BioCardia Reports Positive Consultation with Japan PMDA on CardiAMP Therapy for Ischemic Heart Failure

On December 4, 2024, BioCardia, Inc., a prominent company in the field of cellular and cell-derived therapeutics for cardiovascular and pulmonary conditions, announced the achievement of a significant milestone following a productive meeting with Japan’s Pharmaceutical and Medical Device Agency (PMDA). This meeting centered on the pathway for submitting their primary therapeutic product, BCDA-01, intended for treating ischemic heart failure with reduced ejection fraction (HFrEF).

Peter Altman, Ph.D., who serves as the President and Chief Executive Officer of BioCardia, highlighted several crucial outcomes from this recent discussion with PMDA. Firstly, PMDA has scheduled another consultation after BioCardia submits the final clinical data, which includes a two-year follow-up, to assess whether the evidence is adequate to substantiate claims regarding the safety and efficacy of BCDA-01. Secondly, PMDA remains receptive to considering the findings from the CardiAMP Heart Failure Trial and previous studies as sufficient support for the registration of the CardiAMP Cell Therapy System for heart failure patients in Japan.

Dr. Altman also noted that the company is currently in the process of finalizing data from the fully enrolled CardiAMP Heart Failure Trial, which includes 125 patients. They anticipate that the final data will be ready by the first quarter of 2025.

CardiAMP Cell Therapy for HFrEF (BCDA-01) has been granted Breakthrough Designation by the Food and Drug Administration’s Center for Biological Evaluation and Research (FDA CBER). The development of this therapy has been supported by the Maryland Stem Cell Research Fund. In the United States, all clinical trials involving CardiAMP Cell Therapy (both BCDA-01 and BCDA-02) also benefit from reimbursement provided by the Center for Medicaid and Medicare Services (CMS).

BioCardia, Inc. is based in Sunnyvale, California, and is recognized globally as a leader in the development of cellular and cell-derived therapies for cardiovascular and pulmonary diseases. The company's therapeutic platforms include CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, with three product candidates currently in clinical stages of development. These therapies are facilitated by BioCardia's proprietary Helix™ biotherapeutic delivery system and Morph® vascular navigation product platforms.

BioCardia continues to advance in the field of regenerative medicine, focusing on innovative treatments designed to improve outcomes for patients suffering from severe cardiovascular conditions.