Risk factors
BioCardia (BCDA) risk factors
Item 1A of every BioCardia, Inc. 10-K on file, and what changed from one year to the next. Readings are automated and can be wrong; check the filing for the exact wording.
- FY2025 10-K risk factors79 risks1 reworded
The risk section remained largely unchanged, with only minor edits to tax carryforward disclosures.
Filed Mar 24, 2026 - FY2024 10-K risk factors79 risks
BioCardia is a clinical-stage regenerative medicine company with a net loss of $7.9 million for 2024 and an accumulated deficit of $160.1 million. The company's long-term viability depends on the successful development and commercialization of the CardiAMP Cell Therapy System. The FDA premarket approval pathway for CardiAMP and the recent recommendation by the DSMB to pause the Phase III trial introduce significant regulatory uncertainty.
Filed Mar 26, 2025