ENDRA Life Sciences Provides Update on U.S. Regulatory Strategy for its TAEUS® System
February 09 2022 - 4:05PM
Business Wire
New path developed in consultation with the
FDA to include limited confirmatory clinical data and provide
potential future competitive advantages
ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of
Thermo Acoustic Enhanced UltraSound (TAEUS®), announced today it
will build on the content of its completed 510(k) application and
pursue the De Novo pathway for its TAEUS System, which is intended
to characterize fatty liver tissue as a means to non-invasively
assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD).
ENDRA’s updated regulatory strategy is the result of a
tremendous amount of productive dialogue with the U.S. Food and
Drug Administration (FDA), which led to a clearer understanding of
the path forward to achieve ENDRA’s U.S. market claims for the
TAEUS System. While ENDRA could continue to pursue its 510(k)
application, ENDRA now believes that the potential resulting 510(k)
market claims may understate the TAEUS System's clinical and
commercial value. This is particularly so when ENDRA considers the
remaining effort to demonstrate 510(k) predicate equivalency
compared with the effort involved in the De Novo pathway. For a
similar investment of time and effort, ENDRA believes it can
achieve a stronger market position through the De Novo process with
TAEUS-optimized market claims compared with the 510(k)
approach.
Unlike a 510(k) clearance in which FDA determines “substantial
equivalence” between a new product and another commercially
available product with the same intended use and safety and
efficacy profile (e.g., Ultrasonic imaging systems), the De Novo
process provides a pathway for ENDRA to set the bar for an entirely
new product classification. Further, this regulatory path will
showcase TAEUS’ distinctive capabilities and will highlight TAEUS
as being unique and novel, thereby strengthening TAEUS’ competitive
position when it becomes available for sale in the U.S.
ENDRA’s De Novo submission will involve the following key
steps:
- Leveraging substantial portions of ENDRA’s completed 510(k)
submission, which encompasses many of the same elements as the
intended De Novo submission, including safety and efficacy
data.
- Customizing TAEUS’ proprietary testing methods into “special
controls,” which will become requirements for future product
submissions. This is expected to accelerate 510(k) submissions of
future generations of TAEUS products while creating market-entry
barriers for competitive products.
- Adding limited confirmatory clinical data from a subset of
ENDRA’s existing clinical evaluation sites, which is expected to be
available in 2022.
"We are very encouraged with FDA’s feedback on our TAEUS
System’s safety and performance data as well as their support of a
De Novo pathway, which is well-suited to TAEUS’ low-to-moderate
risk profile and ENDRA’s desired market claims for our novel
technology. ENDRA believes it is now aligned with the FDA on the
scope of the limited confirmatory clinical data, which is the
primary remaining element needed for a De Novo submission. We are
confident that a De Novo request is the strongest path to bring our
TAEUS technology to the U.S. market. We believe this process should
yield sustainable commercial advantages for our TAEUS platform by
establishing a differentiated indication for use and setting the
bar for an entirely new class of products,” stated ENDRA's Chief
Executive Officer Francois Michelon.
The De Novo process provides a pathway for medical devices of
low-to-moderate risk that do not have a marketed predicate device.
The Company plans to voluntarily withdraw its 510(k) application,
which is currently in review with the FDA, and subsequently submit
a De Novo application. ENDRA intends to leverage clinical data from
a subset of its existing global clinical study partnerships to
support the De Novo request. Each clinical site will be screening
patients with MRI-PDFF (magnetic resonance imaging proton density
fat fraction) as well as with TAEUS, and then comparing the results
from the two modalities. ENDRA is committed to generating the
additional data required for the De Novo process as rapidly as
possible in 2022, building on substantial portions of ENDRA’s
completed 510(k) submission.
TAEUS is currently available for sale in countries that
recognize the CE mark, including those in the European Union.
ENDRA's commercialization of TAEUS includes establishing clinical
research partnerships worldwide with an initial focus on Europe and
the U.S. To date the company has established eight research
partnerships, with four in Europe, three in the U.S. and one in
China. In December 2020, ENDRA renewed its collaboration agreement
with the GE Healthcare unit of the General Electric Company,
extending the agreement's term by two years to December 2022. GE
Healthcare is the global leader in clinical ultrasound and has been
ENDRA's partner since 2016.
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), a chronic
liver condition affecting 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 news
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 for ENDRA
include, among others, estimates of the timing of future events and
achievements, such as the expectations regarding the regulatory
approval process for our TAEUS applications, and expectations
concerning ENDRA's business strategy, which may be affected by
risks related to the impact of COVID-19 on its business plan, its
ability to find and maintain development partners, market
acceptance of its technology and the amount and nature of
competition in its industry, its ability to protect its
intellectual property, and other risks and uncertainties described
in its filings with the Securities and Exchange Commission.
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, 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
and 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 news 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/20220209006120/en/
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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