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 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.
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BioCardia initiates patient enrollment at Emory University for Phase III heart failure trial
Emory University School of Medicine is now enrolling patients with ischemic heart failure in BioCardia's pivotal Phase III CardiAMP HF II trial.
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BioCardia: Nasdaq notice for equity $837K vs $2.5M minimum; plan due May 16
Stockholders' equity of $837K as of Dec 31, 2024 is below Nasdaq's $2.5M minimum for continued listing.
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Primary composite efficacy endpoint did not reach statistical significance in overall 115-patient trial.
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BioCardia clarifies CardiAMP-HF call at 4:30PM EDT; no results disclosed
Conference call today, March 31, 2025 at 4:30 PM EDT to discuss two-year CardiAMP-HF results.
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Net loss $7.9M vs $11.6M in 2023; net cash used in ops $8.0M vs $10.0M.
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BioCardia granted Japanese patent for Helix biotherapeutic delivery catheter expiring 2034
Japan Patent Office issued Patent No. 7641330 titled 'Radial and Transendocardial Delivery Catheter'.
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BioCardia freezes primary outcomes data in Phase 3 CardiAMP HF trial; results at ACC 2025
Source data verified and data frozen for 115 patients in double-blind, placebo-controlled Phase 3 trial for ischemic HFrEF.
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BioCardia completes low-dose enrollment in CardiALLO allogeneic MSC HFrEF trial
Enrolled and dosed 3 patients in low-dose cohort (20M cells) of Phase I/II CardiALLO trial.
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BioCardia's CardiAMP HF Phase 3 trial accepted for late-breaking presentation at ACC 2025
Results of double-blind, randomized, placebo-controlled CardiAMP HF Phase 3 study accepted for late-breaking symposium at ACC 2025 in Chicago, March 29-31.
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BioCardia commercially launches Morph DNA steerable introducer product family
Morph DNA steerable introducer family now commercially available; currently used in ongoing cell-therapy clinical trials.
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BioCardia gets positive PMDA consultation; next step after final CardiAMP HF data in Q1 2025
Completed consultation with Japan PMDA; PMDA invited next consultation after submission of final 2-year follow-up data.
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BioCardia reports Q3 2024 net loss $1.7M; CardiAMP data expected Q1 2025
Net loss $1.7M for Q3 2024 vs $2.6M a year ago; R&D expenses fell to $931K from $1.9M.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.65 · Most common event other_material