JLKE, Stroke AI Solution Applied to Japan PMDA... "Targeting the World's 3rd Largest Market"

JLK (CEO Kim Dong-min), the first medical AI company to be listed, announced on the 5th that it has completed the application for approval from Japan's PMDA (Pharmaceuticals and Medical Devices Agency under the Ministry of Health, Labour and Welfare) for its non-contrast CT-based stroke solution, JLK-NCCT.

The JLK-NCCT, which has now completed the PMDA application process, is a solution that analyzes images from non-contrast CT (NCCT), which is most often the first scan performed when a suspected stroke patient arrives at the emergency room, and provides various data.

Stroke is divided into cerebral hemorrhage caused by blood vessel rupture and cerebral infarction caused by blood vessel blockage. JLK-NCCT is characterized by its early recognition of subtle pattern differences in non-contrast CT images, marking suspicious areas and providing volume information necessary for deciding on intervention.

By using this solution, users can receive automatic analysis data on the presence of abnormalities as well as the location and volume of suspicious areas within seconds. It highlights suspicious regions with a visibility-enhanced heatmap, helping to quickly establish diagnosis and treatment plans for hyperacute cerebral hemorrhage and cerebral infarction in emergency situations.

JLK previously obtained approval from Japan's PMDA for two solutions (JLK-CTP, JLK-PWI). JLK-NCCT aims to complete its portfolio of brain perfusion imaging, cerebral hemorrhage, and cerebral infarction solutions through prompt approval, with plans to apply for five stroke solutions to the PMDA within this year alone.

Given that Japan’s aging population is emerging as a serious social issue, JLK expects its stroke solutions to gain even more attention. The company plans to swiftly pursue PMDA approval and entry into the insurance market to increase its market share.

Japan, which has the world’s third-largest medical market, has approximately 36 million elderly people aged 65 and over, ranking first globally in aging ratio. Consequently, it is classified as a country with the highest risk of stroke, an age-related disease, and an urgent need for the adoption of new technologies such as medical AI.

According to a survey by the Korea Trade-Investment Promotion Agency, exports of medical electronic devices to Japan reached $86.16 million by June this year, marking an 18.7% increase compared to the same period last year. This is the second-highest export ratio after the United States, indicating significant growth potential in the related market.

Kim Dong-min, CEO of JLK, stated, "As part of our global expansion, we are focusing on establishing a local solution supply base through ongoing approval processes in the U.S. and Japan. We will make every effort to secure rapid approvals through continuous applications to the U.S. FDA and Japan PMDA and to build a solid sales foundation."