TAEUS Liver System De Novo Submission Advances at US FDA
ENDRA Life Sciences Inc. announced that the Company's De Novo request for the Thermo Acoustic Enhanced UltraSound (TAEUS) liver system has advanced to substantive review with the US Food and Drug Administration (FDA). 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).
“We are very pleased that our FDA De Novo submission has advanced to the substantive review stage," stated ENDRA's Chairman and Chief Executive Officer Francois Michelon. "ENDRA is committed to bringing the TAEUS technology to the U.S market to help clinicians combat the global epidemic of fatty liver disease, which affects over one billion people globally. We look forward to supporting the FDA as they continue their review."
TAEUS is a technology being developed to visualize tissue like MRI, but at a significantly lower cost and at the point of patient care. The solution 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 Steatotic Liver Disease (SLD) (formerly known as NAFLD-NASH), a chronic liver spectrum that affects over one billion people globally.
On August 14, 2023, ENDRA submitted a De Novo request to the FDA using the electronic Submission Template And Resource (eSTAR) system. On August 29, 2023, FDA informed ENDRA that the Company's submission was entering the substantive review period. The FDA's goal is to make a decision about a De Novo request in 150 review days.
The De Novo pathway provides a way to classify novel medical devices for which there is no legally marketed predicate device and if granted, will strengthen TAEUS’ competitive position with its distinctive, patent-protected capabilities as a non-invasive point-of-care tool to aid in the characterization of NAFLD.