ENDRA Life Sciences Submits De Novo Request for its TAEUS® System Liver Fat Application to the U.S. FDA
Announces Positive Topline Data from Clinical Studies Comparing TAEUS with MRI-PDFF
ANN ARBOR, Mich.--(BUSINESS WIRE)-- ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces the submission of a De Novo request to the U.S. Food and Drug Administration (FDA) for the 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.”
ENDRA management will discuss this De Novo submission and provide a general business update during the company’s previously scheduled second quarter financial results conference call, being held today at 4:30 p.m. Eastern time.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology being developed to visualize tissue like MRI, but at 1/50th the cost and at the point of patient care. TAEUS® is designed to work in concert with over 500,000 ultrasound systems in use globally today. TAEUS® is initially focused on the measurement of fat in the liver as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and inflammation (NASH), chronic liver conditions that affect over one billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS®, including visualization of tissue temperature during energy-based surgical procedures. For more information, please visit www.endrainc.com.
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Source: ENDRA Life Sciences Inc.