ENDRA Life Sciences inc (NASDAQ:NDRA) said on Tuesday it has received approval from Health Canada to start human studies with ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUS) clinical system targeting Non-Alcoholic Fatty Liver Disease (NAFLD), a condition which leads to excess fat being stored in the liver.
ENDRA's TAEUS technology uses RF energy to enhance ultrasound and is designed to enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only on CT scans and MRIs at a fraction of the cost.
The first application of the technology will focus on the quantification of fat in the liver for early detection and monitoring of NAFLD, which affects over one billion people globally. The 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.
"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," he said.
Shares of the company jumped 12.75% to a session high of $2.83 on the news.
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"We are pleased to begin the first human studies ... through our collaborators at Robarts Research, and we have already started to recruit volunteers," said 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," Thornton added.
Non-Alcoholic Fatty Liver Disease is a huge global healthcare problem with no practical diagnostic solutions. It is closely associated with obesity, diabetes, hepatitis-C and certain genetic predispositions in which fat accumulates in the liver. NAFLD is estimated to cost the US healthcare system over $100 billion annually.
ENDRA Life Sciences is a company which develops enhanced ultrasound technologies. The company is based in Ann Arbor, Michigan.
Reporting by Rene Pastor, contactable on [email protected]