Full Press Release Details
ENDRA Life Sciences Provides Business Update and Reports Fourth
Quarter and Full Year 2019 Financial Results
ANN ARBOR, Michigan - March 26, 2020 - ENDRA Life Sciences
Inc. ( ENDRA ) (NASDAQ: NDRA), the pioneer of Thermo
Acoustic Enhanced UltraSound (TAEUS ), today provided a
business update and reported fourth quarter and full year 2019
am proud of the many, notable achievements ENDRA has made over the
last year, which have given us strong forward momentum as we move
towards our goal of bringing our breakthrough liver fat measurement
application of the TAEUS technology to the EU and U.S.
markets, said Francois Michelon, Chairman and Chief
Executive Officer. Like others in our industry, we continue
to monitor and evaluate the near and long term potential impacts of
the COVID19 pandemic, and are making required adjustments to ensure
ENDRA remains well positioned to deliver on our
technical file for TAEUS liver device in the EU.
feasibility study of TAEUS liver application at Robarts Research
Institute and reported top-line results.
clinical study partnerships with two leading clinical
team with new Chief Commercial Officer, Renaud Maloberti, and Vice
President of Engineering and Programs, Amy Sitzler.
intellectual property portfolio to 64 filed, issued and licensed
patents and pending patent applications.
Subsequent Events in Q1 2020
Approval for TAEUS FLIP (Fatty Liver Imaging Probe) System
targeting Non-Alcoholic Fatty Liver Disease ( NAFLD )
and Non-Alcoholic Steatohepatitis
collaboration agreement with the GE Healthcare unit of General
Electric Company ( GE ), extending the
agreement's term to January 2021.
Advisory Board with the addition of Raza Malik, M.D., Director of
Hepatology and Associate Chief of the Division of Gastroenterology
at Tufts Medical Center in Boston.
generated from our feasibility study in 2019 and strong clinical
reception to our ongoing pre-commercial activities have reinforced
our excitement about the potential for the TAEUS liver fat
application. We continue to believe it is well positioned to
address a significant clinical need and technology gap for a safe,
non-invasive, cost-effective and point-of-care tool to assess liver
fat in patients with chronic liver conditions like NAFLD and
NASH, continued Michelon. With the receipt of the CE
Mark approval for TAEUS liver system, which was earlier than
anticipated, we are looking forward to ramping up our initial
commercialization efforts in Europe and making our regulatory
filing in the U.S. in the second quarter of
Financial Results for Year Ended December 31, 2019
increased to $10.8 million in FY 2019 from $9.0 million in FY 2018.
The increase was due almost exclusively to increased costs
associated with the development of our TAEUS product
totaled $13.3 million, and after a non-cash deemed dividend related
to the issuance of preferred stock of $4.2 million the loss was
$17.5 million, or ($2.34) per basic and diluted share, as compared
to a net loss of $9.8 million, or ($2.17) per basic and diluted
31, 2019 totaled $6.2 million, as compared to $6.5 million at
December 31, 2018, with no long-term debt outstanding. The decrease
of cash is a result of our spending for normal operations offset by
our funding throughout the year.
2020 Goals & Milestones
commercial strategy with an emphasis on establishing clinical
evaluation reference sites in target markets and executing TAEUS
product marketing communication and education
finalize 510(k) regulatory package with important additional
verification testing targeting submission to the Food and Drug
Administration (FDA) in the second quarter of 2020.
investment in commercial activities and organization to support
pre-launch and early commercial stage activities in partnership
clinical partners and grow the clinical evidence base supporting
TAEUS utility in a clinical setting.
position expected to be sufficient to fund operations through
initial commercialization activities.
Conference Call and Webcast Access
Management will host a conference call and webcast today at 4:30
p.m. ET to discuss the results and provide an update on recent
corporate developments.
U.S./Canada Dial-in Number: 844-602-0380
International Dial-in Number: 862-298-0970
Replay Dial-in Number: 877-481-4010
Replay International Dial-in Number: 919-882-2331
Replay Passcode: 33509
telephone replay will be available March 26, 2020 through 4:30 p.m.
ET on April 9, 2020.
audio webcast will be available through the Events and
Presentations page of the Investors section of the company's
website at www.endrainc.com.
A replay of the webcast will be available on the website for 90
About ENDRA Life Sciences Inc.
Life Sciences Inc. is the pioneer of Thermo Acoustic Enhanced
UltraSound (TAEUS ), a ground-breaking technology that
mirrors some applications similar to CT or MRI, but at
the point of patient care. TAEUS is designed to work in concert
with one million ultrasound systems in global use today. TAEUS is
initially focused on the measurement of fat in the liver, as a
means to assess and monitor NAFLD and NASH, chronic liver
conditions that affect over 1 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. www.endrainc.com
Forward-Looking Statements
statements in this release that are not based on historical fact