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L&C Bio (KOSDAQ: 290650) announced on the 16th that its degenerative arthritis treatment device, MegaCarti®, has been selected by the National Evidence-based Healthcare Collaborating Agency (NECA) for the New Health Technology Assessment (nHTA) Deferment Program.
MegaCarti® is the world’s first cartilage repair medical device based on decellularized human hyaline cartilage tissue. It is directly implanted into damaged cartilage areas to help regenerate hyaline cartilage while reducing pain and promoting tissue integration and remodeling.
The nHTA Deferment Program allows medical devices that have been approved by the Korea Ministry of Food and Drug Safety (MFDS) and are deemed to have no safety concerns to be used in clinical practice for up to two years without undergoing a full nHTA review. During this period, a provisional procedure code is granted, enabling the device to be used on a non-reimbursed basis in hospitals and clinics. MegaCarti® will now be available to patients at university hospitals and orthopedic specialty centers.
CEO Hwan-Chul Lee of L&C Bio stated:
“Being selected for the nHTA Deferment Program enables us to offer MegaCarti® to elderly patients suffering from degenerative arthritis who previously had limited treatment options. We believe this will significantly enhance their quality of life.”
“Even during the deferment period, we will work diligently to build additional clinical evidence to support the full approval process.”
