[Click eStock] "JLJK Already Exceeded Early-Year Targets... Aggressively Targeting US and Japan"

Hanyang Securities announced on the 23rd that JLK is beginning to expand overseas through approvals such as from the U.S. Food and Drug Administration (FDA).

JLK is a medical AI stroke solution specialist company that provides early diagnosis and reading assistance solutions for stroke through artificial intelligence (AI)-based medical imaging and clinical data analysis.

Lee Joon-seok, a researcher at Hanyang Securities, stated in a report on the same day, "In August 2018, JLK became the first in Korea to receive Class 3 approval for AI medical devices from the Ministry of Food and Drug Safety, and at the end of last year, the ischemic stroke diagnosis assistance solution 'JLK-DWI' was the first AI innovation medical technology to be approved for non-reimbursement by the Ministry of Health and Welfare."

He evaluated, "The company possesses 13 solutions that can respond to the entire cycle of stroke patients' hospitalization, treatment, discharge, and rehabilitation, and has played a bridgehead role for the full-scale introduction of AI technology in domestic medical sites."

Currently, JLK's solutions have been installed in over 210 hospitals. 170 hospitals are registered with the National Evidence-based Healthcare Collaborating Agency (NECA), and 55 hospitals are registered with the Health Insurance Review & Assessment Service. Additionally, approvals and applications for the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are also underway.

The researcher said, "The domestic medical AI market has limited scalability due to population structure and insurance systems," adding, "This is one of the factors affecting the recent sluggish stock prices of medical AI companies." He continued, "In this situation, overseas expansion, especially into the U.S. market, is essential for sales growth," and added, "The U.S. market size is about 800 times larger than domestic due to high insurance fees (P) and overwhelmingly large imaging volume (Q)."

He particularly noted, "Among domestic medical AI companies, JLK is the most aggressive in entering overseas markets," explaining, "They are responding to U.S. FDA approvals with core AI stroke solutions 'JLK-VLO,' 'JLK-CTP,' and 'JLK-PWI,' and are preparing for approvals of 'JLK-CTP' and 'JLK-PWI' from Japan’s PMDA."

He forecasted, "On the 17th, JLK-CTP received U.S. FDA approval," and "JLK-PWI is expected to be approved by the fourth quarter of this year." Furthermore, he stated, "The company initially aimed to apply for five AI stroke solutions to the U.S. FDA and obtain approval for one solution at the beginning of the year, but with two solutions already approved, they have exceeded their target."