JLK seeks FDA’s nod for stroke diagnosis AI solution to enter US market

JLK, a medical AI company listed on Kosdaq, has begun knocking on the U.S. market earnestly.

The company heralded its full-scale entry into the U.S. market last Friday (KST) by completing the license application for its AI solution, JLK-LVO, to the U.S. FDA.

JLK-LVO is an AI-based solution that quickly detects large vessel occlusion (LVO) through angiography CT images.

By getting the final FDA approval, JLK plans to maximize sales and profits by entering the U.S. insurance reimbursement market. The company expects a quantum jump in sales as the insurance fee for AI solutions for LVO detection in the U.S. is $1,040 (1.42 million won) per session, dozens of times higher than in Korea.

In addition, as rapid stroke diagnosis, treatment, and transfer decisions are more important in the U.S. due to the long travel distances between hospitals, the company has prepared a perfect localization strategy by embedding the solution in its application, “Snappy.”

Snappy is an application that contains all 11 stroke solutions developed by JLK and is available on mobile and PC. It is characterized by a dedicated chat function among medical staff and a video-sharing function, greatly improving convenience.

"JLK-LVO's entry into the U.S. market will accelerate innovation in the field of early stroke diagnosis and treatment, which we believe will ultimately play an important role in improving patient survival and quality of life," JLK CEO Kim Dong-min said.

Kim continued, "We plan to complete FDA filings for five stroke AI solutions this year and look forward to accelerating our revenue growth by entering the highly reimbursed U.S. healthcare market."