ANN ARBOR, MI / ACCESSWIRE / November 12, 2020 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:NDRA), a developer of enhanced ultrasound technologies, today announced that Rocky Vista University College of Osteopathic Medicine ("RVUCOM") has begun scanning patients in its clinical study of ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUSⓇ) clinical system to assess Non-Alcoholic Fatty Liver Disease ("NAFLD"). The studies are being conducted at RVUCOM's Ivins, Utah location will be the first real-world cases to be performed with TAEUS in the U.S.
ENDRA has received the CE mark to sell the TAEUS system in Europe, and is awaiting clearance by the U.S. Food and Drug Administration for its 510(k) application to begin sales in the U.S. The data from the RVUCOM study, along with other announced and future studies, will be used to further build the clinical evidence base and establish the clinical utility of the TAEUS system in patients with NAFLD to support current and future commercialization efforts.
The goals of the RVUCOM study, include:
- Comparing results obtained with 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 200 volunteers including fatty liver patients and healthy controls to contribute additional diversity and volume of patient data; and,
- Providing ENDRA with ongoing clinical feedback regarding TAEUS product design, clinical workflow and clinical performance.
The principal investigator in the RVUCOM study, Jing Gao, M.D., who is a member of ENDRA's scientific advisory board ("SAB"), commented, "This is an exciting step for ENDRA and for Rocky Vista University as we advance use of the TAEUS platform in a real-world clinical setting. We believe TAEUS has the potential to address a significant unmet clinical need for the robust, practical, non-invasive assessment of liver fat."
"Working with RVUCOM and other leading clinical reference sites is an essential part of building our base of clinical evidence to support commercialization efforts for TAEUS," said ENDRA Chief Commercial Officer Renaud Maloberti. "We look forward to supporting and learning from RVUCOM, as well as other medical facilities that will be evaluating TAEUS."
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