BioCardia Requests FDA Meeting to Discuss Accelerated Approval for CardiAMP Cell Therapy System

BioCardia, Inc. has formally submitted a request for a meeting with the U.S. Food and Drug Administration (FDA) to explore the potential use of an accelerated approval pathway for its CardiAMP® Cell Therapy System. The therapy is designed to address ischemic heart failure, a condition that arises when the heart’s ability to pump blood is impaired due to damage from prior heart attacks.

The company seeks FDA guidance on whether its ongoing clinical data could support accelerated approval under current regulatory frameworks. BioCardia’s CardiAMP® System utilizes autologous bone marrow-derived cells in an effort to improve cardiac function in patients with ischemic heart failure. The system is currently being evaluated in clinical trials, and BioCardia aims to determine if existing trial results may meet the criteria for expedited review and approval.

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Date: April 2, 2026

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GOAI