Biocardia, Inc. shares fall 5.61% premarket after providing update on regulatory activities.

Biocardia, Inc. declined 5.61% in premarket trading. The company provided an update on the anticipated timing of regulatory activities seeking FDA and Japan PMDA approvals for its CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter. The company intends to submit for approval of the Helix Transendocardial delivery System to FDA as a DeNovo 510(k) application based on its safety and performance in twelve cell and gene therapy clinical studies.