ENDRA Provides Update Following In-person Meeting with FDA
2024年5月20日 - 9:00PM
ビジネスワイヤ（英語）
Increases clarity for ENDRA on regulatory path
forward for TAEUS
ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo
Acoustic Enhanced UltraSound (TAEUS®), announced that it has
completed what it considers to be a highly informative
pre-submission meeting with the U.S. Food and Drug Administration
(FDA) related to the clinical trial design of the TAEUS liver
device in support of its U.S. De Novo filing.
Prior to the meeting, ENDRA provided the FDA with a detailed
description of the TAEUS technology to be used in clinical testing,
along with a clinical study synopsis outlining a prospective
hypothesis-driven, statistically powered multicenter clinical study
spanning a fat fraction range representative of steatotic liver
disease in the U.S., ranging from healthy to severe. In support of
the proposed statistical analysis plan, ENDRA provided background
clinical data and statistical analyses from 45 historical study
participants.
The meeting was held at FDA's Maryland headquarters and focused
on ENDRA’s proposed pivotal clinical study. During the meeting
ENDRA also demonstrated the TAEUS procedure using anatomical
phantoms of the liver.
The ENDRA team in attendance included key technical staff, a
regulatory/clinical lead with over 20 years of first-of-a-kind
medical device experience, a senior biostatistician familiar to the
FDA, and liver ultrasound and MRI radiology experts.
Management believes that the meeting was highly informative and
views the FDA’s feedback as very constructive. Based on the
feedback received as well as the Meeting Minutes expected in June,
ENDRA will update its pivotal clinical study protocol and
statistical plan for submission to the FDA as a next step prior to
initiating the study.
"ENDRA's new regulatory approach is focused on close engagement
with the FDA to ensure alignment on our pivotal study design and
statistical plan, in support of a future De Novo submission," said
Michael Thornton, ENDRA's Chief Technology Officer. “We believe
this in-person meeting with the FDA helped clarify the path forward
for ENDRA. We look forward to maintaining close collaboration with
the FDA throughout the process."
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 designed to work in concert
with the more than 700,000 ultrasound systems in use globally
today. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240520140686/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
ENDRA Life Sciences (NASDAQ:NDRA)
過去 株価チャート
から 5 2024 まで 6 2024
ENDRA Life Sciences (NASDAQ:NDRA)
過去 株価チャート
から 6 2023 まで 6 2024
