ENDRA Life Sciences Inc. has announced a significant advancement in its clinical study strategy for the TAEUS Liver device. The company has implemented a 100+ patient pilot study to validate and refine the TAEUS algorithms and design, transitioning from a reliance on retrospective data. This study aims to gather robust evidence for a future De Novo submission to the FDA. Additionally, ENDRA plans to expand the clinical sites involved in the pilot study across the U.S. and Canada. This expansion is intended to further confirm the anticipated improvements of the TAEUS probe and algorithm enhancements. The data collected from these sites will support alignment with the FDA on the pivotal study endpoints and final protocol. ENDRA has already collected liver fat measurement data from over 100 subjects, comparing TAEUS scans against MRI-PDFF, in collaboration with several leading imaging centers. These results are contributing to the company's preparation for the upcoming FDA De Novo pivotal study, aiming to enhance the diagnostic performance of TAEUS Liver technology.
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