VENUS MEDTECH-B(02500) announces the mid-term clinical results of the innovative Cardiovalve transcatheter valve replacement system in the TARGET study.

VENUS MEDTECH-B (02500) announced the mid-term clinical results of the TARGET study of the company's innovative Cardiovalve transcatheter valve replacement system. The TARGET study is a prospective, single-group, multicenter clinical study aimed at evaluating the safety and clinical performance of the Cardiovalve transcatheter valve replacement system. The mid-term clinical trial data of the TARGET study include 125 patients from 25 clinical centers in Germany, Spain, Italy, Canada, and the United Kingdom, with an average age of 77 years. The clinical results of the TARGET study showed: (1) an average device operation time of 5829 minutes, with the shortest device operation time being only 16 minutes; and (2) based on the Tricuspid Valve Academic Research Consortium (TVARC) standard, the overall intraoperative success rate was 88%. The success rate in the device implantation group was as high as 95%. Effectiveness results showed: (1) Improvement in the degree of tricuspid valve regurgitation: A follow-up at 6 months post-operation showed that 100% of patients did not have moderate or severe regurgitation, and this effectiveness was maintained during the 12-month follow-up period; (2) Improvement in heart function according to New York Heart Association criteria: At 6 months post-operation, 88% of patients had improved heart function to I/II grade, which increased to 90% at 12 months. No patients with NYHA IV grade heart function were observed during the 6-month follow-up, and this effectiveness was maintained during the 12-month follow-up; (3) Quality of life: Kansas City Cardiomyopathy Questionnaire scores increased by an average of 20 points at 6 months, and this improvement was maintained during the 12-month follow-up. The 6-minute walk distance increased by an average of 44 meters at 6 months and 32 meters at 12 months during the follow-up. Safety results showed: As determined by the Clinical Events Committee (CEC), the incidence of major adverse events (MAE) in the first 30 days post-operation was as follows: The table above lists the main differences between the previous Cardiovalve TR delivery system (model: CVU0011) and the modified Cardiovalve-TR delivery system (model: CVU0013). Only model CVU0013 is CE certified. In the ITT subgroup, 26 subjects (20.8% of the cohort) experienced MAE within 30 days post-operation. Of these, 14 subjects reported two or more MAEs, with a total of 41 events. The 12-month clinical follow-up data of the TARGET study showed that Cardiovalve demonstrated good safety and clinical performance, with continuous improvement in patient quality of life, and the rate of safety events remained stably low compared to the 30-day follow-up results. 65.8% of patients enrolled in the TARGET study received implantation of a large size (55mm) prosthetic valve. Long-term follow-up data for Cardiovalve and global clinical research evidence are still accumulating. The mid-term clinical data of the Cardiovalve tricuspid valve replacement system released at the PCRL London Valves2025 conference fully demonstrated the excellent clinical effectiveness of the product in treating severe tricuspid regurgitation, receiving high recognition from international clinical experts attending the conference. The company will continue to actively promote the global clinical registration and development process of innovative products, including the Cardiovalve system. Venus Medtech is committed to obtaining commercial approval for competitive products as soon as possible, so that more patients can benefit and achieve the company's internationalization strategy.