DGAP-News: ENDRA Life Sciences Inc.
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04.12.2020 / 09:00
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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. (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 50X lower 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.
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.
Chief Financial Officer
Investor Relations Contact:
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LHA Investor Relations
SOURCE: ENDRA Life Sciences Inc.
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