Results confirm accurate and consistent liver steatosis assessment performance across operators, geographies and patient populations, supporting planned regulatory pathway
ANN ARBOR, Mich.--(BUSINESS WIRE)--$NDRA #MASLD--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 multi-site clinical validation results for TAEUS® Liver that demonstrate strong concordance with MRI-PDFF, high reproducibility and consistent performance across clinical sites.
The analysis combined data from 64 patients in the U.S. and Canada, including an external validation site in London, Ontario, across independent operators and patient populations. TAEUS Liver’s thermoacoustic fat fraction measurement closely tracked MRI‑PDFF results for patients along the full spectrum of metabolic dysfunction‑associated steatotic liver disease (MASLD) and those with elevated body mass index (BMI).
Key results in the analysis included:
- Correlation to MRI-PDFF: r=0.90 (combined cohort)
- Diagnostic accuracy: AUROC 0.95–0.99 at key thresholds
- Mean error: ~3%, consistent across sites
- Reproducibility: ICC=0.89 across operators
- ~90% of measurements within ~5% of MRI values
- No dependence on BMI or body habitus
“The multi‑site data aggregation shows that TAEUS Liver delivers MRI‑like liver fat quantification at the point of patient care, with a strong correlation to MRI‑PDFF of 0.90 and no meaningful bias. We believe the combination of this performance coupled with TAEUS Liver’s portability and low cost could make routine liver fat assessment feasible for the more than two billion people worldwide living with MASLD,” said Alexander Tokman, Chief Executive Officer of ENDRA Life Sciences.
TAEUS Liver is designed to provide MRI‑aligned performance in a portable, point‑of‑care format with an anticipated per‑scan cost of under $200, which is less than 8% of a typical MRI‑PDFF exam. By enabling frequent, affordable assessments, TAEUS Liver could support routine monitoring of treatment‑driven changes in liver fat that are difficult to track with MRI alone. The TAEUS system's performance contrasts sharply with ultrasound techniques, which experience high inter-observer variability and subjective interpretations.
These study results support TAEUS Liver’s objective to deliver a standardized, accurate and repeatable liver fat test for the growing population affected by MASLD. TAEUS Liver 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 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.
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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; our ability to regain and maintain compliance with Nasdaq listing standards; 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; 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; 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.
Contacts
Company Contact:
Investor Relations
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
Alliance Advisors IR
(310) 691-7100
ybriggs@allianceadvisors.com
