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 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 Helix - FDA Process — What Happens Next 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. So the immediate next milestone is mid-October 2026 for FDA's acceptance/refusal decision on the revised pre-submission, followed by late November/December 2026 for written FDA feedback. That then informs the actual De Novo application filing in early-to-mid 2027, with an approval decision likely in Q1–Q2 2028 under the Breakthrough Device acceleration. Also now confirmed: the Center for Biologics Evaluation and Research (CBER) at the FDA has indicated the CardiAMP HF II study may support a Pre-Marketing Application — and a successful Japan PMDA Shonin submission and review could result in market clearance by Q4 2027.

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

$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 BioCardia probably the most advanced in study. I think FDA would expedite its review upon pma submission.

$BCDA could be one of those stocks that goes from one dollar to $40 like ROIV did from three dollar plus.

$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 ...finally hit my average of 1.37. I feel a continuous upward trend is finally here. Paws crossed...

$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 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

$BCDA What is your opinion on the stock? How do you see it performing in the coming weeks?

$BCDA dirty shorts. its been trading low above $1 and they jut got the confirmed today hence the spike. still have the helix pre submition to come And PMDA \

$BCDA that should tell h all… low volume, 3 digits ask and bids and then u have a 10K fake bid

$BCDA they filed an 8-k today. about the event in New York. also they still on time for Q3 PREsubmison for the Helix follow-on-de-Nova pre-submission.