 4.98 ​ — ​ 11,333 ​ 4.98 ​ — 3.90 ​ 70,000 ​ 4.8 ​ 3.90 ​ — ​ 70,000 ​ 3.90 ​ — 3.80 ​ 34,000 ​ 9.7 ​ 3.80 ​ — ​ — ​ — ​ — 3.22 ​ 152,500 ​ 1.3 ​ 3.22 ​ — ​ 152,500 ​ 3.22 ​ — 2.65 ​ 57,500 ​ 3.7 ​ 2.65 ​ — ​ 57,500 ​ 2.65 ​ — 2.53 ​ 60,000 ​ 9.8 ​ 2.53 ​ — ​ — ​ — ​ — 2.39 ​ 81,080 ​ 2.3 ​ 2.39 ​ — ​ 81,080 ​ 2.39 ​ — 2.39 to 10.32 3,030,913 7.51 — — 2,130,107 — — ​ (1) Fully vested options are all exercisable options. ​ (2) Aggregate intrinsic value represents the total pre-tax intrinsic value, based on the Company’s closing stock price of $2.21 at December 31, 2024, which would have been received by the option holders had all in-the-money option holders exercised their options as of that date. ​ ​ 56 Table of Contents Free Shares On March 30, 2022, 40,000 free shares were granted to the Chief Executive Officer of the Company.

On March 30, 2023, all 40,000 free shares were vested and became subject to a 12-month holding period. On November 8, 2022, 291,500 free shares were granted to certain officers and employees of the Company. On November 8, 2024, 181,604 free shares were vested. As of December 31, 2024, 82,984 free shares remain outstanding.

On March 29, 2023, 150,000 free shares were granted to the Chief Executive Officer of the Company. On March 29, 2024, all 150,000 free shares were acquired and became subject to a 12-month holding period. On May 2, 2023, 50,000 free shares were granted to the President of the French subsidiary EDAP TMS France SAS.

On May 2, 2025, all 50,000 free shares will have vested, as long as the conditions set forth in the free share plan are met and will be subject to a 12-month holding period. See Note 17-5 of the consolidated financial statements. ​ Disclosure of any action to recover erroneously awarded compensation Not applicable. ​

Item 7. Major Shareholders and Related Party Transactions Major Shareholders To our knowledge, we are not directly or indirectly owned or controlled by another corporation, by any foreign government, or by any other natural or legal person or persons acting severally or jointly.

On the basis of the notifications received or filed with the SEC and information from the Bank of New York Mellon, as of March 15, 2025, (i) Soleus GP, LLC, filed a report showing beneficial ownership of 7,309,254 ADSs, representing 19.7% of our outstanding ADSs and (ii) Morgan Stanley filed a report showing beneficial ownership of 3,367,685 ADSs, representing 9.01% of our outstanding ADSs.

There are no arrangements known to us whereby we are directly or indirectly owned or controlled by another corporation or government, or by any other natural or legal persons, nor are we aware of any arrangement] that may at a later date result in a change of control of the Company.

All shares issued by the Company have the same voting rights, except the treasury shares held by the Company, which have no voting rights. As of March 15, 2025, 37,661,619 shares were issued, including 37,392,086 outstanding and 269,533 treasury shares.

As of March 15, 2025, there were 37,638,613 ADSs, each representing one Share, all of which were held of record by 20 registered holders (including The Depository Trust Company). As of December 31, 2024, we estimate that approximately 13 million shares, or 35% of our outstanding ordinary shares, were held by U.S. institutional investors.

Related Party Transactions On August 19, 2019, EDAP Technomed Co. Ltd. (Japan) contracted a loan for 80,000,000 JPY. As a current practice in Japan, this loan required a personal guarantee from the representative director, president and CEO of the subsidiary, Mr. Jean-François Bachelard. EDAP TMS S.A., as the parent company, counter-guaranteed this personal loan and agreed to indemnify Mr.

Bachelard, in an indemnification letter dated September 12, 2019, expiring upon loan maturity date of August 26, 2026. On April 22, 2020, EDAP Technomed Co. Ltd (Japan) contracted another loan for 50,000,000 JPY requiring a personal guarantee from the representative director, president and CEO of the subsidiary, Mr. Jean-François Bachelard.

EDAP TMS S.A., as the parent company, counter-guaranteed this personal loan and agreed to indemnify Mr. Bachelard, in an indemnification letter dated June 2, 2020, expiring upon loan maturity date of April 2, 2025. Interests of Experts and Counsel Not applicable. ​ 57 Table of Contents