other material
confidence high
sentiment positive
materiality 0.65
BioCardia CardiALLO heart failure trial passes DSMB review; no safety issues
BioCardia, Inc.
- DSMB recommends study continue as designed after 30-day safety review of 20M-cell dosing cohort.
- No treatment-emergent major adverse cardiac events or immune reactions observed.
- Company plans to enroll 39 participants in the US for Phase 1/2 CardiALLO-HF trial.
- CEO cites potential for nondilutive funding and partnering, and future pivotal trial in USA, Japan.
- High-dose arm targets patients with active inflammation, at least 2x effective dose of prior MSC studies.