BCDA
BioCardia, Inc.1.2800
-0.0200-1.54%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
No earnings call transcript available
Key Stats
Market Cap
13.58MP/E (TTM)
-Basic EPS (TTM)
-1.42Dividend Yield
0%Recent Filings
8-K
CardiAMP trial cuts remodeling
BioCardia announced late-breaking Phase III CardiAMP HF trial echocardiography results on March 3, 2026, presented at THT conference. Treated ischemic HFrEF patients showed reduced pathological left ventricular remodeling versus controls, with p=0.06 end-diastolic and p=0.09 end-systolic volumes. Elevated NTproBNP subgroup differences exceeded 20ml/m² and 15ml/m² (p=0.02, 0.01). Positive remodeling signals better outcomes.
8-K
BioCardia files FDA Pre-Submission
BioCardia completed its FDA Q-Submission Pre-Submission on February 10, 2026, for approval of the Helix Transendocardial Delivery Catheter to deliver therapeutic and diagnostic agents intramyocardially to the heart. Supported by data from fifteen clinical trials across three cardiac indications under the CardiAMP Breakthrough Designation, it seeks alignment on regulatory pathway and timing within 45 days. Helix could become the first approved U.S. transendocardial catheter. Forward-looking statements carry risks.
8-K
CardiAMP data earns late-breaker slot
BioCardia announced echocardiography data from its CardiAMP heart failure cell therapy trial accepted for Late Breaking Oral Presentation at the THT Meeting on March 2, 2026, in Boston. Dr. Amish Raval delivers findings suggesting autologous cells curb pathological ventricular remodeling in selected ischemic HFrEF patients. Data spotlights potential. Forward-looking statements note risks per 10-K.
8-K
Advances to Japan PMDA formal consultation
BioCardia completed its third preliminary clinical consultation with Japan's PMDA on December 16, 2025, for CardiAMP Cell Therapy in HFrEF patients. PMDA cleared the company to advance to formal consultation. Success there enables a Japanese approval filing. Data from three trials show safety and efficacy signals, yet outcomes hinge on regulators.
8-K
Slosman joins BioCardia board
BioCardia appointed Marvin Slosman, CEO of InspireMD and interventional cardiology veteran, to its board effective December 2, 2025, replacing Dr. Richard Krasno whose term ended amicably that day. Slosman joins the Audit Committee, bringing regulatory and commercialization expertise. Shareholders also elected Slosman and approved equity plan amendments and auditor ratification. New blood sharpens strategy.
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