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

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.

Forward-Looking Statements

All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements—based on certain assumptions and describing our future plans, strategies, and expectations—can generally be identified by the use of terms such as "approximate," "anticipate," "attempt," "believe," "could," "estimate," "expect," "forecast," "future," "goal," "hope," "intend," "may," "plan," "possible," "potential," "project," "seek," "should," "will," "would," or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are express differently. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement.

Applicable risks and uncertainties include, among others: expectations regarding our treasury strategy and our ability to execute it successfully; our limited commercial experience, limited cash resources, and history of losses; our ability to obtain adequate financing to fund operations in the future; risks related to shifts in regulatory, accounting, or tax treatment affecting our treasury activities; the potential impact of any changes in financial reporting requirements; the risk that our stock price may be affected by the performance or valuation of assets held in our treasury; a determination that we are an investment company under the Investment Company Act of 1940; our ability to achieve profitability; delays or changes in regulatory requirements, policies, or guidelines; potential delays in submitting required regulatory applications or other submissions to, or receiving approvals from, the U.S. Food and Drug Administration ("FDA") or other regulatory agencies; our ability to obtain and maintain required CE mark certifications and secured required FDA and other governmental approvals for our Thermo Acoustic Enhanced Ultrasound ("TAEUS^®") applications; our ability to develop commercially viable products based on our TAEUS^® technology; market acceptance of our technology; the effect of macroeconomic conditions on our business; results of studies, which may be negative or inconclusive; our ability to secure and maintain development partners; reliance on third parties, collaborations, strategic alliances, and licensing arrangements; the competitive landscape in the healthcare industry; our ability to protect our intellectual property; changes in healthcare industry practices or reimbursement policies; our ability to comply with regulations from federal, state, local, and foreign governmental agencies; our ability to maintain compliance with Nasdaq listing standards; our dependence on key members of management; and other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the Company's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.

You should not rely on forward-looking statements as predictions of future events. Forward-looking statements in this press release speak only as of the date of issuance, and ENDRA assumes no obligation to update such statements to reflect actual results or changes in expectations, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251204350283/en/

Company Contact:

Investor Relations

investors@endrainc.com

www.endrainc.com

Investor Relations Contact:

Yvonne Briggs

Alliance Advisors IR

(310) 691-7100

ybriggs@allianceadvisors.com

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

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