Company to Commence Human Studies with Initial Results Expected in Q4 2018
ANN ARBOR, MI / ACCESSWIRE / October 16, 2018 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ: NDRA), a developer of enhanced ultrasound technologies, through its collaborators at Robarts Research, has received approval from Health Canada for an Investigational Testing Authorization (ITA) to commence human studies with ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUS™) clinical system targeting Non-Alcoholic Fatty Liver Disease (NAFLD). The ITA application was reviewed under a class II designation and the study will be conducted in collaboration with Imaging Laboratories at Robarts Research in London, Canada.
ENDRA's investigational TAEUS technology, which uses RF energy to enhance ultrasound, is designed to enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only on CT & MRI -- at a fraction of the cost, and at the point-of-care. ENDRA's first TAEUS application will focus on the quantification of fat in the liver for early detection and monitoring of NAFLD, which affects over one billion people globally.
"We are pleased to begin the first human studies of ENDRA's TAEUS™ clinical system through our collaborators at Robarts Research, and we have already started to recruit volunteers," explained ENDRA's Chief Technology Officer, Michael Thornton. "These studies, which will yield results in the fourth quarter of 2018, will provide key insights into clinical work flow and TAEUS' quantitative methodologies. This is one of several planned clinical studies for our fatty liver application," concluded Thornton.
Dr. Aaron Fenster, Director of the Imaging Laboratories at Robarts Research and principle investigator for the clinical study said, "We are very excited to lead the first clinical study with a unique ultrasound-based tool for quantifying liver fat at the point of patient care."
"These human studies represent an important step towards our goal of introducing a commercial liver product in Europe in 2019 with support from our partner GE Healthcare," said ENDRA's Chief Executive Officer, Francois Michelon. "We are ramping up ENDRA's pre-commercial activities in 2018, including formal participation at key global liver and radiology conferences where we can build relationships with early-adopter clinicians, and the launch of educational materials about liver disease and ENDRA's technology, some of which you can find on our website: www.endrainc.com.
"Non-Alcoholic Fatty Liver Disease (NAFLD) is a huge global healthcare problem with no practical diagnostic solutions. ENDRA's TAEUS technology has the potential to change that, cost-effectively broadening access to better healthcare for millions of people," concluded Michelon.
About Health Canada
Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of all of Canada 's people and to making this country's population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system. For more information on Health Canada, please click here.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ: NDRA) is a developer of enhanced ultrasound technologies. ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (TAEUS™) platform to enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only with CT & MRI - at a fraction of the cost, and at the point-of-care. ENDRA's first TAEUS application will focus on the quantification of fat in the liver, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease (NAFLD). ENDRA's goal is to bring new capabilities to ultrasound - thereby broadening access to better healthcare. For more information, please visit www.endrainc.com.
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 $100B 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.
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, statements we make regarding the adequacy of protections afforded to us by the patents that we own and the success we may have in, and the cost to us of, maintaining, enforcing and defending those patents; expectations concerning ENDRA's ability to secure regulatory approvals; anticipated product pricing; expectations with respect to current and future partnerships; estimates of the timing of future events and achievements; 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, the following: our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; 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.
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SOURCE: ENDRA Life Sciences Inc.