According to the Zhitong Finance App, Peijia Medical-B (09996) announced that the GeminiOne® transcatheter edge repair (“TEER”) system (“GeminiOne®”) independently developed by the company has recently been approved by the China Drug Administration (“State Drug Administration”) of the People's Republic of China (“State Drug Administration”).

The approval of GeminiOne® marks the Group's formal entry into the commercial treatment of mitral valve reflux, and represents the Group's significant expansion of its transcatheter valve treatment product portfolio based on the existing layout of aortic stenosis and aortic valve reflux treatment. EU MDR CE mark registration application for GeminiOne® and early US feasibility study. The EU MDR CE mark registration application for GeminiOne® has been submitted, and an early US feasibility study is currently underway.

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