ENDRA Life Sciences Submits De Novo Request for its TAEUS® System Liver Fat Application to the U.S. FDA
August 14 2023 - 1:30PM
Business Wire
Announces Positive Topline Data from
Clinical Studies Comparing TAEUS with MRI-PDFF
ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of
imaging technologies and Thermo Acoustic Enhanced UltraSound
(TAEUS®), announces the submission of a De Novo request to the U.S.
Food and Drug Administration (FDA) for the TAEUS system. The TAEUS
system is ENDRA’s proprietary device that is intended to offer
clinicians a tool for the non-invasive assessment of fatty liver
tissue, as an aid in the management of patients with Non-Alcoholic
Fatty Liver Disease (NAFLD).
The submission included patient scans from established clinical
study sites comparing TAEUS liver fat fraction estimates to
MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction),
which is the gold standard for clinical measurement of liver fat
fraction. The study data yielded a sensitivity of 90%. TAEUS
estimates of liver fat fraction were strongly correlated to
MRI-PDFF scores with a Pearson correlation coefficient of
r=0.78.
“The submission of the De Novo request for our TAEUS system is a
significant milestone for ENDRA as it includes additional
confirmatory data from our current clinical study sites that are
consistent with the results from our initial human feasibility
study. We are thrilled to file this request and believe the De Novo
process holds potential to set the bar for an entirely new product
classification by showcasing TAEUS’ capabilities as being novel and
powerful,” stated ENDRA's Chairman and Chief Executive Officer
Francois Michelon. "We believe our submission is robust and we look
forward to working with the FDA as they proceed with their review.
TAEUS has the potential to fulfill an unmet need as a non-invasive,
point-of-care tool for the assessment of fatty liver disease, which
affects more than one billion people globally, and to do so at
one-50th the cost of an MRI.”
ENDRA management will discuss this De Novo submission and
provide a general business update during the company’s previously
scheduled second quarter financial results conference call, being
held today at 4:30 p.m. Eastern time.
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
over 500,000 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 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,
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some forward-looking statements are expressed differently. Examples
of forward-looking statements for ENDRA include, among others:
estimates of the timing of future events and anticipated results of
our development efforts, including the timing for receipt of
required regulatory approvals and product launches; future
financial position and projected costs and revenue; expectations
concerning ENDRA's business strategy; ENDRA’s ability to find and
maintain development partners; market acceptance of ENDRA’s
technology and the amount and nature of competition in its
industry; and ENDRA’s ability to protect its intellectual property.
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
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; the impact of
COVID-19 on ENDRA’s business plans; the ability to find and
maintain development partners; 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/20230814545897/en/
Company: Irina Pestrikova Senior Director, Finance
investors@endrainc.com www.endrainc.com Investor Relations:
Yvonne Briggs LHA Investor Relations (310) 691-7100
YBriggs@lhai.com
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