Expands Study to 50 Subjects for Additional Data Collection
ANN ARBOR, MI / ACCESSWIRE / December 17, 2018 / ENDRA Life Sciences Inc. (''ENDRA'') (NASDAQ: NDRA), a developer of enhanced ultrasound technologies, announced today that the Robarts Research Institute has completed its initial healthy subject enrollment and data collection of 25 subjects.
The Robarts Research Institute team requested and received authorization to expand the study to 50 subjects, which would double the tissue data sets from ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUS™) and gain additional workflow and usability information, expanding the pool of study subjects to be representative of the population distribution of liver fat.
Dr. Aaron Fenster of Robarts Research Institute stated: ''I am pleased at the TAEUS device's ease-of-use and the collaborative interaction between the Robarts Research Institute and ENDRA teams for ongoing improvement and workflow integration, in preparation for the Fatty Liver Imaging Probe (FLIP) system's commercialization. While this is the first human subject testing with TAEUS technology, the ENDRA team, with support from its contractor, StarFish Medical, have clearly done their research homework in identifying user and patient needs and human factors. This rapidly-received approval of the study's expansion allows us to maintain the study's momentum and an additional 25 subjects would provide more data sets for TAEUS in support of an application for a CE mark,'' concluded Dr. Fenster.
''The data we are collecting with our investigational device is critical to our development of tissue correlation data sets to aid clinicians in assessing fatty liver disease, as well as help to finalize our commercial product that is expected to be interoperable with conventional ultrasound imaging systems,'' said ENDRA's CTO, Michael Thornton. ''This study expansion should offer ENDRA additional usability and clinical correlation data, that would further support TAEUS FLIP claims for our anticipated CE Mark, still on schedule for the first half of 2019,'' stated Thornton.
As relayed by the Robarts Research Institute team, the initial 25 study subjects have provided:
- Integration evaluation of hardware and software design elements of the TAEUS platform;
- Substantial user and patient human-factors data, including:
- Clinical workflow; and
- Ergonomic considerations for the FLIP System's intended patient population range, which will support the company's CE mark application and final commercial product design;
- TAEUS liver measurements, coupled with conventional ultrasound imaging, for each study subject; and
- Quantitative MRI liver fat fraction measurements, for correlation to the TAEUS measurements, for each study subject.
The Study Investigators at Robarts Research Institute have registered the study on the National Institute of Health database of global clinical studies here. Robarts Research Institute will continue to update the status of the study as it progresses and as is customary, the study duration was set to 12 months since initiation in September 2018 to allow adequate time for final data analysis, audit, and report compilation. ENDRA and the Robarts Research Institute team are striving to a goal of preliminary study reporting in the first quarter of 2019.
''Human studies require a process that is rigorous and detailed, involving multiple steps to ensure compliance with the approved study protocol including: raw data collection, processing into analyzable data, review of data, data analysis, statistical analysis, and summation of results,'' continued Thornton. '' This process is naturally more involved for first-in-human studies, but we are encouraged with the ease of study ramp-up and believe it is a good indicator of the future commercial ease of use,'' concluded Thornton.
''With the strong clinical interest expressed so far for ENDRA's technology, it is important to remember that any new medical technology, including ENDRA's, benefits from a growing base of clinical data to gain clinical credibility and influence long-established clinical practice,'' said ENDRA's CEO Francois Michelon. ''ENDRA plans to conduct additional human studies in the first part of 2019, as it ramps up to commercialization of its TAEUS liver device expected in Europe in mid-2019. The more data, the better, hence our interest in extending the study,'' concluded Michelon.
For more information on ENDRA's TAEUS technology, please see the November 2018 white paper titled: ‘Thermoacoustic Imaging: A Novel Method for Quantifying Fat in NAFLD' here.
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 Robarts Research Institute, Western University, Canada
Opened in 1986, Robarts Research Institute at Western University is a medical research facility in London, Ontario, with more than 600 people working to investigate some of the most debilitating diseases of our time, from heart disease and stroke to diabetes, Alzheimer's and many forms of cancer.For more information, please visit www.robarts.ca.
Forward-Looking Statements
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 anticipated results and timing of human studies conducted through Robarts Research Institute; ENDRA's ability to secure regulatory approvals; anticipated product pricing; expectations with respect to current and future partnerships, including those with CIMTEC and StarFish; 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 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.
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SOURCE: ENDRA Life Sciences Inc.