Orthopedic and dental implant specialist CG MedTech(056090) is entering the human tissue-based biomaterials business.
CG MedTech said on the 27th that its research and production facility in Seongnam, Regen Hub (REGEN Hub), obtained approval for a tissue bank modification from the Seoul Regional Office of Food and Drug Safety.
With this approval, CG MedTech has established a foundation to carry out everything from securing human tissues for skin and bone to processing, biomaterial development, production, and quality control.
The company will promote a human-derived extracellular matrix (hECM)-based biomaterials business and a human tissue CDMO business centered on Regen Hub. hECM is a material in which cells are removed from human tissue while preserving extracellular matrix components, and it is used in tissue regeneration therapies and the medical aesthetics field.
CG MedTech plans to start with the production of skin-derived hECM and expand the business to materials derived from various tissues, including fat, bone, and cartilage. On Jun. 6, it signed an agreement with Kolon Pharmaceutical for the development, production, and supply of hECM-based biomaterials, securing its first CDMO client.
It will also expand production capacity. The company will establish a system to produce 10,000 units per month by the end of 2026 and 30,000 units per month in the first half of 2027, and later increase it to 60,000 units per month.
It will also apply CGBio's American Association of Tissue Banks (AATB) quality control experience to build a global-level quality control system and push into overseas markets.
Yu Hyun-seung, CEO of CG MedTech, said, "We will nurture Regen Hub as a core base for the hECM biomaterials platform and the human tissue CDMO business."