NDRA’s TAEUS Liver Device Matches MRI Accuracy at Key Fat Thresholds—Potential Game-Changer for Clinical Trials

Clinical-Grade Performance for Liver Disease Monitoring

ENDRA Life Sciences (NASDAQ: NDRA) has unveiled results from a new feasibility study showing that its TAEUS Liver device closely matches the industry-standard MRI-PDFF for assessing liver fat at crucial thresholds used in managing steatotic liver disease (SLD). This performance comes at a fraction of the cost of traditional MRI, positioning TAEUS as an accessible option for frequent, point-of-care use.

Key Accuracy Metrics Reinforce Potential in MASLD/MASH Trials

At clinical decision points—where therapy initiation, reimbursement, and clinical trial inclusion are determined—TAEUS demonstrated remarkable accuracy compared to MRI-PDFF. The device excelled in identifying mild to severe steatosis at both the 12-17% and 20-22% liver fat fraction (LFF) ranges. The study involved 40 subjects with BMI between 21 and 47, reflecting real-world clinical diversity.

The Positive Predictive Value (PPV) demonstrates the device’s reliability in confirming when patients are above treatment thresholds—crucial for both clinical care and drug trial inclusion. High Negative Predictive Value (NPV) supports the use of TAEUS to exclude patients who do not meet criteria for intervention, while the overall accuracy underscores the tool’s ability to mimic MRI results for broader screening and monitoring purposes.

Cost Advantages Poised to Disrupt Clinical Imaging

MRI-PDFF, while effective, remains a financial hurdle, often costing upwards of $2,500 per exam and limiting routine use in large-scale or longitudinal studies. TAEUS is projected to offer similar diagnostic accuracy for under $200—making it over 90% less expensive and dramatically increasing the feasibility of repeated, real-time liver assessments in both patient care and drug development environments.

Broader Implications: Pharma, Regulators, and Scale

These new data may unlock several key growth avenues for ENDRA. For pharmaceutical developers, the TAEUS device opens the door to more frequent patient assessments during MASLD/MASH and GLP-1 drug trials—reducing both timelines and costs. A hybrid approach (TAEUS for ongoing checks, MRI-PDFF for validation) could further lower budgets for the 50+ MASLD/MASH and 250+ GLP-1 trials underway.

The regulatory outlook is also brightened by this study. The findings provide a framework for multicenter, threshold-focused trials—meeting the preferences of agencies like the FDA, which ENDRA plans to engage in 2026 for pivotal study design and approval pathway discussions.

Next Steps: Validation and Market Positioning

A follow-up feasibility study is already in progress in London, Ontario, Canada to confirm results across additional clinical sites. Completion is expected in the coming months, after which the company plans to map out its pivotal clinical strategy with regulatory bodies.

Bottom Line: A Step Toward Democratizing Liver Fat Measurement

By delivering gold-standard accuracy at a much lower cost and with far greater flexibility than MRI, TAEUS could become the backbone of patient monitoring and clinical research in steatotic liver disease. With more than two billion people worldwide at risk, and a rapidly growing landscape of clinical trials and emerging therapies, ENDRA’s latest results put the company on a clear path toward broader clinical and commercial adoption.

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