JLK obtains Japanese PMDA approval for stroke solution ‘JLK-PWI’

JLK Stroke Solution ‘JLK-PWI’

(Health Korea News / Yoo Ji-in) JLK, Korea’s first listed AI medical company, has approved its stroke MR-based solution ‘JLK-PWI (Perfusion Weighted Imaging)’ through the Pharmaceuticals and Medical Devices Agency (PMDA) under Japan’s Ministry of Health, Labor and Welfare. It was announced on the 24th that it had obtained approval from the Devices Agency.

JLK-PWI is a solution that helps determine whether to perform cerebrovascular recanalization by automatically analyzing areas where irreversible brain damage has occurred and areas where blood supply is delayed in brain MR perfusion images. Together with JLK-CTP (brain CT perfusion image analysis solution), which received approval from the U.S. FDA and Japan’s PMDA this month, it is playing a major role in protecting the golden time for acute stroke treatment.

Using this solution, you can quantitatively identify brain areas that can be saved by vascular recanalization and quickly and accurately obtain information for determining treatment policies for critically ill stroke patients. It helps improve the prognosis of patients with acute cerebral infarction by being able to quickly decide whether to undergo emergency surgery (procedure), including thrombectomy (EVT) for patients with hyperacute cerebral infarction.

JLK-PWI also completed its application for approval from the U.S. Food and Drug Administration (FDA) last August. The company expects that obtaining PMDA approval will have a positive impact on the US FDA approval, and plans to pursue expansion into major global markets such as Europe, Southeast Asia, and South America based on obtaining approval in the US and Japan.

A company official said, “Obtaining the JLK-PWI license is the second stroke solution acquisition in Japan following the JLK-CTP solution, which recently obtained both the U.S. and Japan licenses,” adding, “With this approval, JLK’s expansion into the global market is expected to further accelerate.” He said.

According to the Japanese health authorities, Japan is facing a serious level of aging, with the number of people over 75 years old exceeding 20 million, accounting for 39.8% of total medical expenses. Medical expenses amounting to approximately 47.3 trillion yen (approximately 437 trillion won) are being spent annually through public medical insurance alone, the highest ever, and there is a rush to introduce cutting-edge technologies such as AI to reduce the burden of high-cost diseases such as stroke.

The Japanese AI medical market is predicted to grow to $8.9 billion (approximately 11 trillion won) by 2030, and related industries are also attracting attention as future growth engines. Medical AI, a core technology that helps medical staff make quick and accurate decisions, is expected to grow significantly in the Japanese medical market. It is expected to attract attention as a key growth engine.

JLK CEO Kim Dong-min said, “Japan, which has the world’s third-largest medical market, is experiencing an explosive increase in demand for stroke due to rapid aging. Similar to Korea, access to MRI is good, so we have created a solution that can respond to both CT and MRI.” “We expect JLK medical AI solutions to play an important role in the Japanese medical system.”

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Source: www.hkn24.com