ENDRA Life Sciences Announces New Clinical Study Partnership with King’s College Hospital, London
December 13 2021 - 8:00AM
Business Wire
Study to Bolster Clinical Evidence of
Performance of Patented TAEUS® Ultrasound Device in NAFLD Patients
as Early Product Commercialization in Europe Continues
ENDRA Life Sciences Inc. (ENDRA) (NASDAQ: NDRA), a pioneer of
enhanced ultrasound technologies, today announced that King’s
College Hospital, London (KCH) is now partnering with ENDRA for a
clinical study of ENDRA’s Thermo-Acoustic Enhanced Ultrasound
(TAEUS®) device for assessing Non-Alcoholic Fatty Liver Disease
(NAFLD).
“We are thrilled that KCH, a teaching hospital that is
world-renowned for pioneering research in liver disease management
and transplantation, is evaluating TAEUS® as a tool to characterize
NAFLD, a condition that impacts more than 1 billion people
globally,” said ENDRA Life Sciences CEO Francois Michelon. “It’s an
honor for ENDRA to partner with another leading NHS trust. We
believe this new partnership further advances our commercial
strategy as it provides the opportunity to demonstrate the
potential clinical utility of TAEUS® and to build on the clinical
foundation we have established to date.”
This represents the seventh clinical research partnership for
ENDRA globally and is a natural progression from the feasibility
study conducted by the Robarts Research Institute, which used
healthy volunteers to establish the safety and efficacy of the
TAEUS® technology. The data from the KCH study, along with other
ongoing or to-be initiated studies, will be used to bolster the
clinical evidence and further establish the clinical utility of the
TAEUS® ultrasound device in patients with NAFLD. The study will be
led by Dr. Ashley Barnabas, Consultant Hepatologist in the Liver
Unit at King’s College Hospital.
"The current options to assess and monitor liver fat in NAFLD
patients, namely MRI and liver biopsy, can be challenging to
integrate into clinical practice. There is a pressing need for more
practical tools to support and care for patients with this chronic
condition,” said Dr. Barnabas.
The goals of the KCH 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).
- Scanning a target of 75 fatty liver patients to contribute
additional diversity and volume of patient data.
- Publishing the findings of the study in a peer-reviewed medical
journal.
- Providing ENDRA with ongoing clinical feedback on product
design and clinical performance.
- Assisting with establishing the clinical value proposition of
the TAEUS® system in NAFLD to support ongoing
commercialization.
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 Non-Alcoholic Fatty Liver Disease NAFLD is a
condition closely associated with obesity, diabetes, hepatitis C
and certain genetic predispositions in which fat accumulates in the
liver. NAFLD affects over 1 billion people globally and is
estimated to cost the U.S healthcare system over $100 billion
annually. NAFLD is often asymptomatic and if left untreated, can
progress to inflammation (NASH), tissue scarring (fibrosis), cell
death (cirrhosis) and liver cancer. By 2025, NAFLD is forecast to
be the greatest root cause of liver transplants. The only tools
currently available for diagnosing and monitoring NAFLD are
impractical: expensive magnetic resonance imaging (MRI) or an
invasive surgical biopsy.
About King's College Hospital, London King’s College
Hospital NHS Foundation Trust is one of the UK’s largest and
busiest teaching hospitals. The Trust is recognised internationally
for its work in liver disease and transplantation, neurosciences,
cardiac, haemato-oncology, fetal medicine, stroke and major trauma.
In 2013, we acquired the Princess Royal University Hospital,
Orpington Hospital, and some services at Beckenham Beacon and Queen
Mary’s Sidcup following the dissolution of South London Healthcare
NHS Trust. We now provide care to 1.5 million patients in
Southwark, Lambeth, Bromley, Bexley, Lewisham and elsewhere in
south-east London and parts of Kent. Over 10,000 babies are
delivered by our hospitals each year, and over 750 patients come to
our Emergency Departments every day. The Liver Unit at King’s
College Hospital has a world-class reputation for the treatment of
liver-related disorders with an extremely comprehensive set of
services for the management of patients with liver failure,
cirrhosis, liver cancer and portal hypertension. King’s College
Hospital runs one of the largest adult and paediatric liver
transplantation programmes in Europe. It also has one of the
highest throughput of acute hepatology and liver transplants in
Europe.
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
inflammation (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; the timing of; making 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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version on businesswire.com: https://www.businesswire.com/news/home/20211213005131/en/
Company: Irina Pestrikova Senior Director of Finance
(310) 993-3105 investors@endrainc.com www.endrainc.com
Investor Relations: Yvonne K. Briggs LHA Investor
Relations (310) 691-7100 YBriggs@lhai.com
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