ENDRA's TAEUS® Liver Device Demonstrates High-Level Consistency in Clinical Study, Delivering MRI-Level Results at the Point of Patient Care
Achieved Intraclass Correlation Coefficient (ICC) of 0.89 with standard error of measurement (SEM) of 3.3% using independent operators
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.
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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.
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