BioCardia reports promising two-year CardiAMP trial results

SUNNYVALE, Calif. - BioCardia, Inc. (NASDAQ: BCDA), a $13.1 million market cap leader in cell-based therapies for cardiovascular disease, announced two-year outcomes from its Phase 3 CardiAMP-HF study, which revealed significant benefits in patients with ischemic heart failure treated with CardiAMP Cell Therapy. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it faces challenges with negative EBITDA of -$7.93 million in the last twelve months. The study, presented at the American College of Cardiology’s Annual Scientific Session, showed that patients with elevated NTproBNP biomarkers experienced a 13% reduction in heart death equivalents and a 47% relative risk reduction compared to those on medication alone.

The CardiAMP-HF Trial involved 115 patients across 18 centers in the U.S. and Canada, all of whom were on heart failure medication regimens. Results indicated a 3.6% reduction in heart death equivalents and an 8.7% reduction in non-fatal major adverse cardiac and cerebrovascular events (MACCE) for all treated patients compared to those on medication alone. The positive trial results have contributed to BioCardia’s strong recent market performance, with the stock showing a 7.69% return over the past week and trading at $2.80 per share. Quality of life, measured by the Minnesota Living with Heart Failure Questionnaire, improved significantly, and patients demonstrated a 13.9-meter improvement in Six Minute Walk Distance.

The CardiAMP therapy, which has been granted FDA Breakthrough designation, involves a single dose of a patient’s own marrow cells delivered to the heart to potentially stimulate natural healing and improve capillary density, reduce tissue fibrosis, and treat microvascular dysfunction. The therapy combines a pre-procedural cell analysis, a high target dosage of cells, and a minimally-invasive delivery system.

BioCardia’s CEO, Peter Altman, Ph.D., highlighted the durability of the therapy’s benefits, suggesting its potential to prevent disease progression. He also noted the therapy’s capacity to reduce healthcare costs for heart failure, which currently stands at $30 billion annually in the U.S. for inpatient care.

The company plans to discuss the two-year data with the U.S. FDA and Japan PMDA to explore pathways for making the therapy available. The results are based on a press release statement and will be further addressed in a conference call. Analysts maintain optimistic price targets ranging from $6 to $25, with the next earnings report scheduled for May 14, 2025. For deeper insights into BioCardia’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro, which offers exclusive ProTips and detailed research reports covering over 1,400 US stocks.

BioCardia is known for its cellular and cell-derived therapeutics, with several cardiac product candidates in development. Its Helix and Morph product platforms enable the delivery of biotherapeutics. The company cautions that forward-looking statements are not guarantees of future performance and actual results may differ materially.

In other recent news, BioCardia has announced the completion of its Phase 3 CardiAMP Heart Failure study, marking a significant milestone for one of the largest ischemic heart failure patient cohorts in a randomized trial of autologous cell therapy. The data has been transferred to the Statistical Data Analysis Center core laboratory for analysis, with results expected to be presented at the American College of Cardiology 2025 Scientific Sessions. Additionally, BioCardia has completed enrollment for the low-dose cohort in its Phase I/II trial of CardiALLO Allogeneic Mesenchymal Cell Therapy, targeting patients with ischemic heart failure with reduced ejection fraction. This trial aims to establish the safety and efficacy of this novel cell therapy, which could lead to pivotal clinical studies in the U.S. and conditional approval in Japan. Furthermore, BioCardia secured a new patent from the Japan Patent Office for its minimally invasive catheter-based delivery systems for cell and gene-based therapies to the heart. The patent extends until at least September 30, 2034, covering the company’s helical needle-tipped catheter technology. These developments highlight BioCardia’s ongoing efforts to advance its biotherapeutic platforms and deliver innovative treatments for cardiovascular diseases.

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