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Peijia Medical Limited
沛嘉醫療有限公司
(Incorporated in the Cayman Islands with limited liability)
(Stock Code: 9996)
VOLUNTARY ANNOUNCEMENT
RELEASE OF PARTIAL CLINICAL DATA OF
FEASIBILITY STUDIES ON THE HIGHLIFE SAS
TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM
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 of directors (the "Board") of the Company announces that partial clinical data of two feasibility studies of the HighLife SAS Transcatheter Mitral Valve Replacement ("TMVR") system, the Company's licensed-in TMVR product that uses a transeptal approach to treat patients with mitral regurgitation, has been presented at the third Chinese Structural Heart Diseases Congress (第三屆中國結構性心臟病大會), held between April 15-17, 2021.
Technical success, safety events and hemodynamic performance of the first 18 consecutive patients treated in the feasibility studies were reported in the presentation. For these 18 patients, 16 patients had a successful valve implantation and were followed up. There was no conversion to surgery or re-intervention in any of these 18 patients. Of the 16 implanted patients, one passed away during the follow-up period. The remaining 15 patients are alive to date, and have no major stroke, myocardial infarction, left ventricular outflow tract obstruction, device migration, embolization or fracture, and no conversion to surgery. Hemodynamic performance of these 15 patients improved from 3+/4+ mitral regurgitation to non/trace/1+ grade.
Shareholders of the Company and potential investors can refer to the presentation by Dr. Ruediger Lange at the third Chinese Structural Heart Diseases Congress for further details of the product and the clinical studies.
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For further details regarding the Company's collaboration with Highlife SAS, please refer to the announcement of the Company dated December 21, 2020.
THE COMPANY MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET THE HIGHLIFE TMVR SYSTEM SUCCESSFULLY. SHAREHOLDERS OF THE COMPANY AND POTENTIAL INVESTORS ARE ADVISED TO EXERCISE DUE CARE WHEN DEALING IN THE SHARES OF THE COMPANY.
By order of the Board
Peijia Medical Limited
Dr. Yi Zhang
Chairman and Executive Director
Hong Kong, April 19, 2021
As of the date of this announcement, the Board comprises Dr. Yi Zhang, Mrs. Ping Ye Zhang and Ms. Hong Ye as executive Directors, Dr. Zhiyun Yu, Mr. Jifeng Guan, Mr. Fei Chen, Mr. Jun Yang as non-executive Directors, and Dr. Stephen Newman Oesterle, Mr. Robert Ralph Parks, Mr. Wayne Wu and Mr. Wai Ming Yip as independent non-executive Directors.
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