TAEUS Liver demonstrates strong agreement with the industry's imaging gold standard, MRI‑PDFF, across the full spectrum of steatotic liver disease and patient BMI

ENDRA Life Sciences Inc. (NASDAQ:NDRA) ("ENDRA" or the "Company"), a pioneer in biomarker imaging technologies for the early detection and monitoring of metabolic dysfunction-associated liver disease ("MASLD") and metabolic dysfunction-associated steatohepatitis ("MASH"), today announces encouraging preliminary results from a single-site clinical feasibility study evaluating its improved TAEUS Liver device for quantifying liver fat fraction, which is a key biomarker of steatotic liver disease ("SLD").

The preliminary study results indicate the ability of the TAEUS Liver test to accurately quantify liver fat across the full SLD spectrum, with predictive values closely aligned with the imaging gold standard of MRI‑PDFF, a non-invasive imaging technique that uses MRI to quantify the amount of fat in a tissue. These findings strongly support TAEUS's potential as an accurate, non‑invasive and cost-effective point‑of‑care solution that could address the limitations of existing solutions.

"These preliminary results provide compelling evidence that our 2025 optimized TAEUS platform can deliver high accuracy in liver fat measurement while eliminating the cost and accessibility barriers associated with current diagnostic options," said Alexander Tokman, CEO of ENDRA Life Sciences. "This combination could transform screening and longitudinal monitoring in clinical care and drug development, and positions TAEUS as a potentially transformative solution for millions of patients and for the pharmaceutical industry's evolving monitoring needs."

The feasibility study was designed to validate the device's improved performance and de‑risk the design and statistical plan leading to the U.S. Food and Drug Administration ("FDA") pivotal study. Results will be discussed with the FDA in pre‑submission meetings prior to initiating the pivotal study and also will be submitted for publication in a peer-reviewed medical journal.

Study Overview

TAEUS biomarker: Thermoacoustic Fat Fraction (TAFF)
Comparator: Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI‑PDFF), the recognized imaging gold standard for liver fat quantification
Participants: 40 subjects with BMI ranging from 21 to 47; full SLD spectrum of healthy to severe
Analyses: Deming regression, Bland-Altman error plot and Pearson correlation

Clinical and Market Context

Large unmet need: More than 2 billion people worldwide including over 100 million in the U.S. are affected by SLD.
Evolving guidance: Professional societies including AASLD, EASL, the American Diabetes Association and the American Association of Clinical Endocrinology emphasize early screening and ongoing monitoring for SLD.
Robust therapeutics pipeline: 50+ GLP‑1 and other agents in Phase 2 and Phase 3 trials for obesity, type 2 diabetes and MASLD/MASH require accurate, repeatable liver fat quantification for patient selection and monitoring.
Cost/access gap: MRI‑PDFF typically costs over $2,500 per exam and is generally not reimbursed, limiting frequent assessments across 6 to 18 month studies even as some GLP‑1s show liver fat changes in less than eight weeks.
Point‑of‑care opportunity: As a portable, low‑cost modality, TAEUS aims to deliver MRI‑PDFF-like performance at the point of patient care to enable practical, frequent monitoring.

Key Findings

Strong agreement with MRI‑PDFF across the full SLD spectrum: Deming regression showed TAFF with a slope of 1 and an intercept of 0, both within the 95% confidence intervals relative to MRI‑PDFF. Pearson correlation coefficient r=0.89. Deming regression is commonly referenced by the FDA when evaluating new diagnostic technologies. Together, the Deming and Pearson results demonstrate strong statistical agreement with the recognized imaging gold standard.

Consistent accuracy across BMI and disease severity: The Bland-Altman analysis showed >90% of subjects fall within a 5% error margin versus MRI‑PDFF, with an average error of ~3%. The observed error is small and remained consistent across both the BMI range and fatty liver disease stages, contrasting with many ultrasound‑based fat estimation methods where error typically increases in higher‑BMI patients.

"From a clinical perspective, these results look very promising," said Jonathan M. Rubin, M.D., Professor Emeritus of Radiology, University of Michigan Medical School. "The strong agreement with MRI‑PDFF and consistency across the BMI spectrum suggest that TAEUS could help overcome limitations of conventional ultrasound‑based approaches, where error often increases in higher‑BMI patients."

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 this year 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: preliminary results of our feasibility study not being predictive or indicative of final results; 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.

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Company Contact:

Investor Relations

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www.endrainc.com

Investor Relations Contact:

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ENDRA Feasibility Study Demonstrates TAEUS® Accurately Quantifies Liver Fat Fraction, a Key MASLD/MASH Biomarker