11:39 AM EDT, 04/02/2026 (MT Newswires) -- BioCardia ( BCDA ) said Thursday it has requested a meeting with the US Food and Drug Administration to discuss the accelerated approval pathway for the CardiAMP System for ischemic chronic heart failure with reduced ejection fraction.

The request followed its submission of the CardiAMP HF clinical study data, the company said, adding that it expects to have the meeting during this quarter. The meeting will be held under its breakthrough designation for the CardiAMP System.

CardiAMP cell therapy delivers a patient's own bone marrow cells to the heart in a minimally invasive procedure to address microvascular dysfunction, the firm said.

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