Strong Clinical Results for Breakthrough Liver Diagnostic Platform; ENDRA Life Sciences (N A S D A Q: NDRA) $NDRA
The Californer/10341021

ANN ARBOR, Mich. - Californer -- ENDRA Life Sciences Inc. (N A S D A Q: NDRA) is advancing a potentially transformative diagnostic technology aimed at addressing one of the fastest-growing global health challenges—Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

With MASLD now estimated to affect approximately 30% of adults worldwide, the demand for accurate, accessible, and affordable diagnostic tools has never been greater. ENDRA's proprietary Thermo Acoustic Enhanced UltraSound (TAEUS®) technology is being developed to fill that gap by delivering MRI-level measurement capabilities directly at the point of patient care, but at a fraction of the cost.

Recent clinical study results suggest the company's TAEUS® Liver device may offer the precision of expensive imaging modalities combined with the convenience and scalability of ultrasound systems, positioning the technology as a potential game-changer in liver disease detection and monitoring.

Favorable Clinical Study Results Demonstrate Strong Measurement Consistency

TAEUS® Liver Achieves "Good to Excellent" Reliability Metrics for Long-Term Disease Monitoring

On February 26, ENDRA reported encouraging data from a clinical study evaluating the measurement consistency of the TAEUS® Liver device, a key milestone for its development as a diagnostic tool for monitoring MASLD.

The study assessed the platform's performance in real-world clinical settings, examining both repeatability and reproducibility, two critical indicators for diagnostic reliability and regulatory acceptance.

Key findings from the study included:

• Intraclass Correlation Coefficient (ICC): 0.89
• Standard Error of Measurement (SEM): 3.3%

These metrics fall within the "good to excellent" performance range, demonstrating strong consistency across multiple operators and repeated scans.

The clinical trial involved 14 subjects and 56 independent measurements, with multiple operators performing scans to simulate real-world clinical workflows. The resulting data were analyzed using Gage Repeatability and Reproducibility (R&R) methodology, which determines how much variability stems from the measurement system itself versus actual biological differences among patients.

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The results indicate that the TAEUS® platform can deliver highly reliable liver fat measurements regardless of the clinician performing the scan.

A Massive Global Disease Market with Limited Diagnostic Tools

MASLD Impacts More Than Two Billion People Worldwide

Metabolic dysfunction-associated steatotic liver disease represents a massive and growing healthcare challenge.

Closely linked to obesity, diabetes, and metabolic syndrome, MASLD is estimated to affect over two billion people globally, making it one of the most prevalent chronic liver conditions in the world.

Despite its scale, diagnostic tools remain limited.

While MRI-PDFF imaging is considered the gold standard for measuring liver fat, the technology is expensive and not widely accessible for routine patient monitoring. This creates a significant barrier for clinicians seeking to track disease progression or treatment effectiveness.

ENDRA's TAEUS® platform is designed to solve this problem by providing MRI-quality liver fat quantification using ultrasound-based systems, enabling faster, lower-cost testing directly in clinical settings.

Addressing the Limitations of Traditional Ultrasound Imaging

TAEUS® Delivers Objective, Quantitative Measurements

Traditional ultrasound techniques are commonly used in liver assessments but suffer from high inter-observer variability and subjective interpretations, which can limit their effectiveness for precise disease monitoring.

ENDRA's TAEUS® technology is designed to overcome these limitations.

By combining thermoacoustic imaging physics with ultrasound systems, the platform provides quantitative measurement of tissue fat content, enabling clinicians to detect subtle changes in liver fat levels with greater consistency.

This capability is particularly important as new metabolic therapies emerge, where small, incremental improvements in liver fat levels may determine treatment effectiveness.

The ability to detect these changes without relying on repeated MRI scans could significantly improve both patient monitoring and healthcare cost efficiency.

Potential Applications Extend Across Clinical Practice and Drug Development

Pharmaceutical Companies May Utilize TAEUS® for Clinical Trials and Patient Monitoring

The potential applications of ENDRA's technology extend beyond routine clinical care.

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Pharmaceutical companies developing therapies for metabolic and liver diseases require reliable diagnostic tools to identify eligible patients, monitor treatment progress, and evaluate therapeutic outcomes during clinical trials.

TAEUS® could provide an attractive solution by offering frequent, affordable liver fat measurements that would otherwise require expensive MRI imaging.

This capability could make the platform valuable for:

• Patient recruitment for clinical trials
• Monitoring therapeutic effectiveness
• Long-term disease management in clinical practice

As new treatments for metabolic liver disease enter the market, the need for repeatable and cost-efficient diagnostic monitoring tools is expected to grow significantly.

ENDRA's Technology Strategy Combines Precision with Practical Deployment

MRI-Level Insights Delivered Through Ultrasound-Based Systems

ENDRA's approach centers on merging the precision of advanced imaging technologies with the accessibility of ultrasound platforms already widely used in healthcare facilities.

By integrating thermoacoustic technology into ultrasound systems, TAEUS® is designed to provide:

• Quantitative measurement of liver fat
• High repeatability across operators
• Cost-effective point-of-care deployment
• Improved accessibility for large patient populations

This combination could allow healthcare providers to expand screening, improve disease monitoring, and potentially detect liver disease earlier.

Positioned to Address a Large and Growing Global Market

With metabolic diseases rising globally, the demand for scalable diagnostic technologies is increasing rapidly.

ENDRA Life Sciences is positioning its TAEUS® platform to address a massive global population affected by liver disease, offering a diagnostic approach that aims to bridge the gap between high-cost imaging systems and widely accessible ultrasound devices.

If adoption continues to grow, TAEUS® could represent an important advancement in how clinicians identify, monitor, and manage chronic liver disease.

For more information, visit:
www.endrainc.com

Media Contact
ENDRA Life Sciences, Inc. (N A S D A Q: NDRA)
Yvonne Briggs – Investor Relations
investors@endrainc.com
ybriggs@allianceadvisors.com
(310) 691-7100
United States
Website: www.endrainc.com

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