BioCardia Enrolls First Patient in Phase 3 Trial of Cell Therapy for Heart Failure.

BioCardia has announced the enrollment of the first patient in its Phase 3 CardiAMP HF II clinical trial for the treatment of heart failure. The double-blind, randomized controlled trial is evaluating the safety and efficacy of the company's lead autologous cell therapy. The trial is taking place at BayCare Morton Plant Hospital in Clearwater, Florida.

SUNNYVALE, Calif., May 1, 2025 — BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, has announced the enrollment of the first patient in its Phase III randomized, placebo-controlled, double-blind CardiAMP HF II clinical trial. The trial is evaluating the safety and efficacy of BioCardia's lead autologous cell therapy program for the treatment of heart failure at BayCare Morton Plant Hospital in Clearwater, Florida.

The CardiAMP HF II study is a 250-patient, multicenter, procedure-controlled trial that aims to confirm the safety and efficacy results observed in the recently completed CardiAMP HF trial. The trial will assess the efficacy of the therapy in patients with ischemic heart failure with reduced ejection fraction (HFrEF) on guideline-directed medical therapy and elevated NTproBNP levels. The study uses a three-tier composite primary outcome measure, similar to the CardiAMP HF trial, with tier 1 all-cause death, tier 2 nonfatal major adverse cardiac events, and tier 3 using a validated quality of life patient self-assessment instrument.

Dr. Leslie Miller, M.D., Chief of the Congestive Heart Failure and Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida, and CardiAMP HF II Trial Principal Investigator, expressed excitement about the trial's enrollment. "We are excited to lead enrollment in the CardiAMP HF II trial and be able to offer this cell therapy study to our heart failure patients. This investigational therapy has been shown to enhance microvascular function and demonstrated promising clinical outcomes in the recently completed CardiAMP HF Trial, particularly for the patients we are targeting for this trial," said Dr. Miller.

The trial incorporates advancements in the therapeutic approach, including using cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy. Additionally, improvements to the Helix system have been made, including the introduction of the FDA-approved Morph DNA steerable platform.

BioCardia's Chief Executive Officer, Peter Altman, PhD, thanked the BayCare Morton Plant team led by Dr. Miller and Dr. Sharma, as well as other world-class clinical teams engaged in the CardiAMP cell therapy trials. The company is preparing regulatory submissions in Japan and the USA to seek separate approvals of the CardiAMP cell therapy and Helix biotherapeutic delivery platform based on existing clinical data.

The CardiAMP HF II trial is intended to collect confirmatory evidence to support the autologous cell therapy with respect to approvals, adoption, and reimbursement. BioCardia's clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS).

References:
[1] https://www.globenewswire.com/news-release/2025/05/01/3072465/0/en/BioCardia-Announces-First-Patient-in-Phase-3-Randomized-Controlled-Double-Blind-CardiAMP-HF-II-Clinical-Trial-of-the-Company-s-Lead-Cell-Therapy-for-Treatment-of-Heart-Failure.html
[2] https://www.tradingview.com/news/reuters.com,2025-05-01:newsml_GNXb1Qtr4:0-biocardia-announces-first-patient-in-phase-3-randomized-controlled-double-blind-cardiamp-hf-ii-clinical-trial-of-the-company-s-lead-cell-therapy-for-treatment-of-heart-failure/