FIRST PATIENT IMPLANT IN THE FIRST-IN-MAN CLINICAL TRIAL OF THE MonarQ TRANSCATHETER TRICUSPID VALVE REPLACEMENT SYSTEM IN THE WORLD
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 the Company, in partnership with inQB8 Medical Technologies, LLC (“inQB8”), has successfully completed the first patient implant in the first-in-man (FIM) clinical trial of the MonarQ Transcatheter Tricuspid Valve Replacement (“TTVR”) system (“the System”) in the world.
The TTVR procedure was performed on November 21, 2022 at the Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark, by interventional cardiologists Prof. Lars Søndergaard, M.D., Prof. Ole De Becker, M.D. and cardiothoracic surgeon Morten Smerup, M.D., Jacob Moller, M.D. (Echocardiographer), Hasse Moeller-Sorensen, M.D. (Anesthesiologist), along with inQB8 co-founder, executive Chairman, Chief Medical Officer, and cardiac surgeon, Arshad Quadri, M.D. The MonarQ TTVR system is an innovative option for treating tricuspid regurgitation. The System has a unique biodynamic attachment system that utilizes and preserves the heart’s natural motion to secure the implant to the native leaflets, distribute systolic loads, and minimize paravalvular leaks over a wide range of annulus sizes.
Reference is made to the Company’s announcement dated June 10, 2021. The Company entered into a strategic partnership with inQB8 and agreed to acquire the MonarQ TTVR technology, which inQB8 continues to develop on the Company’s behalf. The Company owns the global right of the MonarQ TTVR technology and the product developed on the basis of it. The successful completion of the first patient implant of the FIM clinical trial of the MonarQ TTVR system is a milestone for the Company to expand our global presence and innovative structural heart portfolio. The Company will continue the clinical trial in the hope of bringing a safe and effective product to more and more patients around the world.
