PEIJIA-B (09996.HK): NMPA Approval for Registration Application of GeminiOne® Transcatheter Edge-to-Edge Repair System
- The approval of GeminiOne® represents a significant expansion of the Group's transcatheter valve therapeutic portfolio, following its established presence in the treatment of aortic stenosis and aortic regurgitation.
- The EU MDR CE Mark registration application for GeminiOne® has been submitted, and the U.S. Early Feasibility Study is currently underway (as per the Company's announcements dated 9 February 2026 and 9 April 2026).
- The Company may not be able to ultimately market GeminiOne® successfully, and shareholders and potential investors are advised to exercise caution when dealing in the shares of the Company.
NewTimeSpace News: On 11 September 2026, Peijia Medical Limited (stock code: 09996.HK) made a voluntary announcement. The board of directors of the Company is pleased to announce that the Company's internally developed GeminiOne® Transcatheter Edge-to-Edge Repair ("TEER") System ("GeminiOne®") has recently received approval from the National Medical Products Administration of the People's Republic of China (the "NMPA") for its registration application.
The approval of GeminiOne® marks the Group's entry into the commercial treatment of mitral regurgitation and represents a significant expansion of its transcatheter valve therapeutic portfolio, following its established presence in the treatment of aortic stenosis and aortic regurgitation.
References are made to the Company's announcements dated 9 February 2026 and 9 April 2026 in relation to the EU MDR CE Mark registration application and the U.S. Early Feasibility Study of GeminiOne®, respectively. The EU MDR CE Mark registration application for GeminiOne® has been submitted, and the U.S. Early Feasibility Study is currently underway. The Company may not be able to ultimately market GeminiOne® successfully. Shareholders of the Company and potential investors are advised to exercise caution when dealing in the shares of the Company.
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