VENUS MEDTECH-B (02500): Completion of Clinical Enrollment for CARDIOVALVE TTVR Confirmation Study

Stock News
2025/10/24

VENUS MEDTECH-B (02500) announced that it has successfully completed the enrollment of all 150 patients in the European confirmatory clinical study of its catheter-based valve replacement innovation system, Cardiovalve, for transcatheter tricuspid valve replacement (TTVR). This marks a significant development in the treatment of tricuspid regurgitation and represents an important milestone in the pursuit of CE MDR approval. The TARGET confirmation clinical study is a prospective, multi-center, single-arm study targeting patients with tricuspid regurgitation, conducted across over 30 cardiovascular centers in Europe (primarily Germany, Italy, and Spain), the UK, and Canada, with a total of 150 patients recruited. Cardiovalve is an independently developed catheter-based replacement product that can treat both mitral and tricuspid regurgitation. Compared to similar products, Cardiovalve's approach via the femoral vein significantly enhances treatment safety. The product features a maximum 55mm large valve ring design that accommodates approximately 95% of patients, along with a unique short valve frame design that effectively reduces the risk of left ventricular outflow tract obstruction. Cardiovalve is simple to operate, safe, and highly replicable, requiring only three steps: positioning, anchoring, and releasing. The board is confident that completing the enrollment of all patients in the European confirmatory clinical trial for Cardiovalve is a major milestone in its listing process and represents a significant advancement in innovative therapies for tricuspid regurgitation worldwide. Leveraging the company's established strengths in research and development, manufacturing, and commercialization in the global structural heart disease field, the company will continue to actively promote the global clinical registration development of innovative products, including Cardiovalve, to ensure competitive products are approved promptly, benefiting more patients while achieving the company's internationalization strategy.

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