BioCardia, Inc. Common Stock
BCDABioCardia, Inc. (BCDA) is a biotechnology company focused on developing therapies for cardiovascular disease. It specializes in innovative cell delivery systems and regenerative treatments aimed at improving outcomes for patients with heart-related conditions.
Company News
BioCardia completed a capital raise of 3.5 million shares at $1.279 per share, extending cash runway into Q1 2027 and potentially beyond PMDA approval. The company received FDA confirmation that CardiAMP HF II trial may support premarket approval, and obtained Japan PMDA Record of Advice supporting regulatory submission for CardiAMP cell therapy ...
BioCardia announced that the FDA identified two regulatory pathways for its Helix Transendocardial Delivery Catheter System, with the FDA's preferred route being simultaneous approval with the CardiAMP cell therapy system. The FDA raised no concerns regarding Helix safety data, device performance, or agent compatibility. An alternative DeNovo pat...
BioCardia, Inc. announced it will hold a conference call on March 24, 2026 at 4:30 PM EDT to provide a corporate update and report financial results for the year ended December 31, 2025. The call will include management remarks followed by a Q&A session and will be available via phone and webcast.
BioCardia announced that the FDA has accepted its pre-submission package for the Helix Transendocardial Delivery Catheter, a minimally invasive device for intramyocardial therapeutic and diagnostic agent delivery. The FDA's Center for Devices and Radiological Health (CDRH) will lead the review in consultation with the Center for Biological Evalua...
BioCardia will host a conference call on November 12, 2025 at 4:30 PM EDT to discuss Q3 2025 financial results and provide a corporate update, with options for phone and webcast participation.
