Full Press Release Details
ENDRA Life Sciences Provides Business Update and Reports Second
Quarter 2020 Financial Results
ANN ARBOR, MI / ACCESSWIRE / August 17, 2020 / ENDRA Life
Sciences Inc. ("ENDRA") (NASDAQ:NDRA), the pioneer of Thermo
Acoustic Enhanced UltraSound (TAEUS ), today
provided a business update and reported second quarter 2020
the second quarter, we achieved another major milestone on the path
to commercializing TAEUS with our 510(k) Premarket Notification
submission to the U.S. Food and Drug Administration ("FDA")," said
Francois Michelon, Chairman and Chief Executive Officer. "The
submission represents the culmination of years of scientific
research, quality system implementation, clinical data collection,
and biocompatibility and safety testing. I'm very proud of the
ENDRA team, especially for working tirelessly through an
unprecedented global pandemic to ensure the submission was made on
the aggressive schedule we set before COVID-19 was a
Renaud Maloberti, Chief Commercial Officer, explained, "The FDA
submission builds on the receipt of the CE Mark in Europe for our
TAEUS liver system in the first quarter and positions the company
to begin commercialization in two major markets in the second half
of 2020 to start positively impacting the lives of more than 1
billion people globally affected by Non-Alcoholic Fatty Liver
Disease (NAFLD) and Non-Alcoholic Steatohepatitis
Q2 2020 and Recent Business Highlights
Premarket Notification submission to the U.S. Food and Drug
Administration ("FDA") for TAEUS Fatty Liver Imaging Probe ("FLIP")
on schedule, setting stage for potential clearance and
commercialization in the U.S. in 2020.
partnership with the Medical College of Wisconsin ("MCW"), a
world-renowned healthcare institution, for a clinical study of
ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUS ) device
for assessing Non-Alcoholic Fatty Liver Disease ("NAFLD"). This
represents the third research partnership for ENDRA, which will
help bolster the clinical evidence and further establish the
clinical utility of the TAEUS device in patients with NAFLD, as
commercialization gets underway.
commercialization strategy, following CE Mark approval, including
advancing to final stages of establishing initial evaluation sites
in key markets, as well as hiring an initial salesperson in the
U.K. and identifying leading candidates in other key
intellectual property (IP) portfolio to 72 assets defined, filed
and issued, including key platform patents in the United States,
Europe and China to defend our technology and current and future
clinical applications for which there are currently no practical
with key milestones of establishing clinical evaluation reference
sites in Q3 and initial sales in Europe in Q4 2020.
Financial Results for Quarter Ended March 31, 2020
increased to $2.9 million in the second quarter of 2020, up from
$2.3 million in the same period in 2019. The increase in operating
expenses was primarily due to expenses related to the development
of our TAEUS product line, and costs associated with the
pre-commercialization of TAEUS.
totaled $2.9 million, or ($0.20) per basic and diluted share, as
compared to a net loss of $2.3 million, or ($0.31) per basic and
diluted share in Q2 2019.
June 30, 2020 was $749,000 and totaled approximately $2.4 million
as of August 14, 2020 due primarily to voluntary early warrant
conversions, compared to $6.2 million at December 31, 2019, with no
long-term debt outstanding.
Conference Call and Webcast Access
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
Dial-in Number: 844-369-8774
Dial-in Number: 862-298-0844
Dial-in Number: 877-481-4010
International Dial-in Number: 919-882-2331
telephone replay will be available August 17, 2020 through 4:30
p.m. ET on August 24, 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 MRI, but at 50X lower cost, 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
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 include, among others, estimates of the timing of future
events and achievements, such as the expectations listed above
under the heading "2020 Guidance"; making our 510(k) submission
with the FDA and commercializing the TAEUS device; and expectations