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ENDRA生命科学公司启动TAEUS系统,在德国LMU大学医院启动临床研究

ENDRA Life Sciences Activates TAEUS System to Initiate Clinical Study at LMU University Hospital in Germany

businesswire 等信源发布 2024-10-22 17:56

可切换为仅中文


ANN ARBOR, Mich.--(BUSINESS WIRE)--ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announces the activation of a post market clinical study and first patient scanned with the TAEUS liver system at LMU University Hospital in Munich, one of the leading medical research centers in Europe..

密歇根州安阿伯市——(商业新闻短讯)——热声增强超声波(TAEUS®)的先驱ENDRA Life Sciences Inc.(纳斯达克:NDRA)宣布启动上市后临床研究,并在慕尼黑LMU大学医院(欧洲领先的医学研究中心之一)对第一名患者进行TAEUS肝脏系统扫描。。

LMU University Hospital is conducting a post market clinical study to collect data to assess TAEUS’ liver fat measurement capabilities against the gold standard MRI-PDFF test. This study is intended to collect real-world clinical evidence to further establish the utility of the TAEUS system for metabolic disease management.

LMU大学医院正在进行上市后临床研究,以收集数据,以评估TAEUS的肝脏脂肪测量能力与金标准MRI-PDFF测试。这项研究旨在收集现实世界的临床证据,以进一步确定TAEUS系统在代谢疾病管理中的实用性。

LMU researchers plan to present the findings of the study at future medical congresses followed by a peer-reviewed publication..

LMU研究人员计划在未来的医学大会上介绍这项研究的结果,然后发表同行评审的出版物。。

​​“LMU University Hospital is one of Europe's most highly regarded and influential academic research institutions and we are delighted to commence this partnership. This collaboration is expected to build upon ENDRA's growing portfolio of clinical data and support the company’s FDA De Novo submission targeted for mid-2025.

​​“LMU大学医院是欧洲最受重视和最具影响力的学术研究机构之一,我们很高兴开始这种合作关系。这种合作预计将建立在ENDRA不断增长的临床数据组合的基础上,并支持该公司针对2025年年中的FDA从头提交。

Further, we believe the data will support the adoption of TAEUS technology as the reliable and accurate biomarker for liver fat, marking it as a first strategic step into Germany's healthcare market, the largest in Europe,' stated Alexander Tokman, Acting Chief Executive Officer of ENDRA and Chairman of the Board..

此外,ENDRA代理首席执行官兼董事会主席亚历山大·托克曼(AlexanderTokman)表示,我们相信这些数据将支持采用TAEUS技术作为肝脏脂肪的可靠和准确的生物标志物,标志着它是进入欧洲最大的德国医疗保健市场的第一步。。

About LMU University Hospital Munich

关于慕尼黑LMU大学医院

The LMU University Hospital is one of the largest university hospitals in Germany and Europe. Every year, approximately 500,000 patients trust the competence, care and commitment of more than 11,000 employees in over 50 specialist clinics, institutes and departments. Outstanding facilities of the LMU University Hospital include the oncological center and Bavaria’s largest transplant center TxM.

LMU大学医院是德国和欧洲最大的大学医院之一。每年,约有500000名患者信任50多家专科诊所、研究所和部门的11000多名员工的能力、关怀和承诺。LMU大学医院的杰出设施包括肿瘤中心和巴伐利亚州最大的移植中心TxM。

The LMU University Hospital is represented in all German centers of health research. The Medical Faculty of Ludwig-Maximilians-University Munich and the LMU University Hospital make a significant contribution to the excellence strategy of the Ludwig-Maximilians-University in Munich. Please visit www.lmu-klinikum.de for further information..

LMU大学医院在所有德国健康研究中心都有代表。慕尼黑路德维希·马克西米利安大学医学院和LMU大学医院为慕尼黑路德维希·马克西米利安大学的卓越战略做出了重大贡献。有关更多信息,请访问www.lmu-klinikum.de。。

About ENDRA Life Sciences Inc.

关于ENDRA Life Sciences Inc。

ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology that characterizes tissue similar to an MRI, but at 1/40th the cost and at the point of patient care. TAEUS® is initially focused on the non-invasive assessment of fatty tissue in the liver.

ENDRA Life Sciences是热声增强超声波(TAEUS®)的先驱,这是一种开创性的技术,其特征是组织类似于MRI,但成本仅为患者护理的1/40。TAEUS®最初专注于肝脏脂肪组织的非侵入性评估。

Steatotic liver disease (SLD, formerly known as NAFLD-NASH) is a chronic liver disease spectrum that affects over two billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS®, including non-invasive visualization of tissue temperature during energy-based surgical procedures.

脂肪变性肝病(SLD,以前称为NAFLD-NASH)是一种慢性肝病谱,影响全球20多亿人,目前尚无实用的诊断工具。除了肝脏之外,ENDRA正在探索TAEUS®的其他几种临床应用,包括基于能量的外科手术过程中组织温度的无创可视化。

For more information, please visit www.endrainc.com..

有关更多信息,请访问www.endrainc.com。。

Forward-Looking Statements

前瞻性声明

All statements in this press release that are not based on historical fact are 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of terms such as “approximate,” 'anticipate,' “attempt,” 'believe,' 'could,' 'estimate,' 'expect,' “forecast,” “future,” 'goal,' “hope,” 'intend,' 'may,' 'plan,' “possible,” “potential,” “project,” 'seek,' 'should,' 'will,' “would,” or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are expressed differently.

本新闻稿中所有不基于历史事实的声明均为《1933年证券法》第27A节和《1934年证券交易法》第21E节所指的“前瞻性声明”。基于某些假设并描述我们未来计划、战略和期望的前瞻性陈述通常可以通过使用诸如“近似”、“预期”、“尝试”、“相信”、“可能”、“估计”、“预期”、“预测”、“未来”、“目标”、“希望”、“打算”、“可能”、“计划”、“可能”、“潜在”、“项目”、“寻求”、“应该”、“将会”或其他类似术语(包括上述任何一项的负面影响)来识别,尽管一些前瞻性陈述的表达方式有所不同。

Examples of forward-looking statements for ENDRA include, among others: expectations with respect to FDA requirements regarding its clinical trials and de novo submission for its TAEUS liver device; estimates of the timing of future events and anticipated results of its development efforts, including the timing of submission for and receipt of required regulatory approvals and product launches and sales; statements relating to future financial position and projected costs and revenue; expectations concerning ENDRA's business strategy; and statements regarding ENDRA’s ability to find and maintain development partners.

;估计未来活动的时间安排及其开发工作的预期结果,包括提交和接收所需监管批准以及产品发布和销售的时间安排;与未来财务状况及预计成本和收入有关的报表;对ENDRA业务战略的期望;以及关于ENDRA寻找和维护发展伙伴的能力的声明。

Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements as a result of various factors including, among others: the ability to raise additional capital in order to continue as a going concern; the ability to obtain FDA and other regulatory approvals necessary to sell ENDRA medical devices in c.

;能够获得FDA和其他监管机构的批准,以在c销售ENDRA医疗器械。