{"id":49155,"date":"2025-11-27T21:07:18","date_gmt":"2025-11-27T13:07:18","guid":{"rendered":"https:\/\/flcube.com\/?p=49155"},"modified":"2025-11-27T21:07:19","modified_gmt":"2025-11-27T13:07:19","slug":"bio-hearts-iberirdn-wins-new-zealand-nod-as-only-dual-approach-renal-denervation-system","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=49155","title":{"rendered":"Bio-heart&#8217;s IberiRDN Wins New Zealand Nod as Only Dual-Approach Renal Denervation System"},"content":{"rendered":"\n<p><strong>Shanghai Bio-heart Biological Technology Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2185:HKG\">HKG: 2185<\/a>) announced that its <strong>Iberis Multi-Electrode Renal Denervation (RDN) Catheter System (IberiRDN)<\/strong> has completed registration with the <strong>New Zealand Medicines and Medical Devices Safety Authority (Medsafe)<\/strong>, becoming the <strong>only RDN product globally approved for both Transradial Artery (TRA) and Transfemoral Artery (TFA) approaches<\/strong>, offering a safer and more cost\u2011efficient option for hypertension treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/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>Iberis Multi\u2011Electrode Renal Denervation (RDN) Catheter System (IberiRDN)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Shanghai Bio-heart Biological Technology (2185.HK)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>New Zealand Medicines and Medical Devices Safety Authority (Medsafe)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Registration<\/td><\/tr><tr><td><strong>Key Differentiator<\/strong><\/td><td>Only RDN system globally approved for both TRA and TFA approaches<\/td><\/tr><tr><td><strong>Previous Approval<\/strong><\/td><td>CE Mark (Europe, 2016)<\/td><\/tr><tr><td><strong>Geography<\/strong><\/td><td>New Zealand (strategic Asia\u2011Pacific market)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-profile\">Technology Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> Multi\u2011electrode catheter system delivering radiofrequency energy to renal nerves to modulate blood pressure<\/li>\n\n\n\n<li><strong>Dual\u2011Approach Innovation:<\/strong> <strong>Transradial Artery (TRA)<\/strong> approach makes RDN safer, more effective, and more cost\u2011efficient vs. traditional transfemoral access<\/li>\n\n\n\n<li><strong>Clinical Benefits:<\/strong> Reduced procedure time, lower complication rates, faster patient recovery<\/li>\n\n\n\n<li><strong>Global Positioning:<\/strong> TRA capability addresses unmet need in markets with growing preference for radial access; positions IberiRDN as premium RDN solution<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context-amp-outlook\">Market Context &amp; Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Metric<\/th><th>Value<\/th><\/tr><\/thead><tbody><tr><td><strong>Global RDN Market<\/strong><\/td><td>$280\u202fmillion (2024)<\/td><\/tr><tr><td><strong>Growth CAGR<\/strong><\/td><td>15% (2024\u20112030)<\/td><\/tr><tr><td><strong>China Hypertension Patients<\/strong><\/td><td>245\u202fmillion; ~10% resistant to medication (24.5\u202fmillion eligible)<\/td><\/tr><tr><td><strong>China RDN Market Potential<\/strong><\/td><td>\u00a58\u201112\u202fbillion (US$1.1\u20111.6\u202fbillion) by 2030<\/td><\/tr><tr><td><strong>New Zealand Market Size<\/strong><\/td><td>NZ$15\u201120\u202fmillion (US$9\u201112\u202fmillion)<\/td><\/tr><tr><td><strong>Peak Sales Forecast (IberiRDN)<\/strong><\/td><td><strong>\u00a52.5\u20113.5\u202fbillion<\/strong> (~US$340\u2011480\u202fmillion) globally by 2032<\/td><\/tr><tr><td><strong>Next Markets<\/strong><\/td><td>Australia (TGA filing planned Q1\u202f2026), Japan (PMDA Q3\u202f2026)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitive Landscape:<\/strong> Dominated by <strong>Medtronic\u2019s Symplicity Spyral<\/strong> and <strong>Recor Medical\u2019s Paradise<\/strong>; IberiRDN\u2019s dual\u2011approach offers <strong>differentiation<\/strong><\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> Medsafe registration provides <strong>PIC\/S GMP credibility<\/strong> for broader Asia\u2011Pacific expansion<\/li>\n\n\n\n<li><strong>Reimbursement Path:<\/strong> New Zealand\u2019s public health system likely to adopt RDN for resistant hypertension; PHARMAC listing expected <strong>H2\u202f2026<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding IberiRDN\u2019s market penetration, regulatory expansion, and commercial potential. Actual results may differ materially due to risks including competitive dynamics, reimbursement negotiations, and adoption rates in radial\u2011first markets.<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\/11\/2025112601113_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025112601113_c.\"><\/object><a id=\"wp-block-file--media-61e8e529-d0f8-44d2-b058-93d9c32a7c04\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025112601113_c.pdf\">2025112601113_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025112601113_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-61e8e529-d0f8-44d2-b058-93d9c32a7c04\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced that its Iberis Multi-Electrode Renal Denervation&#8230;<\/p>\n","protected":false},"author":1,"featured_media":49160,"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":[22],"tags":[2607,69,2606,15],"class_list":["post-49155","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device","tag-bio-heart-biological-technology","tag-cvd","tag-hkg-2185","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Bio-heart&#039;s IberiRDN Wins New Zealand Nod as Only Dual-Approach Renal Denervation System - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced that its Iberis Multi-Electrode Renal Denervation (RDN) Catheter System (IberiRDN) has completed registration with the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), becoming the only RDN product globally approved for both Transradial Artery (TRA) and Transfemoral Artery (TFA) approaches, offering a safer and more cost\u2011efficient option for hypertension treatment.\" \/>\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=49155\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bio-heart&#039;s IberiRDN Wins New Zealand Nod as Only Dual-Approach Renal Denervation System\" \/>\n<meta property=\"og:description\" content=\"Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced that its Iberis Multi-Electrode Renal Denervation (RDN) Catheter System (IberiRDN) has completed registration with the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), becoming the only RDN product globally approved for both Transradial Artery (TRA) and Transfemoral Artery (TFA) approaches, offering a safer and more cost\u2011efficient option for hypertension treatment.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=49155\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-27T13:07:18+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-27T13:07:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2702-1.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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