{"id":971019,"date":"2026-06-05T08:05:00","date_gmt":"2026-06-05T12:05:00","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-confirms-cardiamp-hf-ii-may-support-premarket-approval-of-cardiamp-cell-therapy-for-ischemic-hfref\/"},"modified":"2026-06-05T08:05:00","modified_gmt":"2026-06-05T12:05:00","slug":"fda-confirms-cardiamp-hf-ii-may-support-premarket-approval-of-cardiamp-cell-therapy-for-ischemic-hfref","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-confirms-cardiamp-hf-ii-may-support-premarket-approval-of-cardiamp-cell-therapy-for-ischemic-hfref\/","title":{"rendered":"FDA Confirms CardiAMP HF II May Support Premarket Approval of CardiAMP Cell Therapy for Ischemic HFrEF"},"content":{"rendered":"
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SUNNYVALE, Calif., June 05, 2026 (GLOBE NEWSWIRE) — BioCardia\u00ae<\/sup>, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced receipt of FDA minutes from its Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER) on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).<\/p>\n

The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance. PMA is the most rigorous type of device marketing application required by the agency. It is used to establish the safety and effectiveness of high-risk medical devices prior to them being approved for public use.<\/p>\n

FDA had previously indicated that they typically like to see two well designed trials for approval, particularly in large clinical indications such as HFrEF, where there are potentially over one million patients who could benefit from CardiAMP Cell Therapy in the United States. FDA has also previously demonstrated that they consider the CardiAMP Cell Therapy System safe, as this FDA determination is required to enable the Centers for Medicare and Medicaid to reimburse in the CardiAMP HF trials.<\/p>\n

\u201cPatients with ischemic Heart Failure of reduced Ejection Fraction are in great need for therapeutic options,\u201d said Peter Altman, PhD, BioCardia\u2019s Chief Executive Officer. \u201cFDA recognizes this need and the strengths in our completed CardiAMP HF clinical data to be the first of two trials to support Premarket Approval.\u201d<\/p>\n

\n About CardiAMP Cell Therapy<\/strong>\n <\/p>\n

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient\u2019s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Japan Pharmaceutical and Medical Device Agency has indicated that the clinical results from three completed clinical trials for the treatment of ischemic heart failure likely provide sufficient evidence of safety and efficacy to support a successful submission for approval.<\/p>\n

Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use.\u00a0<\/p>\n

\n About BioCardia<\/strong>
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\n \u00ae<\/strong>
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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\u00ae<\/sup>\u00a0autologous and CardiALLO\u2122<\/sup> 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<\/sup> biotherapeutic delivery and Morph\u00ae<\/sup>\u00a0vascular navigation product platforms, and soon the Heart3D\u2122<\/sup> fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit\u00a0www.biocardia.com.<\/p>\n

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