ENDRA’s TAEUS® Liver Device Demonstrates High-Level Consistency in Clinical Study, Delivering MRI-Level Results at the Point of Patient Care

Key Terms

intraclass correlation coefficient technical

A statistical measure of how consistently different measurements or raters agree when assessing the same thing; it tells you whether repeated tests or observers produce similar results rather than random or widely varying outcomes. For investors, a high value means reported data — such as lab readings, clinical endpoint assessments, or credit ratings — are dependable and can be trusted for decision-making, while a low value warns that apparent effects or comparisons may reflect measurement noise, not real differences.

standard error of measurement technical

Standard error of measurement quantifies how much a reported number could randomly differ from the true value because of imperfect measurement, like how a bathroom scale sometimes shows slightly different weights. For investors it signals how much trust to place in reported figures—higher values mean wider uncertainty around metrics such as survey results, credit scores or model outputs, so decisions and risk estimates should allow for that possible variation.

gage repeatability and reproducibility technical

Gage repeatability and reproducibility (GR&R) is a short study that measures how much of the variation in a measurement system comes from the device itself and from different operators using it. Think of checking the same ruler and having different people or repeated readings give slightly different lengths; GR&R quantifies those differences so managers can tell whether measurements are reliable. For investors, a low GR&R means product testing and quality control are dependable, reducing the risk of costly defects, recalls, regulatory problems, or unpredictable production yields.

mri-pdff medical

MRI-PDFF (Magnetic Resonance Imaging-Proton Density Fat Fraction) is a medical imaging technique that measures the amount of fat within the liver or other tissues. For investors, it provides a precise way to assess health risks related to fat buildup, which can impact healthcare costs and the valuation of related companies. Its accuracy helps in monitoring treatment progress and predicting potential medical expenses, making it relevant for healthcare decision-making and investment considerations.

metabolic dysfunction-associated steatotic liver disease medical

A common chronic liver condition marked by excess fat in the liver linked to metabolic problems like obesity, diabetes, or high blood pressure; it ranges from harmless fat buildup to inflammation and scarring. Investors care because its high and growing prevalence drives demand for diagnostics, monitoring tools, drugs, and related healthcare services—think of it like a market need created by a widespread health problem that fuels product and treatment opportunities.

steatotic liver disease medical

Steatotic liver disease is a condition where excess fat builds up in the liver, like a filter becoming clogged with grease, which can impair the organ’s normal functions. It matters to investors because rising prevalence can drive demand for drugs, diagnostics and medical services, raise healthcare and insurance costs, and affect workforce productivity and regulatory scrutiny—factors that influence valuations and revenues across healthcare and related industries.

Achieved Intraclass Correlation Coefficient (ICC) of 0.89 with standard error of measurement (SEM) of 3.3% using independent operators

ANN ARBOR, Mich.--(BUSINESS WIRE)-- ENDRA Life Sciences Inc. (NASDAQ: NDRA) (“ENDRA” or the “Company”), a pioneer in thermoacoustic biomarker imaging for the early detection and monitoring of steatotic liver disease (SLD), today announced favorable results from a clinical study evaluating the measurement consistency of its TAEUS^® Liver device. The study demonstrated the device’s robust intra-user repeatability and inter-user reproducibility, essential factors for long-term monitoring of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which now affects approximately 30% of adults worldwide.

The study involved 14 subjects with independent operators performing several measurements each to assess the platform's performance in real-world clinical conditions. A total of 56 unique measurements were tabulated 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.

TAEUS Liver achieved an ICC of 0.89 with an 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.

"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," 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. This addresses a critical need for clinicians and pharmaceutical companies that require a diagnostic tool to monitor treatment frequently and affordably."

The TAEUS system's performance also 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. TAEUS 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. 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.

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

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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; the repeatability of clinical results across larger trial populations; 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.

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Company Contact:

Investor Relations

investors@endrainc.com

www.endrainc.com

Investor Relations Contact:

Yvonne Briggs

Alliance Advisors IR

(310) 691-7100

ybriggs@allianceadvisors.com

Source: ENDRA Life Sciences Inc.