regulatory
confidence high
sentiment positive
materiality 0.60
BioCardia advances CardiAMP Cell Therapy to formal PMDA consultation for HFrEF in Japan
BioCardia, Inc.
- Completed third preliminary clinical consultation with Japan's PMDA for CardiAMP Cell Therapy (HFrEF).
- PMDA will allow BioCardia to proceed to formal clinical consultation; potential path to regulatory filing.
- Data from three completed Phase I-III trials show improved survival, reduced MACE, and better heart function vs control.
- CEO Peter Altman notes therapy offers a new mechanism of microvascular repair for ischemic HFrEF patients.