ENDRA Files De Novo Request to FDA for TAEUS System Liver Fat Application

ENDRA Life Sciences Inc. has filed a De Novo request to the US Food and Drug Administration (FDA) for its TAEUS system. The TAEUS system is ENDRA’s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD).

The submission included patient scans from established clinical study sites comparing TAEUS liver fat fraction estimates to MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is the gold standard for clinical measurement of liver fat fraction. The study data yielded a sensitivity of 90%. TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.78.

“The submission of the De Novo request for our TAEUS system is a significant milestone for ENDRA as it includes additional confirmatory data from our current clinical study sites that are consistent with the results from our initial human feasibility study. We are thrilled to file this request and believe the De Novo process holds potential to set the bar for an entirely new product classification by showcasing TAEUS’ capabilities as being novel and powerful,” stated ENDRA's Chairman and Chief Executive Officer Francois Michelon. "We believe our submission is robust and we look forward to working with the FDA as they proceed with their review. TAEUS has the potential to fulfill an unmet need as a non-invasive, point-of-care tool for the assessment of fatty liver disease, which affects more than one billion people globally, and to do so at one-50th the cost of an MRI.”