Business
ENDRA Life Sciences Reports First Quarter 2023 Financial Results and Provides a 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\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, 2023 and provided a business update. Highlights include:\n\n\n\nCompleted enrollment of subjects and data collection for FDA De Novo request, with more than 100 TAEUS system scans utilizing new interactive guidance tool performed at global clinical investigational sites. In early 2023, ENDRA implemented a software guidance tool to enhance performance of its TAEUS system at several clinical evaluation sites and recently completed data collection on more than 100 TAEUS scans and MRI confirmatory scans. With the requisite data collection now complete, ENDRA is finalizing that portion of its De Novo request to the U.S. Food and Drug Administration (FDA). The data will also be used to support commercialization of the TAEUS liver device in Europe and, after FDA clearance, in the U.S.\n\n\n\n\n\nPreparing De Novo FDA submission. 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). The De Novo pathway is reserved for novel technologies and should assist ENDRA in achieving the strongest market position with TAEUS-optimized claims. Given the completion of data collection, ENDRA plans to submit the request mid-2023.\n\n\n\n\n\nHighlighted TAEUS’ liver system capabilities at clinical conferences. The ENDRA team continues to drive awareness of the TAEUS system by meeting with prospective customers and partners at clinical conferences in the U.S. and Europe. In the first quarter, ENDRA participated in the Francophone Society of Diabetes annual meeting. In addition, the Company’s peer-reviewed clinical abstract titled “Thermoacoustic assessment of fatty liver disease - an early clinical feasibility study” was accepted for a poster presentation at the prestigious European Association for the Study of the Liver (EASL) Congress, being held June 21-24 in Vienna. Acceptance of this abstract for presentation is a significant step in raising awareness and demonstrating the capabilities of TAEUS among prospecti...