MEDIPOST Gains FDA Approval for Phase 3 Study of CARTISTEM in U.S.
MEDIPOST, a biotechnology company specializing in cell therapy, has secured FDA approval to conduct a single pivotal Phase 3 study for its knee osteoarthritis treatment, CARTISTEM, in the U.S. This agreement marks a significant step in MEDIPOST's efforts to bring its treatment to the U.S. and Canadian markets. The company plans to leverage successful Phase 3 data from South Korea and Japan, along with real-world evidence from 550 patients, to support its U.S. clinical development. This strategy aims to expedite the treatment's commercial entry into the U.S. market.