Jenscare Scientific Co., Ltd. announced that recently, the registration application of Ken-Valve, the transcatheter prosthetic aortic heart valve system independently developed by the Company, has successfully entered the priority approval process (the " Priority Approval Process") of the National Medical Products Administration (" NMPA") for medical devices. For projects entering into the Priority Approval Process, the NMPA will speed up the appraisal and approval procedures in all aspects to shorten the time for rolling-out of products and ensure that the corresponding achievements and products can be soon applied to clinical use. Up to now, only eight products have been approved by the NMPA for priority approval in 2023.

Meanwhile, Ken-Valve is the first product in the field of heart valves selected to enter the Priority Approval Process since NMPA opened the priority approval channel. The Ken-Valve transcatheter prosthetic aortsic valve system was independently developed by the Company, and the indications can cover patients with both aortic valve closure insufficiency or combined aortic valve stenosis. Ken-Valve offers treatment options and solutions for the unmet need for aortic regurgitation in a market with a large reservoir of patients in need of rescue as well as incremental patients with increasing prevalence.

Its multiple advanced design highlights have the advantage of significantly reducing the risk of serious adverse events and increasing procedural success. Ken-Valve has been submitted and accepted for registration which is the second core product of the Company submitted for registration following Lux-Valve, the trans catheter tricuspid valve replacement system independently developed by the Company. Its inclusion in the Priority Approval Process will significantly increase the speed of obtaining registration and approval and accelerate the commercialization of the product.