JLK Completes PMDA Approval Application in Japan for Two Stroke Solutions 'JLK-CTP·JLK-PWI'

JLK, the first medical AI listed company (CEO Dongmin Kim), announced on the 5th that it has completed the regulatory approval application to the Pharmaceuticals and Medical Devices Agency (PMDA) under the Ministry of Health, Labour and Welfare for the supply of its brain perfusion CT image analysis solution JLK-CTP and brain perfusion MR image analysis solution JLK-PWI in Japan. With this, JLK has taken the first step toward entering the Japanese market, one of the global stroke markets.

Japan is the world's third-largest medical market, has the highest aging rate globally, and has an elderly population aged 65 and over of about 36 million, making it a super-aged society and one of the countries with a high risk of stroke, an age-related disease.

JLK had previously completed regulatory approval applications to the U.S. Food and Drug Administration (FDA) for three solutions (JLK-LVO, JLK-CTP, JLK-PWI) to enter the U.S. market. By completing the regulatory approval application for the CT and MR-based brain perfusion analysis solutions to the Japanese health authorities, it is evaluated that the company has opened the door to expanding its presence in the Japanese market.

The company explained that this PMDA regulatory approval application was possible faster than expected by utilizing clinical trial information previously submitted to the U.S. FDA. Since applications for three additional solutions to the U.S. FDA have already been completed, the company added that it will quickly complete the PMDA application procedures for the remaining solutions as well.

Currently, as aging is emerging as a social issue throughout Japan, JLK's stroke solutions are expected to receive more attention. The Japanese government also has a strong will to solve aging problems through digital healthcare technology, making the outlook for the medical AI market positive.

Currently, AI medical devices approved in Japan are mainly used in the diagnostic field. Since JLK's solutions analyze CT and MR images using artificial intelligence to provide quantitative data and enable rapid and accurate diagnosis, they are expected to receive a warm response in the Japanese market as AI medical devices.

The newly applied JLK-CTP and JLK-PWI also automatically analyze areas of irreversible brain damage and areas with delayed blood supply in brain perfusion images using AI, helping to decide whether to perform recanalization procedures on cerebral blood vessels. These two solutions are evaluated as essential solutions to overcome the golden time for acute stroke treatment.

Dongmin Kim, CEO of JLK, said, "With the FDA application in the U.S. followed by the PMDA regulatory approval application in Japan, JLK is focusing on laying the foundation for global expansion," adding, "We will also focus on obtaining additional PMDA approvals for stroke solutions and do our best to achieve prompt results."