PEIJIA-B(09996.HK)：Submits CE Mark Application for Mitral Valve Repair System in the EU Recently
NewTimeSpace News: Peijia Medical Limited (09996.HK) announced on February 9, 2026 that the company has recently officially submitted the EU MDR CE mark registration application for its self-developed GeminiOne® Transcatheter Edge-to-Edge Repair System for the treatment of mitral regurgitation, marking progress in the product's global strategic layout. The registration application for the product in China has also been accepted, and it has obtained approval from the US FDA to initiate early clinical studies.
NewTimeSpace News: Peijia Medical Limited (09996.HK) issued a voluntary announcement on February 9, 2026 that the company has recently officially submitted the EU MDR CE mark registration application for its GeminiOne® Transcatheter Edge-to-Edge Repair System for the treatment of mitral regurgitation, with HighLife SAS as its European partner. This move marks steady progress in the company's advancement of its product globalization strategy.
GeminiOne® is an innovative transcatheter edge-to-edge repair device independently developed by the company. Its unique design includes a sliding mechanical structure, an independent leaflet grasping function and an automatic locking mechanism, which is intended to reduce surgical complexity and adapt to a wider range of anatomical structures.
The announcement also disclosed that the registration application for the product in China has been accepted by the National Medical Products Administration (NMPA) and is currently under review. In addition, the product has obtained the Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct an early feasibility study. The company stated that it will actively advance the registration work of the product in China and Europe.
The company cautioned that the GeminiOne® System may not ultimately be successfully developed and commercialized, and reminded shareholders and potential investors to exercise caution when dealing in the company's shares.
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