Business
ENDRA Life Sciences Builds on CE Mark Approval
The pioneer of Thermo Acoustic Enhanced UltraSound advances its commercialization plan and intellectual property portfolio and reaffirms guidance to file
About this update from Endra Life Sciences Inc.
[{"type":"text","content":"The pioneer of Thermo Acoustic Enhanced UltraSound advances its commercialization plan and intellectual property portfolio and reaffirms guidance to file 510(k) application with the FDA ANN ARBOR, MI / ACCESSWIRE / April 30, 2020 / ENDRA Life Sciences Inc. (\"ENDRA\") (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today provided an update on its progress across a variety of initiatives intended to leverage the recent approval of the CE Mark (Conformité Européene) for its TAEUS FLIP (Fatty Liver Imaging Probe) System. ENDRA also provided an update on the status of its FDA 510(k) submission and intellectual property.\"ENDRA's goal is to develop TAEUS applications in areas of high unmet clinical need. Our initial focus is on helping the more than 1 billion people globally affected by Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH), where there is a desperate need for a practical tool to assess and monitor liver fat,\" said Francois Michelon, Chief Executive Officer of ENDRA. \"The receipt of the CE Mark for our TAEUS liver system in the first quarter was a key milestone, enabling ENDRA to initiate its plan to commercialize the company's disruptive technology in 2020,\" continued Michelon. \"We have been moving aggressively to capitalize on our CE Mark and first-mover advantage through a number of actions, including the launch of new clinical education tools and the development of a network of potential TAEUS evaluation sites in Europe, where we see the greatest opportunity to achieve near-term commercial success.\"The company's recent commercialization activities include several mutually supportive elements, including:Recruiting sales professionals in several high-value European markets, including France and GermanyAdvancing discussions with existing and potential TAEUS evaluation sites, where clinical partners have indicated they are eager to move forward with TAEUS installations and clinical evaluations as soon as practical, in accordance with the industry's current focus on the COVID-19 epidemicEnhancing clinical education tools to support ENDRA's sales and marketing teams, including:A new liver-focused website (www.endrainc.com), launched on April 30, that reinforces our commitment to enabling better, earlier detection of NAFLD AND NASH. The site is being translate...