JLKE, Stroke Large Vessel Occlusion Solution Approved by US FDA... "Full-Scale Entry into the US Market"

JLK (CEO Dongmin Kim), the first medical AI listed company, announced on the 2nd that its AI stroke solution JLK-LVO (JBS-LVO) has obtained FDA 510(k) approval from the U.S. Food and Drug Administration (FDA).

This approval marks the first FDA clearance among JLK's stroke solutions, and the company expects the approval process for other stroke solutions to accelerate. In addition to the approved JLK-LVO, JLK has already completed FDA approval applications for JLK-CTP and JLK-PWI in August. The company aims to complete FDA approval applications for a total of six solutions by the end of this year by submitting three additional solutions. Among these, 2 to 3 stroke solutions are also targeted for additional FDA approvals within this year.

JLK-LVO is an AI-based solution that quickly detects large vessel occlusion (LVO) by analyzing CT cerebral angiography images. After analyzing the CT cerebral angiography images, JLK-LVO sends an alert to physicians, enabling rapid decisions on surgery and contributing to saving lives. Rapid diagnosis of large vessel occlusion is critical in stroke treatment, where every second counts.

The solution demonstrated high performance in U.S. clinical trials conducted for FDA approval, proving its competitiveness in the global market. Notably, the AI-provided imaging analysis results are also transmitted via a mobile app, significantly reducing the time to stroke treatment and expected to help improve patient prognosis.

Furthermore, the U.S. market potential is known to be excellent, as the U.S. NTAP insurance reimbursement for a competitor’s LVO product is set at $1,040 per case (approximately 1.4 million KRW), about 80 times higher than in Korea.

With the final FDA approval of JLK-LVO, JLK plans to actively enter the U.S. insurance reimbursement market to maximize sales and profits. Having secured an optimized FDA approval reference through this approval, the company intends to quickly proceed with FDA approval applications for other stroke solutions and perfectly implement a portfolio for local U.S. sales.

Additionally, JLK’s SnapPi (a mobile medical app), which allows viewing results of all solutions on mobile devices, is expected to contribute to securing the golden time in the U.S., where hospital transfer distances are long, by facilitating rapid stroke diagnosis, procedures, and transfers. SnapPi supports both PC and mobile, enabling real-time sharing of patients’ stroke-related clinical and imaging information and AI-analyzed quantitative data among medical staff anytime and anywhere.

JLK CEO Dongmin Kim stated, “This FDA approval is an important achievement that validates the effectiveness of the FDA approval system we have independently established. Although it will not be easy, we will faithfully carry out the planned FDA approvals and start full-scale global market expansion beginning with the U.S. We will do our best to help more patients through the rapid approval and commercialization of stroke solutions.”