According to the Zhitong Finance App, Jianshi Technology-B (09877) announced that the company's self-developed transducer tricuspid valve replacement system LUX-Valve Plus successfully completed the first batch of subjects implanted in key registered clinical trials (Pivotal Trials) approved by the US Food and Drug Administration (FDA), and breakthrough progress has been made in US registered clinical trials. This marks another important milestone in the Group's globalization strategy after the product obtained EU MDR CE certification.

The US key registered clinical trial of Lux-Valve Plus, a transcatheter tricuspid valve replacement system, is a forward-looking, global multi-center clinical trial covering the US, Canada and several European countries. It will randomly control Edwards Life Sciences' EVOQUE system head-to-head to mainly evaluate the safety and efficacy of LUX-VALVE Plus in patients with severe tricuspid valve reflux.

Based on LUX-VALVE Plus's unique design advantages and excellent clinical performance, its key US registered clinical trials have received active participation from many centers around the world, and we will continue to accelerate its Pivotal Trial clinical trial process.

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