JLK Obtains Stroke Solution Approval from Japan PMDA Following US FDA Clearance

JLK (CEO Dongmin Kim), the first listed company in the medical AI field, announced on the 21st that its brain CT perfusion imaging solution JLK-CTP successfully obtained approval from Japan's PMDA (Ministry of Health, Labour and Welfare) following the U.S. Food and Drug Administration (FDA) approval on the 17th.

JLK-CTP is an AI solution that analyzes brain CT perfusion images to quickly identify areas of reduced cerebral perfusion and the extent of brain damage, enabling physicians to effectively determine whether surgery or intervention is necessary for stroke patients.

A company representative stated, "This PMDA approval marks the first case of JLK's stroke solution receiving regulatory approval in Japan," adding, "Japan, with the world's highest elderly population ratio and the third-largest medical market globally, presents an attractive market, and this approval signals a green light for our full-scale entry into the Japanese medical market."

The Japanese medical market holds significant global potential and is experiencing the fastest super-aging trend. As of last year, out of approximately 120 million people, 36 million are aged 65 or older, accounting for about 30% of the total population, and this ratio is expected to increase to 35% by 2040. Furthermore, the AI medical market in Japan is projected to approach $8.9 billion (approximately 11 trillion KRW) by 2030.

Stroke is a representative geriatric disease, with about 80% of patients developing it after their 60s. In Japan, the demand for diagnosis and treatment of neurological diseases such as stroke is rapidly increasing alongside the growing elderly population. According to Japan's Ministry of Internal Affairs and Communications, about 40% of the population aged 65 and older is expected to experience stroke in the future, and stroke AI solutions are anticipated to achieve significant growth as innovative tools capable of meeting this surging demand.

Professor Manabu Inoue of the National Cerebral and Cardiovascular Center in Japan, who recently visited Korea, stated in an interview, "JLK's stroke AI solution is more innovative and convenient than existing solutions introduced in Japan," adding, "In particular, the performance of the cerebral perfusion (CTA, PWI), diffusion-weighted imaging (DWI), and intracerebral hemorrhage (ICH) solutions is excellent, making them game changers widely used in the stroke diagnosis market in Japan and worldwide."

Meanwhile, with the recent PMDA approval of JLK-CTP, the approval process for the MR-based solution JLK-PWI, for which the application has already been completed, is expected to accelerate. JLK aims to apply for a total of five stroke solutions to the PMDA by the end of this year and to obtain PMDA approval for at least two solutions as part of its aggressive entry into the Japanese medical market.

The company views the consecutive approvals of its flagship solutions as a foundation to simultaneously target the two major markets of the U.S. and Japan, stating that it will rapidly capture the global market based on technology that meets global standards.

In particular, leveraging this achievement, the company plans to strengthen its leading role in AI-based medical solutions in the global healthcare market, drive AI innovation in stroke diagnosis, and contribute to healthcare systems worldwide.

JLK CEO Dongmin Kim said, "The simultaneous acquisition of Japanese PMDA and U.S. FDA approvals for JLK-CTP signifies recognition not only of the technological capabilities of our AI-based medical solution but also of our company's ability to obtain regulatory approvals in major advanced countries."

He added, "Especially in Japan, where clinical research using perfusion imaging is actively conducted and the possibility of insurance reimbursement registration is high, we expect significant sales growth opportunities," and further stated, "In the future, we plan to accelerate expansion into major global markets including Europe and the Middle East, as well as the U.S. and Japan."