BCDA - 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 | Benzinga
SUNNYVALE, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, 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).
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. For the points raised with respect to the pre-clinical package, BioCardia management believes that these can be readily addressed. In the request for additional details with regard to the clinical package, PMDA has signaled that they would not require additional studies in Japan and could approve CardiAMP Cell Therapy based on data from overseas. PMDA indicated they would like to see detailed interim and the final results from the CardiAMP Heart Failure Trial, which has completed patient enrollment and is finishing up study patient follow-up visits. There was discussion that approval of any initial indication may be limited to patients with NT-pro BNP levels > 500pg/ml, which is an eligibility criterion for the CardiAMP Heart Failure II study as recently approved by the U.S. FDA. Formal minutes from the PMDA meeting are expected in four weeks and a follow-up consultation is being planned.
"We are ...