[Click eStock] "JLKE, Accelerated Entry Speed into the US Market"

Shinhan Investment Corp. analyzed on the 23rd that JLK is rapidly entering the U.S. market based on the world's largest 13 types of stroke AI solutions.

Jiwoo Baek, a researcher at Shinhan Investment Corp., stated in a report on the same day, "JLK is visualizing its entry into the U.S. market, which has approximately 80 times higher medical fees and a much larger market size compared to Korea," adding, "The early entrants, Viz AI and Rapid AI, have already obtained FDA approval and insurance reimbursement, leading the smooth entry phase of AI medical devices into the U.S. healthcare market, which will enable the latecomer JLK to quickly expand overseas."

He also explained that JLK is the first company to possess AI solutions covering the entire stroke cycle from hospitalization to rehabilitation, aiming for final FDA approval for more than two of the six solutions currently under FDA application by this year, and that this represents a positive major momentum for entering the U.S. healthcare market in 2025.

Attention was also drawn to the platform ‘SNAPPY’ (hereafter Snapppy), which is equipped with all stroke AI solutions. Utilizing Snapppy can reduce the golden time by 110 minutes, making it optimized for the U.S. healthcare environment that covers patients across wide regions, and is expected to facilitate the expansion of hospital market share within the U.S.

JLK is focusing on the U.S. market, where insurance fees are 80 times higher and the market size is 10 times larger than in Korea, and has completed FDA approval applications for JLK-LVO (large vessel occlusion) and two other solutions. Additionally, it plans to submit applications for three more solutions and aims to receive FDA approval for two solutions within this year. Subsequently, through obtaining CPT (Current Procedure Terminology) codes, it plans to enter 200 hospitals in the first year.

Accordingly, Shinhan Investment Corp. projected that even assuming 50% of the fees compared to competitors, JLK could achieve a minimum sales revenue of approximately 30 billion KRW. Considering the 48 billion KRW capital increase for U.S. market entry funding, FDA certification costs, and post-approval operating expenses, it is predicted that profitability could be achieved by the third quarter of next year, and the estimate could be revised upward depending on the acquisition of insurance fees in the U.S.

Researcher Jiwoo Baek emphasized, "Although JLK is a latecomer to the U.S. market, it possesses the world's largest number of stroke AI solutions and user-friendly applications, and due to insurance fees already obtained by early entrants, the speed of U.S. market entry is actually accelerating," adding, "It is necessary to pay attention to the momentum of entering the U.S. healthcare market, including pursuing FDA approval."