Peijia Medical Limited (Stock Code: 9996) has formally submitted the EU MDR CE Mark registration application for its GeminiOne® Transcatheter Edge-to-Edge Repair (TEER) System, partnering with HighLife SAS in Europe. The submission marks continued progress in the company’s globalization strategy.

GeminiOne® is designed for mitral regurgitation treatment. Its features include a sliding groove mechanism to extend coaptation length, a smaller implant size and delivery system, and an independent leaflet grasp to reduce procedural complexity. The product employs an auto-locking mechanism that avoids repeated locking and unlocking, along with a multi-angular detachment feature to accommodate diverse anatomies. Patented globally, it has undergone multiple freedom-to-operate analyses.

According to the announcement, the GeminiOne® registration application has been accepted by the National Medical Products Administration of the People’s Republic of China and is under review. The system has also obtained Investigational Device Exemption approval from the U.S. Food and Drug Administration for an Early Feasibility Study.

Shareholders and potential investors are advised that the system may not ultimately be developed or marketed successfully, and caution is warranted when dealing in the company’s shares.