BioCardia, Inc.
BCDAW
NASDAQ Capital Market0.01
USD
+0.00
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BioCardia, Inc.
BCDAW
(NASDAQ Capital Market)
Recent
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0.01
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yld
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ROIC.AI
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- BioCardia, Inc. (Nasdaq: BCDA) develops cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases with significant unmet medical needs. Headquartered in Sunnyvale, California, the company traces its origins to a 2016 reverse merger involving assets from Bioheart, Inc., founded in 1999. It operates primarily in the United States, with clinical trials ongoing and regulatory engagements extending to Japan. The company's lead product candidates include its proprietary CardiAMP autologous mononuclear cell therapy (BCDA-01), an FDA-designated Breakthrough Therapy for ischemic heart failure with reduced ejection fraction, manufactured at the bedside using the CardiAMP cell processing system and delivered via catheter-based minimally invasive approach; CardiAMP for chronic myocardial ischemia with refractory angina (BCDA-02); CardiALLO allogeneic culture-expanded mesenchymal stem cell therapy for ischemic heart failure (BCDA-03); and PulmALLO for acute respiratory distress syndrome (BCDA-04). These biotherapeutic platforms target personalized precision medicine, promoting enhanced capillary density, reduced fibrosis, and immunomodulatory effects without post-procedure immunosuppression. Delivery is enabled by the Helix transendocardial biotherapeutic delivery system and Morph DNA steerable introducer products, which support intramyocardial navigation and partner programs in heart failure, chronic myocardial ischemia, and acute myocardial infarction. Recent developments include the closure of a $6.0 million financing in September 2025, providing net proceeds of $5.2 million to support operations into Q2 2026; active enrollment in the ongoing Phase 3 CardiAMP HF II confirmatory trial at sites including Henry Ford Health, University of Wisconsin, and Emory University, targeting patients with elevated heart-stress biomarkers; positive top-line results from the CardiAMP chronic myocardial ischemia roll-in cohort in September 2025, showing an average 80-second increase in exercise tolerance and 82% reduction in angina episodes at six months; completion of the low-dose cohort in the CardiALLO Phase 1/2 trial with no treatment-emergent adverse events and Data Safety Monitoring Board clearance to proceed; a positive preliminary consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on CardiAMP heart failure results, with follow-up anticipated in coming months; planned DeNovo 510(k) submission for the Helix delivery catheter in Q4 2025; and board changes with the election of Marvin Slosman and completion of Dr. Richard Krasno's term in December 2025.