EDAP TMS SA , the global leader in robotic energy-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, further strengthening the company’s market leadership in robotic focal therapy for prostate cancer..

EDAP TMS SA，基于能量的机器人疗法的全球领导者，今天宣布美国食品药品监督管理局（FDA）已授予Focal One高强度聚焦超声（HIFU）系统新的超声成像和工作流程增强功能的510(k)许可，进一步巩固了该公司在前列腺癌机器人局部治疗领域的市场领导地位。

The 510(k) clearance introduces advanced ultrasound imaging, streamlined treatment planning, and an optimized user-interface to the Focal One i launched earlier this year. The next generation ultrasound imaging engine provides real-time visualization and supports the potential development of AI-driven algorithms designed to assist surgeons with tissue ablation visualization and treatment evaluation..

510(k) 许可为今年早些时候推出的 Focal One i 引入了先进的超声成像、简化的治疗规划以及优化的用户界面。新一代超声成像引擎提供实时可视化，并支持潜在开发旨在协助外科医生进行组织消融可视化和治疗评估的 AI 驱动算法。

“We are proud to receive this new FDA clearance, which further enhances the capabilities of the new Focal One i and represents another important technical milestone in Focal One’s product roadmap,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “This achievement demonstrates our team’s continued commitment to innovation and reinforces Focal One’s global leadership in focal therapy.”.

“我们很自豪能够获得这项新的FDA许可，这进一步增强了全新Focal One i的功能，并代表了Focal One产品路线图中的另一个重要技术里程碑，”EDAP TMS首席执行官Ryan Rhodes表示。“这一成就展示了我们团队对创新的持续承诺，并巩固了Focal One在全球聚焦治疗领域的领导地位。”

About EDAP TMS SA

关于EDAP TMS SA

A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP introduced the Focal One® in Europe and in the U.S.

EDAP TMS 是机器人能量治疗领域的公认领导者，开发、制造、推广并全球分销用于多种疾病的微创医疗设备，采用超声波技术。通过结合成像、机器人技术和精准的非侵入性能量传递的最新技术，EDAP 在欧洲和美国推出了 Focal One®。

as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com/.

作为由泌尿科医生主导的前列腺局部疗法的领先技术，具有扩展到前列腺癌以外多种适应症的潜力。欲了解有关公司的更多信息，请访问 https://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.

本新闻稿除包含历史信息外，还包含符合美国联邦证券法相关规定的前瞻性陈述，包括《1933年美国证券法》第27A条（“证券法”）或《1934年美国证券交易法》第21E条中定义的内容，这些陈述可能通过诸如“相信”、“能够”、“考虑”、“可能”、“计划”、“意图”、“旨在”、“或许”、“也许”、“潜力”、“目标”、“针对”、“预计”、“预测”、“展望”、“指南”、“应该”、“将”、“估计”、“预期”和“预见”等词语，或这些词语的否定形式及类似表述加以识别，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的当前预期，并受若干风险和不确定因素的影响，包括我们尚未知晓或目前不认为重要的事项，且无法保证预期事件会发生或所列目标会实现。

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陈述中预期的结果存在重大差异的重要因素包括（但不限于）：我们的高强度聚焦超声（HIFU）设备的临床状态和市场接受度，以及我们的碎石机和分销部门的持续市场潜力；同时也包括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、气候变化及类似新冠疫情（COVID-19）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影响，包括其对我们各项业务或对我们的设备和服务需求的广泛影响。

Other factors that may cause such a difference may also include, but .

可能导致这种差异的其他因素还包括，但 。

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..

前瞻性声明仅在其发布之日有效。除非法律要求，我们不承担因新信息或未来发展而更新这些声明的义务。这些前瞻性声明基于本新闻稿发布之日我们可获得的信息、假设和估计，尽管我们认为这些信息为声明提供了合理依据，但这些信息可能有限或不完整。

Investor Contacts

投资者联系人

Investor Relations

投资者关系

EDAP TMS SA

EDAP TMS SA

[email protected]

电子邮件地址

John Fraunces

约翰·弗劳恩斯

LifeSci Advisors, LLC

生命科学顾问有限公司

(917) 355-2395

(917) 355-2395

[email protected]

电子邮件地址

Source: globenewswire.com

来源：globenewswire.com