ENDRA’s TAEUS® Liver Matches MRI-PDFF Performance at Key Clinical Thresholds, Positioning Device for MASLD/MASH Trial Use

Feasibility study data at 12-22% liver fat cutoffs validate TAEUS as a potential low-cost, point-of-care alternative to MRI-PDFF for patient stratification and trial monitoring

ANN ARBOR, Mich.--(BUSINESS WIRE)--ENDRA Life Sciences Inc. (NASDAQ: NDRA) (“ENDRA” or the “Company”), a pioneer in thermo-acoustic biomarker imaging for early detection and monitoring of steatotic liver disease (SLD), today announced new results from its 2025 TAEUS Liver device feasibility study demonstrating that TAEUS’ thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction (LFF) thresholds of 12-17% and 20-22%.

These thresholds separate mild, moderate and severe disease, are widely used to make clinical therapy decisions in routine practice and are important for enrolling patients in clinical trials. The high accuracy of TAEUS at these specific points strengthens its potential as a practical, low-cost tool for the booming MASLD/MASH and obesity drug development landscape.

“Drug developers and payors need to know if a patient is above or below the specific thresholds that trigger costly therapies, reimbursement of those therapies or trial enrollment,” said Alexander Tokman, CEO of ENDRA Life Sciences. “Our data show TAEUS tracks MRI-PDFF closely across the full SLD spectrum, including the critical 12-22% range. Additionally, at the 8% LFF threshold used for Rezdiffra^™ reimbursement determination, TAEUS delivered a high PPV as well.”

In the recently completed feasibility study of 40 subjects with BMI ranging from 21 to 47, ENDRA evaluated the performance of its TAFF biomarker test against MRI-PDFF at decision thresholds that segment patients from mild to moderate-to-severe steatosis.

TAEUS Key Performance Data vs. MRI-PDFF

• 12-17% LFF Range (Grade 1-2 Steatosis): Average PPV 100.0%, NPV 94%, Accuracy 95%
• 20-22% LFF Range (Grade 2-3 Steatosis): Average PPV 90.0%, NPV 94%, Accuracy 94%

The high Positive Predictive Value (PPV) demonstrates TAEUS’ potential to reliably identify patients above treatment thresholds, which is essential for trial inclusion and therapy escalation, while the high Negative Predictive Value (NPV) supports its use to rule out patients who fall outside of these thresholds. Accuracy reflects how well a diagnostic test correctly identifies the presence or absence of a disease compared to a gold standard for all subjects.

Addressing a Major Cost in Drug Development

With 50+ MASLD/MASH and 250+ GLP-1 trials ongoing, MRI-PDFF is a standard, but costly tool for screening and monitoring, with exams often exceeding $2,500 each. This high-cost limits frequent monitoring and makes large, long-term trials prohibitively expensive.

TAEUS is designed to disrupt this model and make liver fat quantification far more accessible by offering a point-of-care imaging solution at an anticipated cost of less than $200 (or less than 8% the cost of an MRI-PDFF exam) and the ability to perform frequent, longitudinal monitoring (e.g., every 8 weeks) to capture rapid drug-induced changes in LFF, which is impractical with MRI.

Unlocking Strategic Value

The feasibility study results de-risk several potential value-creating pathways for ENDRA:

• Pharma Partnerships: Enable pilot integrations in ongoing trials, potentially using a hybrid model (e.g., TAEUS for frequent checks, MRI-PDFF for confirmation) to drastically reduce imaging costs.
• Regulatory Path: Provide a blueprint for multicenter studies focused on clinical decision thresholds, aligning with regulatory agency preferences.
• Scalable Model: Leverage existing global ultrasound infrastructure for a capital-efficient, usage-based revenue model tied to the growing MASLD/MASH population and clinical trials volume.

“If TAEUS can shift even a fraction of trial imaging from MRI-PDFF to a point-of-care modality with comparable performance, the cost savings to large pharma on a per-trial basis could be significant. We are focused on opportunities where modest investments in additional clinical and technical work can unlock disproportionate commercial and partnering leverage,” concluded Mr. Tokman. “These threshold-based data are a pivotal step in demonstrating TAEUS's utility in real-world clinical and economic decision-making.”

Next Steps

• Ongoing validation: A second feasibility study has begun in London, Ontario, Canada to further validate performance and generalize results beyond a single center, with completion expected in the coming months.
• Regulatory pathway: ENDRA plans to engage the FDA in 2026 on the pivotal study design, endpoints and statistical plan, seeking alignment prior to study initiation in support of a subsequent De Novo submission.

About ENDRA Life Sciences Inc.

ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS^®), a ground-breaking technology being developed to assess tissue fat content and monitor tissue ablation during minimally invasive procedures, 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 and metabolic dysfunction-associated steatohepatitis, chronic liver conditions that affect over two billion people globally, and for which there are no practical diagnostic tools. Our press releases and financial and other material information are routinely posted to and accessible on the Investors section of our website, www.endrainc.com.

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