BCDA BioCardia

BioCardia FDA Accepts De Novo Pre-Submission for Helix Catheter

FDA has accepted BioCardia's revised De Novo pre-submission package for the Helix transendocardial delivery catheter. The agency is expected to provide substantive review with written feedback and hold a meeting with the company this quarter to discuss potential marketing clearance via the De Novo pathway. This builds on prior positive FDA feedback with no safety or performance concerns raised.

BioCardia to Present CardiAMP HF II Trial Design at HFSA 2026

BioCardia will present the CardiAMP HF II trial design and scientific support at the Heart Failure Society of America Annual Scientific Meeting 2026. The ongoing trial may be sufficient to support FDA approval of the CardiAMP cell therapy system. FDA has granted category B designation for the CardiAMP system in three trials.

BioCardia Files Revised De Novo Pre-Submission for Helix Catheter

BioCardia submitted a revised De Novo pre-submission to FDA CDRH for marketing clearance of the Helix catheter for cardiac agent delivery. The filing incorporates prior FDA feedback from May and August 2026 meetings that raised no safety or performance concerns. FDA feedback or meeting is expected within 70 calendar days.

BioCardia Plans Q4 2026 PMDA Shonin Submission for CardiAMP HF and Helix De Novo Pre-Submission

BioCardia confirmed it is targeting a Shonin pre-market submission to Japan's PMDA for CardiAMP autologous cell therapy in ischemic heart failure in Q4 2026, following responses to consultation questions. The company also intends to submit a follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System this quarter after incorporating FDA CDRH advice.

BioCardia: CardiAMP HF II enrollment begins; PMDA, FDA meetings set

The company has initiated enrollment in the confirmatory CardiAMP HF II trial at four U.S. centers and has submitted a Q-Sub request to FDA CBER on approvability of the CardiAMP System. PMDA has scheduled a formal clinical consultation for Q2 2026 to discuss acceptability of existing data for Shonin approval in Japan.

BioCardia plans FDA meeting on CardiAMP approvability in Q4 2025

The company announced it will request an FDA meeting in Q4 2025 to discuss approvability of the CardiAMP system for heart failure. It also plans to submit a DeNovo 510(k) for the Helix delivery catheter in Q4 2025 and expects a follow-up PMDA consultation in Japan that could enable a Japanese approval filing.