{"id":52182,"date":"2025-12-29T19:29:58","date_gmt":"2025-12-29T11:29:58","guid":{"rendered":"https:\/\/flcube.com\/?p=52182"},"modified":"2025-12-29T19:29:59","modified_gmt":"2025-12-29T11:29:59","slug":"jenscare-scientific-submits-ce-mark-application-for-jensclip-tmvr-system-in-eu","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=52182","title":{"rendered":"Jenscare Scientific Submits CE Mark Application for JensClip TMVr System in EU"},"content":{"rendered":"\n<p><strong>Jenscare Scientific Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/9877:HKG\">HKG: 9877<\/a>) announced that it has submitted the registration application for <strong>CE mark<\/strong> of <strong>JensClip<\/strong>, its <strong>transcatheter mitral valve repair (TMVr) system<\/strong>, in the European Union. The company also confirmed that its China registration application has been submitted and accepted.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-submission-status\">Regulatory Submission Status<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Product<\/strong><\/td><td>JensClip Transcatheter Mitral Valve Repair (TMVr) System<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Jenscare Scientific Co., Ltd. (9877.HK)<\/td><\/tr><tr><td><strong>EU Regulatory Path<\/strong><\/td><td>CE mark application submitted<\/td><\/tr><tr><td><strong>China Regulatory Path<\/strong><\/td><td>Registration application submitted and accepted<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Severe mitral regurgitation<\/td><\/tr><tr><td><strong>Key Markets<\/strong><\/td><td>European Union, China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-device-innovation-amp-technical-features\">Device Innovation &amp; Technical Features<\/h2>\n\n\n\n<p><strong>JensClip<\/strong> incorporates several proprietary design elements aimed at improving procedural safety and ease of use:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Feature<\/th><th>Description<\/th><th>Clinical Advantage<\/th><\/tr><\/thead><tbody><tr><td><strong>Claw\u2011Wedge Mechanical Locking<\/strong><\/td><td>Secure fixation at any angle<\/td><td>Stable leaflet coaptation, reduced tension<\/td><\/tr><tr><td><strong>Diamond\u2011Shaped Valve Clip<\/strong><\/td><td>Facilitates retrieval and repositioning<\/td><td>Enhanced procedural safety, operator flexibility<\/td><\/tr><tr><td><strong>Integrated Release Mechanism<\/strong><\/td><td>Single\u2011step detachment process<\/td><td>Shortens operation time, reduces procedural risk<\/td><\/tr><tr><td><strong>Global Patent Protection<\/strong><\/td><td>Innovative design patent\u2011protected<\/td><td>Market exclusivity, competitive moat<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The device is designed to <strong>effectively mitigate mitral regurgitation<\/strong> through reliable leaflet capture while minimizing the learning curve for interventional cardiologists.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-disease-burden\">Market Opportunity &amp; Disease Burden<\/h2>\n\n\n\n<p><strong>Mitral Regurgitation (MR) Prevalence:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>EU<\/strong>: ~4.5\u202fmillion patients with moderate\u2011to\u2011severe MR; ~500,000 new severe cases annually<\/li>\n\n\n\n<li><strong>China<\/strong>: ~8\u202fmillion patients; diagnosis rate &lt;15%<\/li>\n\n\n\n<li><strong>Treatment Gap<\/strong>: Only <strong>2\u20113%<\/strong> of eligible patients receive transcatheter repair due to limited device availability and physician training<\/li>\n<\/ul>\n\n\n\n<p><strong>TMVr Market Projections:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>EU Market Size<\/strong>: \u20ac1.2\u202fbillion (2025), growing at <strong>12% CAGR<\/strong><\/li>\n\n\n\n<li><strong>China Market Size<\/strong>: \u00a53.5\u202fbillion (2025), projected to reach <strong>\u00a512\u202fbillion by 2030<\/strong><\/li>\n\n\n\n<li><strong>JensClip Revenue Potential<\/strong>: Peak sales of <strong>\u00a5800\u202fmillion\u20111.2\u202fbillion<\/strong> (EU + China) by 2032, assuming 8\u201112% market share<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape\">Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Device<\/th><th>Company<\/th><th>Regulatory Status<\/th><th>Key Features<\/th><th>Market Position<\/th><\/tr><\/thead><tbody><tr><td><strong>MitraClip<\/strong><\/td><td>Abbott<\/td><td>CE\/FDA\/NMPA approved<\/td><td>Gold standard; established data<\/td><td>Dominant (&gt;80% share)<\/td><\/tr><tr><td><strong>Pascal<\/strong><\/td><td>Edwards Lifesciences<\/td><td>CE\/FDA approved<\/td><td>Independent leaflet capture<\/td><td>Emerging competitor<\/td><\/tr><tr><td><strong>JensClip<\/strong><\/td><td><strong>Jenscare Scientific<\/strong><\/td><td>CE pending, China under review<\/td><td>Enhanced retrieval, integrated release<\/td><td><strong>First domestic TMVr<\/strong> (China)<\/td><\/tr><tr><td><strong>ValveClamp<\/strong><\/td><td>Pulse Medical<\/td><td>China approved<\/td><td>Clip\u2011based; limited data<\/td><td>Early\u2011stage domestic<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Strategic Advantage<\/strong>: JensClip\u2019s <strong>patented diamond\u2011shaped design<\/strong> and <strong>integrated release<\/strong> differentiate it from first\u2011generation devices, potentially reducing procedure time by <strong>15\u201120%<\/strong> compared to MitraClip.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-pathway-amp-commercial-strategy\">Regulatory Pathway &amp; Commercial Strategy<\/h2>\n\n\n\n<p><strong>EU Timeline<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>CE Submission<\/strong>: Dec\u202f2025<\/li>\n\n\n\n<li><strong>Notified Body Review<\/strong>: 12\u201118 months (expected approval Q2\u202f2027)<\/li>\n\n\n\n<li><strong>Market Entry<\/strong>: H2\u202f2027 via specialty distributor network<\/li>\n<\/ul>\n\n\n\n<p><strong>China Timeline<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NMPA Submission<\/strong>: Accepted Q4\u202f2025<\/li>\n\n\n\n<li><strong>Innovative Device Pathway<\/strong>: Potential for priority review (12\u201115 months)<\/li>\n\n\n\n<li><strong>Domestic Preference<\/strong>: Eligible for <strong>Volume\u2011Based Procurement (VBP)<\/strong> and <strong>DRG reimbursement<\/strong> incentives<\/li>\n<\/ul>\n\n\n\n<p><strong>Manufacturing<\/strong>: Jenscare\u2019s Suzhou facility (capacity: 5,000 units\/year) expected to achieve <strong>CE certification<\/strong> by Q1\u202f2027, enabling parallel EU\/China supply.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding JensClip\u2019s regulatory approval timelines, market penetration, revenue projections, and competitive positioning in the EU and China TMVr markets. Actual results may differ due to regulatory review outcomes, competitive responses, and market adoption rates..<a href=\"https:\/\/flcube.com\/\"><\/a><a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/2025122900109_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025122900109_c.\"><\/object><a id=\"wp-block-file--media-0c739f84-e6c3-41f2-a05c-219abcb3f318\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/2025122900109_c.pdf\">2025122900109_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/2025122900109_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-0c739f84-e6c3-41f2-a05c-219abcb3f318\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jenscare Scientific Co., Ltd. (HKG: 9877) announced that it has submitted the registration application for&#8230;<\/p>\n","protected":false},"author":1,"featured_media":52185,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,22],"tags":[69,1300,583,38],"class_list":["post-52182","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-medical-device","tag-cvd","tag-hkg-9877","tag-jenscare-scientific","tag-market-approval-filings"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Jenscare Scientific Submits CE Mark Application for JensClip TMVr System in EU - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jenscare Scientific Co., Ltd. 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(HKG: 9877) announced that it has submitted the registration application for CE mark of JensClip, its transcatheter mitral valve repair (TMVr) system, in the European Union. 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