Monitor for the Helix De Novo submission acceptance within the next 15 calendar days and for PMDA Shonin submission in Q4 2026. No near-term binary catalyst — the next material event is the FDA's acceptance/refusal decision on the Helix pre-submission.
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Executive Summary
BioCardia filed an 8-K providing a routine update on regulatory timelines for its CardiAMP HF and Helix programs. The company is working toward a PMDA Shonin submission in Japan in Q4 2026 with potential clearance by Q4 2027, and intends to submit a follow-on De Novo pre-submission for the Helix catheter to the FDA this quarter. No financial data, clinical results, or material events were disclosed — this is a procedural milestone update with no immediate catalyst.
Key Facts
- BioCardia is working toward a Shonin pre-market submission to Japan's PMDA in Q4 2026, with potential market clearance by Q4 2027.
- The confirmatory CardiAMP HF II study is actively enrolling at four U.S. centers; FDA CBER indicated the study 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.
- FDA targets initial acceptance/refusal review within 15 calendar days and written feedback or a meeting within 70 calendar days.
- No financial figures, clinical data, or material agreements were disclosed in the filing.
Financial Impact
No financial impact disclosed; regulatory milestones with no associated dollar amounts.
Risk Factors
- Regulatory submissions may be delayed or rejected; FDA or PMDA could request additional data.
- The company's liquidity position and ability to fund ongoing trials and regulatory activities is a stated risk factor.
- CardiAMP HF II trial enrollment and results remain uncertain and could impact any future BLA/PMA path.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-031011 |
| Exhibit: ex_1018881.htm | 0001437749-26-031011 |
| Document: 0001437749-26-031011-index-headers.html | 0001437749-26-031011 |
| Document: 0001437749-26-031011-index.html | 0001437749-26-031011 |
| Document: 0001437749-26-031011.txt | 0001437749-26-031011 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 8d ago | 8-K | $0.8975 $1.04 | ▲ +15.88% | ▲ +15.54% | $0.9000 (+0.28%) |
Oct 19, 2026 8d ago | Press Release | $0.9000 $1.04 | ▲ +15.56% | ▲ +15.22% | $0.9000 (−0.00%) |
Oct 7, 2026 20d ago | 8-K | $1.09 $1.06 | ▼ −2.75% | ▼ −2.33% | $0.9000 (−17.43%) |
Oct 1, 2026 26d ago | 8-K | $1.02 $1.04 | ▲ +1.96% | ▲ +1.22% | $0.9000 (−11.76%) |
Oct 1, 2026 26d 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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