FDA Approves CardiAMP® Heart Failure II Protocol Amendment for Cell Population Analysis Screening

BioCardia, Inc., based in Sunnyvale, California, has reported a significant advancement in its CardiAMP Heart Failure II Trial, a Phase 3 study focusing on its autologous CardiAMP cell therapy for patients with ischemic heart failure and reduced ejection fraction (HFrEF). The FDA has approved a protocol amendment allowing more patients, who would have previously been excluded, to receive additional cell deliveries to meet the target minimum dosage. This adjustment is informed by the CardiAMP Cell Population Analysis, which assesses the therapeutic cell composition for patient selection and treatment planning.

Debby Holmes-Higgin, Vice President of Clinical at BioCardia, emphasized that this development is a notable step forward in autologous cell therapy. The modification is expected to improve dosing outcomes for a broader patient group and enhance the overall clinical experience for patients, physicians, and coordinators involved in the CardiAMP Heart Failure II Trial.

The CardiAMP Cell Population Analysis was designed to identify patients most likely to benefit from the therapy based on their cell composition during screening. The CardiAMP Heart Failure II Trial has refined the algorithm and developed a personalized treatment plan for patients who initially did not meet the acceptance criteria. These personalized plans adjust the number of dosing aliquots for patients with lower concentrations of key cells, thereby increasing the number of patients eligible for the trial.

CardiAMP Cell Therapy, which has received Breakthrough Therapy designation from the FDA, involves using a patient's own bone marrow cells delivered to the heart via a minimally invasive, catheter-based procedure. The therapy aims to trigger the body's natural healing processes. CardiAMP incorporates three unique elements: a pre-procedural cell population analysis for patient selection and treatment planning, a high target dosage of cells, and a proprietary delivery system shown to be safer and more effective in cell retention compared to other methods. Clinical trials have indicated potential benefits such as improved patient survival, reduced major adverse cardiac events, and enhanced quality of life. The development of CardiAMP for heart failure is supported by the Maryland Stem Cell Research Fund and reimbursed by the Center for Medicare and Medicaid Services (CMS) for both treatment and control procedures.

The final results from the CardiAMP Heart Failure I Trial, which enrolled 125 subjects, are expected in November 2024. Interim results have shown a 37% relative risk reduction in all-cause mortality with 90% of follow-up data available. BioCardia's clinical team is actively working with investigational sites to verify data, with the aim of presenting the final results to the FDA and Japan's Pharmaceutical and Medical Device Agency.

The CardiAMP Heart Failure II Trial targets patients who exhibited the most significant benefits during the interim results of the first trial. This particular subgroup demonstrated a substantial reduction in mortality risk and showed promising outcomes approaching statistical significance over two years. The second trial also employs a validated quality of life self-assessment tool as part of the primary endpoint, replacing the six-minute walk test used previously. The study design aims to have over 90% power to demonstrate statistical significance based on interim results from the first trial.

BioCardia continues to work with an esteemed group of cardiologists who played key roles in the first trial and have joined the second trial. Several clinical sites are currently active or in the process of being activated.

BioCardia, Inc. is a global leader in the development of cellular and cell-derived therapies for cardiovascular and pulmonary diseases. The company's biotherapeutic platforms include CardiAMP autologous and CardiALLO allogeneic cell therapies, with three clinical-stage product candidates. These therapies are supported by BioCardia's Helix biotherapeutic delivery and Morph vascular navigation product platforms.