Endra Life Sciences today reported preliminary results from the first-in-man feasibility study of its Thermo Acoustic Enhanced Ultrasound System exploring its ability to measure and analyze liver fat.
The TAEUS platform is designed to allow for the visualization of human tissue composition, function and temperature at a cheaper cost than computed tomography or magnetic resonance imaging and provided at the point-of-care, the Ann Arbor, Mich.-based company said.
Preliminary data came from 25 subjects analyzed with the TAEUS platform as compared with quantitative MRI fat fraction measurements and other indicators including Body Mass Index and abdominal fat thickness as measured by traditional ultrasound.
Results from the trial indicated that 21 subjects in the study had less than 6% liver fat fraction as assessed by MRI, classified in the healthy or normal range, while the other four subjects were found to have between 8% and 22.4% fat fraction, which is classified as mild non-alcoholic fatty liver disease.
Study investigators said that the correlation between thermoacoustic measurements of Endra’s reference designed and the percent fat fraction as measured by MRI had an R2 of 0.61 with a standard error of the mean of 2.98%.
Correlations between BMI with MRI fat fraction were only 0.19, while the correlation of abdominal fat thickness analyzed via ultrasound and MRI fat fraction was 0.31, the company said.
Endra said that some subjects in the trial with ‘mild’ fatty liver based on MRI fat fraction had been incorrectly classified by conventional ultrasound assessment as either normal or severe, while the TAEUS measurements were closely aligned with MRI fat fraction analysis.
”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. We look forward to following up with additional findings in the months to come after we complete data collection on 50 subjects,” CEO Francois Michelon said in a prepared statement.
Endra said that the next step of the feasibility study will look to add subjects that stratify the range of liver fat fraction seen in mild, moderate and severe fatty liver, adding that results from those subjects may vary significantly from initial data.
”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,” CTO Michael Thornton said in a press release.