BCDA: Japan Needs No Clin Trials for Approval CardiAMP

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 thankful that PMDA has signaled that data from outside Japan is likely to be sufficient for approval” said Peter Altman, PhD., BioCardia’s President and Chief Executive Officer. “We continue to work with PMDA to demonstrate that the evidence of patient benefit with low risk from this minimally invasive autologous cell therapy for a life-threatening condition should be sufficient for approval. PMDA approval would enable physicians and patients to consider the CardiAMP cell therapy option alongside other cell therapy approaches for the treatment of heart failure already in clinical use in Japan requiring open heart surgical administration of the cells.”

About the CardiAMP Cell Therapy Program

CardiAMP Cell Therapy – FDA designated as a Breakthrough therapy for HFrEF – 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. Clinical trials for this therapy, including the CardiAMP Heart Failure Trial, have demonstrated positive clinical experience with this autologous cell therapy in almost 200 patient procedures. The trial is supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services. CAUTION - Limited by United States law to investigational use.

About BioCardia ®

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP™ autologous and NK1R+ allogeneic cell therapies are the Company’s biotherapeutic platforms that enable four product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information visit: www.BioCardia.com.