Study to Bolster Clinical Evidence of Performance of Patented TAEUSUltrasound Device in NAFLD Patients as Early Product Commercialization in Europe Continues
ENDRA Life Sciences Inc. (ENDRA) (NASDAQ: NDRA), a pioneer of enhanced ultrasound technologies, today announced that King's College Hospital, London (KCH) is now partnering with ENDRA for a clinical study of ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUS) device for assessing Non-Alcoholic Fatty Liver Disease (NAFLD).
"We are thrilled that KCH, a teaching hospital that is world-renowned for pioneering research in liver disease management and transplantation, is evaluating TAEUS as a tool to characterize NAFLD, a condition that impacts more than 1 billion people globally," said ENDRA Life Sciences CEO Francois Michelon. "It's an honor for ENDRA to partner with another leading NHS trust. We believe this new partnership further advances our commercial strategy as it provides the opportunity to demonstrate the potential clinical utility of TAEUS and to build on the clinical foundation we have established to date."
This represents the seventh clinical research partnership for ENDRA globally and is a natural progression from the feasibility study conducted by the Robarts Research Institute, which used healthy volunteers to establish the safety and efficacy of the TAEUS technology. The data from the KCH study, along with other ongoing or to-be initiated studies, will be used to bolster the clinical evidence and further establish the clinical utility of the TAEUS ultrasound device in patients with NAFLD. The study will be led by Dr. Ashley Barnabas, Consultant Hepatologist in the Liver Unit at King's College Hospital.
"The current options to assess and monitor liver fat in NAFLD patients, namely MRI and liver biopsy, can be challenging to integrate into clinical practice. There is a pressing need for more practical tools to support and care for patients with this chronic condition," said Dr. Barnabas.
The goals of the KCH 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).
- Scanning a target of 75 fatty liver patients to contribute additional diversity and volume of patient data.
- Publishing the findings of the study in a peer-reviewed medical journal.
- Providing ENDRA with ongoing clinical feedback on product design and clinical performance.
- Assisting with establishing the clinical value proposition of the TAEUS system in NAFLD to support ongoing commercialization.
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 Non-Alcoholic Fatty Liver Disease
NAFLD is a condition closely associated with obesity, diabetes, hepatitis C and certain genetic predispositions in which fat accumulates in the liver. NAFLD affects over 1 billion people globally and is estimated to cost the U.S healthcare system over $100 billion annually. NAFLD is often asymptomatic and if left untreated, can progress to inflammation (NASH), tissue scarring (fibrosis), cell death (cirrhosis) and liver cancer. By 2025, NAFLD is forecast to be the greatest root cause of liver transplants. The only tools currently available for diagnosing and monitoring NAFLD are impractical: expensive magnetic resonance imaging (MRI) or an invasive surgical biopsy.
About King's College Hospital, London
King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching hospitals. The Trust is recognised internationally for its work in liver disease and transplantation, neurosciences, cardiac, haemato-oncology, fetal medicine, stroke and major trauma. In 2013, we acquired the Princess Royal University Hospital, Orpington Hospital, and some services at Beckenham Beacon and Queen Mary's Sidcup following the dissolution of South London Healthcare NHS Trust. We now provide care to 1.5 million patients in Southwark, Lambeth, Bromley, Bexley, Lewisham and elsewhere in south-east London and parts of Kent. Over 10,000 babies are delivered by our hospitals each year, and over 750 patients come to our Emergency Departments every day. The Liver Unit at King's College Hospital has a world-class reputation for the treatment of liver-related disorders with an extremely comprehensive set of services for the management of patients with liver failure, cirrhosis, liver cancer and portal hypertension. King's College Hospital runs one of the largest adult and paediatric liver transplantation programmes in Europe. It also has one of the highest throughput of acute hepatology and liver transplants in Europe.
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 inflammation (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; the timing of; making 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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