Study to Bolster Clinical Evidence of Performance of Patented TAEUS Ultrasound Device in NAFLD Patients as Commercialization Begins
ANN ARBOR, MI / ACCESSWIRE / June 8, 2020 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:NDRA), a pioneer of enhanced ultrasound technologies, today announced that the Medical College of Wisconsin ("MCW") a world-renowned healthcare institution, 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 thrilled that MCW, a renowned research institution and pioneer in liver disease management and transplantation is evaluating TAEUS as a tool to characterize NAFLD, a condition that impacts more than one billion people globally," said ENDRA Life Sciences CEO, Francois Michelon. "It's an honor for ENDRA to garner the clinical interest of another leading research institution. We look forward to building our relationship with MCW as we commercialize TAEUS starting in the second half of this year."
This represents the third clinical research partnership for ENDRA in the United States 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 MCW 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, as commercialization begins in the second half of the year. The study will be led by Dr. Achuthan Sourianarayanane, MD, MRCP, Assistant Professor at MCW in the Gastroenterology and Hepatology department, practicing at Froedtert Hospital.
"Currently, the options to assess and monitor liver fat in NAFLD patients, namely MRI and liver biopsy, are difficult to integrate into clinical practice. There is a great need for more practical tools to help manage patients with this chronic condition," said Dr. Sourianarayanane. "We are excited to conduct this study of TAEUS in our patients with NAFLD, and to better understand the potential clinical utility of ENDRA's TAEUS technology."
The goals of the MCW study, include:
- Comparing ENDRA's commercial design 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.
- Providing ENDRA with ongoing clinical feedback on product design and clinical performance.
- Helping to establish the clinical value proposition of the TAEUS system in NAFLD to support ongoing commercialization efforts.
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, 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.
About the Medical College of Wisconsin (MCW)
With a history dating back to 1893, The Medical College of Wisconsin is dedicated to leadership and excellence in education, patient care, research and community engagement. More than 1,400 students are enrolled in MCW's medical school and graduate school programs in Milwaukee, Green Bay, and Central Wisconsin in. MCW's School of Pharmacy opened in 2017. A major national research center, MCW is the largest research institution in the Milwaukee metro area and second largest in Wisconsin. In the last ten years, faculty received more than $1.5 billion in external support for research, teaching, training and related purposes. This total includes highly competitive research and training awards from the National Institutes of Health (NIH). Annually, MCW faculty direct or collaborate on more than 3,100 research studies, including clinical trials. Additionally, more than 1,600 physicians provide care in virtually every specialty of medicine for more than 2.8 million patients annually. MCW-Central Wisconsin partners with health systems in northern Wisconsin, including Aspirus, Ascension and Mayo Clinic and others, to train the next generation of physicians for the region.
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.
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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