ENDRA Life Sciences' TAEUS De Novo Submission Advances to Next Stage of Review with FDA
30 Agosto 2023 - 9:00AM
Business Wire
ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of
imaging technologies and Thermo Acoustic Enhanced UltraSound
(TAEUS®), announces that the Company's De Novo request for the
TAEUS liver system has advanced to substantive review with the U.S.
Food and Drug Administration (FDA). 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).
“We are very pleased that our FDA De Novo submission has
advanced to the substantive review stage," stated ENDRA's Chairman
and Chief Executive Officer Francois Michelon. "ENDRA is committed
to bringing the TAEUS technology to the U.S market to help
clinicians combat the global epidemic of fatty liver disease, which
affects over one billion people globally. We look forward to
supporting the FDA as they continue their review."
On August 14, 2023, ENDRA submitted a De Novo request to the FDA
using the electronic Submission Template And Resource (eSTAR)
system. On August 29, 2023, FDA informed ENDRA that the Company's
submission was entering the substantive review period. The FDA's
goal is to make a decision about a De Novo request in 150 review
days.
The De Novo pathway provides a way to classify novel medical
devices for which there is no legally marketed predicate device and
if granted, will strengthen TAEUS’ competitive position with its
distinctive, patent-protected capabilities as a non-invasive
point-of-care tool to aid in the characterization of NAFLD.
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 Steatotic Liver Disease (SLD) (formerly known
as NAFLD-NASH), a chronic liver spectrum that affects 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,
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:
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/20230830381163/en/
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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