November 20, 2025 — Leads & Copy — ENDRA Life Sciences Inc. (NASDAQ: NDRA) has announced encouraging preliminary results from a clinical feasibility study of its improved TAEUS Liver device, which measures liver fat fraction, a key biomarker of steatotic liver disease (SLD).
The study, conducted at a single site, suggests the TAEUS Liver test can accurately quantify liver fat across the full SLD spectrum. Predictive values closely aligned with MRI‑PDFF, the imaging gold standard, which is a non-invasive MRI technique that quantifies tissue fat.
Alexander Tokman, CEO of ENDRA Life Sciences, stated that these results provide compelling evidence that the optimized 2025 TAEUS platform can deliver high accuracy in liver fat measurement, removing cost and accessibility barriers of current diagnostic options.
This could transform screening and monitoring in clinical care and drug development, positioning TAEUS as a potentially transformative solution for millions of patients and the pharmaceutical industry’s evolving monitoring needs, Tokman said.
The feasibility study was designed to validate the device’s performance and inform the design and statistical plan for the U.S. Food and Drug Administration (“FDA”) pivotal study. ENDRA plans to discuss the results with the FDA in pre‑submission meetings before initiating the pivotal study, and submit them for publication in a peer-reviewed medical journal.
The study included 40 participants with body mass indexes (BMI) ranging from 21 to 47, representing the full SLD spectrum. Thermoacoustic Fat Fraction (TAFF) was used as the TAEUS biomarker, compared against Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI‑PDFF), the recognized imaging gold standard for liver fat quantification. Deming regression, Bland-Altman error plot and Pearson correlation were performed in the analyses.
More than 2 billion people worldwide, including over 100 million in the U.S., are affected by SLD. Organizations including AASLD, EASL, the American Diabetes Association and the American Association of Clinical Endocrinology emphasize early screening and monitoring for SLD.
More than 50 GLP‑1 and other agents are in Phase 2 and Phase 3 trials for obesity, type 2 diabetes and MASLD/MASH, and require accurate, repeatable liver fat quantification for patient selection and monitoring. MRI‑PDFF typically costs over $2,500 per exam and is 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.
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 include strong agreement with MRI‑PDFF across the full SLD spectrum, where Deming regression showed TAFF with a slope of 1 and an intercept of 0, both within the 95% confidence intervals relative to MRI‑PDFF. The Pearson correlation coefficient was r=0.89. Consistent accuracy across BMI and disease severity was also observed, as the Bland-Altman analysis showed >90% of subjects fall within a 5% error margin versus MRI‑PDFF, with an average error of ~3%.
Jonathan M. Rubin, M.D., Professor Emeritus of Radiology, University of Michigan Medical School, said the results look promising, and that 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.
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. 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.
ENDRA Life Sciences Inc. is the pioneer of Thermo Acoustic Enhanced UltraSound (“TAEUS®”), a 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.
Contact: Yvonne Briggs, Investor Relations, 646-480-0374, ENDRA@lhai.com
Source: ENDRA Life Sciences Inc.
