Venus Medtech (Hangzhou) Inc. (2500.HK, hereinafter referred to as the "Company")  announced the successful completion of patient enrollment in the Cardiovalve TARGET study for Transcatheter Tricuspid Valve Replacement (TTVR), with a total of 150 patients enrolled. The completion of enrollment marks a major milestone toward European regulatory approval for Cardiovalve's Transcatheter Tricuspid Valve Replacement (TTVR) system, the company's flagship solution for treating tricuspid regurgitation.

With enrollment now complete, the company is preparing to submit its CE Mark application to European regulators later this year. Pending approval, commercial launch of the Cardiovalve TR system in Europe is projected for 2027.

Building on this achievement, Cardiovalve is also preparing to initiate its AHEAD study, which will evaluate the safety and performance of Cardiovalve's mitral valve replacement system in patients suffering from significant mitral regurgitation (MR). The AHEAD study is designed to support a future CE Mark application for the mitral system.