The board (the “Board”) of directors (the “Directors”) of the Company is pleased toannounce that the Company has recently formally submitted the EU MDR CE Markregistration application for the GeminiOne® Transcatheter Edge-to-Edge Repair (“TEER”)System (the “System”) for the treatment of mitral regurgitation, with HighLife SAS beingthe European partner. The submission of the CE Mark registration application signifies theCompany’s steady progress in advancing its globalization strategy.

GeminiOne® is a novel TEER device internally developed by the Company. Its uniquesliding groove mechanism enables a longer coaptation length, along with a smaller implantsize and delivery system. Additional innovations include an independent leaflet grasp thatreduces procedural complexity, an auto-locking mechanism that prevents repeated lockingand unlocking during the procedure, and a multi-angular detachment that accommodates awider range of anatomy. The design of the System has been patented globally and obtainedclearance through multiple freedom-to-operate analyses.

As at the date of this announcement, the registration application for GeminiOne® has beenaccepted by the National Medical Products Administration of the People’s Republic ofChina and is currently under review. In addition, GeminiOne® has obtained InvestigationalDevice Exemption approval from the U.S. Food and Drug Administration for an EarlyFeasibility Study. The Company will actively advance the registration of the product inChina and Europe, with the aim of bringing safe and effective treatment options to patientswith mitral regurgitation at the earliest practicable opportunities.