ContextVision initiates the clinical phase of its point-of-care ultrasound innovation venture to advance liver disease diagnostics

10 Dec 2025 13:08 CET

ContextVision, a global leader in medical imaging software, today announced
the first patient first visit in its clinical development program for liver
disease diagnostics at the University of Washington (Seattle, USA). This marks
a major milestone in the company's innovation program, following successful
Institutional Review Board (IRB) approval, completion of technical setup, and
validation of investigational ultrasound sequences.

The project, titled "Development of a Quantifiable Ultrasound Biomarker for
Hepatic Steatosis (LYNX)"", aims to develop a novel ultrasound-based
multiparametric biomarker for quantifying hepatic steatosis in patients with
suspected metabolic dysfunction-associated steatotic liver disease (MASLD).
The biomarker will be evaluated against the current gold standard -- Magnetic
Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) -- to enable a
non-invasive, quantitative, and accessible diagnostic tool.

The clinical phase will enroll 110 subjects over the next twelve months,
including both healthy volunteers and patients across the MASLD disease
spectrum. Each participant will undergo imaging using ContextVision's
investigational ultrasound sequences deployed on a Verasonics Vantage NXT,
alongside comparative imaging with EchoSense FibroScan, Philips EPIQ Elite
Ultrasound device, as well as Philips 3T Ingenia Elition MRI system. The study
is registered on ClinicalTrials.gov
(https://clinicaltrials.gov/study/NCT07270601).

"The enrollment of the first patient marks the official start of clinical data
collection and a major step toward developing new quantitative imaging
biomarkers for liver disease," says Gerald Pötzsch, CEO of ContextVision. "We
are proud to collaborate with the University of Washington and our partners,
combining expertise across imaging physics, AI, and clinical research to drive
innovation in non-invasive liver diagnostics."

The LYNX study at the University of Washington is part of ContextVision's Data
Quality initiative, aimed at building AI-powered, organ-specific quantitative
imaging solutions with the ultimate goal of developing digital biomarkers
capable of assisting in early disease detection and monitoring. This program
brings together a global network of partners, including AMRA Medical (Sweden),
University of Waterloo's LITMUS Lab (Canada), and InPhase Solutions AS
(Norway).

Addressing a growing global health challenge
MASLD affects approximately one in four people globally, representing an
estimated 1.8 billion individuals. It is rapidly becoming one of the leading
causes of chronic liver disease, and is strongly associated with obesity,
diabetes, and metabolic syndrome. Despite its prevalence, early diagnosis
remains limited due to reliance on invasive or costly diagnostic methods such
as liver biopsy and MRI. There is an urgent global need for non-invasive,
cost-effective, and scalable imaging tools -- a gap ContextVision aims to fill
through its AI-based liver imaging program.

For more information, please contact
Gerald Pötzsch
Chief Executive Officer, ContextVision
gerald.potzsch@contextvision.com

About ContextVision
ContextVision is a software company specialized in image analysis and
artificial intelligence. As the global market leader within image enhancement,
we are a trusted partner to leading manufacturers of ultrasound, X-ray and MRI
equipment around the world. Our expertise is to develop powerful software
products, based on proprietary technology and artificial intelligence for
image-based applications. Our cutting-edge technology helps clinicians
accurately interpret medical images, a crucial foundation for better diagnosis
and treatment. The company, established in 1983, is based in Sweden with local
representation in the U.S., Japan, China and Korea. ContextVision is listed on
the Oslo Stock Exchange under the ticker CONTX.

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