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FIRST IMPLANTATION IN THE FIM CLINICAL TRIAL OF Sutra Hemi-valve TRANSCATHETER MITRAL VALVE REPAIR SYSTEM
2025-09-12 09:46:34

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

The board (the “Board”) of directors (the “Directors”) of the Company is pleased toannounce that recently, Sutra Medical, Inc. (“Sutra”), a company in which the Groupholds a strategic investment, successfully completed the first implantation in the firstin-man (“FIM”) clinical trial of its Sutra Hemi-valve Transcatheter Mitral Valve RepairSystem. The procedure was performed at Waikato Hospital in New Zealand on an 83-yearold high-risk patient with severe functional mitral regurgitation (“MR”), a condition forwhich conventional treatment options were unsuitable. The patient recovered well and wasdischarged from the hospital on the third day.

Reference is made to the Company’s announcement dated August 27, 2021, the Companyentered into a stock purchase agreement with Sutra, a U.S.-based medical device companythat designs and develops transcatheter solutions to treat valvular heart diseases. As of thedate of this announcement, the Company is the second largest shareholder of Sutra, afterthe founding team of Sutra. Sutra’s key product candidate, Sutra Hemi-valve, is a novelposterior leaflet replacement that restores mitral valve function by coapting seamlessly withthe native anterior leaflet, eliminating MR without obstructing left ventricular outflow tract.


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