JENSCARE-B (ASX: 09877) shares rose sharply, gaining more than 7% in today's trading session.

At the time of writing, the stock was up 7.46% to HK$8.21, with a trading turnover of HK$1.2577 million.

Key Development Driving the Move

The catalyst for the share price increase was a company announcement. JENSCARE-B reported that its self-developed transvenous tricuspid valve replacement system, known as LuX-Valve Plus, has recently obtained CE certification under the European Union's new Medical Device Regulation (MDR).

The company described this as a major milestone in its internationalization strategy.

Product Background and Global Recognition

The LuX-Valve series of products has previously received significant international recognition. It was selected for the European Clinical Expert Committee's scientific advice pilot program, granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), chosen to participate in the FDA's Total Product Lifecycle Advisory Program, and entered China's National Medical Products Administration (NMPA) special review process for innovative medical devices.

Clinical Experience and Market Plans

According to the announcement, the LuX-Valve series has already been clinically implanted in over a thousand patients across dozens of countries and regions spanning five continents. This has provided extensive application experience and addressed a significant clinical treatment gap for patients with tricuspid regurgitation, particularly those with complex anatomical structures.

The company stated it is actively accelerating the commercialization process for LuX-Valve Plus in Europe and globally, aiming to achieve its long-term international strategic objectives.