Core Viewpoint - The company has submitted a CE certification application for its transcatheter mitral valve repair (TMVr) system, JensClip, marking a significant step in its internationalization strategy [1] Group 1 - The JensClip system is the second product for which the company has submitted a CE certification application, following the transcatheter tricuspid valve replacement system, LuX-ValvePlus [1] - The submission of the CE certification is an important milestone for the company's growth and expansion in international markets [1]

Core Viewpoint - The company has submitted a CE certification application for its transcatheter mitral valve repair system, JensClip, marking a significant step in its internationalization strategy [1][2] Group 1: Product Development - JensClip is designed for the treatment of severe mitral regurgitation, featuring a user-friendly and reliable operation [1] - The device incorporates a claw-wedge mechanical locking design that allows for locking at any angle, ensuring stable and reliable coaptation of the leaflets [1] - The diamond-shaped valve clip design facilitates retrieval and repositioning, enhancing safety during the procedure [1] - The integrated detachment design aims to reduce potential operational risks during the detachment process, effectively shortening the operational time [1] Group 2: Clinical and Regulatory Progress - The one-year clinical follow-up results and challenging case applications of JensClip have been presented at major international academic conferences, demonstrating excellent safety and efficacy indicators [1] - The product has completed the registration application submission to the National Medical Products Administration in China and is currently under review [2] - JensClip has successfully commenced clinical applications overseas, with the company actively promoting the registration process to meet broad clinical needs [2]

Core Viewpoint - The company has submitted a CE certification application for its innovative transcatheter mitral valve repair system, JensClip, marking a significant step in its internationalization strategy [1][2] Group 1: Product Overview - JensClip is designed for the treatment of severe mitral regurgitation, featuring a user-friendly and reliable operation [1] - The device includes a claw-wedge mechanical locking design that allows for locking at any angle, ensuring stable and reliable coaptation of the leaflets [1] - The diamond-shaped valve clip design facilitates retrieval and repositioning, enhancing safety during the procedure [1] - The integrated separation design aims to reduce potential operational risks during the separation process, effectively shortening the operational time [1] Group 2: Clinical and Regulatory Progress - The one-year clinical follow-up results and challenging case applications of JensClip have been presented at major international conferences, demonstrating excellent safety and efficacy indicators [1] - In China, the product has completed the submission of its registration application to the National Medical Products Administration and is currently under review [2] - JensClip has successfully commenced clinical applications overseas, with the company actively promoting the registration process to meet broad clinical needs [2]

Core Viewpoint - The company has submitted a CE certification application for its innovative transcatheter mitral valve repair system, JensClip, marking a significant step in its internationalization strategy [1] Group 1: Product Development - JensClip is designed for the treatment of severe mitral regurgitation, featuring a user-friendly and reliable operation [1] - The device incorporates a claw-wedge mechanical locking design that allows for locking at any angle, ensuring stable and reliable coaptation of the leaflets [1] - The diamond-shaped valve clip design facilitates retrieval and repositioning, enhancing safety during the procedure and improving operational convenience [1] - The integrated separation design aims to reduce potential operational risks during the separation process, effectively shortening the device operation time [1] - JensClip's innovative design has been patented globally [1] Group 2: Clinical Trials and Regulatory Progress - One-year clinical follow-up results and challenging case applications of JensClip have been presented at international academic conferences such as EuroPCR, TCT San Francisco, and PCR London Valves, demonstrating excellent safety and efficacy indicators [2] - The product has completed the submission of its registration application to the National Medical Products Administration in China and has received acceptance, currently undergoing the registration review phase [2] - JensClip has successfully commenced clinical applications overseas, and the company is actively promoting the product's registration process to meet widespread clinical needs [2]

本公告乃由寧波健世科技股份有限公司（「本公司」，連 同 其 附 屬 公 司，統 稱「本 集 團」）按 自 願 基 準 作 出，以 向 本 公 司 股 東 及 潛 在 投 資 者 提 供 有 關 本 集 團 最 新 業 務 及 產 品 開 發 的 最 新 資 料。 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的內容概不 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 就 因 本 公 告 全 部或任何部分內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 Jenscare Scientific Co., Ltd. 寧波健世科技股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：9877） 自願公告 JensClip已遞交CE認證註冊申請 承董事會命 寧波健世科技股份有限公司 執行董事兼首席執行官 潘斐先生 香 港，二 零 二 五 年 十 二 月 二 十 八 日 本公司董事（「董 事」）會（「董事會」）欣 然 宣 佈，近 日，本 公 司 經 導 管 介 入 二 尖 瓣 修 復(TMV ...

澄清公告 茲提述本公司日期為二零二五年十月二十八日的公告（「十月二十八日公告」） 及二零二五年十月二十九日的公告（「十月二十九日公告」，連 同 十 月 二 十 八 日 公 告，統 稱「先前公告」）。本 公 告 乃 由 寧 波 健 世 科 技 股 份 有 限 公 司（「本公司」， 連 同 其 附 屬 公 司，統 稱「本集團」）就 先 前 公 告 作 出 澄 清，以 澄 清 先 前 公 告 中 為 糾 正 十 月 二 十 八 日 公 告 中 的 一 項 無 心 之 失 而 作 出 的 修 訂。除 另 有 界 定 者 外，本 公 告 所 用 中 詞 彙 與 先 前 公 告 中 所 用 詞 彙 具 有 相 同 涵 義。 本 公 司 謹 此 澄 清，十 月 二 十 八 日 公 告 中 第 二 頁 所 載 的 有 關 安 全 性 結 果 隨 訪 期 間 的 兩 處 內 容 已 於 十 月 二 十 九 日 公 告 中 修 訂，而 所 有 安 全 性 結 果 已 準 確 呈 列 且 未 做 修 訂，為 方 便 參 考，兩 份 公 告 之 間 所 作 的 更 改 如 下 註 釋： 香港交易及結算所有限公司及香港聯合交易所有限公 ...

Core Insights - The recent clinical trial results for LuX-ValvePlus, JensClip, and Ken-Valve presented at TCT2025 highlight significant advancements in the treatment of heart valve diseases, showcasing their safety, efficacy, and innovative designs [1][2][3][4] Group 1: LuX-ValvePlus - The TRINITY study demonstrated LuX-ValvePlus's excellent safety and efficacy, with a stable low incidence of adverse events and improved patient quality of life over six months [2] - Over 75% of patients in the TRINITY study used larger valve sizes (55mm to 70mm), indicating its broad application, especially for patients with severe tricuspid regurgitation [2] - The device has achieved a 100% procedural success rate in the FDA IDE-EFS study, with pivotal clinical research set to commence soon [2] Group 2: JensClip - JensClip, designed for severe mitral regurgitation, showed a one-year follow-up result with an all-cause mortality rate of only 1.8% and minimal device-related complications [3] - 96.3% of patients exhibited no moderate or severe regurgitation, with significant improvements in various quality of life metrics [3] Group 3: Ken-Valve - Ken-Valve, aimed at high-risk surgical patients with severe aortic regurgitation, demonstrated excellent one-year follow-up results, maintaining stable effective orifice area and low rates of adverse events [4] - The device is available in multiple sizes (23mm to 33mm) and is designed to address complex anatomical challenges, fulfilling the needs of patients with limited treatment options [4] Group 4: Overall Company Positioning - The comprehensive research outcomes across tricuspid, mitral, and aortic valves garnered significant attention and praise from global experts at TCT2025 [4] - The company plans to leverage its extensive clinical experience and innovative product designs to advance the global application and commercialization of its product portfolio [4]

Core Insights - The recent clinical trial results for LuX-ValvePlus, JensClip, and Ken-Valve presented at TCT2025 demonstrate significant advancements in the treatment of heart valve diseases, showcasing their safety and efficacy in various patient populations [1][2][3][4] Group 1: LuX-ValvePlus - The TRINITY study's 6-month follow-up results indicate that LuX-ValvePlus exhibits good safety and efficacy, with a stable low incidence of adverse events compared to the 30-day follow-up [2] - Over 75% of enrolled patients in the TRINITY study used larger valve sizes (55mm, 60mm, 65mm, and 70mm), highlighting its broad application, especially for patients with severe tricuspid regurgitation [2] - The FDA IDE-EFS for LuX-ValvePlus has completed all enrollments with a 100% procedural success rate, and a pivotal study is set to commence [2] Group 2: JensClip - JensClip, designed for treating severe mitral regurgitation, shows excellent one-year follow-up results, with an all-cause mortality rate of only 1.8% and minimal device-related complications [3] - 96.3% of patients demonstrated no moderate or severe regurgitation, with significant improvements in quality of life metrics [3] Group 3: Ken-Valve - Ken-Valve, aimed at high-risk surgical patients with severe aortic regurgitation or mixed aortic stenosis, also shows promising one-year follow-up results, with stable effective orifice area and low rates of adverse events [4] - The device is available in multiple sizes (23mm to 33mm) and is designed to accommodate complex anatomical challenges, addressing the limited treatment options for large annulus patients [4] Group 4: Overall Company and Industry Impact - The comprehensive research outcomes for tricuspid, mitral, and aortic valves have garnered significant attention and praise from global experts at TCT2025 [4] - The company aims to leverage its extensive clinical experience and innovative product designs to advance the global application and commercialization of its product portfolio across various regions [4]

Jenscare Scientific Co., Ltd. 寧波健世科技股份有限公司 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的內容概不 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 就 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的任何損失承擔任何責任。 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：9877） 自願公告 公司多產品組合LuX-Valve Plus TRINITY研 究、JensClip及 Ken-Valve臨床效果於美國TCT 2025發佈的更新 茲提述本公司日期為二零二五年十月二十八日的公告（「十月二十八日公告」）。 本公告乃由寧波健世科技股份有限公司（「本公司」，連 同 其 附 屬 公 司，統 稱「本 集 團」）按 自 願 基 準 作 出，以 向 本 公 司 股 東 及 潛 在 投 資 者 提 供 十 月 二 十 八 日 公 告 的 最 新 資 料，該 公 告 內 容 已 於 本 公 告 重 述，其 中 有 關 安 全 性 結 果 的 最 新 ...

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的內容概不 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 就 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的任何損失承擔任何責任。 Jenscare Scientific Co., Ltd. 寧波健世科技股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：9877） 自願公告 TRINITY是 一 項 全 球 前 瞻 性、多 中 心、單 臂 臨 床 試 驗，主 要 用 於 評 估LuX-Valve Plus於 重 度 三 尖 瓣 反 流 及 外 科 高 危 患 者 中 應 用 的 安 全 性 及 有 效 性。該 項 研 究 共 納入全球20家中心的161例 患 者，其 中18家 中 心 來 自 法 國、德 國、西 班 牙、丹 麥 及 英 國，患 者 平 均 年 齡 為77歲。 – 1 – 本 次 臨 床 研 究 結 果 顯 示： (1) 器械成功率約為97%；及 (2) 平均器械操作時間為41.60±19.62分鐘，其 ...