An email has been sent to your address with instructions for changing your password.
There is no user registered with this email.
Sign Up
To create a free account, please fill out the form below.
Thank you for signing up!
A confirmation email has been sent to your email address. Please check your email and follow the instructions in the message to complete the registration process. If you do not receive the email, please check your spam folder or contact us for assistance.
Welcome to our platform!
Oops!
Something went wrong while trying to create your new account. Please try again and if the problem persist, Email Us to receive support.
ENDRA Life Sciences Expands into China with Shanghai General Hospital Partnership
Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Positive)
Tags
partnership
Rhea-AI Summary
ENDRA Life Sciences Inc. (NASDAQ: NDRA) has received Institutional Review Board approval for a clinical study of its Thermo Acoustic Enhanced UltraSound (TAEUS) device at Shanghai General Hospital, targeting Non-Alcoholic Fatty Liver Disease (NAFLD). This marks ENDRA's first clinical research partnership in Asia, offering strategic entry into China's vast healthcare market, which serves 1.4 billion people. The study will compare TAEUS against MRI-PDFF in 75 patients, enhancing clinical evidence for commercialization.
Positive
Receipt of Institutional Review Board approval for clinical study in China.
Strategic entry into Asia's largest healthcare market, targeting 350 million NAFLD patients.
First clinical research partnership in Asia, promoting TAEUS technology.
Building a strong intellectual property portfolio with eight patents issued in China.
Negative
None.
TAEUS clinical study to serve as gateway for ENDRA into Asia’s largest healthcare market
ANN ARBOR, Mich.--(BUSINESS WIRE)--
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.
Forward-Looking Statements
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.
What is the significance of ENDRA's clinical study approval in China?
ENDRA's approval for a clinical study at Shanghai General Hospital marks a significant step in entering China's healthcare market, targeting the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD).
How will the TAEUS device be tested in the Shanghai General Hospital study?
The TAEUS device will be tested against a baseline measure of liver fat determined by MRI-PDFF in a study involving 75 patients suffering from NAFLD.
What is the market potential for ENDRA's TAEUS technology in China?
With an estimated 350 million people affected by NAFLD in China, the TAEUS technology has substantial market potential as it aligns with the country's healthcare cost-efficiency goals.
Who is leading the clinical study at Shanghai General Hospital?
The study will be led by Prof. Lu Lungen, Vice Chairman of Chinese Society of Hepatology, and Prof. Shen Hua, Head of the International Medical Care Center.
What are the next steps for ENDRA following the study approval?
ENDRA plans to initiate the study in 2022 and will use the clinical feedback to enhance product design and performance for future commercialization.
