全球首植！自体组织工程瓣膜破局

Core Viewpoint - GrOwnValve has developed a revolutionary self-growing heart valve, AdultValve, which utilizes the patient's own tissue, potentially transforming the treatment of heart valve diseases and reducing the need for multiple surgeries [7][19]. Company Overview - GrOwnValve was founded in 2019 by pediatric cardiologist Boris Schmitt and entrepreneur Jasper Emeis, based in Berlin, Germany. The company focuses on developing a revolutionary, self-growing, autologous transcatheter heart valve system [19]. Product Introduction - AdultValve is made from the patient's own pericardial tissue, designed using 3D imaging technology, and features a delivery system for minimally invasive implantation, avoiding open-heart surgery [11][13]. - The valve is expected to have superior biocompatibility and durability, eliminating issues related to calcification and dependence on anticoagulant medications [11][13]. Clinical Trials - The GECT-DZHK28 study, initiated by the German Center for Cardiovascular Research, aims to assess the safety and short-term efficacy of the GrOwnValve transcatheter pulmonary valve, particularly suitable for children as it can grow and remodel with the patient [15][17]. - The study has a budget of approximately €418,966 and aims to recruit 57 patients, with follow-ups every three months for five years [17][18]. Industry Context - Heart valve disease treatment has advanced significantly, but challenges remain regarding valve durability and long-term patient outcomes. There is a growing demand for safer, longer-lasting, and minimally invasive valve solutions, especially for younger patients [6][7].