· Application for product license modification to add ankle cartilage damage indications to the existing knee cartilage damage treatment.
· Hyundai Bioland plans to enter the domestic market with exclusive sales rights for ankle indications after receiving product approval from the MFDS.

MEDIPOST (078160, CEO Oh Won-il) announced on the 27th that it has completed the application for a product license modification with the Ministry of Food and Drug Safety (MFDS) to add ankle cartilage damage to the indications for the stem cell therapy, CARTISTEM^®.

CARTISTEM^®, an innovative therapy using umbilical cord blood-derived stem cells , has been widely used for the treatment of knee cartilage damage since its approval in 2012. This product license modification application is intended to expand CARTISTEM^®‘s applicable indications to include ankle cartilage damage.

In December 2018, MEDIPOST transferred to Hyundai Bioland the rights for the Phase 3 clinical trial of CARTISTEM^® for ankle indications, which was conducted from March 2020 to June 2022 with a total of 102 participants at 6 hospitals in South Korea, including Samsung Medical Center. The results of the trial were announced in last July.

The Phase 3 trial results showed statistically significant differences in cartilage defect regeneration scores and image evaluation structural improvement scores in the treatment group (CARTISTEM^® treatment group) compared to the control group (microfracture). In terms of safety, no statistically significant difference was found between the two groups, and no serious adverse reactions were reported.

MEDIPOST anticipates to successfully pass the review process of the Ministry of Food and Drug Safety based on the clinical data for CARTISTEM^®‘s ankle indications. Should the application for approval be granted, CARTISTEM^® poised to become the first stem cell therapy in South Korea for the treatment of osteochondral lesions of the talus in the ankle joint.

A MEDIPOST representative stated, “Current surgical treatments only offer limited effects for the damage to the osteochondral of the talus, ankle bone, and the long-term prognosis is not good,” and added, “Through this product license application, we expect CARTISTEM^® to offer a new treatment option for many patients.”

Following the approval of the product license by the Ministry of Food and Drug Safety, Hyundai Bioland plans to exercise its exclusive rights to sell in South Korea and to initiate full scale distribution and marketing of the CARTISTEM^® treatment for ankle indications.

A Hyundai Bioland representative stated, “Through our partnership with MEDIPOST, we look forward to further expanding the potential of stem cell therapies and contributing to improving patients‘ quality of life,” and announced that “We plan to supply the therapy through the six university hospitals involved in the clinical trials and specialized hospitals in the Seoul metropolitan area, and subsequently expand to regional markets in the future.”