Core Viewpoint - The mid-term clinical results of the Cardiovalve transcatheter valve replacement system from the TARGET study demonstrate its safety and clinical performance in treating severe tricuspid regurgitation, with positive feedback from international clinical experts at the PCRL London Valves 2025 conference [1][5]. Clinical Results - The TARGET study is a prospective, single-arm, multi-center clinical trial involving 125 patients across 25 centers in Germany, Spain, Italy, Canada, and the UK, with an average patient age of 77 years [1]. - The average procedure time for the device was 58±29 minutes, with the shortest recorded time being 16 minutes, and the overall procedural success rate was 88%, with a success rate of 95% in the device implantation group [1]. Efficacy Results - At the 6-month follow-up, 100% of patients showed no moderate or severe tricuspid regurgitation, with this efficacy maintained at the 12-month follow-up [2]. - According to the New York Heart Association (NYHA) classification, 88% of patients improved to NYHA class I/II at 6 months, increasing to 90% at 12 months, with no patients classified as NYHA class IV during the 6-month follow-up [2]. - Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved by an average of 20 points at 6 months, with sustained efficacy at the 12-month follow-up, and the 6-minute walk distance increased by an average of 44 meters and 32 meters at 6 and 12 months, respectively [2]. Safety Results - The 30-day major adverse event (MAE) rates included an all-cause mortality rate of 6.4%, heart failure readmission rate of 1.6%, and a rate of 3.2% for re-intervention due to progression of tricuspid regurgitation or device-related complications [3]. - The study reported a 12.8% incidence of BARC type IIIb-V bleeding, with 5.6% experiencing major vascular injury at the puncture site [3]. - Among the 125 patients, 20.8% experienced MAEs within 30 days, with a total of 41 events reported [4]. Long-term Follow-up - The TARGET study's 12-month follow-up data indicate that Cardiovalve shows good safety and clinical performance, with sustained improvement in patients' quality of life and a stable low incidence of safety events compared to the 30-day follow-up [4]. - 65.8% of enrolled patients received a large-sized (55mm) prosthetic valve, and long-term follow-up data and global clinical evidence for Cardiovalve are still being collected [4]. Future Development - The company is committed to advancing the global clinical registration and development process for innovative products, including the Cardiovalve system, aiming for timely market approval to benefit more patients and achieve its international strategy [5].

Core Insights - The TARGET study demonstrates the safety and clinical performance of the Cardiovalve transcatheter valve replacement system, with positive mid-term clinical results [1][5] Efficacy Results - 100% of patients showed no moderate or severe tricuspid regurgitation at 6 months, with sustained efficacy at 12 months [2] - 88% of patients improved to NYHA functional class I/II at 6 months, increasing to 90% at 12 months, with no NYHA class IV patients observed during the 6-month follow-up [2] - Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved by an average of 20 points at 6 months, maintained at 12 months; 6-minute walk distance increased by an average of 44 meters at 6 months and 32 meters at 12 months [2] Safety Results - The overall major adverse event (MAE) rate within 30 days post-surgery was 20.8%, with 41 total events reported among 26 patients [3][4] - The all-cause mortality rate was 6.4%, with heart failure readmission at 1.6% and re-intervention due to tricuspid regurgitation progression at 3.2% [3] - The study reported a 12.8% incidence of BARC IIIb-V bleeding events, with 5.6% vascular injury at the puncture site [3] Long-term Follow-up - The TARGET study indicates that Cardiovalve shows good safety and clinical performance over 12 months, with a stable low incidence of safety events compared to the 30-day follow-up [4] - 65.8% of enrolled patients received a large-sized (55mm) prosthetic valve, with ongoing accumulation of long-term follow-up data and global clinical evidence [4] Industry Recognition - The mid-term clinical data presented at the PCR London Valves 2025 conference highlighted the Cardiovalve system's exceptional clinical efficacy in treating severe tricuspid regurgitation, receiving high recognition from international clinical experts [5] - The company aims to advance the global clinical registration and development process for innovative products, including the Cardiovalve system, to benefit more patients and achieve its international strategy [5]

Core Viewpoint - The mid-term clinical results of the Cardiovalve transcatheter valve replacement system from the TARGET study demonstrate its safety and clinical performance, highlighting its effectiveness in treating severe tricuspid regurgitation [1] Group 1: Clinical Study Overview - The TARGET study is a prospective, single-arm, multi-center clinical trial conducted across 25 clinical centers in Germany, Spain, Italy, Canada, and the UK, involving 125 patients with an average age of 77 years [1] - The average procedure time for the device was 58±29 minutes, with the shortest recorded procedure time being 16 minutes [1] - The overall intraoperative success rate was reported at 88% according to the TVARC standard, with a success rate of 95% for the device implantation group [1] Group 2: Product Recognition and Future Plans - The mid-term clinical data for the Cardiovalve tricuspid valve replacement system was presented at the PCR London Valves 2025 conference, receiving high recognition from international clinical experts [1] - The company aims to actively advance the global clinical registration and development process for innovative products, including the Cardiovalve system, to expedite market approval and benefit more patients while pursuing its internationalization strategy [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責， 對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全 部 或 任 何部分內容而產生或因倚賴該等內容而引致之任何損失承擔任何責任。 杭州啓明醫療器械股份有限公司 Venus Medtech (Hangzhou) Inc. （股份代號：2500） （於中華人民共和國註冊成立的股份有限公司） 自願性公告 業務最新情況 本公告由杭州啓明醫療器械股份有限公司（「本公司」，連同其附屬公司統稱「本集團」） 自 願 刊 發，以 告 知 股 東 及 潛 在 投 資 者 有 關 本 集 團 最 新 業 務 發 展 及 新 產 品 研 發 進 度 的最新資訊。 本 公 司 董 事 會（「董事會」）欣 然 宣 佈 本 公 司 的 創 新 經 導 管 瓣 膜 置 換 系 統Cardiovalve的 TARGET研 究（「TARGET研 究」）中 期 臨 床 結 果。TARGET研究為一項前瞻性、單組、 多中心臨床研究，旨在評估Cardiovalve經導管瓣膜置換系統的安全性及臨床表現。 TARGE ...