$NDRA ENDRA’s TAEUS® Liver Device Demonstrates High-Level Consistency in Clinical Study, Delivering MRI-Level Results at the Point of Patient Care
https://www.businesswire.com/news/home/202602...tient-Care
Achieved Intraclass Correlation Coefficient (ICC) of 0.89 with standard error of measurement (SEM) of 3.3% using independent operators
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 favorable results from a clinical study evaluating the measurement consistency of its TAEUS® Liver device. The study demonstrated the device’s robust intra-user repeatability and inter-user reproducibility, essential factors for long-term monitoring of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which now affects approximately 30% of adults worldwide.
The study involved 14 subjects with independent operators performing several measurements each to assess the platform's performance in real-world clinical conditions. A total of 56 unique measurements were tabulated to generate comprehensive Gage Repeatability and Reproducibility (R&R) results. This methodology quantifies how much observed measurement variability comes from the measurement system itself rather than true patient-to-patient differences, a critical factor for regulatory validation and clinical decision-making around diagnostic and treatment thresholds.
TAEUS Liver achieved an ICC of 0.89 with an SEM of 3.3%, which is considered in the "Good to Excellent" performance range. These results demonstrate the device’s high reliability regardless of the clinician performing the scan and consistent repeatability when a single user performs back-to-back measurements.
"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," stated 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 TAEUS system's performance also contrasts sharply with traditional ultrasound techniques, which suffer from high inter-observer variability and subjective interpretations. These study results support TAEUS’s objective to deliver a standardized, accurate and repeatable liver fat test for the growing population affected by MASLD. TAEUS 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 seamlessly combines the precision traditionally associated with expensive imaging modalities with the practical deployment advantages of ultrasound-based systems.
https://www.businesswire.com/news/home/202602...tient-Care
Achieved Intraclass Correlation Coefficient (ICC) of 0.89 with standard error of measurement (SEM) of 3.3% using independent operators
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 favorable results from a clinical study evaluating the measurement consistency of its TAEUS® Liver device. The study demonstrated the device’s robust intra-user repeatability and inter-user reproducibility, essential factors for long-term monitoring of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which now affects approximately 30% of adults worldwide.
The study involved 14 subjects with independent operators performing several measurements each to assess the platform's performance in real-world clinical conditions. A total of 56 unique measurements were tabulated to generate comprehensive Gage Repeatability and Reproducibility (R&R) results. This methodology quantifies how much observed measurement variability comes from the measurement system itself rather than true patient-to-patient differences, a critical factor for regulatory validation and clinical decision-making around diagnostic and treatment thresholds.
TAEUS Liver achieved an ICC of 0.89 with an SEM of 3.3%, which is considered in the "Good to Excellent" performance range. These results demonstrate the device’s high reliability regardless of the clinician performing the scan and consistent repeatability when a single user performs back-to-back measurements.
"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," stated 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 TAEUS system's performance also contrasts sharply with traditional ultrasound techniques, which suffer from high inter-observer variability and subjective interpretations. These study results support TAEUS’s objective to deliver a standardized, accurate and repeatable liver fat test for the growing population affected by MASLD. TAEUS 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 seamlessly combines the precision traditionally associated with expensive imaging modalities with the practical deployment advantages of ultrasound-based systems.
