BioCardia shared its third-quarter results and plans for its cell therapy and delivery system in Japan and the U.S.

BCDA · BioCardia, Inc.

The AI's read

BioCardia says Japan's regulator is satisfied with its answers to questions before a possible application. The FDA also accepted a revised pre-submission for Helix, but neither program has approval yet. The company is still preparing applications and enrolling patients in its CardiAMP HF II study. These steps support progress, though the excerpt gives no financial figures for the quarter.