Investing.com -- ENDRA Life Sciences (NASDAQ:NDRA) stock fell 10% after the company announced new results from its 2025 TAEUS Liver device feasibility study showing the device’s thermo-acoustic fat fraction measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction thresholds.
The study demonstrated that ENDRA’s TAEUS device performed with high accuracy at liver fat fraction thresholds of 12-17% and 20-22%, which separate mild, moderate, and severe steatotic liver disease. At the 12-17% range, the device showed an average positive predictive value (PPV) of 100%, negative predictive value (NPV) of 94%, and accuracy of 95%. For the 20-22% range, it delivered a PPV of 90%, NPV of 94%, and accuracy of 94%.
ENDRA is positioning the TAEUS device as a low-cost alternative to MRI-PDFF for patient stratification and monitoring in clinical trials. While an MRI-PDFF exam can cost over $2,500, ENDRA anticipates its solution will cost less than $200, potentially reducing imaging costs in drug development for metabolic dysfunction-associated steatotic liver disease (MASLD) and obesity.
"Drug developers and payors need to know if a patient is above or below the specific thresholds that trigger costly therapies, reimbursement of those therapies or trial enrollment," said Alexander Tokman, CEO of ENDRA Life Sciences.
The company has begun a second feasibility study in London, Ontario to further validate performance beyond a single center, with completion expected in the coming months. ENDRA plans to engage with the FDA in 2026 regarding pivotal study design in support of a future De Novo submission.
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