Core Viewpoint - Peijia Medical Limited has submitted the CE Mark registration application for its GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System, marking a significant step in its globalization strategy and commitment to expanding in international markets [2][4]. Group 1: Product Development - The GeminiOne TEER device features a unique sliding groove mechanism for longer coaptation length while maintaining a smaller implant size and delivery system [3]. - It incorporates an independent leaflet grasping design to reduce procedural complexity, an auto-locking mechanism to prevent repeated locking and unlocking, and a multi-angular detachment capability for accommodating various anatomical variations [3]. - The design has been patented globally and has passed multiple freedom-to-operate analyses [3]. Group 2: Regulatory Progress - In addition to the EU submission, the GeminiOne registration application has been accepted by the National Medical Products Administration (NMPA) of China and is under review [4]. - The system has received Investigational Device Exemption (IDE) approval from the U.S. FDA for an Early Feasibility Study in the United States [4]. Group 3: Company Overview - Peijia Medical, established in 2012 and headquartered in Suzhou, China, focuses on the interventional procedural medical device market and aims to become a leading global medical device platform for structural heart and neurovascular diseases [8]. - The company currently has four TAVR systems and nearly twenty neurointerventional devices registered in China, along with various innovative product candidates at different development stages [8].