PEIJIA-B(09996): Submitting EU MDR CE mark registration application for GeminiOne end-to-end repair system via catheter-edge guiding.

PEIJIA-B (09996) announced that the company has officially submitted an EU MDR CE mark registration application for the GeminiOne transcatheter edge-to-edge repair (TEER) system for the treatment of mitral valve regurgitation. HighLife SAS is its European partner. Submitting the CE mark registration application signifies steady progress in advancing the company's globalization strategy. GeminiOne is an innovative TEER device developed internally by the company. Its unique sliding grooved mechanical structure maintains a small implant size and delivery system while achieving a longer coaptation arm length. Other innovations include an independent leaflet grasp function to reduce surgical complexity, an automatic locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angle release design to adapt to a wider range of anatomical structures. The system's design has been patented globally and has passed multiple freedom-to-operate analyses. As of the date of this announcement, the registration application for GeminiOne has been accepted by the National Medical Products Administration of the People's Republic of China and is currently under review. Additionally, GeminiOne has received approval from the U.S. Food and Drug Administration for an investigational device exemption to conduct early feasibility studies. The company will actively pursue the registration of this product in China and Europe, aiming to provide safe and effective treatment options for patients with mitral valve regurgitation as soon as possible.