BioCardia reports 2025 net loss $8.2M; cash $2.5M; regulatory milestones for CardiAMP anticipated

BioCardia, Inc.

Net loss $8.2M (2025) vs $7.9M (2024); revenue $0; cash $2.5M at year-end.
R&D expenses $5.0M (+$0.6M YoY) due to CardiAMP HF trial closeout and Japan regulatory work.
CardiAMP HF II trial enrolling at 4 sites; Yale echo data showed reduced LV remodeling in treated patients.
FDA Q-Sub on CardiAMP approval pathway expected Q1 2026; Japan PMDA formal consultation Q2 2026.
Helix delivery system Pre-Submission accepted by FDA; meeting with CDRH/CBER scheduled Q2 2026.

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