· Achieved an average annual growth rate of 36% since launch, recording the highest revenue among stem cell therapies in Korea
· Preparing for U.S. Phase 3 IND, patient enrollment for Phase 3 clinical trials nearly completed in Japan, with other global clinical trials smoothly in progress
· Participated in BIO USA, discussing with global pharmaceutical companies on the progress of CARTISTEM®’s clinical trials and partnership opportunities
MEDIPOST (CEO Wonil Oh) announced on the 24th that the cumulative number of patients treated with CARTISTEM®, its stem cell therapy for knee osteoarthritis, has exceeded 30,000.
First approved in 2012, CARTISTEM® is the world’s first allogeneic umbilical cord blood-derived stem cell therapy proven for its long-term efficacy by reducing inflammation and regenerating damaged cartilage to its natural state.
Since receiving marketing approval in Korea, CARTISTEM® has gained steady recognition, especially after former national soccer team coach Guus Hiddink underwent surgery on both knees in 2014 and 2022 respectively. More recently, tennis legend Lee Hyung-taik also returned to daily life following CARTISTEM® treatment.
CARTISTEM® sales have achieved an average annual growth rate of 36% from launch through 2023, becoming the first stem cell therapy in Korea to surpass KRW 20 billion in annual sales and marking the highest revenue in the market. According to the National Health Insurance Service, the number of knee osteoarthritis patients in Korea exceeded 3 million in 2022 and continues to rise. CARTISTEM® is indicated for patients regardless of age or gender and is expected to see continued sales growth as it can treat both degenerative osteoarthritis, common in older adults, and osteoarthritis in younger individuals often caused by repeated traumas.
Global regulatory agencies have recognized the clinical outcomes and long-term follow-up data of CARTISTEM®‘s domestic trials, allowing direct entry into confirmatory trials for regulatory approval and commercialization. In the U.S., after discussions with the FDA, MEDIPOST was granted permission to skip Phase 2 and is now focused on finalizing clinical protocols and preparing the Investigational New Drug (IND) application for Phase 3 clinical trials. In Japan, CARTISTEM® has also bypassed Phases 1 and 2, advancing directly to Phase 3, where more than 90% of the target patient enrollment has been completed. Screening and administration are currently underway, with full administration expected to conclude in the second half of this year.
To drive its global expansion, MEDIPOST participated in the 2024 BIO International Convention (BIO USA), the world’s largest pharmaceutical and biotech exhibition, engaging in high-level discussions with global pharmaceutical companies on the progress of CARTISTEM®’s clinical trials and potential business opportunities, including licensing opportunities.
MEDIPOST CEO Wonil Oh remarked, “It is truly rewarding to see CARTISTEM®, the result of years of dedicated effort, offer hope to countless patients who have suffered from knee pain for over a decade. We are committed to continuing global clinical trials to expand CARTISTEM®’s impact beyond Korea and improve the quality of life for knee osteoarthritis patients worldwide.”