BioCardia Inc. (BCDA), on Friday announced the receipt of a Consultation Record from the Japanese Pharmaceutical and Medical Devices Agency (PDMA) to support regulatory approval of the CardiAMP Cell Therapy for the treatment of ischemic heart failure.
CardiAMP was developed as a cell therapy wherein a patient's own bone marrow cells are delivered to the heart through a catheter to increase capillary density and reduce tissue fibrosis. It previously received a breakthrough designation from the U.S. Food and Drug Administration (FDA).
BioCardia received requests from the PDMA for post-marketing supply plans to support the marketing authorization. Additionally, the company must provide information on the criteria for patient selection, the clinical decision-making framework, and appropriate medical infrastructure and specialist involvement.
The submission to the PDMA will be supported by positive outcomes from three trials conducted by BioCardia. CardiAMP previously treated patients with elevated biomarkers linked to heart stress, and reduced incidence of heart failure of reduced ejection fraction (HFrEF).
Initial commercialization is planned while conditional post-market studies continue. The company believes that the documentations will support a review by the PDMA, which is estimated to take 7 months. If approval is granted, the Ministry of Health, Labor and Welfare (MHLW) may issue the certificate enabling commercialization.
BCDA closed Thursday at $0.92, up 1.83%.
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