BCDA News & Events

BioCardia announced the outcome of its pre-submission meeting with FDA on the Helix Transendocardial Delivery Catheter System. FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns on Helix safety data, device performance, or compatibility with general classes of agents. FDA's preferred route of Helix approval was simultaneous with the approval of the CardiAMP cell therapy system for the treatment of heart failure. FDA also suggested a follow-on pre-submission incorporating agency advice could enable Helix approval via the DeNovo pathway.

BioCardia reported a positive outcome in its formal clinical consultation with Japan's Pharmaceutical and Medical Device Agency, PMDA. PMDA has determined that the clinical safety and efficacy evidence for the CardiAMP Cell Therapy in ischemic heart failure is likely sufficient to support market clearance. Good alignment was achieved in the meeting on the acceptability of the foreign clinical data that has been developed in the United States, the indications for use in patients, the approach for introduction of the therapy in Japan, and the need for continued post marketing studies in Japan. The Company will await the minutes from PMDA to provide detailed feedback and timeline for potential filing.

BioCardia reported submission to FDA of the CardiAMP HF clinical study data and on its plans to meet with the FDA to discuss the accelerated approval pathway for the CardiAMP System for ischemic chronic heart failure with reduced ejection fraction. This meeting request is in line with previous guidance and BioCardia expects to have the meeting during this quarter. The meeting will be held under BioCardia's FDA Breakthrough Designation for the CardiAMP System. The key objectives of the meeting are to obtain FDA feedback on the acceptability of BioCardia's proposed submission for approval based on the safety seen in the CardiAMP HF Trial, the well-characterized clinical response data for the 125 ischemic HFrEF patients enrolled into the trial, and the low risk and high potential benefit profile in the subgroup with elevated biomarkers of heart stress participating in the trial.

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