BioCardia Announces CardiAMP Heart Failure Pivotal Trial Continues with First Patient Randomized in COVID-19 Era
SAN CARLOS, Calif. – June 29, 2020 – BioCardia®, Inc., (OTC: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the Company has resumed cases in the CardiAMP Heart Failure Trial. The first patient procedure completed since elective procedures were paused due to COVID-19 took place at Morton Plant Hospital in Clearwater, Florida this month. New consents have also taken place at additional centers.
“We are pleased to be able to resume enrollment at several sites for our lead clinical program and look forward to cases taking place in July and August,” said BioCardia CEO Peter Altman, PhD. “As study centers resume elective procedures, we are working closely with our clinical partners to implement new FDA recommendations for clinical trials with respect to COVID-19 in order to minimize the impact on our patients, as well as the trial ahead. COVID-19 has been reported to cause heart damage, and some of our clinical investigators are seeing an increased amount of heart damage in patients who have avoided treatment due to fear of COVID-19 exposure. Our cardiac programs have the potential to help address this growing clinical need and are even more important in the current clinical landscape.”
The CardiAMP Heart Failure Trial is studying CardiAMP cell therapy, an autologous bone marrow-derived mononuclear cell formulation designed to stimulate the body’s natural healing response in treating heart failure which develops after a heart attack. The trial is evaluating the cell therapy’s ability to improve patient survival, exercise capacity and quality of life, as well as its safety. The CardiAMP Heart Failure Trial is the first multicenter clinical trial of an autologous cell therapy to prospectively select patients based on cell potency to maximize the probability of patient benefit.
The ongoing multi-center, double-blinded, randomized (3:2), controlled pivotal CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40 centers nationwide. The national co-principal investigators are Amish Raval, MD, of the University of Wisconsin and Carl Pepine, MD, of the University of Florida, Gainesville.
In March 2020, the Data Safety Monitoring Board indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned. To date, 75 patients have been enrolled at 25 active centers. The trial is sponsored, in part, by the Maryland Stem Cell Research Foundation and has reimbursement from the Centers for Medicare and Medicaid Services (CMS).
For additional resources and to learn more about the CardiAMP Heart Failure Trial, visit www.biocardia.com.
BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company's products include the Helix transendocardial delivery system and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix System and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information, visit www.BioCardia.com.