$NDRA ENDRA Life Sciences Reports Multi-Site Validation of TAEUS® Liver Device Demonstrating MRI-like Accuracy and Reproducibility
https://www.businesswire.com/news/home/202605...ducibility
Results confirm accurate and consistent liver steatosis assessment performance across operators, geographies and patient populations, supporting planned regulatory pathway
ANN ARBOR, Mich.--(BUSINESS WIRE)--ENDRA 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.
The 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).
Key results in the analysis included:
Correlation to MRI-PDFF: r=0.90 (combined cohort)
Diagnostic accuracy: AUROC 0.95–0.99 at key thresholds
Mean error: ~3%, consistent across sites
Reproducibility: ICC=0.89 across operators
~90% of measurements within ~5% of MRI values
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.
TAEUS 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 variability and subjective interpretations.
These study results support TAEUS Liver’s objective to deliver a standardized, accurate and repeatable liver fat test for the growing population affected by MASLD. TAEUS Liver could be deployed in routine clinical practice to address large, underserved populations and could potentially be utilized by pharmaceutical companies for patient recruitment and follow-up in clinical trials. As new metabolic therapies enter the market, the ability to detect small, incremental changes in liver fat without the cost burden of repeated MRI scans becomes increasingly important. ENDRA’s innovative approach with TAEUS combines the precision traditionally associated with expensive imaging modalities with the practical deployment advantages of ultrasound-based systems.
https://www.businesswire.com/news/home/202605...ducibility
Results confirm accurate and consistent liver steatosis assessment performance across operators, geographies and patient populations, supporting planned regulatory pathway
ANN ARBOR, Mich.--(BUSINESS WIRE)--ENDRA 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.
The 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).
Key results in the analysis included:
Correlation to MRI-PDFF: r=0.90 (combined cohort)
Diagnostic accuracy: AUROC 0.95–0.99 at key thresholds
Mean error: ~3%, consistent across sites
Reproducibility: ICC=0.89 across operators
~90% of measurements within ~5% of MRI values
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.
TAEUS 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 variability and subjective interpretations.
These study results support TAEUS Liver’s objective to deliver a standardized, accurate and repeatable liver fat test for the growing population affected by MASLD. TAEUS Liver could be deployed in routine clinical practice to address large, underserved populations and could potentially be utilized by pharmaceutical companies for patient recruitment and follow-up in clinical trials. As new metabolic therapies enter the market, the ability to detect small, incremental changes in liver fat without the cost burden of repeated MRI scans becomes increasingly important. ENDRA’s innovative approach with TAEUS combines the precision traditionally associated with expensive imaging modalities with the practical deployment advantages of ultrasound-based systems.
