PRESS RELEASE : ENDRA Life Sciences Announces New Clinical Study Partnership with the Centre Hospitalier Universitaire d'Angers, France

 
 DGAP-News: ENDRA Life Sciences Inc. / Key word(s): Alliance 
ENDRA Life Sciences Announces New Clinical Study Partnership with the Centre 
Hospitalier Universitaire d'Angers, France 
 
2020-12-04 / 09:00 
The issuer is solely responsible for the content of this announcement. 
 
*ENDRA Life Sciences Announces New Clinical Study Partnership with the 
Centre Hospitalier Universitaire d'Angers, France* 
 
_Study to Bolster Clinical Evidence of Performance of Patented TAEUS 
Ultrasound Device in NAFLD Patients as Commercialization Begins_ 
 
*ANN ARBOR, MI / ACCESSWIRE / December 3, 2020 /* ENDRA Life Sciences Inc. 
[1] (ENDRA) (NASDAQ:NDRA), a pioneer of enhanced ultrasound technologies, 
today announced that Centre Hospitalier Universitaire d'Angers, France (CHU 
Angers), a world-renowned healthcare institution, is partnering with ENDRA 
for a clinical study of ENDRA's Thermo Acoustic Enhanced UltraSound 
(TAEUS(TM)) device for assessing Non-Alcoholic Fatty Liver Disease (NAFLD). 
 
"We are thrilled that CHU Angers, a renowned French clinical and teaching 
institution, is evaluating TAEUS as a tool to characterize NAFLD, a 
condition that impacts more than 1 billion people globally," said ENDRA Life 
Sciences Chief Commercial Officer Renaud Maloberti. "It's an honor for ENDRA 
to garner the clinical interest of this leading research institution. We 
look forward to building our relationship with CHU Angers as we begin 
commercializing TAEUS in Europe." 
 
This is the second clinical research partnership for ENDRA in Europe and the 
fifth globally. It is a natural progression from the feasibility study 
conducted by the Robarts Research Institute in Canada, and the first 
evaluation site that was deployed earlier this month at Rocky Vista 
University in the United States. The data from the CHU Angers study, along 
with other ongoing or to-be-initiated studies, will be used to bolster the 
clinical evidence and further establish the clinical utility of the TAEUS 
ultrasound device in patients with NAFLD, as commercialization begins. The 
study will be led by Pr. Christophe Aube, MD, PUPH, Chair of the Radiology 
department in close association with Pr. Jerome Boursier, MD, PUPH, Chair of 
the Hepatology department. 
 
"NAFLD and NASH are rapidly rising among the population and the options to 
assess and monitor liver fat in NAFLD patients, namely MRI and liver biopsy, 
are difficult to integrate into routine clinical practice. Clinicians need 
to have access to more practical tools to help manage patients with this 
chronic condition," said Pr. Aube. "We are looking forward to conducting 
this evaluation of TAEUS in our patients with NAFLD, and to better 
understanding the potential clinical utility of ENDRA's TAEUS technology as 
it compares to MRI," added Pr. Boursier. 
 
The goals of the CHU Angers study include: 
 
? Comparing ENDRA's commercial design TAEUS liver device against a 
baseline measure of liver fat as determined by the current standard of 
care, MRI-PDFF (magnetic resonance imaging proton density fat fraction). 
 
? Scanning a target of 75 fatty liver patients to contribute additional 
diversity and volume of patient data. 
 
? Providing ENDRA with ongoing clinical feedback on product design and 
clinical performance. 
 
? Assisting with the establishment of the clinical value proposition of 
the TAEUS system in NAFLD to support ongoing commercialization efforts. 
 
*About Non-Alcoholic Fatty Liver Disease (NAFLD)* 
 
NAFLD is a condition closely associated with obesity, diabetes, hepatitis C 
and certain genetic predispositions in which fat accumulates in the liver. 
NAFLD affects over 1 billion people globally and is estimated to cost the 
U.S healthcare system over $100 billion annually. NAFLD is often 
asymptomatic and if left untreated, NAFLD can progress to inflammation 
(NASH), tissue scarring (fibrosis), cell death (cirrhosis) and liver cancer. 
By 2025, NAFLD is forecast to be the greatest root cause of liver 
transplants. The only tools currently available for diagnosing and 
monitoring NAFLD are impractical: expensive Magnetic Resonance Imaging (MRI) 
or an invasive surgical biopsy. 
 
*About the Centre Hospitalier Universitaire d'Angers (CHU Angers)* 
 
The University Hospital of Angers is a reference healthcare hub with the 
threefold mission of healthcare, teaching and research. As both a local 
hospital and a national center of expertise, the hospital reconciles 
innovation with community service on a daily basis. As one of the region's 
largest healthcare providers treating more than 190,000 patients a year and 
with 1,357 beds and places, quality is a key consideration for Angers 
University Hospital, especially when it comes to patient care. 
 
The Hepatology axis, including NAFLD and hepatic fibrosis, is one of the six 
major research priorities of the University Hospital of Angers. It brings 
together a multidisciplinary team of academic physicians specialized in 
digestive diseases, and is supported by four transversal functional units: 
Histology Department; Radiology Department; Biochemistry & Molecular 
Biology; and a dedicated Clinical Research Unit. The Clinical Research Unit 
of the Hepato-Gastroenterology Department has qualified engineers and 
technicians in charge of the day-to-day clinical research work (management 
of data entry operators, organization of samples logistics and specific 
biological analysis, etc.). This unit is highly experienced in clinical 
research with around 103 academic and industrials studies currently ongoing. 
The Hepato-Gastroenterology Department is one of the leading centers in 
France for inclusion in NAFLD and NASH clinical trials. 
 
*About ENDRA Life Sciences Inc.* 
 
ENDRA Life Sciences Inc. is the pioneer of Thermo Acoustic Enhanced 
UltraSound (TAEUS(TM)), a ground-breaking technology that mirrors some 
applications similar to CT or MRI, but at 50Xlower cost and 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. [2] 
 
*Forward-Looking Statements* 
 
All 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 regarding 
milestones and future sales; the timing of; making our 510(k) submission 
with the FDA and commercializing the TAEUS device; and expectations 
concerning ENDRA's business strategy. Forward-looking statements involve 
inherent risks and uncertainties which 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, 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 release speak only as of the date of 
this release, 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. 
 
*Company Contact:* 
 
David Wells 
Chief Financial Officer 
[phone] 
[e-mail] 
www.endrainc.com [3] 
 
*Investor Relations Contact:* 
 
Kim Sutton Golodetz 
LHA Investor Relations 
[phone] 
[e-mail] 
 
*SOURCE:* ENDRA Life Sciences Inc. 
 
2020-12-04 Dissemination of a Corporate News, transmitted by DGAP - a 
service of EQS Group AG. 
The issuer is solely responsible for the content of this announcement. 
 
The DGAP Distribution Services include Regulatory Announcements, 
Financial/Corporate News and Press Releases. 
Archive at www.dgap.de 
1152756 2020-12-04 
 
 
1: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=d15341b17699bda860ca40862afccbd2&application_id=1152756&site_id=vwd&application_name=news 
2: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=77b82564c2a3851cb0cd10097faad02f&application_id=1152756&site_id=vwd&application_name=news 
3: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=a93999538d892e861cf9a22c0efeab4a&application_id=1152756&site_id=vwd&application_name=news

(END) Dow Jones Newswires

December 04, 2020 03:00 ET (08:00 GMT)