{"id":3519,"date":"2026-01-07T09:01:34","date_gmt":"2026-01-07T09:01:34","guid":{"rendered":"https:\/\/bacta-implants.com\/?p=3519"},"modified":"2026-01-07T09:03:46","modified_gmt":"2026-01-07T09:03:46","slug":"mit-der-herstellungserlaubnis-ins-jahr-2026","status":"publish","type":"post","link":"https:\/\/bacta-implants.com\/en\/mit-der-herstellungserlaubnis-ins-jahr-2026\/","title":{"rendered":"\ud83c\udf89 Starting 2026 with a manufacturing approval \ud83c\udf89"},"content":{"rendered":"<p>We are starting 2026 with the achievement of an official manufacturing approval for <strong>our round window niche implant (RNI)!<\/strong><\/p>\n\n\n\n<p>Why is this so important? Our RNIs fall within the scope of highly regulated medicinal products. Only with the manufacturing license can we test our RNIs in an initial clinical study.<\/p>\n\n\n\n<p>The competent authority certifies our GMP (Good Manufacturing Practice) compliant production and grants us permission to manufacture our individualized drug-releasing implants for the treatment of inner ear disorders using 3D printing \u2013 the green light to apply for the <strong>clinical trial (Phase Ib\/II)<\/strong> .<\/p>\n\n\n\n<p>The clinical trial is intended to confirm that our RNIs are safe and that the active ingredients they contain reach the inner ear from the middle ear and can thus be detected in the perilymph (inner ear fluid). In addition, the anti-inflammatory effect of our RNIs in cochlear implant patients will be investigated.<\/p>\n\n\n\n<p>The trial aims to prove that our implants can deliver active ingredients locally to hard-to-reach areas of the body, enabling effective therapy with low drug doses and thus fewer side effects.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"758\" src=\"https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-1024x758.jpg\" alt=\"Foto der Herstellungserlaubnis ohne sichtbare Details\" class=\"wp-image-3521\" srcset=\"https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-1024x758.jpg 1024w, https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-300x222.jpg 300w, https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-768x569.jpg 768w, https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-1536x1138.jpg 1536w, https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-2048x1517.jpg 2048w, https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-16x12.jpg 16w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>We are proud to be one step closer to our vision of effective personalized therapy for sudden hearing loss.<\/p>\n\n\n\n<p>Sincere thanks to our partners at MHH and our sponsors. We look forward to taking the next step together!<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Wir starten ins Jahr 2026 mit dem Erreichen der Herstellungserlaubnis f\u00fcr unsere Rundfensternischenimplantate (RNI)! Warum ist das so wichtig? Unsere RNIs fallen in den Bereich der hoch regulierten Arzneimittel. Nur mit der Herstellungserlaubnis k\u00f6nnen wir unsere RNIs in einer ersten klinischen Studie pr\u00fcfen. Die zust\u00e4ndige Beh\u00f6rde bezeugt unsere GMP (Good Manufacturing Practice) konforme Produktion und [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":3521,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[30],"tags":[78,22,18,76,77],"class_list":["post-3519","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-3d-druck","tag-additive-manufacturing","tag-drug-delivery-implants","tag-herstellungserlaubnis","tag-klinische-studie"],"uagb_featured_image_src":{"full":["https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-scaled.jpg",2560,1896,false],"thumbnail":["https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-150x150.jpg",150,150,true],"medium":["https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-300x222.jpg",300,222,true],"medium_large":["https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-768x569.jpg",768,569,true],"large":["https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-1024x758.jpg",1024,758,true],"1536x1536":["https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-1536x1138.jpg",1536,1138,true],"2048x2048":["https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-2048x1517.jpg",2048,1517,true],"trp-custom-language-flag":["https:\/\/bacta-implants.com\/wp-content\/uploads\/2026\/01\/herstellungserlaubnis-16x12.jpg",16,12,true]},"uagb_author_info":{"display_name":"MKnabel","author_link":"https:\/\/bacta-implants.com\/en\/author\/mknabel\/"},"uagb_comment_info":0,"uagb_excerpt":"Wir starten ins Jahr 2026 mit dem Erreichen der Herstellungserlaubnis f\u00fcr unsere Rundfensternischenimplantate (RNI)! Warum ist das so wichtig? Unsere RNIs fallen in den Bereich der hoch regulierten Arzneimittel. Nur mit der Herstellungserlaubnis k\u00f6nnen wir unsere RNIs in einer ersten klinischen Studie pr\u00fcfen. Die zust\u00e4ndige Beh\u00f6rde bezeugt unsere GMP (Good Manufacturing Practice) konforme Produktion und&hellip;","_links":{"self":[{"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/posts\/3519","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/comments?post=3519"}],"version-history":[{"count":4,"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/posts\/3519\/revisions"}],"predecessor-version":[{"id":3543,"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/posts\/3519\/revisions\/3543"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/media\/3521"}],"wp:attachment":[{"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/media?parent=3519"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/categories?post=3519"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bacta-implants.com\/en\/wp-json\/wp\/v2\/tags?post=3519"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}