HMG Biologics is the Italian operating company of KCFB S.A., a privately owned biotechnology company established in 2019, built on the extensive experience of the founding partners in the biotech sector. KCFB specializes in regenerative medicine, focusing on the creation and delivery of innovative clinical treatments, particularly aimed at addressing chronic lower limb ulcers and other chronic wounds, through the development of Advanced Therapy Medicinal Products (ATMPs) as outlined under EU Regulation 1394/2007.
Our products are based on a proprietary, patented technology platform utilizing human cells as biocarriers of alarmins, which are endogenous molecules that are consistently available and released through our company’s unique industrial process. These alarmins play a crucial role in restoring the normal microenvironment of wounds, making them particularly relevant for the treatment of chronic lower limb ulcers and other chronic wounds. Currently, no available Advanced Therapy Medicinal Products offer such a significant cure potential in the field of regenerative medicine.
FBPlus is our first Advanced Therapy Medicinal Product (ATMP), a novel allogeneic epidermal and dermal substitute designed for the treatment of chronic lower limb ulcers (CLLU). It is characterized by its content of HMGB1 group proteins, which serve as markers for its role as a biocarrier of alarmines, promoting tissue regeneration and repair in the context of chronic wounds. Additionally, it is classified as a Tissue Engineering Product by the EMA, reflecting its significance in regenerative medicine.
FBPlus is capable of restoring the normal microenvironment of chronic wounds, particularly in the treatment of chronic lower limb ulcers, thereby activating the healing process efficiently. Currently, we are not aware of any Advanced Therapy Medicinal Products that employ this same mechanism of action with comparable efficacy in the field of regenerative medicine.