ANN ARBOR, Mich.– ENDRA Life Sciences Inc. has announced that early findings from its ongoing multisite pilot study are already leading to meaningful enhancements in the performance of its TAEUS® Liver system. The imaging technology, developed as a more accessible alternative to MRI for assessing liver fat, is now being refined to improve both accuracy and repeatability through updates to its probe design and proprietary algorithms.
The TAEUS system is designed to quantify liver fat using ultrasound-based technology, offering a potentially more affordable and scalable approach than MRI-PDFF, the current gold standard for diagnosing and monitoring metabolic liver disease. The ongoing study, conducted in collaboration with multiple imaging centers across the U.S. and Canada, has gathered data from over 100 patients to directly compare TAEUS results with MRI-based measurements.
“These compelling results from our data-rich, multisite clinical approach highlight the value of our technology and have revealed rapid product enhancement opportunities,” said Alexander Tokman, CEO of ENDRA. “We believe these improvements will significantly de-risk our upcoming FDA De Novo pivotal study and help position TAEUS Liver as a differentiated, competitive tool in the marketplace.”
As part of a strategic shift in its clinical development pathway, ENDRA last year moved away from using retrospective data from a small patient pool. Instead, the company initiated a forward-looking, 100-plus patient pilot study aimed at fine-tuning the TAEUS device and algorithms ahead of FDA review. Based on current progress, ENDRA plans to add new clinical sites to the pilot phase to further validate the anticipated improvements.
Following the completion of the pilot study and discussions with the U.S. Food and Drug Administration, the company expects to launch a statistically powered, prospective pivotal trial involving around 250 patients. This next-phase study will be designed to generate robust evidence in support of a De Novo regulatory submission.
The enhancements to the TAEUS Liver platform, combined with the company’s recalibrated clinical strategy, signal strong momentum for ENDRA as it prepares for regulatory review. By aligning its study protocol with FDA expectations and demonstrating performance against MRI benchmarks, ENDRA aims to offer a clinically credible and cost-effective tool for detecting and monitoring liver disease in broader healthcare settings. (Source: IANS)
