Biocardia, INC 8-K filings
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Biocardia, INCBioCardia announced positive primary endpoint results from its CardiAMP Cell Therapy trial for chronic myocardial ischemia, showing improved exercise tolerance and reduced angina.
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Biocardia, INCBioCardia and CART-Tech have formed an exclusive partnership to develop and commercialize Heart3D Fusion Imaging for cardiac interventions.
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Biocardia, INCBioCardia, Inc. reported increased net losses and cash burn in Q2 2025, while advancing multiple cardiovascular cell therapy clinical trials and securing a new patent.
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Biocardia, INCBioCardia, Inc. announced anticipated regulatory submission timelines for its CardiAMP Cell Therapy System and Helix Transendocardial Delivery Catheter to the FDA and Japan PMDA.
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Biocardia, INCBioCardia, Inc. has submitted its CardiAMP autologous cell therapy for clinical consultation with Japan's Pharmaceuticals and Medical Devices Agency, marking a significant step towards potential regulatory approval in a key market.
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Biocardia, INCBioCardia, Inc. announced that Henry Ford Health has commenced patient enrollment for its pivotal Phase 3 CardiAMP HF II trial targeting ischemic heart failure.
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Biocardia, INCBioCardia, Inc. has successfully completed a private placement, securing approximately $570,000 through the sale of common stock and warrants, with significant investment from its board members and executive officers.
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Biocardia, INCBioCardia, Inc. announced the grant of a new United States patent for its Helix Biotherapeutic Delivery System, enhancing its intellectual property in minimally invasive cardiovascular therapy.
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Biocardia, INCBioCardia announces positive two-year results from its CardiAMP HF Trial and reports its first quarter 2025 financial results, highlighting progress in its cardiovascular and pulmonary disease therapies.
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Biocardia, INC8-K: BioCardia Initiates Patient Enrollment at University of Wisconsin for CardiAMP HF II Pivotal Study
BioCardia announces the start of patient enrollment at the University of Wisconsin for its Phase 3 CardiAMP HF II trial, evaluating cell therapy for ischemic heart failure.
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Biocardia, INCBioCardia has announced the enrollment of the first patient in its Phase 3 CardiAMP HF II clinical trial for heart failure treatment.
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Biocardia, INCBioCardia, Inc. has entered into a Securities Purchase and Registration Rights Agreement for a private placement of common stock and warrants, expected to close on April 23, 2025.
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Biocardia, INCBioCardia announces that the independent Data Safety Monitoring Board (DSMB) recommended the CardiALLO Heart Failure Phase 1/2 clinical trial continue as designed after reviewing 30-day safety data from the 20 million cell dosing cohort.
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Biocardia, INCBioCardia announces that Emory University School of Medicine is now enrolling patients in its Phase III CardiAMP HF II trial for ischemic heart failure.
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Biocardia, INCBioCardia, Inc. received a notice from Nasdaq for failing to meet the minimum stockholders' equity requirement for continued listing.
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Biocardia, INCBioCardia, Inc. clarifies the timing of its conference call to discuss the two-year results of the CardiAMP-HF study, scheduled for today, March 31, 2025, at 4:30 PM EDT.
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Biocardia, INCBioCardia announces positive two-year results from its Phase 3 CardiAMP-HF trial, demonstrating increased survival, decreased cardiac events, and improved quality of life in ischemic heart failure patients treated with CardiAMP cell therapy.
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Biocardia, INCBioCardia announces its 2024 financial results, highlighting reduced operating losses and R&D expenses, and anticipates presenting CardiAMP HF Trial data at the American College of Cardiology Scientific Sessions.
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Biocardia, INCBioCardia, Inc. announces the grant of a Japanese patent for its Helix biotherapeutic delivery system, expanding its patent portfolio for minimally invasive catheter-based therapies.
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Biocardia, INC8-K: BioCardia Announces Data Freeze in CardiAMP Heart Failure Trial, Results to be Presented at ACC 2025
BioCardia completes data verification and freezes primary outcomes data for its Phase 3 CardiAMP HF study, with results slated for presentation at the American College of Cardiology 2025 Scientific Sessions.
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Biocardia, INCBioCardia announces the completion of enrollment and dosing in the low dose cohort of its CardiALLO Phase I/II trial, evaluating allogeneic mesenchymal stem cells for treating ischemic heart failure.
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Biocardia, INCBioCardia's Phase 3 CardiAMP HF study results will be presented at the American College of Cardiology 2025 Scientific Sessions in a late-breaking symposium.
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Biocardia, INCBioCardia has announced the commercial availability of its Morph DNA steerable introducer product family, which is currently used in the company's ongoing clinical trials.
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Biocardia, INCBioCardia has successfully completed a consultation with Japan's PMDA regarding the registration of its BCDA-01 therapy for ischemic heart failure, with the next consultation planned after the submission of final clinical trial data.
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Biocardia, INCBioCardia reported its third quarter 2024 financial results and provided updates on its clinical trials, including the completion of patient follow-up in the CardiAMP Heart Failure Trial.
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Biocardia, INCBioCardia has completed the final follow-up visit in its Phase III clinical trial for CardiAMP cell therapy for heart failure, moving closer to potential regulatory approvals.
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Biocardia, INCBioCardia has regained full compliance with Nasdaq listing requirements after demonstrating adherence to the Equity Rule, following a period of balance sheet improvements and capital raising.
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Biocardia, INCBioCardia successfully closed a $7.2 million public offering, priced at-the-market, to fund working capital and advance its biotherapeutic programs.
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Biocardia, INCBioCardia, Inc. has entered into agreements to sell common stock and warrants in a public offering, expecting net proceeds of $6.3 million.
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Biocardia, INCBioCardia has announced the pricing of an upsized public offering expected to generate $7.2 million in gross proceeds.