BCDA BioCardia, Inc.
Price Chart
Executive Summary
BioCardia announced FDA confirmation that its ongoing CardiAMP Heart Failure II trial may support a Premarket Approval (PMA) submission for the CardiAMP Cell Therapy System in ischemic HFrEF. This regulatory milestone de-risks the path to market for a therapy targeting a large patient population, but the company remains pre-revenue with no financial data provided in the filing.
Actionable Insight
The FDA's acceptance of a single pivotal trial for PMA is a significant regulatory de-risking event for a pre-revenue biotech. Monitor for trial enrollment updates and the Q4 2026 Japan PMDA submission as the next catalysts.
Key Facts
- FDA CBER confirmed the ongoing CardiAMP HF II trial may support a PMA for market clearance.
- CardiAMP Cell Therapy has FDA Breakthrough Device designation.
- Japan's PMDA indicated three completed clinical trials likely provide sufficient evidence for approval.
- Upcoming catalyst: Japan PMDA submission targeted for Q4 2026.
- No financial data, revenue, or guidance was disclosed in this filing.
Financial Impact
No financial figures provided; pre-revenue clinical-stage company.
Risk Factors
- Trial may fail to meet endpoints, preventing PMA approval.
- Company has limited liquidity and may need to raise capital to complete the trial.
- Single-trial PMA approvals are rare and FDA may still require additional data.
Market Snapshot
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-019653 |
| Exhibit: ex_972814.htm | 0001437749-26-019653 |
| Document: 0001437749-26-019653-index-headers.html | 0001437749-26-019653 |
| Document: 0001437749-26-019653-index.html | 0001437749-26-019653 |
| Document: 0001437749-26-019653.txt | 0001437749-26-019653 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 12, 2026
2d ago
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8-K
| $0.8165 awaiting T+5 | awaiting T+5 | — | $0.8800 (+7.78%) |
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Jun 8, 2026
6d ago
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8-K
| $0.8800 awaiting T+5 | awaiting T+5 | — | $0.8800 (+0.00%) |
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Jun 8, 2026
6d ago
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Press Release
| $0.8800 awaiting T+5 | awaiting T+5 | — | $0.8800 (+0.00%) |
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Jun 5, 2026
9d ago
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8-K
| $1.20 awaiting T+5 | awaiting T+5 | — | $0.8800 (−26.67%) |
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May 28, 2026
17d ago
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8-K
| $0.9200 $0.8700 | ▼ −5.43% | ▼ −5.39% | $0.8800 (−4.35%) |
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May 15, 2026
4w ago
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8-K
| $1.01 $0.9600 | ▼ −4.95% | ▼ −5.91% | $0.8800 (−12.87%) |
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May 15, 2026
4w ago
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Press Release
| $1.01 $0.9600 | ▼ −4.95% | ▼ −5.91% | $0.8800 (−12.87%) |
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May 11, 2026
4w ago
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Press Release
| $1.12 $0.9000 | ▼ −19.64% | ▼ −19.72% | $0.8800 (−21.43%) |
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May 8, 2026
5w ago
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8-K
| $1.11 $1.09 | ▼ −1.80% | ▼ −3.27% | $0.8800 (−20.72%) |
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Apr 28, 2026
6w ago
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8-K
| $1.14 $1.13 | ▼ −0.88% | ▼ −2.57% | $0.8800 (−22.81%) |
US Market Status
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