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Monday, August 11, 2025

BioCardia's CardiAMP Cell Therapy Hits Key Endpoints in Phase 3 Heart Failure Trial, FDA Meet Ahead



BioCardia (NASDAQ:BCDA) reported Q2 2025 financial results and significant progress in its cardiovascular therapeutics pipeline. The company's flagship CardiAMP HF Trial showed promising two-year results, with treatment groups demonstrating lower incidence of death and complications, particularly significant in patients with elevated NTproBNP (p=0.02).

Financial highlights include increased R&D expenses to $1.4M in Q2 2025, a net loss of $2.0M, and a current cash balance of approximately $1.1M providing runway into October 2025. The company strengthened its intellectual property portfolio with a new US patent for its biotherapeutic delivery catheter systems.

Key upcoming milestones include FDA meetings on CardiAMP HF approvability in Q4 2025, Japan PMDA clinical review, and planned FDA submission for the Helix biotherapeutic delivery system in Q3 2025.

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