JENSCARE-B: LUX-VALVE PLUS approved for entry into Hong Kong and Macau medical device market

According to the Zhitong Finance APP, JENSCARE-B (09877) announced that its subsidiary Jenscare Scientific (Netherlands) B.V. has officially received approval for its product LuX-Valve Plus through the transjugular tricuspid valve replacement system to enter the Hong Kong and Macau Medical Device Directory, allowing for commercial clinical use in designated medical institutions in the Greater Bay Area.

The "Hong Kong and Macau Medical Device Pass" is a medical innovation policy implemented in the Guangdong-Hong Kong-Macao Greater Bay Area, allowing public hospitals in Hong Kong and Macau to use drugs or medical devices that have been purchased and are urgently needed in mainland clinical settings, approved for use in designated medical institutions in the Greater Bay Area, aiming to meet patients' urgent needs for advanced medical technology, provide more diversified treatment options for patients, and offer an efficient access channel for innovative medical devices.

LuX-Valve Plus has successfully passed the "Hong Kong and Macau Medical Device Pass" approval due to its extensive successful clinical application experience in important countries and regions worldwide, including the Asia-Pacific, North America, Europe, South America, and the Middle East, excellent clinical performance, and unique advanced product design, enabling it to be commercially applied in clinical settings in the Greater Bay Area, with the potential to meet the urgent treatment needs of numerous patients with tricuspid regurgitation in the region.

LuX-Valve Plus is an independently developed transcatheter tricuspid valve replacement system specifically designed for patients with severe tricuspid regurgitation and high surgical risk. There is a significant unmet clinical need for tricuspid regurgitation, especially for patients with severe tricuspid annular dilation and complex anatomical structures, who have long lacked safe and effective treatment options. LuX-Valve Plus features globally innovative interventricular anchoring and a self-adaptive anti-leak ring valve design, combined with a transjugular approach, and offers seven size models ranging from 40mm to 70mm, suitable for various anatomical challenges with almost no other treatment options for tricuspid regurgitation patients, demonstrating excellent clinical performance. The product has successfully completed numerous implantations worldwide, and follow-up results show that LuX-Valve Plus has good safety and excellent efficacy, with its technological advancement and clinical value widely recognized in the international market.

In addition, the company will fully seize the opportunities presented by the "Hong Kong and Macau Medical Device Pass" policy, actively promote the commercialization of LuX-Valve Plus in the Greater Bay Area, accelerate market penetration, and actively serve the unmet clinical needs of a large number of patients, while also accumulating key experience for further expansion into domestic and overseas markets, driving the group's revenue to achieve long-term sustainable growth