Final results demonstrate a significantly higher salvage treatment free survival rate (STFS) at 30 months of 89.6% in the HIFU-treated arm versus 86.2% in patients who underwent radical prostatectomy (RP)

最终结果表明，HIFU治疗组30个月时的无挽救治疗生存率（STFS）显着高于接受根治性前列腺切除术（RP）的患者，分别为89.6%和86.2%

Functional evaluation criteria show better results with respect to urinary continence and erectile function in patients receiving HIFU therapy versus patients receiving RP

功能评估标准显示，接受HIFU治疗的患者与接受RP治疗的患者相比，在尿失禁和勃起功能方面效果更好

Final study results were presented during a plenary session of the AUA focused on paradigm-shifting and practice-changing clinical trials in urology

最终的研究结果发表在AUA的全体会议上，重点是泌尿外科的范式转变和改变实践的临床试验

HIFI Study is the largest clinical study ever conducted evaluating treatment outcomes with Focal One robotic HIFU, enrolling a total of 3,328 prospective patients, including 1,967 consecutive HIFU patients and 1,361 RP patients across 46 centers

HIFI研究是有史以来使用Focal One机器人HIFU评估治疗结果的最大临床研究，共招募了3328名前瞻性患者，包括46个中心的1967名连续HIFU患者和1361名RP患者

LYON, France, May 6, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced a recent presentation highlighting the positive, final results from a large, prospective, multicenter, non-inferiority study, the HIFI Study, comparing Focal One® high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) at the 119th American Urological Association Annual Meeting (AUA 2024), which took place from May 3-6, 2024, in San Antonio, Texas, USA.

2024年5月6日，法国里昂-机器人能量疗法的全球领导者EDAP TMS SA（Nasdaq:EDAP）最近宣布了一项演讲，重点介绍了一项大型，前瞻性，多中心，非劣效性研究的积极最终结果，HIFI研究，比较了2024年5月3日至6日在美国德克萨斯州圣安东尼奥举行的第119届美国泌尿外科协会年会（AUA 2024）上的Focal One®高强度聚焦超声（HIFU）与根治性前列腺切除术（RP）。

Professor Pascal Rischmann of Rangueil University Hospital in Toulouse, France, and lead investigator of the HIFI Study, highlighted the final results from the study during an oral presentation at the AUA plenary session, “Paradigm-shifting, Practice-changing Clinical Trials in Urology”..

法国图卢兹兰圭尔大学医院的Pascal Rischmann教授和HIFI研究的首席研究员在AUA全体会议上的口头报告中强调了这项研究的最终结果，“范式转变，实践改变泌尿外科临床试验”。。

HIFI is the first prospective, multi-center, investigator-sponsored study comparing robotic HIFU to RP in the management of prostate cancer. The study, which ran from April 2015 through March 2022, compared Focal One HIFU versus RP as a first line treatment for patients with localized prostate cancer (grade groups <3).

HIFI是第一项前瞻性，多中心，研究者赞助的研究，比较机器人HIFU和RP在前列腺癌治疗中的作用。该研究于2015年4月至2022年3月进行，比较了局灶性HIFU与RP作为局限性前列腺癌患者（3级组）的一线治疗方法。

A total of 3,328 patients from 46 treatment centers were included: 1,967 consecutive patients were treated with EDAP’s robotic HIFU technologies, where Focal One was used for 90% of the patients. 1,361 patients underwent radical prostatectomy surgery. All patients were followed for 30 months..

共纳入来自46个治疗中心的3328名患者：1967名连续患者接受了EDAP的机器人HIFU技术治疗，其中90%的患者使用了Focal One。1361例患者接受了根治性前列腺切除术。所有患者均接受了30个月的随访。。

Select data highlights:

选择数据突出显示：

At 30 months, the STFS was higher in the HIFU arm (89.6%) compared with RP arm (86.2%)

在30个月时，HIFU组的STF（89.6%）高于RP组（86.2%）

The propensity score-adjusted result is similar to the univariate result (HR=0.75 [0.55-1.03], p=0.076). After adjustment on different variables (Age, BMI, ASA score, Grade Group, prostate volume, PSA) the results are similar to the univariate analysis: the risk of salvage treatment is lower in the HIFU arm compared to RP.

倾向评分调整结果与单变量结果相似（HR=0.75[0.55-1.03]，p=0.076）。在对不同变量（年龄，BMI，ASA评分，分级组，前列腺体积，PSA）进行调整后，结果与单变量分析相似：与RP相比，HIFU组的挽救治疗风险较低。

International Continence Society (ICS) score, a measure of urinary incontinence, was significantly lower after HIFU for 3 of the 4 questions

HIFU后，4个问题中的3个问题的国际失禁学会（ICS）评分（尿失禁的衡量标准）显着降低

Urinary Symptom Profile (USP) showed a significantly lower stress incontinence score for patients after HIFU than RP (0 vs 1, p < 0.001)

HIFU后患者的尿路症状谱（USP）显示压力性尿失禁评分明显低于RP（0 vs 1，p<0.001）

International Index of Erectile Function-5 (IIEF-5), a well validated measurement of erectile function, decreased significantly less after HIFU than after RP in patients 69 and older with a score of 15 or higher at baseline (median Δ = -8 vs -13 p < 0.001)

国际勃起功能指数-5（IIEF-5）是一种经过充分验证的勃起功能测量方法，在基线得分为15分或更高的69岁及以上患者中，HIFU后勃起功能的下降幅度明显小于RP后的下降幅度（中位数=-8 vs-13 p<0.001）

Post-procedural benefits of HIFU on both erectile function and urinary continence were demonstrated despite patients in the HIFU-treated group being an average of 9.6 years older (median age was 74.7 years for HIFU vs 65.1 years for RP, p<0.0001)

尽管HIFU治疗组患者平均年龄为9.6岁（HIFU的中位年龄为74.7岁，RP的中位年龄为65.1岁，p<0.0001），但HIFU对勃起功能和尿失禁的术后益处均得到证实

“The final results from the HIFI Study clearly demonstrate that treatment with robotic HIFU for the management of localized prostate cancer is at least as effective as radical prostatectomy, but with added potential for improved safety outcomes with respect to urinary continence and sexual function,” said Professor Pascal Rischmann.

Pascal Rischmann教授说：“HIFI研究的最终结果清楚地表明，机器人HIFU治疗局限性前列腺癌至少与根治性前列腺切除术一样有效，但在尿失禁和性功能方面具有改善安全性的潜力。”。

“It is increasingly evident that the application of robotic HIFU has growing relevance in the management of localized disease, and these final results from the HIFI Study provide conclusive evidence in support of this technology as a safe, effective, and less invasive approach to remove cancerous tissue from the prostate.”.

“越来越明显的是，机器人HIFU的应用在局部疾病的管理中具有越来越大的相关性，HIFI研究的这些最终结果提供了确凿的证据，支持该技术作为一种安全，有效且侵入性较小的方法从前列腺中去除癌组织。”。

“As the largest and most rigorous clinical study ever conducted to evaluate treatment outcomes with Focal One robotic HIFU, the final results from the HIFI Study provide clear and compelling evidence that supports the use of robotic HIFU as an important and growing treatment option for the management of prostate cancer,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS.

EDAP TMS首席执行官Ryan Rhodes说：“作为有史以来规模最大、最严格的评估Focal One机器人HIFU治疗效果的临床研究，HIFI研究的最终结果提供了明确而令人信服的证据，支持使用机器人HIFU作为前列腺癌管理的重要且不断增长的治疗选择。”。

“We believe the final results from the HIFI study not only represent an important clinical milestone for EDAP, but also serves as a further validation of Focal One as the best focal therapy of choice for the management of men diagnosed with early-stage prostate cancer. EDAP remains well positioned to deliver this technology as we continue to build world-class treatment programs for urologists centered around our leading Focal One robotic HIFU technology platform.”.

“我们相信，HIFI研究的最终结果不仅代表了EDAP的一个重要临床里程碑，而且还进一步验证了Focal One是治疗早期前列腺癌男性的最佳聚焦治疗选择。随着我们继续围绕我们领先的Focal One机器人HIFU技术平台为泌尿科医生建立世界一流的治疗计划，EDAP仍然能够很好地提供这项技术。”。

About the American Urological Association (AUA) Annual Meeting

关于美国泌尿外科协会（AUA）年会

The AUA Annual Meeting is the world's foremost meeting of urologists. It attracts more than 11,000 practicing physicians and healthcare professionals to the largest gathering of urological professionals worldwide. With over 300 technical exhibitors, more than 90 educational courses, and over 2,000 accepted abstracts, it delivers the latest in urologic medicine – providing needed tools to healthcare professionals as they continue to improve patient care.

AUA年会是世界上最重要的泌尿科医生会议。它吸引了11000多名执业医生和医疗保健专业人员参加全球最大规模的泌尿外科专业人员聚会。它拥有300多家技术展商、90多个教育课程和2000多篇被接受的摘要，提供了泌尿医学的最新成果，为医疗保健专业人员提供了继续改进患者护理所需的工具。

Additional information on the meeting can be found at https://annual2024summit.com/aua/index.php.

有关会议的其他信息，请访问https://annual2024summit.com/aua/index.php.

About EDAP TMS SA

关于EDAP TMS SA

A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in Europe and in the U.S.

EDAP TMS是全球治疗超声市场公认的领导者，它使用超声波技术开发、制造、推广和分销全球各种病理的微创医疗设备。EDAP TMS将成像和治疗方式方面的最新技术与全系列机器人HIFU设备相结合，在欧洲和美国推出了Focal One®。

as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu™ Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith® i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL).

作为理想前列腺组织消融所有要求的答案。随着ExactVu™微型超声波设备的加入，EDAP TMS现在是唯一一家提供从前列腺癌诊断到局部治疗的完整解决方案的公司。EDAP TMS还生产和销售其他医疗设备，包括Sonolith®i-move碎石机和激光，用于使用体外冲击波碎石术（ESWL）治疗尿路结石。

For more information on the Company, please visit http://www.edap-tms.com, us.hifu-prostate.com and www.focalone.com..

有关该公司的更多信息，请访问http://www.edap-tms.com，us.hifu-prostate.com和www.focalone.com。。

Forward-Looking Statements

前瞻性声明

In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance.

除历史信息外，本新闻稿还包含适用联邦证券法含义范围内的前瞻性声明，包括1933年《美国证券法》（“证券法”）第27A节或1934年《美国证券交易法》第21E节，可以用“相信”、“可以”、“考虑”、“可以”、“计划”、“打算”、“旨在”、“可能”、“可能”、“潜在”、“目标”、“目标”、“项目”、“预测”、“预测”、“雄心壮志”、“指南”、“应该”、“将会”、“估计”、“期望”和“预期”等词或这些和类似表达的否定词来识别，这些表达反映了我们对未来事件和财务表现的看法。

Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved.

此类声明基于管理层当前的期望，并受到许多风险和不确定性的影响，包括我们尚不清楚或我们目前认为不重要的事项，并且无法保证预期事件会发生或所设定的目标会实际实现。

Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services..

可能导致实际结果与前瞻性声明中预期结果存在重大差异的重要因素包括，我们HIFU设备的临床状况和市场接受度，我们碎石和分销部门的持续市场潜力，以及与当前全球通货膨胀环境、不确定的全球经济、政治和金融环境、地缘政治不稳定、气候变化和新型冠状病毒大流行等流行病或其他公共卫生危机相关的风险，以及它们对我们业务运营的相关影响，包括它们对我们业务的影响或对我们设备和服务的需求。。

Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections 'Cautionary Statement on Forward-Looking Information' and 'Risk Factors' in the Company's Annual Report on Form 20-F..

可能导致这种差异的其他因素也可能包括但不限于公司向证券交易委员会提交的文件中所述的因素，特别是公司年度报告表20-F中“前瞻性信息警示声明”和“风险因素”部分中所述的因素。。

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete..

前瞻性声明仅在做出之日起生效。除法律要求外，我们没有义务根据新信息或未来发展情况对其进行更新。这些前瞻性声明基于截至本新闻稿发布之日我们可获得的信息、假设和估计，虽然我们认为这些信息构成了这些声明的合理基础，但这些信息可能是有限的或不完整的。。

Company Contact

公司联系人

Blandine Confort

布兰丁·康福特

Investor Relations / Legal Affairs

投资者关系/法律事务

EDAP TMS SA

EDAP TMS SA

+33 4 72 15 31 50

+33 4 72 15 31 50

bconfort@edap-tms.com

bconfort@edap-tms.com

Investor Contact

投资者联系人

John Fraunces

约翰·弗劳恩斯

LifeSci Advisors, LLC

LifeSci Advisors有限责任公司

(917) 355-2395

(917) 355-2395

jfraunces@lifesciadvisors.com

jfraunces@lifesciadvisors.com