BioCardia Files Request for Meeting With FDA to Discuss Accelerated Approval Pathway for CardiAMP® System in Ischemic Heart Failure
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
Company Research
Source: GlobeNewswire
SUNNYVALE, Calif., April 02, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported submission to United States Food and Drug Administration (FDA) of the CardiAMP HF clinical study data and on its plans to meet with the FDA to discuss the accelerated approval pathway for the CardiAMP® System for ischemic chronic heart failure with reduced ejection fraction (HFrEF). This meeting request is in line with previous guidance and BioCardia expects to have the meeting during this quarter. The meeting will be held under BioCardia’s FDA Breakthrough Designation for the CardiAMP System. The key objectives of the meeting are to obtain FDA feedback on the acceptability of BioCardia’s proposed submission for approval based on the safety seen in the CardiAMP HF Trial, the well-characterized clinical response data for the 125 ischemic HFrEF patients enrolled into
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News
- BioCardia Files Request for Meeting With FDA to Discuss Accelerated Approval Pathway for CardiAMP® System in Ischemic Heart Failure [Yahoo! Finance]Yahoo! Finance
- BioCardia Inc (BCDA) Q4 2025 Earnings Call Highlights: Promising Clinical Results Amid ... [Yahoo! Finance]Yahoo! Finance
- BioCardia outlines imminent CardiAMP FDA submission and targets regulatory catalysts as trial data signals clinical benefit [Seeking Alpha]Seeking Alpha
- BioCardia, Inc. (BCDA) Q4 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
- BioCardia Reports 2025 Business Highlights and Financial ResultsGlobeNewswire
BCDA
Sec Filings
- 4/2/26 - Form 8-K
- 3/26/26 - Form 4
- 3/24/26 - Form 8-K
- BCDA's page on the SEC website