FIRST PATIENT ENROLLMENT IN THE MULTI-CENTER REGISTRATION CLINICAL TRIAL OF GeminiOne® TRANSCATHETER EDGE-TO-EDGE REPAIR SYSTEM IN CHINA

This announcement is made by Peijia Medical Limited (the “Company”, together with its subsidiaries, the “Group”) on a voluntary basis to provide the shareholders of the Company and potential investors with updated information in relation to the latest business and new product development progress of the Group. 

The board (the “Board”) of directors (the “Directors”) of the Company is pleased to announce that on November 24, 2022, the Company has enrolled the first patient in the multi-center registration clinical trial of GeminiOne® transcatheter edge-to-edge repair (“TEER”) system (the “System”). The first procedure was successfully completed by Prof. Xiangbin Pan and his team at Fuwai Yunnan Cardiovascular Hospital. The procedure went smoothly and the overall instrument handling time was only approximately thirty minutes. The registration clinical trial of GeminiOne® TEER system is a prospective, multi-center, single-arm study of assessing the safety and efficacy of the System for treating patients with moderate to severe or severe degenerative mitral regurgitation, led by Prof. Shengshou Hu, member of the Chinese Academy of Engineering. Results from this multi-center registration clinical trial would be included in the Company’s future submission of registration application to the National Medical Products Administration.

GeminiOne® TEER system is an edge-to-edge repair device independently developed by the Company. The product has a unique design, which enables a longer coaptation length while still maintaining smaller implant size and delivery system. Other innovations include its independent leaflet grasp that reduces the complexity of the procedure, auto-locking mechanism that avoids repeatedly lock and unlock during the procedure, as well as multiangular detachment that copes with a wider range of anatomy.