Business
ENDRA Life Sciences Reports Fourth Quarter and Full Year 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 and year ended December 31, 2022, and provided a business update. Highlights include:\n\n\nOver 100 TAEUS system scans performed at global clinical evaluation sites in 2022 and deployed a new interactive guidance tool. To enhance the performance of the TAEUS system across a range of clinical users, ENDRA provided a guidance tool to assist operators at its clinical evaluation sites in early 2023. This tool provides interactive graphical feedback to guide users in positioning the TAEUS probe and to enable measurements with more reliability and higher repeatability. Data from these scans will be used in ENDRA’s submission of its De Novo request to the U.S. Food and Drug Administration (“FDA”), and to support the commercialization of the TAEUS liver device in Europe and, after FDA approval, in the U.S.\n\n\nFocused efforts to finalize and submit De Novo request to the FDA. In the U.S., ENDRA is pursuing the De Novo regulatory pathway for its TAEUS liver device, which is intended to characterize fatty liver tissue as a non-invasive means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD). ENDRA plans to submit the request as soon as the requisite TAEUS scans and MRI confirmatory data are obtained from scans using the new interactive guidance tool. The De Novo pathway, reserved for novel technologies, should assist ENDRA in achieving the strongest market position with TAEUS-optimized claims.\n\n\nRenewed collaboration agreement with GE HealthCare for two additional years through December 2024. GE HealthCare continues to support ENDRA by, among other things, facilitating introductions to GE HealthCare clinical ultrasound customers worldwide.\n\n\nEnhanced clinical awareness of TAEUS’ liver system through demonstrations at hepatology and radiology clinical conferences. In 2022, the ENDRA team met with prospective customers and key partners at 11 clinical conferences in the U.S. and Europe. The commercial team is continuing its market-awareness activities and is targeting participation in nine clinical conferences in 2023.\n\n\nExpanded global intellectual property portfolio to...