BioCardia

125 Shoreway Road, Suite B

San Carlos

California

94070

United States

(650) 226-0120

(650) 631-3731

[email protected]

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BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announced that the first patient was enrolled and treated in its CardiALLO Allogeneic Mesenchymal Cell Therapy Phase I/II trial

News | Cardiovascular Clinical Studies

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

December 19, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

December 19, 2023

Japan’s PMDA asked for further details on a number of elements included in BioCardia’s CardiAMP preclinical and clinical packages in order to gain approval.

News | 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

November 30, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

November 30, 2023

BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol

News | FDA

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

November 17, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

November 17, 2023

Novel platform for structural heart interventions now in human use, with ability to improve patient recovery and reduce anesthesia and hospital stays

News | Cardiovascular Clinical Studies

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

October 12, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

October 12, 2023

the Company is exploring development of a new Phase III clinical trial protocol

News | Heart Failure

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

September 8, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

September 08, 2023

BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the ongoing Phase III pivotal CardiAMP Cell Therapy Heart Failure Trial

News | Cardiovascular Clinical Studies

BioCardia Announces DSMB Recommendation to Pause New Enrollment in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial While Additional Blinded Data is Collected

July 24, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

July 24, 2023

BioCardia's CardiAMP cell therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. The therapy incorporates a pre-procedural screening assay to identify those patients who are likely responders to the therapy, a first for a cardiac cell therapy.

News | Stem Cell Therapies

BioCardia Announces First Patient Treated in CardiAMP Cell Therapy Trial for Chronic Myocardial Ischemia

October 28, 2021 – The first patient has been treated in a new trial using stem cell therapy to treat chronic myocardial ...

October 28, 2021

BioCardia Announces CardiAMP Heart Failure Pivotal Trial Continues with First Patient Randomized in COVID-19 Era

News | Heart Failure

BioCardia Resumes Cases in the CardiAMP Heart Failure Trial

June 30, 2020 — BioCardia, Inc. announced that the company has resumed cases in the CardiAMP Heart Failure Trial. The ...

June 30, 2020

News | Catheters

BioCardia Initiates Commercial Release of Avance Steerable Introducer

October 23, 2019 — BioCardia announced the U.S. commercial availability of its Avance Bi-Directional Steerable ...

October 23, 2019

Technology | Catheters

Biocardia Receives FDA Clearance for Avance Steerable Introducer Family

May 16, 2019 — BioCardia Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Avance steerable ...

May 16, 2019