Peijia Medical Limited announced that it has formally submitted the European Union Medical Device Regulation (EU MDR) CE Mark registration application for its internally developed GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for the treatment of mitral regurgitation, with HighLife SAS being the Company's European partner.

The CE Mark submission represents a significant milestone in Peijia Medical's globalization strategy and underscores the Company's continued commitment to expanding its presence in major international markets.

GeminiOne is a novel TEER device internally developed by the Company. The system features a unique sliding groove mechanism that enables a longer coaptation length while maintaining a smaller implant size and delivery system. It also incorporates an independent leaflet grasping design intended to reduce procedural complexity, an auto-locking mechanism that helps prevent repeated locking and unlocking during the procedure, and a multi-angular detachment capability that allows the device to accommodate a wider range of anatomical variations. The design of the System has been patented globally and has obtained clearance through multiple freedom-to-operate (FTO) analyses.

In addition to the EU submission, the registration application for GeminiOne has been accepted by the National Medical Products Administration (NMPA) of the People's Republic of China and is currently under review. The system has also received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (U.S. FDA) to conduct an Early Feasibility Study (EFS) in the United States.

Peijia Medical will continue to actively advance regulatory registrations in China and Europe, aiming to bring safe and effective treatment options to patients with mitral regurgitation at the earliest practicable opportunity.