ENDRA Life Sciences Receives Canadian Approval for Human Studies of its Taeus Device to Detect Non-Alcoholic Fatty Liver Disease

October 16, 2018
  • Non-Alcoholic Fatty Liver Diesease affects over 1 billion people globally
  • TAEUS provides information previously only available via CT and MRI cheaper and at the point of care
  • The company just raised $3.1M in a public offering

ENDRA Life Sciences Inc (NASDAQ: NDRA), announced on 10/16/18 that is 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.

ENDRA is also developing TAEUS for use in other applications. It believes that its ability to display tissue temperature in real time will be of use in guiding energy based surgery. Additionally the company is developing capabilities around vascular imaging.

On 10/15/18, ENDRA announced that it had raised approximately $3.1 million in a public offering.

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