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ENDRA Life Sciences Receives CE Mark for its TAEUS(R) Clinical Product Targeting Non-Alcoholic Fatty Liver Disease
First regulatory clearance paves the way to commercialize TAEUS in European markets U.S. FDA submission expected during H1:20ANN ARBOR, MI / ACCESSWIRE /
About this update from Endra Life Sciences Inc.
[{"type":"text","content":"First regulatory clearance paves the way to commercialize TAEUS in European markets U.S. FDA submission expected during H1:20ANN ARBOR, MI / ACCESSWIRE / March 10, 2020 / ENDRA Life Sciences Inc. (\"ENDRA\") (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announced today that it has received Conformité Européene (\"CE\") Mark approval for its TAEUS FLIP (Fatty Liver Imaging Probe) System. TAEUS is initially focused on the non-invasive measurement of liver fat to identify and monitor Non-Alcoholic Fatty Liver Disease (\"NAFLD\") and Non-Alcoholic Steatohepatitis (\"NASH\"), chronic liver conditions that affect over one billion people globally and are precursors to fibrosis, cirrhosis and cancer. The CE marking indicates that TAEUS FLIP System complies with all applicable European Directives and Regulations in the European Union and other CE Mark geographies, including the 27 EU member states. ENDRA will now notify the competent authorities that it has received the CE Mark, and register the TAEUS product in each of the initial target markets.The company also provided an update on the status of its planned U.S. FDA regulatory submission, which is in preparation and expected to be submitted during the first half of 2020.\"CE Mark approval is a milestone achievement for ENDRA, as it marks our first regulatory approval for the TAEUS device, and paves the way for us to commercialize the TAEUS liver application in our initial international target markets, such as Germany and France,\" said Francois Michelon, Chairman and CEO of ENDRA.\"Our EU commercial team looks forward to working with our partners at GE Healthcare in Europe to introduce our TAEUS liver technology to clinicians in our initial target markets,\" said Renaud Maloberti, Chief Commercial Officer of ENDRA. \"We will ramp up our supply chain near-term, and focus our efforts on getting the TAEUS systems into the hands of clinical influencers, an essential step in providing strong local references for our commercial team.\"ENDRA will provide additional information on its EU commercial plans for TAEUS, regulatory and other activities during the upcoming Q4, 2019 conference call on March 26th.About ENDRA Life Sciences Inc.ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology being developed to...