Core Viewpoint - The approval of LuX-Valve Plus for commercial clinical use in the Greater Bay Area marks a significant advancement in addressing the unmet clinical needs of patients with severe tricuspid regurgitation, particularly in high-risk surgical cases [1][2] Group 1: Product Approval and Market Entry - Jenscare Scientific's LuX-Valve Plus has been officially approved to enter the Hong Kong-Macao Medical Device Directory, allowing its use in designated medical institutions in the Greater Bay Area [1] - The "Hong Kong-Macao Medical Device Pass" policy aims to facilitate the entry of urgently needed medical devices and drugs into the mainland, enhancing patient access to advanced medical technologies [1] Group 2: Product Features and Clinical Performance - LuX-Valve Plus is designed specifically for patients with severe tricuspid regurgitation and complex anatomical structures, offering a solution where few effective treatments exist [2] - The product features innovative design elements such as inter-ventricular anchoring and adaptive anti-leak rings, available in seven sizes from 40mm to 70mm, demonstrating excellent clinical performance and safety [2] Group 3: Strategic Market Expansion - The company plans to leverage the "Hong Kong-Macao Medical Device Pass" policy to accelerate the commercialization of LuX-Valve Plus in the Greater Bay Area, aiming to meet the significant clinical demand [2] - Successful implantation and follow-up results globally have established LuX-Valve Plus's clinical value and advanced technology, which will support the company's long-term revenue growth and market expansion [2]
健世科技-B(09877)：LUX-VALVE PLUS获准进入港澳药械通