ANN ARBOR, Mich. — ENDRA Life Sciences Inc. reported multi-site clinical validation results for its TAEUS Liver device, showing strong agreement with MRI-based liver fat measurements and consistent performance across clinical sites.
The Ann Arbor-based company is developing thermoacoustic biomarker imaging technology for the early detection and monitoring of steatotic liver disease.
ENDRA said the analysis included data from 64 patients in the U.S. and Canada, including an external validation site in London, Ontario. The study evaluated TAEUS Liver across independent operators and patient populations.
The company said TAEUS Liver’s thermoacoustic fat fraction measurement closely tracked MRI-PDFF results across patients with metabolic dysfunction-associated steatotic liver disease and elevated body mass index.
Key results included a 0.90 correlation with MRI-PDFF in the combined cohort, diagnostic accuracy with AUROC values of 0.95 to 0.99 at key thresholds, mean error of about 3% across sites and reproducibility of 0.89 across operators. ENDRA said about 90% of measurements were within about 5% of MRI values, with no dependence on BMI or body habitus.
“The multi-site data aggregation shows that TAEUS Liver delivers MRI-like liver fat quantification at the point of patient care, with a strong correlation to MRI-PDFF of 0.90 and no meaningful bias. We believe the combination of this performance coupled with TAEUS Liver’s portability and low cost could make routine liver fat assessment feasible for the more than two billion people worldwide living with MASLD,” said Alexander Tokman, Chief Executive Officer of ENDRA Life Sciences.
ENDRA said TAEUS Liver is designed to provide MRI-aligned performance in a portable, point-of-care format, with an anticipated per-scan cost of less than $200. The company said that cost would be less than 8% of a typical MRI-PDFF exam.
The company said the device could make frequent liver fat assessments more practical, including for monitoring changes tied to treatment. ENDRA said the technology is intended to offer a standardized and repeatable test for liver fat measurement in patients affected by metabolic dysfunction-associated steatotic liver disease.
ENDRA said TAEUS Liver could be used in routine clinical practice and may also support pharmaceutical companies in patient recruitment and follow-up for clinical trials. The company said the ability to detect incremental liver fat changes without repeated MRI scans could become more important as new metabolic therapies enter the market.
