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健世科技-B(09877):LUX-VALVE PLUS TRINITY研究及JENSCLIP临床研究随访结果于EUROPCR 2025发布,展现良好的安全性和疗效表现
智通财经网· 2025-05-23 14:29
Core Insights - The recent clinical trial results for LuX-ValvePlus and JensClip were presented at EuroPCR 2025, highlighting their safety and efficacy in treating severe tricuspid and mitral valve regurgitation [1][2] Group 1: LuX-ValvePlus - The TRINITY trial is a global, prospective, multi-center, single-arm clinical study assessing the safety and efficacy of LuX-ValvePlus in high-risk patients with severe tricuspid regurgitation [1] - The study included 161 patients from 20 centers worldwide, primarily from France, Germany, Spain, Denmark, and the UK [1] - The 30-day follow-up results demonstrated good safety and efficacy, with a low incidence of adverse events and improved quality of life for patients [1] - LuX-ValvePlus offers an excellent treatment option for patients with severe tricuspid regurgitation, particularly for those with large annuli, where treatment options are currently limited [1] - Long-term follow-up data and FDA clinical research data for LuX-ValvePlus are still being collected [1] Group 2: JensClip - JensClip is an innovative medical device designed for the treatment of severe mitral valve regurgitation, noted for its ease of use and reliability [2] - The one-year follow-up results showed a low all-cause mortality rate of only 1.8%, with minimal device-related complications [2] - 96.3% of patients exhibited no moderate or severe regurgitation, along with sustained improvements in various clinical metrics such as NYHA functional class, Kansas City Cardiomyopathy Questionnaire scores, and six-minute walk distance [2]
亏损同比收窄52.2%!健世科技最新年报
思宇MedTech· 2025-03-26 07:38
报名:首届全球眼科大会 | 议程更新 报名:首届全球心血管大会 | 奖项申报 报名:首届全球骨科大会 | 奖项评选 合作伙伴征集:2025全球手术机器人大会 心未来 2025年3月24日, 健世科技 发布了2024年度业绩公告。 2024年,公司主营业务尚未产生收入,利润端 亏损 1.8亿元 ,亏损同比收窄 52.2% 。经计算,公司24H2亏损0.75亿元,亏损同比收窄61.6%。 公司经营亮点: 三尖瓣介入置换产品 LuX-Valve Plus 在中国大陆已完成注册临床试验一年期随访,并积极根据国家药监局注册审批要求递交数据; 于欧洲进行以获取CE认证为目标的临床试验完成全部入组;在美国已经进入临床试验阶段,美国本土 临床积极推进中。 # 财报数据 主动脉瓣反流(或兼并狭窄)置换产品 Ken-Valve 已于近期获得国家药监局批准上市注册,预计于2025年上半年实现商业化植入。 二尖瓣反流修复产品 JensClip 完成确证性临床试验全部入组以及一年期随访,临床结果优异,预计在2025年尽快递交国家药监 局注册申请。 # 关于 健世科技 宁波健世科技股份有限公司 (09877.HK,简称" 健世科技 ", ...