BioCardia®, Inc. (NASDAQ:BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that it submitted its CardiAMP autologous cell therapy investigational heart failure treatment for clinical consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This milestone marks a significant step toward potential regulatory approval in Japan, a key market for advanced heart failure therapies.

Japan's PMDA consultation process is a critical component of Japan's regulatory pathway for new medical products. In addition to responding to PMDA's questions stemming from previous consultations, the submission made consisted of a detailed clinical data package including the full CardiAMP HF Trial data, along with the principal clinical portion of the Summary Technical Documentation, or STED, which is an extensive summary of the technical information to demonstrate to regulatory authorities that the CardiAMP System meets safety and performance requirements. 

The PMDA clinical consultation of CardiAMP heart failure therapy will involve a comprehensive review of the clinical data from the recently completed CardiAMP HF trial, including whether the efficacy and safety of the CardiAMP system are adequately ensured, the proposed target patient populations indicated by the data, and how the investigational therapy may appropriately fit into the continuum of care for heart failure patients in Japan.

Alignment with PMDA on the acceptability of the clinical data and positioning of the CardiAMP system for Japanese patients with heart failure could enable BioCardia to submit for approval of the CardiAMP system for market entry in Japan.

BioCardia remains committed to advancing innovative treatments for heart failure and is evaluating opportunities to collaborate with partners in Japan.