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

$BCDA global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the FDA has accepted its pre-submission package for marketing clearance of its Helix catheter ("Helix") intended for therapeutic and diagnostic agent delivery.

$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.

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

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 * CardiAMP regulatory progress: Japan’s PMDA has indicated support for a regulatory submission for CardiAMP in ischemic heart failure. The company is also advancing the CardiAMP HF II trial in the U.S. * Helix catheter opportunity: BCDA is pursuing regulatory progress for its Helix system, which could provide another commercial avenue beyond CardiAMP. Recent company presentations have focused on CardiAMP, Helix and Heart3D. * Cash runway improved: BCDA raised about $4.9M through its ATM in Q2, and management said the company had runway into 2027. * Potentially significant catalyst: A successful Japanese regulatory submission/approval could materially change the company’s valuation because BCDA is currently valued like a very early-stage biotech.

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

$BCDA it probably had raised sufficient funds via atm during high volume days to carry itself through Helix approval, and its phase 3 iinterim.

$BCDA tell me better stock to buy right now than this. I can't put my all money in this basket😅

$BCDA last day tomorrow. they said they was going to have the pre submission q3. and they confirmed that only 6 days ago for follow-on Helix Nova pre-sub

$BCDA I have a feeling they are going to drop offering .. soon it will drop to .50s iam out

$BCDA the highly successful Chinese study using stem cells for heart disease used invasive surgery. If BioCardia could break into Chinese market replacing invasive surgery, it will be huge.

$BCDA I find helix one of the safest catheters around that does its job and has broad patent protection. Cardiac surgeons know how valuable an effective and safe catheter is for delivery of stem cells.

$BCDA poor bio companies always have to face these issues to get drug out.. shorties take this advantage and make money out of it

$BCDA Upcoming Events - August 12: Q2 2026 Earnings call - click here for replay/download of the call: Sept 12-14: H.C. Wainwright Annual Global Investment Conference, NYC Oct 9-12 : Heart Failure Society of America, Phoenix Oct 23- 25: Japan Heart Failure Society Annual Meeting, Toyama Oct 31- Nov 3: TCT 2026, San Diego Dec 7 -9 : Global Cardio Vascular Clinical Trialists Forum, Washington DC

$BCDA BioCardia is preparing a Shonin pre-market regulatory submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) for approval of CardiAMP Cell Therapy for ischemic heart failure, targeted for the fourth quarter of 2026. PMDA’s formal Consultation Record of Advice supports a regulatory submission based on the Company’s three completed clinical trials and noted that the positive outcomes observed in the clinical data were credible.

$BCDA 1.21 reclaim and hold opens $1.35 then $1.52, while $1.05-$1.06 is the line in the sand before $0.92 Pumpers sold into each other after hours