Filing summary
BioCardia, Inc. filed this Form 8-K on October 1, 2026, reporting an event on that date. The company’s common stock trades on the Nasdaq Capital Market under the symbol BCDA.
Business and regulatory update
BioCardia reported that it completed a revised Pre-Submission to the FDA’s Center for Devices and Radiological Health under the Q-Submission program. The submission concerns the Helix Catheter for therapeutic and diagnostic agent delivery to the heart. Completion of a Pre-Submission is not FDA approval or clearance.
Financial results and changes
This 8-K provides no revenue, profit, cash flow, margin, debt, liquidity, or other financial results, and no comparable-period financial data.
Outlook, risks, and contingencies
The filing does not describe FDA feedback, a review timeline, approval prospects, or financial guidance. It refers to an October 1, 2026 press release as Exhibit 99.1, but the press-release text is not included in the supplied filing content.
Investor verification
- Review Exhibit 99.1 for details about the revised submission and any stated next steps.
- Verify subsequent FDA feedback, requested information, and expected regulatory milestones.
- Check later filings for any financial or operational effects associated with development of the Helix Catheter.