LiverScope^®

Fast, Accurate Point-of-Care Diagnostics. Non-invasive. Simple to Use.

Point-of-Care Diagnostics

LiverScope®, Liver Disease Diagnostics

LiverScope® Probe

Point-of-Care

Simple and Accurate Test

Revolutionary Point-of-Care Liver Disease Diagnostics.

Benefits

CAUTION – LiverScope® is an investigational device. Limited by Federal (or United States) law to investigational use

Advantages.

LiverScope® is offering a game-changing solution to the challenges faced by conventional liver disease diagnostic methods. Experience the power of cutting-edge technology, combined with patient comfort and accuracy – with LiverScope®.

Livivos addresses the urgent need to diagnose liver disease with the high accuracy of MRI but in a point-of-care setting. Biopsies are invasive and expensive, Ultrasound-based methods are intrinsically limited in fat measurement accuracy, and MRI, although non-invasive and accurate, requires highly trained operators and is not broadly available.

Convenience for Patients & Operators.

Scheduling and patient comfort advantages open the possibility for frequent and accurate liver disease diagnosis. LiverScope® supports preventive medicine, effective disease progression monitoring, and accurate clinical treatment management.

Performance Validation - Liver Fat.

Calibration Standards

QUANTIFICATION of liver fat is key for assessing liver health as many treatments are directed at reducing liver fat (anti-steatotic). Measuring fat accurately helps determine the treatment’s mechanism and efficacy.

LiverScope® reads the Proton Density Fat Fraction (PDFF), a measure of liver fat which was developed for clinical MRI. The diagnosis is completed without the need for a radiologist.

The LiverScope® performance was quantified using a series of certified phantom samples from Calimetrix. Calimetrix provides advanced quantitative MRI PDFF reference specimens for clinical and research measurements.

LiverScope® PDFF values show a high linear correlation to certified MRI PDFF values, with an R-squared > 0.99. The quantitative method provides a reliable means for steatosis grading.

In-Vivo Studies.

Clinical Study at University of California, San Diego

LiverScope®‘s performance was evaluated with an in-vivo clinical study with volunteers at UC San Diego. For each participant, the Livivos’s PDFF results were compared to the PDFF attained by an FDA-cleared MRI method (GE IDEAL IQ).

LiverScope® liver fat measurements show remarkable equivalence to MRI PDFF

Linear Correlation R-squared > 0.94

Reference:

“Point-of-care magnetic resonance technology to measure liver fat: Phantom and first-in-human pilot study”