{"id":18542,"date":"2022-02-03T08:44:48","date_gmt":"2022-02-03T16:44:48","guid":{"rendered":"https:\/\/marketdepth.com\/?p=18542"},"modified":"2022-02-03T08:44:49","modified_gmt":"2022-02-03T16:44:49","slug":"biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure","status":"publish","type":"post","link":"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/","title":{"rendered":"BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure"},"content":{"rendered":"\n<p>BioCardia, Inc. (NASDAQ: BCDA) has <a href=\"http:\/\/www.biocardia.com\/investors\/press-releases\/id\/1037?pressReleaseId=122\">announced<\/a> that the United States Food and Drug Administration has granted Breakthrough Device Designation for the CardiAMP Cell Therapy System for the treatment of heart failure.\u00a0 The CardiAMP Cell Therapy utilizes a patient\u2019s own bone marrow cells delivered to the heart in a minimally invasive catheter-based procedure.\u00a0 The therapy adds a pre-procedural screening assay to identify patients that may be likely responders.\u00a0 \u201cIt is exciting for the field of cardiology that the FDA has recognized the potential of a cell therapy to improve the lives of patients struggling with heart failure. Getting this therapy fast-tracked and to patients more quickly than traditional methods would give us new options and a greater armamentarium to assist our patients in need. I am enthusiastic about completing the U.S. pivotal trial of the CardiAMP Cell Therapy to build the body of evidence necessary to support this accelerated FDA path,\u201d said Carl Pepine, MD, MACC, Professor in the Division of Cardiovascular Medicine at the University of Florida.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">FDA Breakthrough Device<\/h5>\n\n\n\n<p>\u201cWe thank the FDA for granting Breakthrough Device Designation to the CardiAMP Cell Therapy System and recognizing its potential to provide more effective treatment for heart failure, a major achievement for this unique therapy,\u201d said&nbsp;Peter Altman, Ph.D., President and Chief Executive Officer of BioCardia. \u201cThe published results from our clinical trials to date &nbsp;<a href=\"http:\/\/www.biocardia.com\/investors\/press-releases\/id\/1037?pressReleaseId=122#_edn3\">[3]<\/a>,&nbsp;<a href=\"http:\/\/www.biocardia.com\/investors\/press-releases\/id\/1037?pressReleaseId=122#_edn4\">[4]<\/a>.&nbsp;<a href=\"http:\/\/www.biocardia.com\/investors\/press-releases\/id\/1037?pressReleaseId=122#_edn5\">[5]<\/a>,<a href=\"http:\/\/www.biocardia.com\/investors\/press-releases\/id\/1037?pressReleaseId=122#_edn6\">[6]<\/a>,&nbsp;<a href=\"http:\/\/www.biocardia.com\/investors\/press-releases\/id\/1037?pressReleaseId=122#_edn7\">[7]<\/a>&nbsp;have met our high expectations in showing the therapy\u2019s ability to address the loss of heart function in ischemic heart failure. &nbsp;We look forward to completing our Phase III trial and engaging with the FDA as we move closer to the prospect of benefiting patients whose lives are severely impacted by this disease.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"BioCardia, Inc. (NASDAQ: BCDA) has announced that the United States Food and Drug Administration has granted Breakthrough Device Designation for the CardiAMP Cell Therapy System for the treatment of heart failure.\u00a0 The CardiAMP Cell Therapy utilizes a patient\u2019s own bone marrow cells delivered to the heart in a minimally invasive catheter-based procedure.\u00a0 The therapy adds&#8230; <a class=\"view-article\" href=\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/\">View Article<\/a>","protected":false},"author":3,"featured_media":18543,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":0,"footnotes":""},"categories":[31,17,8,11,16],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure - MarketDepth<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure - MarketDepth\" \/>\n<meta property=\"og:description\" content=\"BioCardia, Inc. (NASDAQ: BCDA) has announced that the United States Food and Drug Administration has granted Breakthrough Device Designation for the CardiAMP Cell Therapy System for the treatment of heart failure.\u00a0 The CardiAMP Cell Therapy utilizes a patient\u2019s own bone marrow cells delivered to the heart in a minimally invasive catheter-based procedure.\u00a0 The therapy adds... View Article\" \/>\n<meta property=\"og:url\" content=\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/\" \/>\n<meta property=\"og:site_name\" content=\"MarketDepth\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/marketdepthnews\" \/>\n<meta property=\"article:published_time\" content=\"2022-02-03T16:44:48+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-02-03T16:44:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/marketdepth.com\/wp-content\/uploads\/2022\/02\/Heart-monitor-hospital.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"MarketDepth\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@MarketDepthNews\" \/>\n<meta name=\"twitter:site\" content=\"@MarketDepthNews\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"MarketDepth\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/\"},\"author\":{\"name\":\"MarketDepth\",\"@id\":\"https:\/\/marketdepth.com\/#\/schema\/person\/1c07fd6f269e57bf07013b63d7245f69\"},\"headline\":\"BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure\",\"datePublished\":\"2022-02-03T16:44:48+00:00\",\"dateModified\":\"2022-02-03T16:44:49+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/\"},\"wordCount\":302,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/marketdepth.com\/#organization\"},\"articleSection\":[\"Business\",\"Headlines\",\"Healthcare\",\"Investing\",\"What's Hot\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/\",\"url\":\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/\",\"name\":\"BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure - MarketDepth\",\"isPartOf\":{\"@id\":\"https:\/\/marketdepth.com\/#website\"},\"datePublished\":\"2022-02-03T16:44:48+00:00\",\"dateModified\":\"2022-02-03T16:44:49+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/marketdepth.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/marketdepth.com\/#website\",\"url\":\"https:\/\/marketdepth.com\/\",\"name\":\"MarketDepth\",\"description\":\"Stock Market News &amp; Headlines\",\"publisher\":{\"@id\":\"https:\/\/marketdepth.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/marketdepth.com\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/marketdepth.com\/#organization\",\"name\":\"MarketDepth\",\"url\":\"https:\/\/marketdepth.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/marketdepth.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/marketdepth.com\/wp-content\/uploads\/2021\/05\/MarketDepth-Placeholder-1.jpg\",\"contentUrl\":\"https:\/\/marketdepth.com\/wp-content\/uploads\/2021\/05\/MarketDepth-Placeholder-1.jpg\",\"width\":1500,\"height\":1000,\"caption\":\"MarketDepth\"},\"image\":{\"@id\":\"https:\/\/marketdepth.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/marketdepthnews\",\"https:\/\/twitter.com\/MarketDepthNews\",\"https:\/\/www.instagram.com\/marketdepth\/\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/marketdepth.com\/#\/schema\/person\/1c07fd6f269e57bf07013b63d7245f69\",\"name\":\"MarketDepth\",\"url\":\"https:\/\/marketdepth.com\/author\/3\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure - MarketDepth","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/","og_locale":"en_US","og_type":"article","og_title":"BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure - MarketDepth","og_description":"BioCardia, Inc. (NASDAQ: BCDA) has announced that the United States Food and Drug Administration has granted Breakthrough Device Designation for the CardiAMP Cell Therapy System for the treatment of heart failure.\u00a0 The CardiAMP Cell Therapy utilizes a patient\u2019s own bone marrow cells delivered to the heart in a minimally invasive catheter-based procedure.\u00a0 The therapy adds... View Article","og_url":"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/","og_site_name":"MarketDepth","article_publisher":"https:\/\/www.facebook.com\/marketdepthnews","article_published_time":"2022-02-03T16:44:48+00:00","article_modified_time":"2022-02-03T16:44:49+00:00","og_image":[{"width":1920,"height":1080,"url":"https:\/\/marketdepth.com\/wp-content\/uploads\/2022\/02\/Heart-monitor-hospital.jpg","type":"image\/jpeg"}],"author":"MarketDepth","twitter_card":"summary_large_image","twitter_creator":"@MarketDepthNews","twitter_site":"@MarketDepthNews","twitter_misc":{"Written by":"MarketDepth","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/#article","isPartOf":{"@id":"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/"},"author":{"name":"MarketDepth","@id":"https:\/\/marketdepth.com\/#\/schema\/person\/1c07fd6f269e57bf07013b63d7245f69"},"headline":"BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure","datePublished":"2022-02-03T16:44:48+00:00","dateModified":"2022-02-03T16:44:49+00:00","mainEntityOfPage":{"@id":"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/"},"wordCount":302,"commentCount":0,"publisher":{"@id":"https:\/\/marketdepth.com\/#organization"},"articleSection":["Business","Headlines","Healthcare","Investing","What's Hot"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/","url":"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/","name":"BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure - MarketDepth","isPartOf":{"@id":"https:\/\/marketdepth.com\/#website"},"datePublished":"2022-02-03T16:44:48+00:00","dateModified":"2022-02-03T16:44:49+00:00","breadcrumb":{"@id":"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/marketdepth.com\/biocardia-announces-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/marketdepth.com\/"},{"@type":"ListItem","position":2,"name":"BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure"}]},{"@type":"WebSite","@id":"https:\/\/marketdepth.com\/#website","url":"https:\/\/marketdepth.com\/","name":"MarketDepth","description":"Stock Market News &amp; Headlines","publisher":{"@id":"https:\/\/marketdepth.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/marketdepth.com\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/marketdepth.com\/#organization","name":"MarketDepth","url":"https:\/\/marketdepth.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/marketdepth.com\/#\/schema\/logo\/image\/","url":"https:\/\/marketdepth.com\/wp-content\/uploads\/2021\/05\/MarketDepth-Placeholder-1.jpg","contentUrl":"https:\/\/marketdepth.com\/wp-content\/uploads\/2021\/05\/MarketDepth-Placeholder-1.jpg","width":1500,"height":1000,"caption":"MarketDepth"},"image":{"@id":"https:\/\/marketdepth.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/marketdepthnews","https:\/\/twitter.com\/MarketDepthNews","https:\/\/www.instagram.com\/marketdepth\/"]},{"@type":"Person","@id":"https:\/\/marketdepth.com\/#\/schema\/person\/1c07fd6f269e57bf07013b63d7245f69","name":"MarketDepth","url":"https:\/\/marketdepth.com\/author\/3\/"}]}},"_links":{"self":[{"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/posts\/18542"}],"collection":[{"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/comments?post=18542"}],"version-history":[{"count":1,"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/posts\/18542\/revisions"}],"predecessor-version":[{"id":18544,"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/posts\/18542\/revisions\/18544"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/media\/18543"}],"wp:attachment":[{"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/media?parent=18542"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/categories?post=18542"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/marketdepth.com\/wp-json\/wp\/v2\/tags?post=18542"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}