LuX-Valve Plus Approved for Hong Kong-Macao Medicine and Equipment Connect

LuX-Valve Plus has successfully obtained this approval for commercial clinical application in mainland of GBA by leveraging its extensive successful clinical application experience, outstanding clinical performance, and unique and advanced product design in major countries/regions worldwide, including Asia-Pacific, North America, Europe, South America, and Middle East. Through this access pathway, LuX-Valve Plus is expected to initially meet the urgent and substantial treatment needs of patients suffering from tricuspid regurgitation (TR) in the region.

LuX-Valve Plus has successfully obtained this approval for commercial clinical application in mainland of GBA by leveraging its extensive successful clinical application experience, outstanding clinical performance, and unique and advanced product design in major countries/regions worldwide, including Asia-Pacific, North America, Europe, South America, and Middle East. Through this access pathway, LuX-Valve Plus is expected to initially meet the urgent and substantial treatment needs of patients suffering from tricuspid regurgitation (TR) in the region.

LuX-Valve Plus is an independently developed transcatheter tricuspid valve replacement system designed for patients with severe TR and high surgical risk. TR presents significant unmet clinical needs, particularly in cases involving severely dilated tricuspid annular and complex anatomical structures, where safe and effective treatment options have long been scarce. LuX-Valve Plus features a globally innovative valve design with ventricular-septum anchoring and a self-adaptive anti-leak ring. Delivered via transjugular approach and available in seven sizes (40mm-70mm), it is suitable for patients with TR presenting various anatomical challenges and barely has other treatment options. The product has been successfully implanted worldwide, with follow-up results showing good safety and efficacy profiles. Its technological advancement and clinical value have gained widespread recognition in the international market.

The Company will fully take advantage of this policy opportunity to actively promote commercial implantation of LuX-Valve Plus, accelerate market penetration, and proactively address the substantial unmet clinical needs. It will further accumulate essential experience for the subsequent comprehensive expansion of LuX-Valve Plus in global markets, driving the Company to achieve long-term sustainable revenue growth.

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