JLK, a medical artificial intelligence (AI) company, is spearheading a groundbreaking multi-center clinical study. The initiative aims to validate the real-world application and clinical effectiveness of its AI-powered stroke imaging analysis solution across 22 hospitals nationwide.
JLK announced its leadership role in the AI Transformation (AX)-Sprint project, a collaborative effort involving 41 vascular specialists from participating hospitals. The data collection process will be overseen by Dr. Kim Beom-jun from Bundang Seoul National University Hospital.
This ambitious project represents a nationwide clinical platform designed to verify the clinical efficacy of AI medical devices. It’s based on extensive real-world evidence gathered from actual patient care settings.
JLK plans to leverage data from over 2,500 patients to simultaneously validate the performance of its suite of imaging analysis solutions. These include computed tomography (CT) perfusion (JLK-CTP), magnetic resonance imaging (MRI) perfusion (JLK-PWI), and diffusion-weighted imaging (JLK-DWI) analysis tools. The company aims to establish a robust clinical foundation for AI-driven treatment decisions.
A key focus of the study is evaluating an AI platform that supports clinical decision-making for thrombectomy (EVT) procedures. The platform integrates critical information on core infarction, penumbra, mismatch, and bleeding risk.
The data gathered from this multi-center trial will serve multiple purposes. JLK intends to use it as evidence for new medical technology assessments and to facilitate entry into the health insurance system. Additionally, the company plans to leverage these findings to expand its presence in domestic medical institutions and penetrate international markets.
Currently, JLK’s AI stroke solution is deployed in leading university hospitals across South Korea. The company is also expanding globally, bolstered by approvals from the U.S. Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Kim Dong-min, Chief Executive Officer (CEO) of JLK, emphasized the significance of the AX-Sprint project, stating that this is the largest stroke AI clinical initiative in the country, involving 22 hospitals. Its goal is to establish a trusted AI standard for healthcare professionals, based on extensive clinical evidence from real-world medical settings. It’s aiming to create a virtuous cycle that drives new medical technology assessments, expands the presence in medical institutions, and facilitates the entry into the global market.