TAEUS clinical study to serve as gateway for ENDRA into Asia’s largest healthcare market
ENDRA Life Sciences Inc. (ENDRA) (NASDAQ: NDRA), a pioneer of enhanced ultrasound technologies, today announced it has received Institutional Review Board approval from China’s renowned Shanghai General Hospital (Shanghai First People’s Hospital Affiliated with Shanghai Jiao Tong University), 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,” stated Francois Michelon, Chief Executive Officer 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 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,” stated Prof. 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 (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.
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. Food and Drug Administration.
About Shanghai General Hospital (Shanghai First People’s Hospital Affiliated with Shanghai Jiao Tong University)
Shanghai General Hospital was founded in 1864 by French consuls as one of the largest and earliest Western medicine hospitals in China. Shanghai General has remained a leader in national and local medical circles. For 25 consecutive years, Shanghai General Hospital has been awarded as the civilized model unit by Shanghai municipal government. As a Class A tertiary general hospital, Shanghai General manages four local hospitals and has close collaborative relationships with other public hospitals in the surrounding provinces. For more information, please visit www.shgh.cn (https://eng.shgh.cn).
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 1/50th the cost and at the point of patient care. TAEUS® is designed to work in concert with 400,000 cart-based 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 Non-Alcoholic Steatohepatitis (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.
All statements in this release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "goal," "estimate," "anticipate" or other comparable terms. Examples of forward-looking statements include, among others, estimates of the timing of future events and achievements, such as the expectations regarding milestones and future sales, our 510(k) submission with the FDA and commercializing the TAEUS® device; and expectations concerning ENDRA's business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; the impact of COVID-19 on our business plans; our ability to find and maintain development partners, market acceptance of our technology, the amount and nature of competition in our industry; our ability to protect our intellectual property; and the other risks and uncertainties described in ENDRA's filings with the Securities and Exchange Commission. The forward-looking statements made in this release speak only as of the date of this release, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.
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