ENDRA Life Sciences Plans to Submit De Novo Request to U.S. FDA for its TAEUS System in Coming Weeks

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS), announces an update to its plan to submit a De Novo request for the TAEUS system to the U.S. Food and Drug Administration (FDA).

“I’m pleased to announce that preparation of the De Novo documentation by the end of the third quarter is substantially complete,” said ENDRA's Chairman and Chief Executive Officer Francois Michelon. “Our remaining efforts are focused on the TAEUS and MRI confirmatory data portion of the submission with ENDRA's clinical collaborators, and we expect to submit the De Novo request in the coming weeks. We appreciate the continued support of shareholders as we believe the De Novo process will assist ENDRA in achieving the strongest market position in the United States with TAEUS-optimized claims.”

The TAEUS system is intended to characterize fatty liver tissue as a means to non-invasively assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD). TAEUS is already approved for sale in countries that recognize the CE mark, including those in the European Union. The De Novo request provides a pathway in the United States for an entirely new product classification and, if granted, promises to strengthen TAEUS’ competitive position with its distinctive, patent-protected capabilities as a non-invasive point-of-care tool to characterize NAFLD, which impacts over one billion people globally.

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 1/50^th 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.