BioCardia Announces FDA Approval of IND Application for Allogeneic NK1R+ Human Mesenchymal Stem Cells for Ischemic Heart Failure
BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application to initiate a first-in-human Phase I/II clinical trial of its Neurokinin-1 receptor positive (NK1R+) allogeneic human mesenchymal stem cell (MSC) therapy for the treatment of patients with ischemic heart failure.
BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure
BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure. It is believed to be the first cardiac cell therapy to receive FDA Breakthrough Device status.
