Business
ENDRA Life Sciences Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Conference call begins at 4:30 p.m. Eastern time today ANN ARBOR, Mich.--(BUSINESS WIRE)-- ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo
About this update from Endra Life Sciences Inc.
[{"type":"text","content":"\nConference call begins at 4:30 p.m. Eastern time today\n\n ANN ARBOR, Mich.--(BUSINESS WIRE)--\nENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three months and year ended December 31, 2021 and provided a business update. Highlights of the fourth quarter of 2021 and recent weeks include:\n\n\nAchieved clarity on the U.S. regulatory strategy for the TAEUS system. After extensive and productive dialogue with the U.S. Food and Drug Administration (FDA), ENDRA is now pursuing the De Novo pathway for its TAEUS System, which is intended to characterize fatty liver tissue as a non-invasive means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD). The De Novo request will build upon ENDRA's completed 510(k) submission and the pathway provides ENDRA with the opportunity to set the bar for an entirely new product classification, which should yield important and sustainable commercial advantages for the TAEUS platform. The company intends to include clinical data from a subset of its existing global clinical research partnerships to satisfy the data requirements for the De Novo request as rapidly as possible.\n\n\nExpanded into China with an eighth clinical study partner. ENDRA’s latest research partnership, with China’s renowned Shanghai General Hospital (Shanghai First People’s Hospital Affiliated with Shanghai Jiao Tong University), further validates ENDRA’s technology and provides a strategic entry point into China’s healthcare market, which seeks to deliver cost-effective services to 1.4 billion citizens including an estimated 350 million people with NAFLD and Non-Alcoholic Steatohepatitis (NASH).\n\n\nSecured an additional European clinical study partnership with King’s College Hospital in London. This is ENDRA’s fourth clinical research partnership in Europe. Data from the King’s College Hospital study, along with other ongoing or to-be-initiated studies, will be used to bolster clinical evidence and further establish the clinical utility of the TAEUS device for assessing NAFLD-NASH.\n\n\nPartnered with VGI Health Technology (VGI) to support its upcoming Phase 2 study of its NAFLD-NASH drug candidate. ENDRA signed a collaboration agreement with VGI to incorporate TAEUS as an add-on technology to support VGI’s patient screening...