Ultrasound technology provider ENDRA Life Sciences Inc. announces that it has received Institutional Review Board approval from China’s Shanghai General Hospital, for the first clinical study of ENDRA’s Thermo Acoustic Enhanced UltraSound (TAEUS) device to assess non-alcoholic fatty liver disease (NAFLD) in that market.
“ENDRA is honored to bring our TAEUS technology to China through one of the country’s most prestigious healthcare institutions, Shanghai General,” says Francois Michelon, CEO of ENDRA. “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. We believe ENDRA’s point-of-care TAEUS technology aligns very well with China’s goal of shifting delivery of healthcare services from urban centers to community clinics.”
Shanghai General Hospital ranks as a 3A level center, the highest level in China’s 9-level healthcare facility classification system and is further rated A++ by China’s National Health Commission, which is awarded to only 12 of China’s estimated 35,000 healthcare facilities. Shanghai General Hospital delivers the highest quality care to an estimated 4 million inpatients and outpatients annually across a range of clinical specialties.
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 the world’s most populous market. In anticipation of introducing the TAEUS platform to China, ENDRA has been building a robust intellectual property portfolio with eight patents issued to date in China.
The study is expected to begin in 2022 and will be led by Prof. Lu Lungen, vice chairman of the Chinese Society of Hepatology, head of Shanghai General Hospital’s gastroenterology department, and Prof. Shen Hua, head of Shanghai General Hospital’s International Medical Care Center.
“We are committed to maintaining a first-class modern hospital that is research-driven and provides low-cost, high-efficiency clinical care. We look forward to using ENDRA’s TAEUS technology with our NAFLD patients as a promising alternative to more invasive or costly techniques,” says Lungen.
The goals of the study include comparing ENDRA’s TAEUS® liver device against a baseline measure of liver fat as determined by the current standard-of-care MRI-PDFF (MRI proton density fat fraction) in 75 patients. The study will also provide ENDRA with ongoing clinical feedback on product design and clinical performance.
TAEUS is currently cleared for sale in countries that recognize the CE mark, including those in the European Union, and a 510(k) application has been submitted to the U.S. FDA.