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ENDRA Life Sciences Reports Multi-Site Validation of TAEUS® Liver Device Demonstrating MRI-like Accuracy and Reproducibility
Results confirm accurate and consistent liver steatosis assessment performance across operators, geographies and patient populations, supporting planned
About this update from Endra Life Sciences Inc.
[{"type":"text","content":"\nResults confirm accurate and consistent liver steatosis assessment performance across operators, geographies and patient populations, supporting planned regulatory pathway\n\n\n ANN ARBOR, Mich.--(BUSINESS WIRE)--\nENDRA Life Sciences Inc. (NASDAQ: NDRA) (“ENDRA” or the “Company”), a pioneer in thermoacoustic biomarker imaging for the early detection and monitoring of steatotic liver disease (SLD), today announced multi-site clinical validation results for TAEUS® Liver that demonstrate strong concordance with MRI-PDFF, high reproducibility and consistent performance across clinical sites.\n\n\nThe analysis combined data from 64 patients in the U.S. and Canada, including an external validation site in London, Ontario, across independent operators and patient populations. TAEUS Liver’s thermoacoustic fat fraction measurement closely tracked MRI‑PDFF results for patients along the full spectrum of metabolic dysfunction‑associated steatotic liver disease (MASLD) and those with elevated body mass index (BMI).\n\n\nKey results in the analysis included:\n\n\n\nCorrelation to MRI-PDFF: r=0.90 (combined cohort)\n\n\n\nDiagnostic accuracy: AUROC 0.95–0.99 at key thresholds\n\n\n\nMean error: ~3%, consistent across sites\n\n\n\nReproducibility: ICC=0.89 across operators\n\n\n\n~90% of measurements within ~5% of MRI values\n\n\n\nNo dependence on BMI or body habitus\n\n\n\n“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.\n\n\nTAEUS Liver is designed to provide MRI‑aligned performance in a portable, point‑of‑care format with an anticipated per‑scan cost of under $200, which is less than 8% of a typical MRI‑PDFF exam. By enabling frequent, affordable assessments, TAEUS Liver could support routine monitoring of treatment‑driven changes in liver fat that are difficult to track with MRI alone. The TAEUS system's performance contrasts sharply with ultrasound techniques, which experience high inter-observer variabilit...