Study to Bolster Clinical Performance Evidence of TAEUS® Ultrasound Device in NAFLD Patients as Commercialization Begins
ANN ARBOR, MI / ACCESSWIRE / February 17, 2021 / ENDRA Life Sciences Inc. (ENDRA) (NASDAQ:NDRA), a pioneer of enhanced ultrasound technologies, today announced that Inselspital University Hospital in Bern, Switzerland is 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 very excited that Inselspital Bern, a renowned Swiss clinical and teaching institution, is evaluating TAEUS® as a non-invasive tool to characterize NAFLD, a condition that impacts more than 1 billion people globally," said ENDRA Life Sciences Chief Commercial Officer Renaud Maloberti. "ENDRA is honored to add this leading research institution to our growing list of clinical study partnerships. We look forward to working with Inselspital Bern as we begin commercializing TAEUS® in Europe."
This is the third clinical research partnership for ENDRA in Europe and the sixth globally. The data from the Inselspital Bern 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 Prof. Annalisa Berzigotti, MD, PhD, group leader, Department for BioMedical Research (DBMR) and senior hepatologist at the University Clinic for Visceral Surgery and Medicine (UVCM) of the Inselspital, University Hospital of Berne.
"We look forward to evaluating ENDRA's TAEUS® technology with our NAFLD and NASH patients as a promising alternative to more invasive techniques. If successful, this evaluation might allow us to better manage patients with this chronic condition," said Prof. Berzigotti.
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).
- Scanning a target of 75 fatty liver patients to contribute additional diversity and volume to the pool of patient data.
- Providing ENDRA with ongoing clinical feedback on product design and clinical performance.
ENDRA's commercialization of TAEUS® includes establishing clinical research partnerships worldwide, such as this partnership with Inselspital Bern, with an initial focus on Europe and the U.S. To date the company has established six research partnerships, including three in Europe and three in the U.S. In December 2020 ENDRA renewed its collaboration agreement with the GE Healthcare unit of General Electric Company, extending the agreement's term by two years to December 16, 2022. GE Healthcare is the global leader in clinical ultrasound and has been ENDRA's partner since 2016.
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)
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, NAFLD 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 Inselspital, University Hospital Bern
The Inselspital plays an important role as a university hospital in the Swiss healthcare system. We are a medical, high technology and knowledge center with an international presence where science and research meet.
The hospital, founded in 1354, is rooted in the community like no other institution. It plays an important economic role with high added value. Around 8,300 employees do their best every day in the Inselspital, the "city of health", so that around 44,000 inpatients experience the best possible medical and individual care every year. We offer highly specialized, tertiary medical services - including transplant medicine - with a pronounced interdisciplinary approach and high quality of interpersonal care. As a teaching organization, we constantly review our strategic corporate positions and principles - especially with regard to the changing health policy framework. We want to continue to guarantee high-quality services in medicine, teaching and research.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences Inc. is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology that mirrors some applications similar to CT or MRI, but at 50x lower cost and at the point of patient care. TAEUS® is designed to work in concert with one million ultrasound systems in global use today. TAEUS® is initially focused on the measurement of fat in the liver, as a means to assess and monitor NAFLD and NASH, chronic liver conditions that affect over 1 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.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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SOURCE: ENDRA Life Sciences Inc.