ENDRA Life Sciences reports liver device validation results

ENDRA Life Sciences Inc. (NASDAQ: NDRA) announced multi-site clinical validation results for its TAEUS Liver device, showing correlation with MRI-PDFF measurements across 64 patients in the U.S. and Canada.

The study analyzed data from patients across independent operators and clinical sites, including an external validation site in London, Ontario. The company's thermoacoustic fat fraction measurement tracked MRI-PDFF results for patients with metabolic dysfunction-associated steatotic liver disease and those with elevated body mass index.

The validation results showed a correlation to MRI-PDFF of r=0.90 for the combined patient cohort. Diagnostic accuracy measured AUROC 0.95-0.99 at key thresholds, with a mean error of approximately 3% consistent across sites. Reproducibility showed ICC=0.89 across operators, with approximately 90% of measurements within 5% of MRI values.

"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," said Alexander Tokman, Chief Executive Officer of ENDRA Life Sciences.

The TAEUS Liver device is designed as a portable, point-of-care system with an anticipated per-scan cost of under $200, compared to typical MRI-PDFF exam costs. The technology aims to provide liver fat assessment for patients with steatotic liver disease.

ENDRA Life Sciences develops thermoacoustic biomarker imaging technology for liver disease detection and monitoring. The company focuses on tissue fat measurement in the liver for assessing steatotic liver disease conditions.

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