JLK's shares surge on FDA approval of AI prostate cancer diagnostic solution

Shares of JLK, a Korean AI-based medical imaging company, reached their daily upper limit on the Kosdaq market on Monday after the company announced that its prostate cancer diagnostic solution, MEDIHUB Prostate, received 510(k) clearance from the U.S. FDA.

As of 2:00 p.m., the company's shares stood at 16,050 won ($11.56), up 29.96 percent from the previous trading day. 

MEDIHUB Prostate, developed by JLK in collaboration with Asan Medical Center and the University of Missouri, leverages multiparametric prostate MR imaging for diagnosing and monitoring prostate cancer.

The solution utilizes the Prostate Imaging Reporting and Data System (PIRADS) score and integrates AI to analyze MR images, providing comprehensive diagnostic data including PIRADS assessment and Prostate-Specific Antigen (PSA) density.

"We plan to penetrate the U.S. market using our solutions for significant diseases," JLK CEO Kim Dong-min said. "This year, we aim to submit five solutions to the FDA, with at least one receiving reimbursement approval to facilitate clinical use."

In detail, JLK intends to submit approximately three more solutions to the FDA between August and October this year, Kim added.

Kim also expressed optimism about an FDA approval for their already submitted stroke solution, LVO (Large Vessel Occlusion).

Based on the FDA approval of their first solution, JLK plans to intensify its U.S. market strategy.

"We are committed to deploying all resources to establish a strong foothold in the U.S. market and will revise our strategies to ensure aggressive market penetration," Kim emphasized.

According to a 2023 report by the Global Cancer Observatory, prostate cancer is among the most prevalent cancers among men in OECD countries. In the U.S., prostate cancer is the most commonly diagnosed cancer in men and a leading cause of cancer-related deaths. The risk of developing latent prostate cancer for American men over the age of 50 is estimated to be as high as 40 percent.

Annually, more than 288,300 new cases of prostate cancer are diagnosed in the U.S., with approximately 34,700 men dying from the disease. Global Market Insights, a drug market research firm, projected that the prostate cancer market will reach $21.5 billion by 2030, with an annual growth rate of 12.4 percent.