{"id":997474,"date":"2026-08-24T08:34:04","date_gmt":"2026-08-24T12:34:04","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/"},"modified":"2026-08-24T08:34:04","modified_gmt":"2026-08-24T12:34:04","slug":"biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/","title":{"rendered":"BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval"},"content":{"rendered":"<div class=\"mw_release\">\n<p>SUNNYVALE, Calif., Aug.  24, 2026  (GLOBE NEWSWIRE) &#8212; BioCardia<sup>\u00ae<\/sup>, Inc.\u00a0[Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).\u00a0\u00a0<\/p>\n<p>FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing.<\/p>\n<p>\u201cWe intend to submit the follow-on pre-submission for Helix incorporating agency advice this quarter which could enable Helix approval via the De Novo pathway,\u201d said BioCardia Chief Executive Officer Peter Altman, PhD. \u201cIf successful, an independent Helix market clearance should enhance development and commercial partnering for high value investigational cell, gene, and protein therapeutics.\u201d<\/p>\n<p>\n        <strong>About Helix Transendocardial Delivery Catheter<\/strong>\n      <\/p>\n<p>The Helix transendocardial delivery catheter is an enabling platform for minimally invasive targeted delivery of therapeutic and diagnostic agents to the heart intramyocardially. It enables agents to be delivered precisely within the heart with superior retention over other therapeutic delivery modalities, and to many regions of the heart that other delivery methods cannot reach. The Helix includes a specialized small distal helical needle which engages the heart tissue from within the chamber of the heart and provides stability within the dynamic beating heart to safely enable agent delivery.\u00a0<\/p>\n<p>\n        <strong>About BioCardia<\/strong><br \/>\n        <sup><br \/>\n          <strong>\u00ae<\/strong><br \/>\n        <\/sup>\n      <\/p>\n<p>BioCardia, Inc.,\u00a0headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP<sup>\u00ae<\/sup>\u00a0autologous and CardiALLO\u2122 allogeneic cell therapies are the Company\u2019s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix\u2122 biotherapeutic delivery and Morph<sup>\u00ae<\/sup>\u00a0vascular navigation product platforms, and soon the Heart3D\u2122 fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit\u00a0www.biocardia.com.<\/p>\n<p>\n        <strong>Upcoming Catalysts:<\/strong>\n      <\/p>\n<p>\n        <strong>CardiAMP Cell Therapy<\/strong>\n      <\/p>\n<p>Q4 \u201826 Peer Reviewed Manuscript<\/p>\n<p>Q4 \u201826 Japan PMDA Submission for Approval<\/p>\n<p>Q4 \u201827 Japan Approval<\/p>\n<p>Q3 \u201828 HF II completes enrollment<\/p>\n<p>Q3 \u201829 HF II Topline Data<\/p>\n<p>\n        <strong>Helix Delivery<\/strong>\n      <\/p>\n<p>Q3 \u201826 FDA Pre-Sub Amendment<\/p>\n<p>\n        <strong>Heart3D Fusion Imaging<\/strong>\n      <\/p>\n<p>Q1 \u201927 First in Man Ready<\/p>\n<p>\n        <strong>Forward Looking Statements:<\/strong>\n      <\/p>\n<p>This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to submission for and subsequent market clearance of the Helix Transendocardial Delivery Catheter and the achievement of any of the anticipated upcoming catalysts. These forward-looking statements are made as of the date of this press release.<\/p>\n<p>We may use terms such as \u201cbelieves,\u201d \u201cestimates,\u201d \u201canticipates,\u201d \u201cexpects,\u201d \u201cplans,\u201d \u201cintends,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cmight,\u201d \u201cwill,\u201d \u201cshould,\u201d \u201capproximately\u201d or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company\u2019s liquidity position and its ability to raise additional funds, as well as the Company\u2019s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia\u2019s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled \u201cRisk Factors\u201d and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.<\/p>\n<p>\n        <strong>Media Contact: <\/strong><br \/>\n        <br \/>Miranda Peto, Investor Relations<br \/>Email:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=tj0-i1buTuOXo8IE2D8vAyBBkaBTIqxY1FKIK6ApqM_q2i1iaOrpOhJeqXJVMICzeaSRMd2vCT9QkrcOGNx0kBVPHhwC5boSlCVDUN1UWhs=\" rel=\"nofollow\" target=\"_blank\"><u>mpeto@BioCardia.com<\/u><\/a><br \/>Phone: 650-226-0120<\/p>\n<p>\n        <strong>Investor Contact: <\/strong><br \/>\n        <br \/>David McClung, Chief Financial Officer<br \/>Email:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=wYcNDtv3gapB2AkAf2-7hlAi1aiTJlUqdoKpGiqEDWdG7yFOSWo_cLamaIxR_DAGct_UTTdQr3ScLHg36LkJNYu6REK2y3HHV2JHhc414ryWr3Kz4eOYpUqixVWpfqSR\" rel=\"nofollow\" target=\"_blank\"><u>investors@BioCardia.com<\/u><\/a><br \/>Phone: 650-226-0120<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTgxNDYyMSM3Nzk5MTg4IzIwMTk4MTk=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/MDM0ZTFjYzEtNTk5YS00ZTY5LWI0MjEtODBmNmZjZWY5NjNkLTEwMzEzOTEtMjAyNi0wOC0yNC1lbg==\/tiny\/BioCardia-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) &#8212; BioCardia\u00ae, Inc.\u00a0[Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).\u00a0\u00a0 FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing. \u201cWe intend to submit the follow-on pre-submission for Helix incorporating agency advice this quarter which could enable Helix approval via the De Novo pathway,\u201d said BioCardia Chief Executive Officer Peter Altman, PhD. \u201cIf successful, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-997474","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) &#8212; BioCardia\u00ae, Inc.\u00a0[Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).\u00a0\u00a0 FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing. \u201cWe intend to submit the follow-on pre-submission for Helix incorporating agency advice this quarter which could enable Helix approval via the De Novo pathway,\u201d said BioCardia Chief Executive Officer Peter Altman, PhD. \u201cIf successful, &hellip; Continue reading &quot;BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-08-24T12:34:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTgxNDYyMSM3Nzk5MTg4IzIwMTk4MTk=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval\",\"datePublished\":\"2026-08-24T12:34:04+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\\\/\"},\"wordCount\":664,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTgxNDYyMSM3Nzk5MTg4IzIwMTk4MTk=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\\\/\",\"name\":\"BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval - 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Market Newsdesk","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:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/","og_locale":"en_US","og_type":"article","og_title":"BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval - Market Newsdesk","og_description":"SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) &#8212; BioCardia\u00ae, Inc.\u00a0[Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).\u00a0\u00a0 FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing. \u201cWe intend to submit the follow-on pre-submission for Helix incorporating agency advice this quarter which could enable Helix approval via the De Novo pathway,\u201d said BioCardia Chief Executive Officer Peter Altman, PhD. \u201cIf successful, &hellip; Continue reading \"BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/","og_site_name":"Market Newsdesk","article_published_time":"2026-08-24T12:34:04+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTgxNDYyMSM3Nzk5MTg4IzIwMTk4MTk=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval","datePublished":"2026-08-24T12:34:04+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/"},"wordCount":664,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTgxNDYyMSM3Nzk5MTg4IzIwMTk4MTk=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/biocardia-announces-fda-confirms-helix-transendocardial-delivery-catheter-meeting-minutes-supporting-follow-on-de-novo-pre-submission-for-approval\/","name":"BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval - 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