バイオカルディア【BCDA】の掲示板

Integrated Timeline
（November 12, 2025 PR)

● Q4 2025
• CardiAMP HF Japan: PMDA Clinical Review begins
• CardiAMP HF: FDA meeting request on approvability submitted
• Helix Biotherapeutic Delivery System: De Novo 510(k) submission to FDA

● Q1 2026
• CardiAMP HF (Heart Failure): Publication of the CardiAMP HF manuscript
• CardiAMP CMI (Chronic Myocardial Ischemia): Publication of roll-in cohort data
• CardiALLO MSC Therapy (Heart Failure): Nondilutive funding milestone

● Ongoing (2025–2026)
• CardiAMP HF II enrollment continues (Phase 3b)