BioCardia, Inc. Updates FDA Helix Pre‑Submission & PMDA Shonin Timing

What Happened
On September 23, 2026, BioCardia, Inc. (BCDA) filed a Form 8-K (Item 8.01) to announce and attach a press release that confirms timing and provides an update on its FDA Helix pre‑submission and the PMDA CardiAMP HF Shonin submission. The press release is furnished as Exhibit 99.1 to the 8‑K filed the same day.

Key Details

• Filing date: September 23, 2026 (Form 8‑K, Item 8.01).
• Press release attached as Exhibit 99.1 to the Form 8‑K.
• Subject of update: timing and status for the FDA Helix pre‑submission and the PMDA CardiAMP HF Shonin submission.
• No earnings, financial results, or executive changes were reported in this filing.

Why It Matters
Regulatory interactions and timing updates are material for investors because they can affect development timelines, potential market approvals, and future commercialization plans in the U.S. and Japan. This 8‑K does not include financial information or personnel changes; it simply publicizes the company’s latest regulatory timing updates via the attached press release. Investors should review the full press release (Exhibit 99.1) for details and monitor future filings for regulatory milestones or financial impacts.