BioCardia Reports Third Quarter 2026 Business Highlights and Financial Results
Key Highlights
- ➤Japan PMDA application materials process completed; CardiAMP submission targeted Q4 2026/Q1 2027
- ➤Cash and equivalents $2.2 million, with anticipated runway into 2027
- ➤Helix De Novo submission expected Q1 2027, approval targeted mid-2027
- ➤Q3 net loss $1.817 million versus $1.483 million year-earlier
- ➤Q3 operating cash use $1.7 million, unchanged from the prior year
Expert Statements
Peter Altman, Chief Executive Officer of BioCardia
“We believe that our CardiAMP autologous cell therapy is on track to be the first approved minimally invasive biologic therapy for the treatment of heart failure in a first world country based on the recent interactions with Japan’s Pharmaceutical and Medical Devices Agency”
Peter Altman, Chief Executive Officer of BioCardia
“In addition, in the coming months, we aim to be able to submit our Helix transendocardial delivery platform for FDA approval, which would be the first delivery system of its type approved in the United States. This promises to be an exciting year ahead.”
SUNNYVALE, Calif., Nov. 12, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the third quarter 2026 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2026 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session.
“We believe that our CardiAMP autologous cell therapy is on track to be the first approved minimally invasive biologic therapy for the treatment of heart failure in a first world country based on the recent interactions with Japan’s Pharmaceutical and Medical Devices Agency,” said Peter Altman, PhD, Chief Executive Officer of BioCardia. “In addition, in the coming months, we aim to be able to submit our Helix transendocardial delivery platform for FDA approval, which would be the first delivery system of its type approved in the United States. This promises to be an exciting year ahead.”
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