Monitor the Q4 2026 Shonin submission to Japan's PMDA and the FDA CDRH's response to the Helix De Novo pre-submission within 70 calendar days. These regulatory steps are binary catalysts but remain contingent on future outcomes — no near-term revenue inflection is implied.
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Executive Summary
BioCardia provided a regulatory milestone update, highlighting a planned Q4 2026 Shonin pre-market submission to Japan's PMDA for CardiAMP cell therapy (potential clearance by Q4 2027) and a follow-on De Novo pre-submission for the Helix delivery catheter to the FDA's CDRH this quarter. The confirmatory CardiAMP HF II trial is actively enrolling in the U.S. with FDA CBER indicating it may support a Pre-Marketing Application. These are procedural updates with no financial data or definitive regulatory outcomes, making the filing routine and neutral in impact.
Key Facts
- BioCardia is working toward a Shonin pre-market regulatory submission to Japan's PMDA in Q4 2026, with potential market clearance by Q4 2027.
- The CardiAMP HF II confirmatory study is actively enrolling in the U.S. at four centers; FDA CBER indicated it may support a Pre-Marketing Application.
- BioCardia intends to submit a follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System to FDA CDRH this quarter.
- No financial results, guidance, or material agreements were disclosed in the press release.
Financial Impact
No financial figures provided; regulatory milestones are procedural and do not carry immediate revenue or cost impact.
Risk Factors
- Regulatory submissions may be delayed or rejected, particularly the PMDA Shonin application and FDA De Novo clearance.
- BioCardia's liquidity position and ability to raise additional funds are noted as risk factors, which could impact clinical and regulatory timelines.
- The CardiAMP HF II trial's enrollment pace and eventual data readout remain uncertain.
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3367551 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 7d ago | 8-K | $0.8975 $1.04 | ▲ +15.88% | ▲ +15.54% | $0.9000 (+0.28%) |
Oct 19, 2026 7d ago | Press Release | $0.9000 $1.04 | ▲ +15.56% | ▲ +15.22% | $0.9000 (−0.00%) |
Oct 7, 2026 19d ago | 8-K | $1.09 $1.06 | ▼ −2.75% | ▼ −2.33% | $0.9000 (−17.43%) |
Oct 1, 2026 25d ago | 8-K | $1.02 $1.04 | ▲ +1.96% | ▲ +1.22% | $0.9000 (−11.76%) |
Oct 1, 2026 25d ago | Press Release | $1.02 $1.04 | ▲ +1.96% | ▲ +1.22% | $0.9000 (−11.76%) |
Sep 23, 2026 4w ago | 8-K | $1.05 $1.07 | ▲ +1.90% | ▲ +1.99% | $0.9000 (−14.29%) |
Sep 23, 2026 4w ago | Press Release | $1.05 $1.07 | ▲ +1.90% | ▲ +1.99% | $0.9000 (−14.29%) |
Sep 10, 2026 6w ago | 8-K | $1.10 $1.08 | ▼ −1.82% | ▼ −2.67% | $0.9000 (−18.18%) |
Aug 24, 2026 9w ago | 8-K | $1.06 $1.13 | ▲ +6.60% | ▲ +6.28% | $0.9000 (−15.09%) |
Aug 5, 2026 11w ago | Press Release | $0.9500 $0.9496 | ▼ −0.04% | ▲ +0.12% | $0.9000 (−5.26%) |
US Market Status
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