Monitor for FDA acceptance/refusal acceptance within 15 days and FDA written feedback or meeting within 70 days for Helix Catheter clearance. No financial data in this filing.
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Executive Summary
BioCardia filed a revised De Novo pre-submission with the FDA CDRH for its Helix Catheter, a device for therapeutic and diagnostic agent delivery to the heart. The FDA previously raised no safety or performance concerns and agreed there are two pathways to marketing clearance. The FDA targets initial acceptance review within 15 days and written feedback or a meeting within 70 days.
Key Facts
- Revised De Novo pre-submission for Helix Catheter completed and filed with FDA CDRH on October 1, 2026.
- FDA previously agreed there are two pathways for Helix marketing clearance and raised no concerns regarding safety data, device performance, or compatibility with general classes of agents.
- FDA targets initial acceptance/refusal review within 15 calendar days and aims to issue written feedback or hold a meeting within 70 calendar days.
- Helix has clinical data from 15 trials including nearly 500 patients.
- FDA clearance could enable Helix to be the first device of its kind cleared for market release.
Financial Impact
No financial impact stated; regulatory milestone with no revenue or financial data in filing.
Risk Factors
- FDA may not accept the pre-submission or may require additional data.
- No guarantee of marketing clearance or timeline.
- No financial data or revenue in filing.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-031665 |
| Exhibit: ex_1021267.htm | 0001437749-26-031665 |
| Document: 0001437749-26-031665-index-headers.html | 0001437749-26-031665 |
| Document: 0001437749-26-031665-index.html | 0001437749-26-031665 |
| Document: 0001437749-26-031665.txt | 0001437749-26-031665 |
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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