ENDRA Life Sciences Inc., pioneer in thermo-acoustic biomarker imaging, announced new results from its 2025 feasibility study of the TAEUS Liver device, demonstrating that its thermo-acoustic fat fraction measurement closely aligns with MRI-PDFF at critical liver fat fraction thresholds of 12-17 percent and 20-22 percent. These thresholds separate mild, moderate, and severe disease, which are important for making treatment decisions and for enrolling patients in clinical trials. The high accuracy of TAEUS at these points underscores its potential as a practical, low-cost tool for the growing MASLD, MASH, and obesity drug development markets.

Health Technology Insights: Hallmark Health Forms Executive Advisory Board

Alexander Tokman, CEO of ENDRA Life Sciences, explained that drug developers and payors require precise information on whether a patient meets thresholds that determine access to therapies, reimbursement eligibility, or trial participation. He emphasized that the new data show TAEUS tracks MRI-PDFF closely across the entire spectrum of steatotic liver disease, including the critical 12-22 percent range. He also noted that at the 8 percent threshold used for Rezdiffra reimbursement, TAEUS achieved a high positive predictive value, demonstrating reliability even at lower liver fat levels.

The feasibility study involved 40 subjects with body mass indices ranging from 21 to 47. ENDRA compared the TAEUS thermo-acoustic fat fraction test to MRI-PDFF at decision points that separate mild, moderate, and severe steatosis. In the 12-17 percent range corresponding to grade 1-2 steatosis, TAEUS achieved an average positive predictive value of 100 percent, a negative predictive value of 94 percent, and overall accuracy of 95 percent. In the 20-22 percent range corresponding to grade 2-3 steatosis, it achieved an average positive predictive value of 90 percent, a negative predictive value of 94 percent, and overall accuracy of 94 percent. These results indicate that TAEUS can reliably identify patients above treatment thresholds, which is crucial for trial enrollment and therapy escalation, while also ruling out patients who fall outside these thresholds.

Health Technology Insights: TestDynamics Launches Unified Medical Imaging AI System

The current landscape of MASLD, MASH, and obesity drug trials relies heavily on MRI-PDFF, a highly accurate but expensive imaging modality, often costing more than $2,500 per exam. This cost limits frequent monitoring and makes large-scale, long-term trials financially challenging. TAEUS offers a point-of-care alternative that is expected to cost under $200 per exam, representing less than eight percent of the cost of MRI-PDFF, and enables frequent, longitudinal monitoring to capture rapid drug-induced changes in liver fat fraction that would be impractical with MRI.

The feasibility study also highlighted several strategic opportunities for ENDRA. The device could be integrated into ongoing clinical trials as part of a hybrid imaging model, where TAEUS is used for frequent monitoring and MRI-PDFF is used for confirmation, significantly reducing imaging costs for pharmaceutical partners. TAEUS also provides a potential blueprint for multicenter studies focused on clinical decision thresholds, aligning with regulatory agency preferences. Finally, the device leverages existing global ultrasound infrastructure, supporting a capital-efficient, usage-based revenue model that could scale alongside the growing MASLD and MASH patient population and clinical trial volume.

Tokman noted that if TAEUS can replace even a portion of MRI-PDFF imaging in trials with comparable performance, the resulting cost savings for large pharmaceutical companies could be substantial. He added that the threshold-based data from the feasibility study are a pivotal step in demonstrating the device’s utility for real-world clinical and economic decision-making.

ENDRA is moving forward with a second feasibility study in London, Ontario, Canada, to validate the performance of TAEUS across multiple centers. The study is expected to be completed in the coming months. In 2026, ENDRA plans to engage with the FDA on the design, endpoints, and statistical plan for a pivotal study, seeking alignment prior to initiating a submission under the De Novo pathway.

The study results mark an important milestone for TAEUS as it continues to develop a cost-effective, scalable solution for liver fat quantification. By combining high accuracy with accessibility and frequent monitoring capabilities, TAEUS has the potential to transform MASLD and MASH drug development, making advanced imaging more practical for researchers, clinicians, and patients alike.

Health Technology Insights: IKS Health Appoints New Chief Marketing and Chief Legal and Compliance Officers

To participate in our interviews, please write to our HealthTech Media Room at info@intentamplify.com