BioCardia Q1 net loss $2.3M; PMDA determines CardiAMP safety/efficacy likely sufficient for Japan approval

BioCardia, Inc.

2026-Q1 EPS reported -$0.21

Net loss $2.3M in Q1 2026 vs $2.7M in Q1 2025; cash $951k as of March 31, 2026.
PMDA Formal Clinical Consultation determined clinical safety and efficacy likely sufficient for market clearance; alignment on foreign data.
FDA expressed no safety concerns, benefits intriguing; confirmed PMA pathway; recommended continuing CardiAMP HF II confirmatory trial.
FDA agreed on two Helix clearance pathways; milestones: Euro PCR presentation Q2 2026, Japan Shonin submission Q4 2026.

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