[Featured Stock] JLK, Prostate Cancer Diagnosis AI Solution Receives FDA Approval

JLKE stock surged. The news that the artificial intelligence (AI) prostate cancer diagnosis solution ‘MEDIHUB Prostate’ received FDA 510(k) approval appears to have influenced the stock price.

At 10:44 a.m. on the 24th, JLKE was trading at 16,050 KRW, up 29.96% from the previous trading day.

MEDIHUB Prostate, approved by the FDA, is an AI prostate cancer diagnosis solution developed by JLKE through clinical trials with Seoul Asan Medical Center and the University of Missouri in the United States. It utilizes multiparametric prostate MR imaging for the diagnosis and follow-up of prostate cancer. A thorough histological understanding of the disease and extensive experience with MR imaging are required.

Since the diagnosis difficulty varies depending on the interpreting physician’s expertise, the globally recognized biomarker PIRADS (Prostate Imaging Reporting and Data System) score is standardized and used. The AI comprehensively analyzes prostate MR images and provides necessary data such as prostate-specific antigen diagnosis.

JLKE CEO Kim Dong-min explained, "We plan to enter the U.S. market using solutions for diseases with market potential," and added, "We have set an aggressive goal to apply for FDA approval for five solutions this year." He further stated, "Our goal is to obtain U.S. insurance reimbursement for at least one solution so that it can be billed in medical settings."

He continued, "Between August and October this year, we will apply for FDA approval for about three solutions," and added, "We cautiously expect good news soon regarding the stroke solution LVO (Large Vessel Occlusion) solution that we have applied for FDA approval."