BioCardia, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsBioCardia, Inc. is a clinical-stage cell therapy company developing autologous and allogeneic therapies for cardiovascular and pulmonary diseases, with no current product revenue.
What they do
BioCardia develops cell-based therapies and delivery systems for cardiac and pulmonary indications. Its lead candidate, CardiAMP Cell Therapy, is an autologous bone marrow-derived cell therapy being studied for ischemic heart failure (BCDA-01) and refractory angina (BCDA-02). The company also has the Helix transendocardial delivery catheter and other allogeneic and delivery technology platforms. As of 2025, the company generated no revenue.
Revenue drivers
- CardiAMP Cell Therapy (BCDA-01) — Autologous cell therapy for ischemic heart failure with reduced ejection fraction; in pivotal trial (CardiAMP HF II) and preparing Japan PMDA submission for Q4 2026; no revenue yet.
- CardiAMP Cell Therapy (BCDA-02) — Same therapy for chronic myocardial ischemia with refractory angina; primary results presented at EuroPCR in May 2026; no revenue yet.
- Helix transendocardial delivery catheter — Delivery system for cardiac biologics; FDA DeNovo pre-submission meeting held in May 2026, DeNovo approval considered possible; not yet commercialized.
Recent performance
BioCardia reported no revenue for fiscal 2025 and for the quarters ended March, June, September, and December 2025. Net loss for fiscal 2025 was $8.2 million, with operating cash flow of negative $7.4 million. As of June 30, 2026, cash and equivalents were $4.1 million, total assets $4.8 million, and shareholder equity $2.7 million. In Q2 2026, the company highlighted regulatory progress but did not report any product sales.
Strategy
Management is focused on advancing CardiAMP Cell Therapy through regulatory approval, targeting a Japan PMDA submission in Q4 2026 and continuing U.S. pivotal trial enrollment. They are also pursuing DeNovo clearance for the Helix delivery catheter. The company is engaged in business development to monetize its cell therapies and its delivery technologies. They emphasize efficient capital use while achieving clinical and regulatory milestones.
Risks
- Going concern and capital needs — The company has a history of losses, no revenue, and limited cash ($4.1M as of June 30, 2026); it will require substantial additional financing to continue operations.
- Regulatory uncertainty — No cell-based therapy has been approved for a cardiac indication in the U.S., and the FDA approval process for CardiAMP is novel and uncertain.
- Clinical trial delays — Patient enrollment in clinical trials has been difficult and may continue to be challenging, potentially delaying development and approval.
- Nasdaq listing risk — The company received a delisting notice or listing-rule failure notification in June 2026, which could affect its stock liquidity and capital raising.
Outlook
Management expects to submit the CardiAMP Cell Therapy PMDA submission in Japan in Q4 2026 and is awaiting FDA minutes on the Helix DeNovo pre-submission. They plan to continue active enrollment in the CardiAMP HF II trial, with three additional patients expected to qualify and two procedures scheduled in the near term. The company is also working to engage a Designated Marketing Authorization Holder (DMAH) in Japan to enable future sales.