Key facts: CardiAMP advances in US, Japan; FDA flags two Helix paths
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BioCardia (BCDA) has launched a CardiAMP Phase III trial and advanced the CardiALLO Phase 1/2 study, reporting no safety issues. The FDA has flagged two potential clearance paths for the Helix system, preferring simultaneous approval with CardiAMP. The company reported a Q1 2026 net income of negative $2.259 million and has cut R&D costs following the closure of the CardiAMP HF Trial.
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