BioCardia Enters Next Phase In Heart Failure Treatment With First Patient In Phase 3 CardiAMP HF II Trial

BioCardia, Inc., a global leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases, has announced the enrollment of its first patient in the Phase III CardiAMP HF II clinical trial. This double-blind, randomized, placebo-controlled study will evaluate the company’s lead autologous cell therapy program for the treatment of heart failure. The trial is being conducted at BayCare Morton Plant Hospital in Clearwater, Florida. This marks an important milestone in BioCardia’s ongoing efforts to advance innovative therapies for heart failure.

Dr. Leslie Miller, M.D., Chief of the Congestive Heart Failure and Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida. Dr. Miller is also a CardiAMP HF II Trial Principal Investigator and member of the Executive Steering Committee, said in a statement, “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. The unique ability to personalize this treatment based on a patient’s own cellular characteristics make CardiAMP cell therapy attractive for treating heart failure. The approach preserves all therapeutic options for our patients, including repeated cell therapy, and avoids the need for immunosuppression. I congratulate and thank our team at Morton Plant Hospital for achieving this important milestone in enrolling the first patient in the world’s first confirmatory Phase 3 cardiac cell therapy trial for heart failure.”

Dr. Rakesh Sharma, M.D., Interventional Cardiologist at BayCare Morton Plant Hospital in Clearwater, and CardiAMP HF II investigator, “Our first CardiAMP HF II study procedure went smoothly and per protocol. Our efforts in cardiac cell therapy over many years have supported the potential of this CardiAMP cell therapy where cells are harvested, processed, and delivered into the heart muscle by our research team. I value the Helix minimally invasive cell intramyocardial delivery platform for its ability to enable targeting of specific segments in the heart with confidence and find the new Morph DNA steerable navigation catheter to be an elegant enhancement.” 

Peter Altman, PhD, BioCardia President and Chief Executive Officer, stated, “We are thankful for the Baycare Morton Plant team led by Dr. Miller and Dr. Sharma as well as the many other world-class clinical teams engaged in the CardiAMP cell therapy trials. We are preparing regulatory submissions in Japan and the USA intended to seek separate approvals of the CardiAMP cell therapy and Helix biotherapeutic delivery platform based on our existing TAB MI1, TAC-HFT2,3, and CardiAMP HF4 clinical data. The CardiAMP HF II trial is intended to collect confirmatory evidence to support this autologous cell therapy with respect to approvals, adoption, and reimbursement.”