Recent 8-K filings for BCDA
Highest-materiality recent filing
BioCardia announces PMDA acceptance of CardiAMP data for ischemic heart failure clearance in Japan
- PMDA determined CardiAMP safety/efficacy data likely sufficient for market clearance in ischemic heart failure.
- Alignment reached on acceptability of US foreign clinical data, indications for use, and introduction approach.
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BioCardia to present CardiAMP HF II trial design at HFSA; FDA says trial may support approval
Poster titled "Cardiac Delivery of Autologous Minimally Processed Cell Therapy in HFrEF: Multicenter, Double Blind RCT (CardiAMP HF II)" to be presented at HFSA 2026 in Phoenix, Oct 9-12, 2026.
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BioCardia files revised De Novo pre-submission to FDA for Helix Catheter approval
Revised Pre-Submission to FDA CDRH under Q-Submission program covers the Helix Catheter for therapeutic and diagnostic agent delivery to the heart.
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BioCardia updates FDA Helix pre-submission and PMDA CardiAMP HF Shonin timing
PMDA Shonin pre-market submission targeted for Q4 2026; possible market clearance by Q4 2027.
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BioCardia regains Nasdaq minimum bid price compliance; matter closed
On Sept 21, 2026, Nasdaq notified BioCardia its closing bid price was ≥$1.00 for 10 straight business days.
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BioCardia targets Q4 2026 Shonin submission for CardiAMP; FDA supports PMA path
Targets Q4 2026 Shonin pre-market submission to Japan's PMDA for CardiAMP cell therapy for ischemic heart failure.
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FDA confirmed final meeting minutes from May 2026 Pre-Submission Meeting on Helix Transendocardial Delivery Catheter System.
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BioCardia receives Nasdaq deficiency notice for bid price below $1.00
Received Nasdaq notice on Aug 19, 2026; bid price below $1.00 for 30 consecutive business days.
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BioCardia Q2 net loss narrows to $1.6M; PMDA supports CardiAMP Japan filing
Q2 2026 net loss $1.6M vs $2.0M year-ago; H1 loss $3.9M vs $4.8M.
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Japan PMDA supports potential approval of CardiAMP for ischemic HFrEF; submission planned for Q4 2026.
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BioCardia regains Nasdaq minimum equity compliance after $4.9M ATM raise
Nasdaq extended compliance deadline to Oct 7, 2026 after company submitted plan to regain minimum $2.5M equity.
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BioCardia raises $4.4M via ATM share sale, extends cash runway into Q1 2027
Sold 3,509,604 shares at average $1.279 on June 5, 2026; net proceeds ~$4.4M.
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BioCardia: FDA confirms CardiAMP HF II trial may support PMA for HFrEF therapy
FDA CBER Q-Sub meeting minutes confirm ongoing CardiAMP HF II trial may support Premarket Approval (PMA) for market clearance.
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BioCardia Japan PMDA supports CardiAMP cell therapy submission for HFrEF; submission planned Q4 2026
PMDA Consultation Record confirms alignment on remaining questions; positive outcomes credible.
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BioCardia CardiAMP CMI trial: +179 sec exercise tolerance, 82% fewer angina episodes at EuroPCR
Open-label cohort results presented at EuroPCR; no treatment-emergent major adverse cardiac events.
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Net loss $2.3M in Q1 2026 vs $2.7M in Q1 2025; cash $951k as of March 31, 2026.
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BioCardia announces FDA alignment on Helix catheter clearance pathways; no safety concerns
FDA agreed two pathways for Helix marketing clearance: simultaneous with CardiAMP cell therapy approval or DeNovo via follow-on pre-submission.
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BioCardia announces allowance of Japanese patent for Heart3D Fusion Imaging software
Japanese patent allowed for 'Target Site Selection, Entry, and Update with Automatic Remote Image Annotation'.
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BioCardia announces PMDA acceptance of CardiAMP data for ischemic heart failure clearance in Japan
PMDA determined CardiAMP safety/efficacy data likely sufficient for market clearance in ischemic heart failure.
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Stockholders' equity was $895,000 as of Dec. 31, 2025, well below the $2.5M minimum required by Nasdaq Listing Rule 5550(b)(1).
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Submitted CardiAMP HF clinical study data to FDA; meeting expected Q2 2026 under Breakthrough Designation.
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BioCardia reports 2025 net loss $8.2M; cash $2.5M; regulatory milestones for CardiAMP anticipated
Net loss $8.2M (2025) vs $7.9M (2024); revenue $0; cash $2.5M at year-end.
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BioCardia FDA accepts pre-submission package for Helix catheter; review meeting early Q2
FDA accepted pre-submission package for Helix Transendocardial Delivery Catheter; substantive review and meeting scheduled early Q2 2026.
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BioCardia reports positive echo results from Phase III HFrEF trial; reduced ventricular remodeling
CardiAMP cell therapy reduced left ventricular end-diastolic volume (p=0.06) and end-systolic volume (p=0.09).
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BioCardia files FDA Pre-Submission for Helix transendocardial catheter approval
Completed Pre-Submission (Q-Submission) to FDA for Helix catheter for intramyocardial delivery.
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Echocardiography data from CardiAMP HF trial accepted for Late Breaking Clinical Trial Oral Presentation at THT Meeting.
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BioCardia advances CardiAMP Cell Therapy to formal PMDA consultation for HFrEF in Japan
Completed third preliminary clinical consultation with Japan's PMDA for CardiAMP Cell Therapy (HFrEF).
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BioCardia elects Marvin Slosman to board; Dr. Richard Krasno completes term
Marvin Slosman, CEO of InspireMD, elected to BioCardia board effective Dec. 2, 2025.
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BioCardia appoints Farhan Shahab as VP of Quality
Farhan Shahab named Vice President of Quality, effective November 24, 2025.
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BioCardia reports Q3 2025 results, $6M financing, and regulatory milestones for cell therapies
Closed $6.0 million financing with net proceeds of $5.2 million in September 2025.
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BioCardia announces first patient enrolled at Henry Ford Health in Phase 3 CardiAMP HF II trial
First patient enrolled at Henry Ford Health in Phase 3 CardiAMP HF II trial for ischemic heart failure with reduced ejection fraction.
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BioCardia enrolls first patient at Wisconsin in Phase 3 CardiAMP HF II trial
First patient enrolled at University of Wisconsin School of Medicine and Public Health in Phase 3 CardiAMP HF II trial.
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BioCardia sets 2025 annual meeting for Dec 2; record date Oct 8; nomination deadline Oct 17
Annual meeting on Tuesday, December 2, 2025 at 9:00 a.m. PT in Palo Alto, CA.
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BioCardia regains Nasdaq compliance; stock continues trading on Capital Market
Received Nasdaq notice on Oct 1, 2025 confirming compliance with Listing Rule 5550(b)(1).
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BioCardia regains Nasdaq compliance after raising $7.35M through equity offerings
Raised net proceeds of $0.7M (Apr), $0.5M (Jun), $5.1M (Sep public offer), and $1.0M from ATM sales (Apr–Sep 2025).
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BioCardia gets positive PMDA preliminary consultation on CardiAMP HF trial for Japan approval
Positive preliminary PMDA consultation on CardiAMP Heart Failure Trial data; formal clinical consultation expected by year-end 2025.
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BioCardia closes $5.1M net equity offering with insider participation
Sold 4,800,000 shares of common stock and warrants for 4,800,000 shares at combined price of $1.25 per unit, raising $6M gross proceeds.
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Open-label roll-in cohort (N not given) met primary endpoint; no treatment-emergent major adverse cardiac events.
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Public offering of 4,800,000 shares and short-term warrants for 4,800,000 shares at $1.25 per unit.
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BioCardia and CART-Tech enter exclusive pact for Heart3D Fusion Imaging
Exclusive development/commercialization agreement for Heart3D Fusion Imaging, enhancing 2D x-rays with 3D anatomical models.
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BioCardia Q2 net loss $2M, cash ~$1.1M after ATM; runway into Oct 2025
Net loss of $2.0M for Q2 2025 vs $1.6M in Q2 2024; R&D expenses up to $1.4M.
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BioCardia provides Q3/Q4 2025 timelines for FDA and PMDA submissions for CardiAMP and Helix
Helix DeNovo 510(k) submission to FDA planned for Q3 2025; based on >4,000 intramyocardial deliveries.
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BioCardia submits CardiAMP cell therapy for PMDA clinical consultation in Japan
Submitted clinical data package including full CardiAMP HF trial results and STED to Japan's PMDA on July 24, 2025.
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Henry Ford Health enrolls first patients in BioCardia's Phase 3 CardiAMP HF II trial
Henry Ford Health (Detroit) is now enrolling ischemic HFrEF patients in BioCardia's pivotal CardiAMP HF II trial.
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BioCardia raises ~$570K in private placement of stock and warrants
Sold 274,696 shares and warrants at $2.075/unit, gross proceeds ~$570,000.
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BioCardia granted US Patent No. 12,311,127 for Helix catheter delivery system
Patent covers radial and trans-endocardial delivery catheter for biologic therapies.
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Two-year results from Phase 3 CardiAMP HF trial (presented Mar 30) showed increased survival, fewer CV events, improved QoL; significant in NTproBNP-elevated subset (p=0.02).
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BioCardia initiates patient enrollment at University of Wisconsin for CardiAMP HF II Phase 3 trial
University of Wisconsin now enrolling ischemic HFrEF patients in BioCardia's pivotal Phase 3 CardiAMP HF II trial.
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BioCardia announces first patient enrolled in Phase 3 CardiAMP HF II heart failure trial
First patient enrolled in Phase 3 randomized, double-blind, placebo-controlled CardiAMP HF II trial at BayCare Morton Plant Hospital in Clearwater, Florida.
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BioCardia raises $775k in private placement of common stock and warrants
Gross proceeds of ~$775k from sale of 406,818 shares and 406,818 warrants at $1.905/unit.
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BioCardia CardiALLO heart failure trial passes DSMB review; no safety issues
DSMB recommends study continue as designed after 30-day safety review of 20M-cell dosing cohort.
Earnings & guidance
Materiality & sentiment trend
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