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.
MEDIPOST secured the FDA's agreement by leveraging its successful Phase 3 clinical study data from both South Korea and Japan. In addition, its South Korea based Real-World Evidence (RWE) data from approximately 550 patients who were treated with CARTISTEM® a minimum of three years ago, will also be included in the proposed evidentiary package to the FDA as confirmatory evidence to support the anticipated outcome for the U.S. Phase 3 study.
Antonio Lee, Global President of MEDIPOST and CEO of MEDIPOST K.K. (Japan) and Co-CEO of MEDIPOST Inc. (U.S.), stated, "We will leverage the time & cost saving advantages secured through this agreement, together with our successful experience in conducting Phase 3 trials both in South Korea and Japan, to ensure the smooth execution of our U.S. Phase 3 study." He continued, "Together with the recent clinical success in Japan, this milestone catalyzes our U.S. commercialization strategy and global partnership discussions.", "We are also pleased to partner with the U.S. FDA and appreciate their willingness to show regulatory flexibility to support accelerating novel advanced therapeutic products' entry into the U.S. market."
About MEDIPOST
Founded in 2000, MEDIPOST is a global stem cell therapy company with integrated capabilities spanning across discovery research and clinical development of allogeneic cell therapy assets, cord blood banking, and cell and gene therapy contract development and manufacturing (CDMO) business portfolios. MEDIPOST successfully commercialized the world's first regulatory-approved (2012) allogeneic human umbilical cord blood-derived mesenchymal stem/stromal cell (hUCB-MSC) therapy product, CARTISTEM®, for the treatment of knee osteoarthritis patients across all age groups. Since the product launch in 2012, over 36,000 patients have received CARTISTEM® treatment in South Korea.
SOURCE MEDIPOST
Share this article