Venus MedTech (Hangzhou) Inc. has announced the formal submission of all application materials for CE MDR marking to a European Notified Body for its Cardiovalve transcatheter tricuspid valve replacement system. This voluntary announcement updates shareholders and potential investors on the latest business development and product research progress. The Cardiovalve System is designed to treat both mitral and tricuspid regurgitation, featuring a transfemoral approach and a large annulus design suitable for approximately 95% of patients. The company cautioned that there is no guarantee of eventual marketing approval for the product. No grant or funding from multiple organizations was mentioned.

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