Business
ENDRA Life Sciences Reports First Quarter 2022 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 ended March 31, 2022, and provided a business update. Highlights of the first quarter of 2022 and recent weeks include:\n\n\nRaised $8.7 million in gross proceeds, extending cash runway. The company raised a total of $8.7 million in gross proceeds year-to-date from the sale of common stock through its at-the-market (ATM) equity facility, of which $7.8 million was raised subsequent to the close of the first quarter. With this bolstered cash position, management believes ENDRA is capitalized to fund operations through several important milestones, including ramping-up commercial activities in Europe and advancing the TAEUS system through the regulatory process in the U.S.\n\n\n\nReached clarity on the U.S. regulatory strategy for the TAEUS system and on track to submit De Novo request in the third quarter. After extensive and productive dialogue with the U.S. Food and Drug Administration (FDA), ENDRA is pursuing the De Novo pathway for its TAEUS Liver 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 pathway will build upon ENDRA's completed 510(k) application and 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 novel TAEUS platform. Under the De Novo process, the company intends to provide smaller-scale TAEUS human study data, which will come from ENDRA's existing clinical study sites and is not expected to add material expenses to ENDRA.\n\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 interest in 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\n\nG...