ENDRA's TAEUS Liver Device Achieves MRI-Level Consistency in MASLD Clinical Study
核心洞察
ENDRA Life Sciences reported that its TAEUS Liver device (搜索) achieved an intraclass correlation coefficient of 0.89 with 3.3% standard error of measurement in a clinical study evaluating measurement consistency for metabolic dysfunction-associated steatotic liver disease (搜索).
The study involved 14 subjects with independent operators performing 56 unique measurements to assess the device's repeatability and reproducibility in real-world clinical conditions.
The results demonstrate the device's potential to deliver MRI-level liver fat quantification at point of care with significantly lower cost than traditional MRI-PDFF, addressing barriers for over two billion people affected by MASLD (搜索).
ENDRA Life Sciences has demonstrated that its TAEUS Liver device (搜索) can deliver MRI-level measurement consistency for liver fat quantification, potentially addressing a critical diagnostic gap for the more than two billion people worldwide affected by metabolic dysfunction-associated steatotic liver disease (搜索) (MASLD (搜索)).
The clinical study evaluated the measurement consistency of the TAEUS Liver device (搜索) across multiple operators and demonstrated robust intra-user repeatability and inter-user reproducibility. These factors are essential for the long-term monitoring of MASLD (搜索), which now affects approximately 30% of adults worldwide.
Clinical Study Design and Results
The study involved 14 subjects with independent operators performing several measurements each to assess the platform's performance in real-world clinical conditions. Researchers collected a total of 56 unique measurements 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.
The TAEUS Liver device (搜索) achieved an intraclass correlation coefficient (ICC) of 0.89 with a standard error of measurement (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.
Addressing Clinical and Economic Barriers
"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 (搜索)," 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."
The CEO emphasized that this addresses a critical need for clinicians and pharmaceutical companies that require a diagnostic tool to monitor treatment frequently and affordably.
Advantages Over Traditional Methods
The TAEUS system's performance 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 (搜索).
The device 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.
Technology and Clinical Applications
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. The company is pioneering Thermo Acoustic Enhanced UltraSound (TAEUS) technology, which is being developed to assess tissue fat content at the point of patient care.
TAEUS is focused on the measurement of fat in the liver as a means to assess and monitor steatotic liver disease (搜索) and metabolic dysfunction-associated steatohepatitis (搜索), chronic liver conditions that affect over two billion people globally, and for which there are no practical diagnostic tools.
In February 2024, ENDRA announced the installation of its first TAEUS liver system at London's King's College Hospital NHS Foundation Trust in the UK, marking an important milestone in the device's clinical deployment.