国内首个 常州瑞培生科“自体细胞采集器”获批上市

Company Overview - Jiangsu Ruipai Life Science Technology Co., Ltd. (Ruipai Bio) has developed the PrimCell autologous cell collector, which has received medical device registration approval, making it the first autologous skin cell instant collection product approved for clinical use in China [1] - Established in 2021, Ruipai Bio focuses on skin regeneration technology and related clinical product research and industrialization [1] Product Innovation - The PrimCell autologous cell collector is an innovative artificial skin treatment system designed for skin injury repair management, applicable for burn wounds, vitiligo, superficial scars, and chronic wounds [1] - The product utilizes a proprietary two-step method to quickly isolate skin cells from healthy tissue, allowing immediate application of the harvested autologous skin cells to the wound, effectively using the patient's own wound as an incubator for skin regeneration [1] Market Context - The development of engineered skin represents a significant milestone in wound repair over the past 30 years, moving beyond traditional skin grafting methods and offering new hope for patients [1] - Despite advancements in engineered skin, the complexity and high costs of in vitro skin tissue construction have limited the clinical application and promotion of classic artificial skin products [1] Supporting Technology - Ruipai Bio has also developed a real-time cell detection and analysis system, a fully automated high-throughput counting machine that analyzes epidermal cell concentration, viability, diameter, and aggregation rate during surgery [2] - This system ensures the stable acquisition of viable skin cells with over 90% viability, supporting the treatment efficacy of the PrimCell technology [2] Industry Development - The biotechnology and new medical device cluster in Changzhou has been rapidly developing, with nearly 590 companies projected in 2024 and a production value exceeding 50 billion yuan [2] - The Changzhou Life and Health Industry Park is a key development hub for this cluster, ranking 21st in the national biopharmaceutical industrial park comprehensive competitiveness ranking [2]