JENSCARE-B (09877) announced that its subsidiary Jenscare Scientific (Netherlands) B.V.'s LuX-Valve Plus transjugular tricuspid valve replacement system has been officially approved for inclusion in the Hong Kong-Macao Drug and Device Connect medical device catalog, enabling commercial clinical use at designated medical institutions in mainland cities of the Greater Bay Area.
The "Hong Kong-Macao Drug and Device Connect" is an innovative medical policy implemented in China's Guangdong-Hong Kong-Macao Greater Bay Area. It allows drugs or medical devices that have been procured and used by Hong Kong and Macao public hospitals and are urgently needed for mainland clinical practice to be used at designated medical institutions in the mainland Greater Bay Area after approval. This policy aims to meet patients' urgent needs for advanced medical technologies, provide more diversified treatment options for patients, and create an efficient access pathway for innovative medical devices.
LuX-Valve Plus successfully obtained approval through the "Hong Kong-Macao Drug and Device Connect" program based on its extensive successful clinical application experience across global regions including Asia-Pacific, North America, Europe, South America, and the Middle East, excellent clinical performance, and unique advanced product design. This approval enables commercial clinical application in the mainland Greater Bay Area, expected to prioritize meeting the urgent treatment needs of numerous tricuspid regurgitation patients in the region.
LuX-Valve Plus is a self-developed transcatheter tricuspid valve replacement system specifically designed for patients with severe tricuspid regurgitation who are at high surgical risk. Tricuspid regurgitation represents a significant unmet clinical need, particularly for patients with severe tricuspid annular dilatation and complex anatomical structures, who have long lacked safe and effective treatment options.
Through its globally innovative septal anchoring and adaptive anti-leak ring valve design, combined with transjugular access approach, LuX-Valve Plus offers seven size options ranging from 40mm to 70mm. It is suitable for tricuspid regurgitation patients with various anatomical structural challenges who have virtually no other treatment alternatives, demonstrating excellent clinical performance.
The product has successfully completed numerous implantations globally, with follow-up results demonstrating LuX-Valve Plus's favorable safety profile and excellent efficacy outcomes. Its technological advancement and clinical value have gained widespread recognition in international markets.
Furthermore, the company will fully capitalize on the "Hong Kong-Macao Drug and Device Connect" policy opportunities, actively promote commercial implantation of LuX-Valve Plus in the Greater Bay Area, accelerate market penetration, and actively serve patients' unmet clinical needs. This will also accumulate key experience for subsequent comprehensive expansion in domestic and overseas markets, driving sustainable long-term revenue growth for the group.