COMPANY
BioCardia
FDA-cleared device company Clinical Phase 2
Our four clinical stage marrow derived cell therapy programs include autologous (using a patient's own cells) and allogeneic (using cells manufactured from patient donors) approaches. From company website Source · Oct 12, 2026
Timeline
- Trial start Phase 1: AllogeneiC Expanded Human MSC Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial source ↗
- Raise Follow-on offering: $6M (total, as published), announced Sep 18, 2025. Source: company release on GlobeNewswire. source ↗
- Partnership Partnership / licensing announced Aug 13, 2025. Source: SEC filing. source ↗
- Trial start Not phased (device or behavioral study): CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction source ↗
- Trial start Phase 1/Phase 2: Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells source ↗
- Trial start Not phased (device or behavioral study): CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial source ↗
- Trial start Phase 3: CardiAMP™ Cell Therapy for Heart Failure Trial source ↗
- Trial start Phase 1: Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone source ↗
Upcoming milestones
- 2026-12 (ESTIMATED) · Phase 1/Phase 2 · Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells · NCT05925608
- Apr 1, 2027 (ESTIMATED) · Not phased · CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction · NCT06258447
Funding
Clinical trials (lead sponsor) 6
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06258447 | CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction | Not phased (device or behavioral study) | Recruiting | Aug 1, 2024 | Apr 1, 2027 (estimated) |
| NCT05491681 | AllogeneiC Expanded Human MSC Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial | Phase 1 | Withdrawn | Jan 4, 2026 | Jan 4, 2026 (actual) |
| NCT03455725 | CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial | Not phased (device or behavioral study) | Active, not recruiting | Jun 30, 2021 | Feb 19, 2025 (actual) |
| NCT05925608 | Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells | Phase 1/Phase 2 | Active, not recruiting | Aug 23, 2023 | 2026-12 (estimated) |
| NCT02438306 | CardiAMP™ Cell Therapy for Heart Failure Trial | Phase 3 | Completed | 2016-12 | 2025-02 (actual) |
| NCT00507468 | Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone | Phase 1 | Completed | 2005-12 | 2009-03 (actual) |
NIH awards 2
- NIH award 1R43HL097775-01A2 FY2011: $136,593 awarded for that fiscal year; activity R43 (SBIR); PI ROUY, DIDIER B; recipient as written: BIOCARDIA, INC., Sunnyvale, CA. Cell retention and biodistribution after transe source ↗
- NIH award 1R43EB008925-01A1 FY2009: $100,000 awarded for that fiscal year; activity R43 (SBIR); PI ROUY, DIDIER B; recipient as written: BIOCARDIA, INC., Sunnyvale, CA. Endomyocardial Catheter Delivery of Artificial source ↗