Monitor for FDA substantive review feedback and the upcoming meeting this quarter, which will determine the likelihood and timeline of De Novo clearance. A positive outcome could unlock partnering revenue and re-rate the stock.
Price Chart
Executive Summary
BioCardia announced FDA acceptance of its De Novo pre-submission package for the Helix transendocardial delivery catheter, a key regulatory milestone. FDA has agreed on two potential marketing clearance pathways and raised no safety or performance concerns. The company expects substantive FDA review and a meeting this quarter, which could lead to expanded partnering opportunities for targeted cardiac delivery of therapeutics.
Key Facts
- FDA accepted BioCardia's De Novo pre-submission package for the Helix catheter
- FDA agreed on two pathways for marketing clearance and raised no safety or performance concerns
- BioCardia expects FDA substantive review with written feedback and a meeting this quarter
- Helix catheter has been used in 15 clinical trials with nearly 500 patients
- Marketing clearance could expand partnering opportunities for targeted cardiac delivery
Financial Impact
No financial terms disclosed; potential revenue from partnering and commercialization of Helix catheter if cleared
Risk Factors
- FDA may still request additional data or raise concerns during substantive review
- BioCardia may need additional funding to support commercialization and partnership efforts
- De Novo clearance is not guaranteed and could be delayed or denied
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3383509 |
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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