MEDIPOST Secures FDA Agreement on Single Pivotal Phase 3 Study with Confirmatory Evidence BLA Filing Strategy for CARTISTEM® in the U.S.

SEOUL, South Korea, June 4, 2026 /PRNewswire/ -- MEDIPOST, a fully integrated commercial stage cell therapy biotechnology company, announced today that it has secured the FDA's agreement to conduct a single pivotal Phase 3 study for CARTISTEM® in the U.S. This milestone marks a significant step forward in MEDIPOST's mission to bring its first-in-class knee osteoarthritis treatment CARTISTEM® to patients in both the U.S. and Canada.

By securing this agreement, MEDIPOST seeks to accelerate CARTISTEM®'s U.S. development timeline while simultaneously improving the company's financial efficiency. Furthermore, the company now expects a significant reduction in the overall U.S. clinical development timeline and clinical development costs with an earlier BLA filing timepoint, which could facilitate an expedited commercial entry to the U.S. market than previously expected.