BCDA News & Events

BioCardia announced the FDA has accepted its pre-submission package for the approval of its Helix Transendocardial Delivery Catheter intended for intramyocardial therapeutic and diagnostic agent delivery. BioCardia has had preliminary meetings with both FDA Center for Devices and Radiological Health and FDA Center for Biological Evaluation and Research on this submission in recent weeks. CDRH is expected to lead the review in consultation with CBER. CDRH has acknowledged the CBER CardiAMP Cell Therapy Breakthrough Designation enabled by Helix. The Helix transendocardial delivery catheter is an enabling platform for minimally invasive targeted delivery of therapeutic and diagnostic agents to the heart intramyocardially

BioCardia reported late breaking echocardiography results from its Phase III clinical trial for ischemic heart failure of reduced ejection fraction, which affects millions of patients in the United States. The clinical results were presented by Dr. Amish Raval, M.D., Professor of Medicine at University of Wisconsin School of Medicine and Public Health and CardiAMP HF Trial National Co-Principal Investigator, in the late breaking clinical trial oral presentation session of the Technology and Heart Failure Therapeutics on behalf of the CardiAMP HF Investigators. The presentation was titled: Autologous Cell Therapy May Curb Pathological Ventricular Remodeling in Chronic Ischemic HFrEF Patients Selected for Favorable Cell Characteristics - Late Breaking Echocardiography Results from the CardiAMP HF Trial. Dr. Raval reported that patients receiving the autologous CardiAMP cell therapy under investigation demonstrated positive evidence of decreased pathological left ventricular remodeling over time compared to patients not receiving the treatment. These results correlated to findings for the trial primary and key secondary endpoints of reduced fatal and non-fatal major adverse cardiovascular events and improved quality of life measures for treated patients

BioCardia completed its Pre-Submission to FDA under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter for intramyocardial therapeutic and diagnostic agent delivery. The data supporting safety and effectiveness for the Helix Pre-Submission is from fifteen well-controlled clinical trials of cell and gene therapy delivery to the heart using Helix, where patients were enrolled in three primary cardiac clinical indications. The Helix Pre Submission has been made under the CardiAMP Cell Therapy System FDA Breakthrough Designation, which the Helix underlies. BioCardia seeks to align with FDA on the regulatory pathway and timing for approval in the next 45 days. An application for market clearance could soon follow.

BioCardia announces it has completed a third preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency, PMDA, on CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced Ejection Fraction, HFrEF. The meeting was held in further preparation for formal clinical consultation on acceptability of the existing clinical data for submission of an application for approval. Based on the discussions in the most recent meeting, PMDA said it will allow BioCardia to advance to formal clinical consultation. Should PMDA agree in formal consultation that the available data provides sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan.