BCDA
NASDAQBioCardia Inc.
SectorHealth CareIndustryBiotechnology: Biological Products (No Diagnostic Substances)
Website
News25/Ratings1
News · 26 weeks50-40%
2025-10-262026-04-19
Mix2190d
- SEC Filings10(48%)
- Other6(29%)
- Insider3(14%)
- Earnings2(10%)
Latest news
25 items- INSIDERSEC Form 4 filed by Altman Peter4 - BioCardia, Inc. (0000925741) (Issuer)
- SECBioCardia Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits8-K - BioCardia, Inc. (0000925741) (Filer)
- PRBioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart FailureSUNNYVALE, Calif., April 20, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ:BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported a positive outcome in its formal clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA). PMDA has determined that the clinical safety and efficacy evidence for the CardiAMP® Cell Therapy in ischemic heart failure is likely sufficient to support market clearance. Good alignment was achieved in the meeting on the acceptability of the foreign clinical data that has been developed in the United States, the indications for use in patients, the approac
- SECBioCardia Inc. filed SEC Form 8-K: Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing8-K - BioCardia, Inc. (0000925741) (Filer)
- PRBioCardia Files Request for Meeting With FDA to Discuss Accelerated Approval Pathway for CardiAMP® System in Ischemic Heart FailureSUNNYVALE, Calif., April 02, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ:BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported submission to United States Food and Drug Administration (FDA) of the CardiAMP HF clinical study data and on its plans to meet with the FDA to discuss the accelerated approval pathway for the CardiAMP® System for ischemic chronic heart failure with reduced ejection fraction (HFrEF). This meeting request is in line with previous guidance and BioCardia expects to have the meeting during this quarter. The meeting will be held under BioCardia's FDA Breakthrough Designation for
- SECBioCardia Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits8-K - BioCardia, Inc. (0000925741) (Filer)
- INSIDERSEC Form 4 filed by Altman Peter4 - BioCardia, Inc. (0000925741) (Issuer)
- SECBioCardia Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits8-K - BioCardia, Inc. (0000925741) (Filer)
- SECSEC Form S-8 filed by BioCardia Inc.S-8 - BioCardia, Inc. (0000925741) (Filer)
- SECSEC Form 10-K filed by BioCardia Inc.10-K - BioCardia, Inc. (0000925741) (Filer)
- PRBioCardia Reports 2025 Business Highlights and Financial ResultsSUNNYVALE, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the year ended December 31, 2025 and filed its annual report on Form 10-K with the Securities and Exchange Commission. The Company will host a corporate update conference call today, on Tuesday, March 24, 2026, at 4:30 PM ET, in which it will discuss business highlights. Call details and dial-in are provided below. Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) In parallel
- PRBioCardia to Host 2025 Financial Results and Corporate Update Conference Call on March 24, 2026SUNNYVALE, Calif., March 19, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will provide a corporate update and report its financial results for the year ended December 31, 2025 by conference call on Tuesday, March 24, 2026 at 4:30 PM EDT. Following management's formal remarks, there will be a question-and-answer session. Participants can register for the conference by navigating to https://dpregister.com/sreg/10207584/1039b7a7360. Please note that registered participants will receive their dial-in number upon registration. For those who have not
- SECBioCardia Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits8-K - BioCardia, Inc. (0000925741) (Filer)
- PRBioCardia Announces Pre-Submission Approval Package for Helix Transendocardial Delivery Catheter Accepted by FDASUNNYVALE, Calif., March 17, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the FDA has accepted its pre-submission package for the approval of its Helix Transendocardial Delivery Catheter ("Helix") intended for intramyocardial therapeutic and diagnostic agent delivery. BioCardia has had preliminary meetings with both FDA Center for Devices and Radiological Health (CDRH) and FDA Center for Biological Evaluation and Research (CBER) on this submission in recent weeks. CDRH is expected to lead the review in consultation with CBER. CDRH has acknowledge
- SECBioCardia Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits8-K - BioCardia, Inc. (0000925741) (Filer)
- PRBioCardia Late Breaking Echocardiography Clinical Results from CardiAMP HF Trial Presented at Technology and Heart Failure Therapeutics (THT)SUNNYVALE, Calif., March 03, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported late breaking echocardiography results from its Phase III clinical trial for ischemic heart failure of reduced ejection fraction (HFrEF), which affects millions of patients in the United States. The clinical results were presented by Dr. Amish Raval, M.D., Professor of Medicine at University of Wisconsin School of Medicine and Public Health and CardiAMP HF Trial National Co-Principal Investigator, in the late breaking clinical trial oral presentation session of the Technology
- SECBioCardia Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits8-K - BioCardia, Inc. (0000925741) (Filer)
- PRBioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the HeartSUNNYVALE, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported it has completed its Pre-Submission to FDA under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter ("Helix") for intramyocardial therapeutic and diagnostic agent delivery. The data supporting safety and effectiveness for the Helix Pre-Submission is from fifteen well-controlled clinical trials of cell and gene therapy delivery to the heart using Helix, where patients were enrolled in three primary cardiac clinical indications. The Helix
- INSIDERPresident and CEO Altman Peter bought $5,650 worth of shares (5,000 units at $1.13), increasing direct ownership by 2% to 273,866 units (SEC Form 4)4 - BioCardia, Inc. (0000925741) (Issuer)
- SECBioCardia Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits8-K - BioCardia, Inc. (0000925741) (Filer)
- PRBioCardia Announces Late Breaking Echocardiography Results from the CardiAMP HF Trial to be Presented at Technology and Heart Failure Therapeutics (THT)SUNNYVALE, Calif., Feb. 03, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced echocardiography data for the CardiAMP Cell Therapy for the treatment of heart failure has been accepted for Late Breaking Clinical Trial Oral Presentation at the Technology and Heart Failure Therapeutics (THT) Meeting, which takes place March 2-4 in Boston, Massachusetts. On behalf of the CardiAMP HF investigators, the presentation will be made by Dr. Amish Raval, M.D., Professor of Medicine at UW School of Medicine and Public Health and CardiAMP HF Trial National Co-Principal
- INSIDERPresident and CEO Altman Peter bought $1,194 worth of shares (900 units at $1.33), increasing direct ownership by 0.34% to 268,866 units (SEC Form 4)4 - BioCardia, Inc. (0000925741) (Issuer)
- SECSEC Form S-8 filed by BioCardia Inc.S-8 - BioCardia, Inc. (0000925741) (Filer)
- INSIDERPresident and CEO Altman Peter bought $1,444 worth of shares (1,100 units at $1.31), increasing direct ownership by 0.41% to 267,966 units (SEC Form 4)4 - BioCardia, Inc. (0000925741) (Issuer)
- SECBioCardia Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits8-K - BioCardia, Inc. (0000925741) (Filer)