{"id":77038,"date":"2026-08-28T20:32:18","date_gmt":"2026-08-28T12:32:18","guid":{"rendered":"https:\/\/flcube.com\/?p=77038"},"modified":"2026-08-28T20:32:19","modified_gmt":"2026-08-28T12:32:19","slug":"asieris-wins-eu-ce-certification-for-apld-2304-the-worlds-first-portable-single-use-blue-light-flexible-cystoscope","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=77038","title":{"rendered":"Asieris Wins EU CE Certification for APLD-2304, the World&#8217;s First Portable Single-Use Blue-Light Flexible Cystoscope"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Jiangsu Asieris Pharmaceuticals Co., Ltd.<\/strong> (SHA: 688176) announced that its <strong>APLD-2304<\/strong> flexible cystoscope has obtained <strong>EU CE certification<\/strong>. Billed as the world&#8217;s first portable single-use blue-light flexible cystoscope with photodynamic diagnostic capability, the approval gives <strong>Asieris<\/strong> a first-mover position in drug-device combination diagnostics for <strong>bladder cancer<\/strong> as it expands into the European market.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Element<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td>Agency<\/td><td>European Union (EU) notified body<\/td><\/tr><tr><td>Approval Type<\/td><td>CE certification<\/td><\/tr><tr><td>Product<\/td><td><strong>APLD-2304<\/strong> portable single-use blue-light flexible cystoscope<\/td><\/tr><tr><td>Indication<\/td><td>Examination and imaging during urological diagnostic procedures<\/td><\/tr><tr><td>Date<\/td><td>28 Aug 2026<\/td><\/tr><tr><td>Next Steps<\/td><td>European commercialization of <strong>APLD-2304<\/strong> and the paired <strong>Hexvix<\/strong> drug-device combination solution<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-product-profile-amp-innovation\" class=\"wp-block-heading\">Product Profile &amp; Innovation<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Device:<\/strong> <strong>APLD-2304<\/strong> flexible cystoscope \u2014 portable, flexible, sterile, single-use design<\/li>\n\n\n\n<li><strong>Technology:<\/strong> World&#8217;s first portable single-use cystoscope featuring blue-light photodynamic diagnostic capability<\/li>\n\n\n\n<li><strong>Combination Solution:<\/strong> Paired with the blue-light imaging agent <strong>Hexvix<\/strong> to form a bladder cancer diagnostic drug-device combination<\/li>\n\n\n\n<li><strong>Clinical Goal:<\/strong> Improve <strong>bladder cancer<\/strong> detection rates and reduce recurrence rates<\/li>\n\n\n\n<li><strong>Physician &amp; Patient Benefits:<\/strong> Enhanced physician convenience, improved patient comfort, and reduced risk of cross-infection versus reusable scopes<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-competitive-positioning\" class=\"wp-block-heading\">Competitive Positioning<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Differentiator<\/th><th>Significance<\/th><\/tr><\/thead><tbody><tr><td>First-in-category<\/td><td>No competing portable single-use blue-light flexible cystoscope on the market<\/td><\/tr><tr><td>Drug-device combination<\/td><td>Bundles the device with <strong>Hexvix<\/strong> imaging agent, creating an integrated diagnostic workflow<\/td><\/tr><tr><td>Single-use design<\/td><td>Eliminates reprocessing burden and cross-infection risk \u2014 a growing priority in endoscopy<\/td><\/tr><tr><td>Blue-light imaging<\/td><td>Photodynamic detection enhances visualization of lesions missed under standard white-light cystoscopy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">By pairing a single-use delivery device with a blue-light imaging agent, <strong>Asieris<\/strong> moves beyond selling a standalone instrument toward an integrated diagnostic ecosystem. The single-use architecture directly addresses persistent concerns around reprocessing costs and cross-infection in flexible endoscopy, while photodynamic diagnosis targets the high recurrence burden that drives repeated surveillance procedures in bladder cancer care.<\/p>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>European Entry:<\/strong> <strong>EU CE certification<\/strong> opens the European urology market for <strong>Asieris<\/strong>, adding a major international footprint to the company&#8217;s portfolio beyond China<\/li>\n\n\n\n<li><strong>Bladder Cancer Dynamics:<\/strong> Bladder cancer requires one of the most intensive long-term surveillance regimens of any malignancy, supporting recurring demand for cystoscopy-based diagnostics<\/li>\n\n\n\n<li><strong>Combination Economics:<\/strong> The <strong>APLD-2304<\/strong> + <strong>Hexvix<\/strong> pairing creates dual revenue streams per procedure and reinforces customer stickiness across the diagnostic workflow<\/li>\n\n\n\n<li><strong>Strategic Validation:<\/strong> The milestone validates <strong>Asieris&#8217;s<\/strong> drug-device combination strategy and differentiates the company (SHA: 688176) from conventional endoscope manufacturers competing primarily on hardware<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong> \u2013 This brief contains forward-looking statements regarding commercialization, market adoption, and competitive positioning. Actual results may differ materially due to regulatory, commercial, and other risks. Not investment advice.<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\/2026\/08\/688176_20260828_2KN2.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688176_20260828_2KN2.\"><\/object><a id=\"wp-block-file--media-ee02aeb1-7b49-4e10-b8f3-8f5266889ac5\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/688176_20260828_2KN2.pdf\">688176_20260828_2KN2<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/688176_20260828_2KN2.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-ee02aeb1-7b49-4e10-b8f3-8f5266889ac5\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that its APLD-2304 flexible cystoscope has obtained&#8230;<\/p>\n","protected":false},"author":1,"featured_media":77040,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,22],"tags":[316,15,1127],"class_list":["post-77038","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-medical-device","tag-asieris-pharmaceuticals","tag-product-approvals","tag-sha-688176"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Asieris Wins EU CE Certification for APLD-2304, the World&#039;s First Portable Single-Use Blue-Light Flexible Cystoscope - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that its APLD-2304 flexible cystoscope has obtained EU CE certification. Billed as the world&#039;s first portable single-use blue-light flexible cystoscope with photodynamic diagnostic capability, the approval gives Asieris a first-mover position in drug-device combination diagnostics for bladder cancer as it expands into the European market.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=77038\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Asieris Wins EU CE Certification for APLD-2304, the World&#039;s First Portable Single-Use Blue-Light Flexible Cystoscope\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that its APLD-2304 flexible cystoscope has obtained EU CE certification. 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(SHA: 688176) announced that its APLD-2304 flexible cystoscope has obtained EU CE certification. Billed as the world's first portable single-use blue-light flexible cystoscope with photodynamic diagnostic capability, the approval gives Asieris a first-mover position in drug-device combination diagnostics for bladder cancer as it expands into the European market.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=77038#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=77038"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=77038#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/2803.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/2803.webp","width":1080,"height":608,"caption":"Asieris Wins EU CE Certification for APLD-2304, the World's First Portable Single-Use Blue-Light Flexible Cystoscope"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=77038#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Asieris Wins EU CE Certification for APLD-2304, the World&#8217;s First Portable Single-Use Blue-Light Flexible Cystoscope"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/2803.webp","_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/77038","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=77038"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/77038\/revisions"}],"predecessor-version":[{"id":77041,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/77038\/revisions\/77041"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/77040"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=77038"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=77038"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=77038"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}