- New Findings Support Positive, Clinically Useful Correlation to Reference MRI –
- Feasibility Study Now Complete, Additional Clinical Studies at Other Sites Expected to be Initiated by Year-End –
ANN ARBOR, MI / ACCESSWIRE / September 26, 2019 / ENDRA Life Sciences Inc. (“ENDRA”) (NASDAQ:NDRA), a pioneer of enhanced ultrasound technologies, today reported that Robarts Research Institute has completed the second phase of the Thermo Acoustic Enhanced Ultrasound (TAEUS) feasibility study of liver fat and, in conjunction with the EASL Nonalcoholic Fatty Liver Disease (NAFLD) Summit in Seville, Spain, ENDRA provided top level findings from the study.
A total of 26 volunteer subjects were scanned and rescanned with updated probe architecture and a modified measurement procedure. One subject did not complete the study (no available reference Magnetic Resonance Imaging Proton Density Fat Fraction, or MRI-PDFF), and was excluded. Relative to the first study phase, the 25 subjects scanned in the second phase represented a more broadly distributed population of liver fat, with 15 out of 25 having a clinically relevant liver fat fraction of 5% or greater. Pre-defined TAEUS measurement requirements, related to signal quality and anatomical consistency with conventional ultrasound, excluded seven additional subjects from the final analysis. Eighteen subject data sets were used to determine top line results including correlation with the MRI-PDFF reference measurement, and sensitivity and specificity of the TAEUS measurement to correctly identify subjects with clinically elevated liver fat (≥5% as measured by MRI-PDFF) vs. subjects with healthy levels of liver fat (<5%).
The coefficient of determination, comparing the TAEUS measurement to the subjects’ percent liver fat fraction, as measured by MRI-PDFF was R2=0.54, with a standard error of the mean of 4.4%. In contrast, the coefficient of determination BMI (Body Mass Index) compared to MRI-PDFF was R2=0.14 and the coefficient of determination for abdominal fat thickness (as determined by ultrasound) compared with MRI-PDFF was R2=0.14. TAEUS measurements had an estimated sensitivity of 90% and an estimated specificity of 75% to correctly identify subjects with clinically elevated liver fat (≥5% as measured by MRI-PDFF). For context, MRI is reported to have a sensitivity of 68-87%, and a specificity of 83-98% (≥6.4% as measured by biopsy). ENDRA believes the results from the feasibility study indicate that the TAEUS device can be a clinically useful tool for assessing liver fat. The full data set from the feasibility study is expected to be submitted by the Robarts Research Institute for peer reviewed publication at a later date.
”Completion of this first in-human feasibility study is a major milestone for ENDRA, and represents great progress made towards our goal of addressing a significant unmet clinical need in the management of patients with serious chronic liver conditions, like NAFLD and NASH,” said ENDRA Life Sciences CEO, Francois Michelon. “This feasibility study, and further clinical studies that we expect to be initiated by year-end, will help build the clinical use case for TAEUS in the assessment of liver fat, and aid in the refinement of features to optimize our go-to-market commercial product for clinicians and patients. We thank the Robarts Research Institute, and the study volunteers, for their contributions to this effort.”
“Our TAEUS feasibility study objectives were achieved: We evaluated the TAEUS liver device design with respect to clinical safety and functionality, which guided scanning workflow and device modifications that were incorporated into the second phase of the study,” said ENDRA Life Sciences CTO, Michael Thornton. “The performance of the TAEUS development platform in the second phase of the study met the threshold of what we believe will position TAEUS as a clinically useful tool for the assessment of liver fat in a clinical point-of-care setting.”
About the Robarts Research Institute Feasibility Study
The purpose of the Robarts study, which utilized a TAEUS development platform, was to demonstrate safety and feasibility of the device in a clinical research setting and to inform technical improvements, workflows and clinical performance of updated versions of the device. Fifty volunteer study subject data sets (in two, 25-study subject phases) were analyzed and compared with quantitative MRI-PDFF 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.
Top line results from the first phase of the study were reported by ENDRA in March of 2019 here. The second phase of the study, which utilized the TAEUS development platform with probe modifications channeled from the first phase of the study, was conducted under the same protocol and contained 25 healthy volunteer study subjects with a broader distribution of fat fractions. This second set of data scans included five subjects rescanned from the first cohort.
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 finalize the full analysis of the data and submit the final results for clinical conferences and publication at a future date. 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 is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS™), a ground-breaking technology that visualizes tissue like CT or MRI, but at 50Xlower 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 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 the results of human studies and the nature of data obtained from such studies; expectations concerning the anticipated design and timing of future clinical studies; 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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