Pivotal Trial Phase | BioCardia's CardiAMP cell therapy system enters critical Phase 3 trial, with potential to revolutionize heart failure treatment amid financial challenges |
Regulatory Milestones | FDA protocol amendment and CMS reimbursement approval boost CardiAMP HF II trial, expanding patient eligibility and mitigating study costs |
Market Dynamics | Explore BioCardia's position in the competitive cell therapy landscape, with promising early results setting high expectations for cardiovascular treatment |
Financial Outlook | Analysts project trial completion by 2025, with price targets ranging from $4 to $25, despite current negative EBITDA and cash burn concerns |
Metrics to compare | BCDA | Sector Sector - Average of metrics from a broad group of related Healthcare sector companies | Relationship RelationshipBCDAPeersSector | |
|---|---|---|---|---|
P/E Ratio | −1.2x | −1.3x | −0.4x | |
PEG Ratio | −0.02 | −0.04 | 0.00 | |
Price/Book | −8.8x | 1.4x | 2.6x | |
Price / LTM Sales | - | 60.7x | 3.0x | |
Upside (Analyst Target) | - | 333.1% | 56.0% | |
Fair Value Upside | Unlock | 12.2% | 9.1% | Unlock |
BioCardia, Inc., a clinical-stage regenerative medicine company, develops cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases in the United States. The company’s lead product candidate is CardiAMP, an autologous mononuclear cell therapy system in Phase III clinical trial for the treatment of ischemic heart failure with reduced ejection fraction and refractory angina resulting from chronic myocardial ischemia. It also provides CardiALLO, an allogeneic mesenchymal stem cell therapy which is in phase II for ischemic heart failure; allogeneic cell therapy platform; and PulmALLO, an allogeneic mesenchymal stem cell therapy for acute respiratory distress syndrome. In addition, the company offers the Helix biotherapeutic delivery system for minimally invasive targeted delivery of biologic agents to the heart; Heart3D for fusion imaging; and morph DNA and avance steerable introducers. It has a license and distribution agreement with Biomet Biologics, LLC. BioCardia, Inc. is based in Sunnyvale, California.