regulatory
confidence high
sentiment positive
materiality 0.75
BioCardia gets positive PMDA consultation; next step after final CardiAMP HF data in Q1 2025
BioCardia, Inc.
- Completed consultation with Japan PMDA; PMDA invited next consultation after submission of final 2-year follow-up data.
- PMDA remains open to using CardiAMP Heart Failure Trial and prior trials for registration in Japan.
- Company anticipates final data from 125-patient CardiAMP HF trial in Q1 2025.
- BCDA-01 holds FDA Breakthrough Designation; U.S. trials supported by CMS reimbursement.