BioCardia completes PMDA clinical consultation for CardiAMP system
BCDA•BioCardia completed Japan’s PMDA clinical consultation process for its CardiAMP cell therapy system, advancing toward a marketing approval application. The company targets first patient treatment and commercial revenues in Japan in 2028.
1. Japan approval process
BioCardia completed the clinical consultation process with Japan’s PMDA for its CardiAMP cell therapy system, advancing toward submission of a marketing approval application. The company targets first patient treatment and commercial revenues in Japan in 2028.
