ANN ARBOR, Mich. – December 4, 2025 — ENDRA Life Sciences has released compelling new feasibility data showing that its TAEUS® Liver diagnostic device closely matches the performance of MRI-PDFF, the clinical gold standard for liver fat quantification, at the key thresholds used to diagnose and stratify steatotic liver disease (SLD), MASLD, and MASH. These findings position TAEUS® as a scalable, point-of-care alternative capable of transforming patient selection and monitoring for the rapidly expanding metabolic liver disease therapeutic market.
Science Significance
In a 40-subject feasibility study, TAEUS’ thermo-acoustic fat fraction (TAFF) measurement demonstrated 95% accuracy in the 12–17% liver fat fraction (LFF) range and 94% accuracy in the 20–22% range, aligning with the MRI-PDFF thresholds that separate mild, moderate, and severe steatosis. This scientific validation highlights the device’s ability to provide non-invasive, repeatable, and quantitative liver fat analysis at a fraction of MRI’s cost. The technology’s ability to detect treatment-relevant thresholds supports its use in tracking rapid metabolic changes, particularly for emerging GLP-1 class therapies and MASH interventions.
Regulatory Significance
The feasibility data offer a clear framework for regulatory progression. ENDRA is preparing for a 2026 FDA engagement to discuss pivotal trial design, statistical endpoints, and validation requirements for a De Novo submission. Regulators have increasingly emphasized threshold-aligned performance data, and TAEUS’ strong predictive values across clinical decision points support its potential path to first-in-class clearance as an affordable liver diagnostics tool. Parallel validation in Canada will further strengthen the regulatory evidence base by providing multi-site reproducibility data.
Business Significance
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With more than 50 active MASLD/MASH trials and 250+ GLP-1 trials worldwide, MRI-PDFF remains a critical but cost-prohibitive tool, often exceeding $2,500 per scan. ENDRA’s TAEUS device, expected to cost under $200 per assessment, offers a disruptive economic advantage for pharmaceutical sponsors, CROs, and trial networks. The data unlock several commercial pathways: Pharma partnerships using hybrid imaging strategies (TAEUS for frequent monitoring, MRI for confirmation). A usage-based revenue model, leveraging existing ultrasound infrastructures globally. Expansion into trial imaging cost-reduction strategies for GLP-1 and metabolic drug developers facing unprecedented enrollment volumes. These cost efficiencies could save large trial sponsors millions per phase, accelerating TAEUS adoption in the drug development ecosystem.
Patients’ Significance
SLD and MASH affect more than two billion people globally, yet diagnosis remains limited by access to MRI and the impracticality of frequent imaging. TAEUS offers patients a fast, affordable, non-invasive, and widely deployable method for assessing liver fat at the point of care. Improved monitoring can enhance early detection, optimize therapeutic decision-making, enable faster adjustments to treatment, and reduce dependence on invasive biopsies. The capacity for frequent longitudinal monitoring—critical in metabolic diseases with rapid response curves—represents a major step toward equitable liver disease management.
Policy Significance
Healthcare systems worldwide are grappling with escalating costs associated with metabolic diseases. Tools like TAEUS support value-based care models, enabling payors to enforce evidence-based reimbursement thresholds, such as the 8% LFF criterion used in the U.S. for GLP-1 reimbursement. By providing accurate, low-cost assessments, TAEUS could influence coverage policies, clinical guidelines, and population-level screening programs aimed at reducing the long-term burden of liver disease. Its alignment with regulatory preferences for quantitative biomarkers further positions it as a pivotal instrument in future policy frameworks.
ENDRA’s new feasibility data represent a significant milestone in the evolution of liver diagnostics, demonstrating that point-of-care imaging can match MRI’s accuracy at a fraction of the cost. As the company advances toward regulatory engagement and broader clinical validation, TAEUS stands poised to reshape liver disease research, improve patient access to essential monitoring, and reduce the economic strain of metabolic disorders. With its strong scientific foundation and clear commercial relevance, TAEUS® is emerging as a transformative technology for the global MASLD/MASH diagnostic and therapeutic landscape.
Source: ENDRA Life Sciences Inc. press release
