ANN ARBOR, MI / ACCESSWIRE / March 29, 2019 / ENDRA Life Sciences Inc. (”ENDRA”) (NASDAQ: NDRA), a developer of enhanced ultrasound technologies, has reported initial findings on the first human Thermo Acoustic Enhanced Ultrasound (TAEUS) feasibility study of liver fat on 25 subjects at the Robarts Research Institute.
To date, 25 healthy volunteer study subject TAEUS data sets have been analyzed and compared with quantitative MRI fat fraction measurements, acquired for each subject, along with other indicators such as Body Mass Index (BMI) and abdominal fat thickness as measured by traditional ultrasound.
21 study subjects had less than 6% liver fat fraction by MRI, which is clinically categorized as ‘healthy/normal’ range liver fat fraction. The other four study subjects fell into the 8%-22.4% fat fraction, typically categorized as ‘mild’ NAFLD. No study subject was eliminated from the analysis, and no subjects were yet enrolled in the ‘moderate’ (26%-37%) or ‘severe’ (>37%) liver fat fraction grades of NAFLD.
The correlation between thermoacoustic measurements of ENDRA’s reference design and the percent fat fraction by MRI had an R2 of 0.61, with a standard error of the mean of 2.98%.
In contrast, the correlations between BMI (Body Mass Index) with MRI fat fraction was only 0.19 and the correlation of abdominal fat thickness (as determined by ultrasound) with MRI fat fraction was 0.31.
Interestingly, some subjects with ‘mild’ fatty liver (based on MRI fat fraction) were incorrectly classified by conventional (non-TAEUS) ultrasound assessment as normal or severe, while TAEUS measures showed close agreement with MRI fat fraction in those subjects.
The next phase of feasibility studies will aim to add study subjects that stratify the range of liver fat fraction seen in mild, moderate and severe fatty liver, that ranges from 6% – 50% liver fat by MRI. Those findings of 50 subjects may vary significantly from these initial data.
ENDRA will also be participating (Booth #514) in the American Institute of Ultrasound in Medicine (AIUM) Conference in Orlando, Florida on April 6-10, to build relationships and discuss the data with an estimated 1,400 clinicians, sonographers and scientists attending the meeting.
”We are pleased with the initial findings from our proprietary reference design and it is very encouraging to see a correlation to MRI on such a small group of subjects right out of the gate,” said ENDRA Life Sciences CEO, Francois Michelon. ”We look forward to following up with additional findings in the months to come after we complete data collection on 50 subjects.”
”In addition to the Robarts study, we plan to initiate several additional North American and European clinical studies in 2019 to build a strong base of clinical data to support our initial commercialization efforts in Europe, following an anticipated CE Mark,” said ENDRA Life Sciences CTO, Michael Thornton.
ENDRA’s investigational TAEUS technology, which uses RF energy to enhance ultrasound, is designed to enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only on 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 NAFLD, which affects over one billion people globally.
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. 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 NonAlcoholic 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 the results of pending human studies and nature of the data obtained from such studies; the adequacy of protections afforded to us by the patents that we own and the success we may have in, and the cost to us of, maintaining, enforcing and defending those patents; expectations concerning ENDRA’s ability to secure regulatory approvals; 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.
SOURCE: ENDRA Life Sciences Inc.
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