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- **Clinical Milestones**: CardiAmp HF II trial enrolling at four centers; Japan PMDA consultations and FDA meeting in Q4 2025. BCDA02 CMI data shows 80-second exercise improvement in five patients.
- **Financial Stability**: $5.3 million cash runway to Q2 2026; no immediate funding needs. R&D expenses up 0.5% YoY due to trial expansion.
- **Regulatory Focus**: Helix system FDA submission Q4 2025; potential Japan approvals for CardiAmp HF and allogeneic stem cells.
- **Partnerships & Innovation**: Heart 3D fusion imaging with CARTech for enhanced delivery; NIH funding for BCDA03 trial.

**【CEO Summary Section】**
- **CardiAmp Cell Therapy Progress**: FDA breakthrough designation for ischemic heart failure; three clinical trials show promise. PMDA consultations in Japan for potential approval, with FDA meeting planned for Q4 2025.
- **CardiAmp HF II Trial**: 250-patient phase III trial enrolling at four centers, using advanced cell analysis for dosing. Medicare reimbursement for all patients. Long-term follow-up data positive, with no safety issues.
- **BCDA02 (Chronic Myocardial Ischemia)**: Open-label rolling cohort of five patients shows 80-second increase in exercise tolerance and 82% reduction in angina episodes. Results being prepared for publication.
- **BCDA03 (Allogeneic Stem Cells)**: Phase I-II trial with 39 patients; seeking NIH funding for completion, expected in Q1 2026. Potential conditional approval in Japan.
- **Helix Delivery System**: FDA 510(k) submission planned for Q4 2025. Integration with heart 3D fusion imaging for enhanced delivery.

**【CFO Financial Commentary】**
- **Q3 2025 Financials**: R&D expenses $936,000 (up 0.5% YoY) due to HF II trial and regulatory activities. SG&A $0.6 million (down 25% YoY) from lower compensation. Net loss $1.5 million, cash $5.3 million, providing runway to Q2 2026.
- **Cash Position**: $6 million from September financing and ATM sales. No immediate need for additional funding.

**【Q&A Highlights】**
- **CMI Data Clarity**: Five-patient rolling cohort shows significant improvement; trial design includes Hawthorne effect mitigation (1-month observation period).
- **Enrollment Challenges**: Resource constraints and site startup costs; no safety or efficacy hurdles. Enrollment expected to accelerate post-regulatory clarity.
- **Japan and FDA Strategy**: PMDA consultations focus on existing data sufficiency. FDA meeting to discuss approvability based on phase II/III results.
- **Funding for BCDA03**: High probability of NIH grant in Q1 2026, enabling trial completion without dilution.

BioCardia, Inc. (BCDA) Q3 2025 Earnings Call Transcript

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