Scans first patient in post-CE mark clinical study with Munich’s center of excellence in Europe’s largest healthcare market
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.
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 researchers plan to present the findings of the study at future medical congresses followed by a peer-reviewed publication.
“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. 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.
About LMU University Hospital Munich
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. 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.
About 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. 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. For more information, please visit www.endrainc.com.
Forward-Looking Statements
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. 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. 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 certain markets in a timely manner, or at all; the ability to develop a commercially feasible technology and its dependence on third parties to design and manufacture its products; ENDRA’s ability to maintain compliance with Nasdaq listing standards; ENDRA’s dependence on its senior management team; market acceptance of ENDRA’s technology and the amount and nature of competition in its industry; ENDRA’s ability to protect its intellectual property; and the other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recent Annual Report on Form 10-K and in subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this press release speak only as of the date of issuance, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.
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