BioCardia’s Q3 2025 update highlights progress in its cell therapy programs and delivery technologies, supported by a recent $6M financing.
●BCDA-01 CardiAMP (Autologous; HFrEF)
Three completed trials show consistent safety and benefit, with strongest effects in patients with elevated cardiac stress biomarkers. Two randomized double-blind trials met statistical significance on the composite endpoint now used in the ongoing Phase 3 CardiAMP HF II study. A positive preliminary PMDA meeting in Japan may lead to a market-entry submission. BioCardia plans to request an FDA approvability meeting in Q4 2025.
●BCDA-02 CardiAMP (Refractory Angina)
Roll-in cohort data show clear improvement: 80 seconds exercise tolerance, 82% reduction in angina episodes, and no treatment-emergent MACE, suggesting additive benefit on top of GDMT.
●BCDA-03 CardiALLO (Allogeneic MSCs)
The low-dose 20M-cell cohort showed no adverse events, arrhythmias, rejection, or allergic responses. DSMB approved continuation. This is the first study focused on ischemic HF with active inflammation.
●Delivery Platforms
The Helix catheter supports all programs and is planned for DeNovo 510(k) submission in Q4 2025. Heart3D imaging enables rapid, precise intramyocardial injections.
●Financials
R&D was $0.936M; SG&A $0.6M; net loss improved to $1.5M. Cash balance of $5.3M provides runway into Q2 2026.
●Milestones
PMDA review and FDA meeting request (Q4 2025); CardiAMP HF manuscript and angina cohort publication (Q1 2026); CardiALLO funding target (Q1 2026); Helix 510(k) submission (Q4 2025).
直近マイルストーン（最大の注目点）
• 日本 PMDA クリニカルレビュー（Q4 2025）
→ 2025年Q4の PMDA 2回目ミーティング。
ここで「承認申請可能」とのガイダンスが出るかどうか。これが最大の分岐点。もし PMDA が「申請可能」と判断すれば、2026年〜2027年に日本承認の道筋が現実化🍵
• FDA approvability meeting（Q4 2025）
• Helix 510(k) 提出（Q4 2025）
• CardiAMP HF 論文公開（Q1 2026）
• CardiAMP 狭心症データの論文化（Q1 2026）
• CardiALLO 非希薄化資金の獲得（Q1 2026）
BioCardia – Q3 2025 Summary
BioCardia’s Q3 2025 update highlights progress in its cell therapy programs and delivery technologies, supported by a recent $6M financing.
●BCDA-01 CardiAMP (Autologous; HFrEF)
Three completed trials show consistent safety and benefit, with strongest effects in patients with elevated cardiac stress biomarkers. Two randomized double-blind trials met statistical significance on the composite endpoint now used in the ongoing Phase 3 CardiAMP HF II study. A positive preliminary PMDA meeting in Japan may lead to a market-entry submission. BioCardia plans to request an FDA approvability meeting in Q4 2025.
●BCDA-02 CardiAMP (Refractory Angina)
Roll-in cohort data show clear improvement: 80 seconds exercise tolerance, 82% reduction in angina episodes, and no treatment-emergent MACE, suggesting additive benefit on top of GDMT.
●BCDA-03 CardiALLO (Allogeneic MSCs)
The low-dose 20M-cell cohort showed no adverse events, arrhythmias, rejection, or allergic responses. DSMB approved continuation. This is the first study focused on ischemic HF with active inflammation.
●Delivery Platforms
The Helix catheter supports all programs and is planned for DeNovo 510(k) submission in Q4 2025. Heart3D imaging enables rapid, precise intramyocardial injections.
●Financials
R&D was $0.936M; SG&A $0.6M; net loss improved to $1.5M. Cash balance of $5.3M provides runway into Q2 2026.
●Milestones
PMDA review and FDA meeting request (Q4 2025); CardiAMP HF manuscript and angina cohort publication (Q1 2026); CardiALLO funding target (Q1 2026); Helix 510(k) submission (Q4 2025).
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