BCDA BioCardia Inc.

$BCDA How Novel Is the Helix? A True Category-Creator BioCardia's CEO stated the goal plainly: this pre-submission "should lead to our Helix catheter being the first approved transendocardial delivery catheter system in the United States." That's the critical framing — not "better than the competition" but the only one of its kind with FDA clearance.

$BCDA BioCardia Announces FDA Acceptance of De Novo Pre-Submission Package for Helix™ Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this Quarter

$BCDA Could be an interesting week. BioCardia Files Revised De Novo Pre-Submission for FDA Approval of Helix™ Catheter on Oct 1. “The FDA targets providing an initial acceptance/refusal review within 15 calendar days and aims to issue written feedback or hold a meeting within 70 calendar days.”

$BCDA Get ready for BOOM! It likely won’t be tied to a catalyst event. With no explanation the stock will go through the ceiling… peops on the sifelines and bleachers wondering what happened. It might be based on a key catalyst, or it could be based on majority shareholders forcing price higher because… well, because they can….. and then we have a new trading range - maybe $6 or higher.

$BCDA couldn't help myself, had to buy more... I fear this is your last chance to get it near 1$..👈👈

$BCDA indicated FDA acceptance of its Helix Catheter De Novo pre-submission package, with a review meeting expected this quarter.

Latest company news, October 19, 2026: The FDA accepted BioCardia's updated De Novo pre-submission package for the Helix catheter; written FDA feedback and a meeting are expected this quarter. A pre-submission is a request for feedback, not a marketing application or clearance. BioCardia ($BCDA) Stock Hub: Can Helix and Japan Advance Within the Funding Window? Not investment advice. More details in our stock hub.

$BCDA I really hope ones they submit the PMDA. that will really ouch the price up what’s your thoughts

$BCDA Haha, off day with this stock. Nobody wants to make their move. Peter show them how it's done😋

$BCDA looks like peter is out of money with those 500 share chunks, but he still keeps buying🤝 maybe I should too