BioCardia, Inc. 8-K

What Happened
BioCardia, Inc. announced on February 10, 2026 that it completed a Pre-Submission under the U.S. Food and Drug Administration’s Q‑Submission program for its Helix Transendocardial Delivery Catheter, intended for intramyocardial delivery of therapeutic and diagnostic agents. The company filed a press release about the event as Exhibit 99.1 to its Form 8‑K.

Key Details

• Event: Completed FDA Pre-Submission (Q‑Submission) for the Helix Transendocardial Delivery Catheter.
• Date filed: Form 8‑K dated February 10, 2026.
• Purpose of device: Intramyocardial delivery of therapeutic and diagnostic agents.
• Disclosure: Press release attached as Exhibit 99.1 to the Form 8‑K.

Why It Matters
A Q‑Submission Pre-Submission is an early regulatory step that lets a company get formal feedback from the FDA on testing, clinical study design, and data expectations. For investors, this milestone signals BioCardia is advancing regulatory engagement for the Helix catheter — a necessary step before formal submissions that could support future clinical trials or marketing applications. The filing does not report approvals, timelines, or financial results; it simply confirms the company has initiated structured regulatory dialogue with the FDA.