ANN ARBOR, Mich. — ENDRA Life Sciences Inc. said its TAEUS Liver device demonstrated high measurement consistency in a recent clinical study, delivering reliability levels comparable to MRI while operating at the point of patient care.
The company said the study evaluated intra-user repeatability and inter-user reproducibility of the thermoacoustic imaging platform, which is designed for the early detection and monitoring of steatotic liver disease, including Metabolic Dysfunction-Associated Steatotic Liver Disease. The condition affects an estimated 30% of adults worldwide.
The trial involved 14 subjects, with independent operators performing multiple scans to assess real-world clinical performance. A total of 56 measurements were analyzed using Gage Repeatability and Reproducibility methods to determine how much variability stemmed from the measurement system rather than patient differences — a key consideration for regulatory validation and clinical decision-making.
TAEUS achieved an Intraclass Correlation Coefficient of 0.89 and a standard error of measurement of 3.3%, metrics that fall within what is generally considered a good-to-excellent performance range. The results indicate that the device delivers consistent results across different operators and maintains repeatability during back-to-back scans by the same clinician.
“While MRI-PDFF remains the gold standard for liver fat quantification, its high cost and limited availability create significant barriers for the more than two billion people afflicted by MASLD,” said Alexander Tokman, chief executive officer of ENDRA Life Sciences. “These new performance data showing a 3.3% SEM and a 0.89 ICC strongly support our belief that TAEUS can deliver consistent results similar to an MRI, but at the point of patient care and at a much lower cost. This addresses a critical need for clinicians and pharmaceutical companies that require a diagnostic tool to monitor treatment frequently and affordably.”
The company said TAEUS also compares favorably with traditional ultrasound techniques, which can be subject to high inter-observer variability and subjective interpretation. ENDRA believes the device could be integrated into routine clinical practice and potentially used in clinical trials for patient recruitment and treatment monitoring, particularly as new metabolic therapies enter the market and demand increases for frequent, cost-effective liver fat assessment.
ENDRA said its thermoacoustic approach is designed to combine the precision of advanced imaging modalities with the accessibility and deployment advantages of ultrasound-based systems.
