BioCardia Files FDA Pre-Submission for Helix Catheter After 15 Clinical Trials
BioCardia completed its FDA Q-Submission Pre-Submission for the Helix Transendocardial Delivery Catheter, using safety and efficacy data from fifteen controlled clinical trials across three cardiac indications. The company seeks FDA alignment on regulatory pathway within 45 days under its CardiAMP Breakthrough Designation, paving way for market clearance application.
1. Pre-Submission Completed
BioCardia has submitted a Pre-Submission under the FDA’s Q-Submission program for the Helix Transendocardial Delivery Catheter, aiming to secure alignment on the regulatory pathway within 45 days and prepare for a future market clearance application.
2. Clinical Data Package
The Pre-Submission is supported by safety and effectiveness data drawn from fifteen well-controlled clinical trials encompassing three primary cardiac indications, demonstrating procedural safety and enhanced delivery retention compared to existing modalities.
3. Breakthrough Designation Context
Helix falls under the CardiAMP Cell Therapy System’s FDA Breakthrough Device Designation, which could expedite review and facilitate streamlined approval of both the catheter system and related autologous and allogeneic cell therapies.
4. Strategic Implications
FDA clearance of Helix is expected to de-risk BioCardia’s cardiovascular cell and gene therapy programs, create partnership opportunities with biopharmaceutical companies, and position Helix as a first-in-class minimally invasive delivery platform.