BioCardia, Inc.

165 articles about BioCardia, Inc.

• BioCardia Reports Fourth Quarter and Full Year 2023 Business Highlights and Financial Results

  3/27/2024

  BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the year ended December 31, 2023 and filed its annual report on Form 10-K with the Securities and Exchange Commission.

• BioCardia to Host 2023 Financial Results and Corporate Update Conference Call on March 27, 2024

  3/20/2024

  BioCardia ®, Inc. today announced it will report its financial results for the year ended December 31, 2023 and provide a corporate update by conference call on Wednesday, March 27, 2024 at 4:30 PM ET.

• BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership

  3/13/2024

  BioCardia, Inc. and StemCardia, Inc. announced a long-term partnership to advance StemCardia’s investigational pluripotent stem cell product candidate for the treatment of heart failure.

• BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study

  3/12/2024

  BioCardia, Inc. announced Centers for Medicare & Medicaid Services approval for reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure.

• BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure

  3/4/2024

  BioCardia, Inc. (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, today announced positive interim results from the Phase III randomized controlled trial of its CardiAMP® autologous cell therapy in 110 randomized patients with advanced chronic heart failure at a mean 20-month follow-up, (CardiAMP HF).

• BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA

  2/8/2024

  BioCardia, Inc. is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates: autologous CardiAMP ® cell therapy and allogeneic CardiALLO™ cell therapy.

• BioCardia Announces Two Scientific Abstracts Have Been Accepted at the 2024 Technology and Heart Failure Therapeutics Conference

  1/31/2024

  BioCardia, Inc. (“BioCardia” or the “Company”) (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates: autologous CardiAMP cell therapy and allogeneic CardiALLO cell therapy.

• BioCardia Biotherapeutic Delivery and Morph Access Innovations Business Development Update for Shareholders

  1/3/2024

  BioCardia completed 2023 with three active clinical programs of its autologous and allogeneic cell therapies to treat heart disease, with a focus on ischemic heart failure of reduced ejection fraction.

• BioCardia Doses First Patient in CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells for the Treatment of Ischemic Heart Failure of Reduced Ejection Fraction

  12/19/2023

  BioCardia ® , Inc.  today announced that the first patient was enrolled and treated in its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial for the treatment of patients with New York Heart Association Class II and III ischemic heart failure of reduced ejection fraction (HFrEF).

• BioCardia Announces Expected CardiAMP Heart Failure Japan Approval Timeline Based on Pharmaceutical and Medical Device Agency Consultation Minutes

  12/18/2023

  BioCardia, Inc. today announced that Japan Pharmaceutical and Medical Device Agency (PMDA) minutes support the Company’s understanding that CardiAMP autologous cell therapy may be approved for the treatment of patients with ischemic heart failure.

• BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval

  11/29/2023

  BioCardia, Inc. [Nasdaq: BCDA] today provided an update after its recent consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure of reduced ejection fraction (HFrEF).

• BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure

  11/14/2023

  BioCardia, Inc. today announced the Food and Drug Administration (FDA) approval of its Phase III clinical trial of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure.

• BioCardia Reports Third Quarter 2023 Business Highlights and Financial Results

  11/8/2023

  BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the third quarter of 2023 and filed its quarterly report on Form 10-Q for the three and nine months ended June 30, 2023 with the Securities and Exchange Commission.

• BioCardia to Host Q3 2023 Corporate Update and Financial Results Conference Call on November 8, 2023

  11/1/2023

  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 three and nine months ended September 30, 2023 by conference call on Wednesday, November 8, 2023 at 4:30 PM ET.

• BioCardia Announces Completion of Enrollment in Phase III CardiAMP HF Trial and Plans for CardiAMP HF Trial II

  10/11/2023

  BioCardia®, Inc. announces completion of enrollment in its CardiAMP Heart Failure Trial and initiation of a discussion with the FDA on a second pivotal study protocol adapted for the responders in the initial trial with the objective of gaining FDA marketing approval.

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  BioCardia’s Cell Therapy Unlikely to Meet Primary Endpoint in Phase III Heart Failure

  9/6/2023

  Interim data from the company’s late-stage clinical trial suggests its cell therapy treatment for heart failure likely won’t meet the primary efficacy endpoint, BioCardia announced on Tuesday.

• BioCardia Announces Clarification and Next Steps on its Autologous CardiAMP Cell Therapy Programs

  9/6/2023

  BioCardia®, Inc. announced a clarification and next steps on its autologous CardiAMP cell therapy programs.

• BioCardia Announces Interim Efficacy Results in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial

  9/5/2023

  BioCardia ® , Inc.  today announced it has finalized external review of interim data and evaluated interim efficacy results for the ongoing Phase III pivotal trial of  CardiAMP ®  Cell Therapy for Heart Failure.

• BioCardia Reports Second Quarter 2023 Business Highlights and Financial Results

  8/9/2023

  BioCardia, Inc. reports financial results for the second quarter of 2023 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2023 with the Securities and Exchange Commission.

• BioCardia to Host Q2 2023 Financial Results and Corporate Update Conference Call on August 9, 2023

  8/2/2023

  BioCardia®, Inc. today announced it will report its financial results for the three and six months ended June 30, 2023 and provide a corporate update by conference call on Wednesday, August 9, 2023 at 4:30 PM ET.