BioCardia Presents CardiAMP HF II Trial Design at Heart Failure Society of America Annual Scientific Meeting
Key Highlights
- ➤CardiAMP HF II presentation details a multicenter, double-blind randomized trial design
- ➤FDA says ongoing CardiAMP HF II trial may support approval
- ➤FDA grants CardiAMP category B designation across three clinical trials
- ➤BioCardia advances confirmatory trial with world-class centers
- ➤Regulatory submissions continue with FDA and Japan’s PMDA
Expert Statements
Peter Altman, President and CEO of BioCardia, and member of HFSA
“In parallel to ongoing regulatory submissions with FDA and Japan’s PMDA related to our therapy, we are advancing the confirmatory CardiAMP HF II trial with world class centers,”
Peter Altman, President and CEO of BioCardia, and member of HFSA
“At the HFSA Annual Scientific meeting this weekend we have scheduled meetings with leaders in heart failure care to discuss the evidence supporting this therapy and collaborative efforts to provide this new therapeutic option to patients who have plateaued on available therapies and may benefit from minimally invasive autologous cell therapy.”
SUNNYVALE, Calif., Oct. 07, 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 announced the upcoming presentation of a scientific poster entitled “Cardiac Delivery of Autologous Minimally Processed Cell Therapy in HFrEF: Multicenter, Double Blind RCT (CardiAMP HF II)” at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 taking place in Phoenix, AZ from October 9 – 12, 2026.
The presentation includes details on the design and scientific support for the CardiAMP™ HF II Study. The objective of the study is to determine efficacy of high dose autologous cell treatment for patients with ischemic heart failure of reduced ejection fraction (HFrEF), who are on guideline directed medical therapy but still exhibit undesirable elevated biomarkers of heart stress. This presentation will become available through the Scientific Publications on BioCardia’s website.
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