ENDRA Life Sciences Activates TAEUS System to Initiate Clinical Study at LMU University Hospital in Germany
October 22 2024 - 8:00AM
Business Wire
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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version on businesswire.com: https://www.businesswire.com/news/home/20241022791335/en/
Company Contact: Richard Jacroux Chief Financial Officer
investors@endrainc.com www.endrainc.com
Investor Relations Contact: Yvonne Briggs LHA Investor
Relations (310) 691-7100 ybriggs@lhai.com
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