ContextVision AB

Regulatory Filings • Dec 10, 2025

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

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

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.