ENDRA Life Sciences, an enhanced ultrasound technologies company in Ann Arbor, announced it is expanding into China’s Shanghai General Hospital after receiving Institutional Review Board approval for the first clinical study of it Thermo Acoustic Enhanced UltraSound (TAEUS) device for assessing non-alcoholic fatty liver disease (NAFLD).
“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.”
Shanghai General — or Shanghai First People’s Hospital Affiliated with Shanghai Jiao Tong University — is a 3A level center, the highest level in China’s 9-level health care facility classification system. Further, it is rated A++ by China’s National Health Commission, which is awarded to only 12 of the country’s estimated 35,000 healthcare facilities.
The collaboration is ENDRA’s eighth, but its first in Asia. Part of its goal is to contribute to the clinical evidence support the TAEUS device in patients with NAFLD in China. It will serve as a reference site to support the commercialization of the device in the world’s most populous market.
“We are committed to maintaining a first-class modern hospital that is research-driven and provides low-cost, high-efficiency clinical care,” says Lu Lungen, vice chairman of the Chinese Society of Hepatology and head of the hospital’s gastroenterology department. “We look forward to using ENDRA’s TAEUS technology with our NAFLD patients as a promising alternative to more invasive or costly techniques.”
The study is expected to begin in 2022 and will be led by Lungen and Shen Hua, head of Shanghai General Hospital’s International Medical Care Center. Besides establishing a body of clinical data, another goal is comparing the device against a baseline measure of liver fat determined by the current standard-of-care in 75 patients.
TAEUS is currently cleared for sale in countries that recognize the CE mark, including those in the European Union. A 510(k) application has been submitted to the U.S. Food and Drug Administration.
Shanghai General Hospital was founded in 1864 by French consuls as one of the largest and earliest Western medicine hospitals in China. For 25 consecutive years, it has been awarded as the civilized model unit by the Shanghai municipal government. It manages four local hospitals and has close collaborative relationships with other public hospitals in the surrounding provinces.