other material
confidence high
sentiment positive
materiality 0.70
BioCardia announces first patient enrolled in Phase 3 CardiAMP HF II heart failure trial
BioCardia, Inc.
- First patient enrolled in Phase 3 randomized, double-blind, placebo-controlled CardiAMP HF II trial at BayCare Morton Plant Hospital in Clearwater, Florida.
- 250-patient multicenter study targeting ischemic HFrEF patients with elevated NTproBNP; composite primary endpoint includes death, nonfatal MACE, and quality of life.
- Company preparing regulatory submissions in Japan and the USA based on prior CardiAMP HF, TAC-HFT, and TABMMI trial data.
- Advances include cell population analysis at screening to define treatment doses and use of FDA-approved Morph DNA steerable catheter.