SUNNYVALE, Calif. — October 7, 2026
BioCardia announced that it will present the design and scientific rationale for its CardiAMP™ HF II clinical trial at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Phoenix, Arizona, taking place October 9–12. The scientific poster, titled “Cardiac Delivery of Autologous Minimally Processed Cell Therapy in HFrEF: Multicenter, Double Blind RCT (CardiAMP HF II),” will outline the study’s design and supporting evidence for evaluating autologous cell therapy in patients with heart failure with reduced ejection fraction (HFrEF). The presentation comes as BioCardia advances CardiAMP HF II as a confirmatory study and continues regulatory activities in the United States and Japan.
CardiAMP HF II Evaluates Autologous Cell Therapy
The CardiAMP HF II study is designed to evaluate the efficacy of high-dose autologous cell therapy in patients with ischemic HFrEF who remain on guideline-directed medical therapy but continue to show elevated biomarkers associated with cardiac stress. The study uses a multicenter, double-blind randomized controlled trial design intended to generate confirmatory evidence for the CardiAMP therapy approach. BioCardia is developing CardiAMP as a minimally invasive treatment that uses a patient’s own cells, with the goal of providing an additional therapeutic option for patients whose condition remains inadequately addressed despite available heart failure treatments. The company said the HFSA presentation will provide further details on the clinical design and scientific basis of the ongoing study.
FDA Category B Status Supports Development Path
BioCardia said the FDA has granted Category B designation for the CardiAMP cell therapy system in three separate clinical trials after determining that underlying questions related to the safety and effectiveness of the device type had been resolved or that the device type could be safe and effective. Importantly, the FDA has also recently agreed that the ongoing CardiAMP HF II trial may be sufficient to support FDA approval. This regulatory feedback provides a significant development milestone as BioCardia continues advancing the confirmatory study. The company is also pursuing regulatory submissions involving CardiAMP with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), while using data generated through the clinical program to support the therapy’s potential regulatory pathway.
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BioCardia Advances CardiAMP Toward Broader Access
The CardiAMP HF II program represents a key component of BioCardia’s broader cardiovascular cell therapy strategy. Company leadership plans to use the HFSA meeting to engage with heart failure specialists and discuss evidence supporting the therapy and potential collaborative efforts to expand treatment options. BioCardia said CardiAMP is intended for patients who have plateaued on available therapies and may benefit from minimally invasive autologous cell treatment. The company’s broader pipeline includes CardiAMP autologous and CardiALLO™ allogeneic cell therapy platforms, supported by its Helix biotherapeutic delivery and Morph® vascular navigation technologies. With regulatory discussions progressing and the confirmatory HF II study underway, BioCardia is positioning CardiAMP for potential advancement toward regulatory approval and clinical adoption in ischemic HFrEF.
Source::BioCardia press release
