JLKE, Fourth US FDA 510k Approval 'Great Achievement'... Brain MR Perfusion Imaging Analysis Solution

JLK (CEO Dongmin Kim), the first medical AI listed company, announced on the 6th that its AI perfusion imaging stroke solution JLK-PWI obtained approval from the U.S. Food and Drug Administration (FDA) 510(k), following the Japanese PMDA approval on the 22nd of last month.

This FDA approval marks JLK's fourth achievement, including its prostate cancer solution, with the company having secured FDA approvals for all submitted solutions: ▲MEDIHUB Prostate ▲JLK-LVO ▲JLK-CTP ▲JLK-PWI.

JLK stated that with this approval, the effectiveness of its independently developed FDA approval system has been fully validated. The company plans to apply for three additional stroke solutions to the FDA within this year and will focus on obtaining solution approvals and local insurance reimbursements.

JLK-PWI is a solution that automatically analyzes brain MR perfusion images to provide quantitative indicators of the core area of cerebral infarction with low recovery potential and the brain perfusion deficit area with reduced blood supply. It operates based on diffusion-weighted MR imaging (DWI) and perfusion-weighted MR imaging (PWI), automatically analyzing essential information for acute cerebral infarction treatment decisions and providing it to medical staff.

When using the solution, it is possible to quantitatively identify brain areas that can be saved through vascular recanalization, enabling rapid and accurate understanding of information necessary for treatment decisions in critical stroke patients. In particular, it helps improve prognosis for acute cerebral infarction patients by enabling swift decisions on emergency surgery (procedures), including thrombectomy (EVT) for hyperacute cerebral infarction patients.

The company expects this approval to make a significant impact on the U.S. medical AI market. Although the total number of scans is lower compared to the U.S., the solution was developed based on domestic data with a significantly higher MRI scan rate relative to cerebral infarction patients, suggesting it can predict lesions more accurately than competitors Rapid AI and Viz AI.

In fact, a performance validation comparative study conducted last year on 414 cerebral infarction patients at Chonnam National University Hospital showed that the U.S. competitor Rapid AI's product failed to detect lesions in 61.4% of all cerebral infarction patients, whereas JLK's solution failed in only 1.9% of patients, demonstrating superior performance in detecting core cerebral infarction lesions.

Recently, considering that acute cerebral infarction procedures are expanding to smaller vessel infarctions, JLK-PWI, which has strengths in detecting small lesions, is expected to better identify patients requiring reperfusion procedures compared to Rapid AI's solution, indicating sufficient competitiveness in the global market.

JLK CEO Dongmin Kim said, "With the FDA approval of JLK-PWI, we can widely promote the excellence of JLK's MRI solutions in the U.S. market," adding, "Going forward, JLK will firmly establish its position in the U.S. as the world's first company to possess a full-cycle stroke solution covering both CT and MRI."