PEIJIA-B (09996) announced that it has formally submitted the EU MDR CE mark registration application for the GeminiOne® transcatheter edge-to-edge repair (TEER) system, intended for the treatment of mitral regurgitation. HighLife SAS serves as its European partner. The submission of the CE mark application reflects the company's steady progress in advancing its global strategy. GeminiOne® is an innovative TEER device developed internally by the company. Its unique sliding-groove mechanical design maintains a compact implant size and delivery system while achieving longer clip arm length. Other innovations include an independent leaflet capture function to reduce procedural complexity, an automatic locking mechanism that prevents repeated locking and unlocking during surgery, and a multi-angle release design adaptable to a wider range of anatomies. The system's design has been patented globally and has passed multiple freedom-to-operate analyses. As of the announcement date, the registration application for GeminiOne® has been accepted by the National Medical Products Administration of China and is under review. Additionally, GeminiOne® has received Investigational Device Exemption approval from the U.S. Food and Drug Administration to conduct an early feasibility study. The company will actively advance the product's registration in China and Europe, committed to providing safe and effective treatment options for patients with mitral regurgitation as soon as possible.