ANN ARBOR, MI / ACCESSWIRE / July 1, 2019 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ: NDRA), a developer of enhanced ultrasound technologies, today announced that it is partnering with Rocky Vista University College of Osteopathic Medicine ("RVUCOM") for a clinical study of ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUS™) clinical system assessing Non-Alcoholic Fatty Liver Disease ("NAFLD").
This clinical study of patients with fatty liver disease 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 RVUCOM study, along with other studies the company expects to initiate near term, will be used to build the clinical evidence base and establish the clinical utility of the TAEUS clinical system in patients with NAFLD.
The goals of the RVUCOM study, which is subject to finalization of a definitive clinical study agreement, include:
- Comparing ENDRA's commercial design TAEUS liver device against a baseline measure of liver fat as determined by 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 regarding product design, clinical workflow and clinical performance.
- Aiding the delineation of the TAEUS clinical value proposition in NAFLD to support commercialization efforts.
The principal investigator in the RVUCOM study, Dr. Jing Gao, who is a member of the ENDRA scientific advisory board ("SAB"), commented, "We are excited to work with ENDRA to advance the development of the TAEUS platform in NAFLD. We think TAEUS has the potential to address a significant unmet clinical need for better methods of non-invasive assessment of liver fat."
"We are very happy to collaborate with RVUCOM for additional human studies of our proprietary TAEUS clinical system," said ENDRA CTO, Michael Thornton. "As previously communicated, we plan to initiate several clinical studies in order to build a strong base of clinical data to support our initial commercialization efforts in Europe, following an anticipated CE Mark later this year."
About ENDRA Life Sciences Inc.
ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ: NDRA) is a developer of enhanced ultrasound technologies. ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (TAEUS™) platform to enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only with CT & MRI - at a fraction of the cost, and at the point-of-care. ENDRA's first TAEUS application will focus on the quantification of fat in the liver, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease (NAFLD). ENDRA's goal is to bring new capabilities to ultrasound - thereby broadening access to better healthcare. For more information, please visit www.endrainc.com.
About Rocky Vista University
Rocky Vista University is an independent, privately-funded health sciences university. The University has campus locations in Parker, CO and Ivins, UT and is fully accredited by the Higher Learning Commission. The College of Osteopathic Medicine is fully accredited by the Commission on Osteopathic College Accreditation Additionally, Rocky Vista University owns and operates the Rocky Vista Health Center in Parker, Colorado, a primary care medical facility which provides continued health care and health maintenance for its patients. For more information, please visit www.RVUCOM.edu/.
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, statements we make regarding expectations concerning the anticipated design and timing of a clinical study conducted through RVUCOM, including the number of patients included in such study; estimates of the timing of future events and achievements, including obtaining a CE Mark 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, the following: our entry into a definitive clinical study agreement with RVUCOM on acceptable terms prior to initiating the clinical study; our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; 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.
SOURCE: ENDRA Life Sciences Inc.