Endra Life Sciences’ TAEUS De Novo submission moves to next stage of FDA review

ENDRA Life Sciences announces that the company’s De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration FDA . The TAEUS system is ENDRA’s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease NAFLD. “We are very pleased that our FDA De Novo submission has advanced to the substantive review stage,” stated ENDRA’s Chairman and Chief Executive Officer Francois Michelon. “ENDRA is committed to bringing the TAEUS technology to the U.S market to help clinicians combat the global epidemic of fatty liver disease, which affects over one billion people globally. We look forward to supporting the FDA as they continue their review.” On August 14 , ENDRA submitted a De Novo request to the FDA using the electronic Submission Template And Resource eSTAR system. On August 29, FDA informed ENDRA that the Company’s submission was entering the substantive review period. The FDA’s goal is to make a decision about a De Novo request in 150 review days. The De Novo pathway provides a way to classify novel medical devices for which there is no legally marketed predicate device and if granted, will strengthen TAEUS’ competitive position with its distinctive, patent-protected capabilities as a non-invasive point-of-care tool to aid in the characterization of NAFLD.