This is a routine conference announcement with no new material data. Monitor the Q4 2026 timeline for the Japan PMDA submission and any CardiAMP HF II trial enrollment updates for the next meaningful catalyst.
Price Chart
Executive Summary
BioCardia filed an 8-K announcing that CEO Peter Altman will present at the H.C. Wainwright 28th Annual Global Investment Conference on September 14-16, 2026. The attached press release recaps recent regulatory progress, including preparation of a Shonin submission to Japan's PMDA for CardiAMP cell therapy targeted for Q4 2026, FDA confirmation that the ongoing CardiAMP HF II pivotal trial may support a PMA, and FDA meeting minutes supporting a follow-on De Novo pre-submission for the Helix delivery system. This is a routine investor conference announcement with no new material financial data or definitive regulatory milestones.
Key Facts
- CEO Peter Altman will present at H.C. Wainwright 28th Annual Global Investment Conference, September 14-16, 2026.
- BioCardia is preparing a Shonin pre-market submission to Japan's PMDA for CardiAMP cell therapy, targeted for Q4 2026.
- FDA meeting minutes from June confirmed the ongoing CardiAMP HF II pivotal trial may support a Premarket Approval (PMA) in the U.S.
- FDA meeting minutes from August support a follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System, to be submitted in Q3 2026.
- The company is advancing Heart3D Fusion Imaging with partner CART-Tech toward a potential FDA 510(k) submission.
Financial Impact
No financial figures reported in this filing.
Risk Factors
- No new financial data or definitive regulatory milestones were announced.
- The company's liquidity position and ability to raise additional funds remain key risks as noted in the forward-looking statements.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-030023 |
| Exhibit: ex_1014043.htm | 0001437749-26-030023 |
| Document: 0001437749-26-030023-index-headers.html | 0001437749-26-030023 |
| Document: 0001437749-26-030023-index.html | 0001437749-26-030023 |
| Document: 0001437749-26-030023.txt | 0001437749-26-030023 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 8d ago | 8-K | $0.8975 $1.04 | ▲ +15.88% | ▲ +15.54% | $0.9259 (+3.16%) |
Oct 19, 2026 8d ago | Press Release | $0.9000 $1.04 | ▲ +15.56% | ▲ +15.22% | $0.9259 (+2.88%) |
Oct 7, 2026 20d ago | 8-K | $1.09 $1.06 | ▼ −2.75% | ▼ −2.33% | $0.9259 (−15.06%) |
Oct 1, 2026 26d ago | 8-K | $1.02 $1.04 | ▲ +1.96% | ▲ +1.22% | $0.9259 (−9.23%) |
Oct 1, 2026 26d ago | Press Release | $1.02 $1.04 | ▲ +1.96% | ▲ +1.22% | $0.9259 (−9.23%) |
Sep 23, 2026 4w ago | 8-K | $1.05 $1.07 | ▲ +1.90% | ▲ +1.99% | $0.9259 (−11.82%) |
Sep 23, 2026 4w ago | Press Release | $1.05 $1.07 | ▲ +1.90% | ▲ +1.99% | $0.9259 (−11.82%) |
Sep 10, 2026 6w ago | 8-K | $1.10 $1.08 | ▼ −1.82% | ▼ −2.67% | $0.9259 (−15.83%) |
Aug 24, 2026 9w ago | 8-K | $1.06 $1.13 | ▲ +6.60% | ▲ +6.28% | $0.9259 (−12.65%) |
Aug 5, 2026 11w ago | Press Release | $0.9500 $0.9496 | ▼ −0.04% | ▲ +0.12% | $0.9259 (−2.54%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers