ENDRA Life Sciences (NASDAQ:NDRA) received Institutional Review Board approval from China’s Shanghai General Hospital for the first clinical study, expected to begin in 2022, of ENDRA’s Thermo Acoustic Enhanced UltraSound (TAEUS) device to assess non-alcoholic fatty liver disease (NAFLD) in China.
“This partnership is a clear validation of ENDRA’s technology and provides an important strategic entry point into China’s healthcare market, which seeks to deliver cost-effective health services to 1.4 billion citizens, including an estimated 350 million people affected by NAFLD-NASH,” Francois Michelon, CEO of ENDRA, said in a statement.
The goals of the study include comparing TAEUS against a baseline measure of liver fat as determined by the current standard-of-care, MRI-PDFF (magnetic resonance imaging proton density fat fraction), in 75 patients. The study will also provide ENDRA with ongoing clinical feedback on product design and clinical performance.
This is ENDRA’s first clinical research partnership in Asia and the eighth globally. The collaboration will contribute to the clinical evidence for the TAEUS ultrasound device in patients with NAFLD in China and will be a reference site to support commercialization of TAEUS in China. In anticipation of introducing the TAEUS platform to China, ENDRA has been building an intellectual property portfolio, with eight patents issued to date in China.
TAEUS is currently CE Marked in the EU and a 510(k) application has been submitted to the FDA.
