ENDRA Life Sciences Expands into China with Shanghai General Hospital Partnership
January 24 2022 - 8:15AM
Business Wire
TAEUS clinical study to serve as gateway for
ENDRA into Asia’s largest healthcare market
ENDRA Life Sciences Inc. (ENDRA) (NASDAQ: NDRA), a pioneer of
enhanced ultrasound technologies, today announced it has received
Institutional Review Board approval from China’s renowned Shanghai
General Hospital (Shanghai First People’s Hospital Affiliated with
Shanghai Jiao Tong University), for the first clinical study of
ENDRA’s Thermo Acoustic Enhanced UltraSound (TAEUS®) device
to assess Non-Alcoholic Fatty Liver Disease (NAFLD) in that
market.
“ENDRA is honored to bring our TAEUS® technology to China
through one of the country’s most prestigious healthcare
institutions, Shanghai General,” stated Francois Michelon, Chief
Executive Officer of ENDRA. “This partnership is a clear validation
of ENDRA’s technology and provides an important strategic entry
point into China’s healthcare market, which seeks to deliver
cost-effective health services to 1.4 billion citizens including an
estimated 350 million people affected by NAFLD-NASH. We believe
ENDRA’s point-of-care TAEUS® technology aligns very well with
China’s goal of shifting delivery of healthcare services from urban
centers to community clinics.”
Shanghai General Hospital ranks as a 3A level center, the
highest level in China’s 9-level healthcare facility classification
system, and is further rated A++ by China’s National Health
Commission, which is awarded to only 12 of China’s estimated 35,000
healthcare facilities. Shanghai General Hospital delivers the
highest quality care to an estimated 4 million inpatients and
outpatients annually across a range of clinical specialties.
This is ENDRA’s first clinical research partnership in Asia and
the eighth globally. The collaboration will contribute to the
clinical evidence for the TAEUS® ultrasound device in patients with
NAFLD in China and will be a reference site to support
commercialization of TAEUS® in the world’s most populous market. In
anticipation of introducing the TAEUS® platform to China, ENDRA has
been building a robust intellectual property portfolio with eight
patents issued to date in China.
The study is expected to begin in 2022 and will be led by Prof.
Lu Lungen, Vice Chairman of Chinese Society of Hepatology, Head of
Shanghai General Hospital’s Gastroenterology Department, and Prof.
Shen Hua, Head of Shanghai General Hospital’s International Medical
Care Center.
“We are committed to maintaining a first-class modern hospital
that is research-driven and provides low-cost, high-efficiency
clinical care. We look forward to using ENDRA’s TAEUS® technology
with our NAFLD patients as a promising alternative to more invasive
or costly techniques,” stated Prof. Lungen.
The goals of the study include comparing ENDRA’s TAEUS® liver
device against a baseline measure of liver fat as determined by the
current standard-of-care MRI-PDFF (magnetic resonance imaging
proton density fat fraction) in 75 patients. The study will also
provide ENDRA with ongoing clinical feedback on product design and
clinical performance.
TAEUS® is currently cleared for sale in countries that recognize
the CE mark, including those in the European Union, and a 510(k)
application has been submitted to the U.S. Food and Drug
Administration.
About Shanghai General Hospital (Shanghai First People’s
Hospital Affiliated with Shanghai Jiao Tong University)
Shanghai General Hospital was founded in 1864 by French consuls as
one of the largest and earliest Western medicine hospitals in
China. Shanghai General has remained a leader in national and local
medical circles. For 25 consecutive years, Shanghai General
Hospital has been awarded as the civilized model unit by Shanghai
municipal government. As a Class A tertiary general hospital,
Shanghai General manages four local hospitals and has close
collaborative relationships with other public hospitals in the
surrounding provinces. For more information, please visit
www.shgh.cn (https://eng.shgh.cn).
About ENDRA Life Sciences Inc. ENDRA Life Sciences is the
pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a
ground-breaking technology being developed to visualize tissue like
MRI, but at 1/50th the cost and at the point of patient care.
TAEUS® is designed to work in concert with 400,000 cart-based
ultrasound systems in use globally today. TAEUS® is initially
focused on the measurement of fat in the liver as a means to assess
and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and
Non-Alcoholic Steatohepatitis (NASH), chronic liver conditions that
affect over one 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
visualization of tissue temperature during energy-based surgical
procedures. For more information, please visit
www.endrainc.com.
Forward-Looking Statements All statements in this 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 forward-looking terms such as
"believe," "expect," "may," "will," "should," "could," "seek,"
"intend," "plan," "goal," "estimate," "anticipate" or other
comparable terms. Examples of forward-looking statements include,
among others, estimates of the timing of future events and
achievements, such as the expectations regarding milestones and
future sales, our 510(k) submission with the FDA and
commercializing the TAEUS® device; and expectations concerning
ENDRA's business strategy. Forward-looking statements involve
inherent risks and uncertainties which could cause actual results
to differ materially from those in the forward-looking statements,
as a result of various factors including, among others, our ability
to develop a commercially feasible technology; receipt of necessary
regulatory approvals; the impact of COVID-19 on our business plans;
our ability to find and maintain development partners, market
acceptance of our technology, the amount and nature of competition
in our industry; our ability to protect our intellectual property;
and the other risks and uncertainties described in ENDRA's filings
with the Securities and Exchange Commission. The forward-looking
statements made in this release speak only as of the date of this
release, 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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Company Contact: Irina Pestrikova Senior Director,
Finance investors@endrainc.com www.endrainc.com Investor
Relations Contact: Yvonne Briggs LHA Investor Relations (310)
691-7100 ybriggs@lhai.com
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