The FDA has granted Breakthrough Device Designation for BioCardia Inc's (NASDAQ:BCDA) CardiAMP Cell Therapy System to treat heart failure.
- The company noted that it is believed to be the first cardiac cell therapy to receive FDA Breakthrough Device status.
- CardiAMP Cell Therapy uses a patient's own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure.
- Related: H.C. Wainwright Sees Over 400% Upside For BioCardia Stock.
- The therapy incorporates a pre-procedural screening assay to identify patients who may be likely responders, a first for cardiac cell therapy, and designed to enhance the patient selection.
- Eligible patients receive a high dose of cells using an intramyocardial delivery system.
- CardiAMP Cell Therapy is designed to potentially stimulate the body's natural healing response, provoking a beneficial paracrine reaction to repair the heart.
- The CardiAMP Cell Therapy Heart Failure Trial is a U.S. pivotal trial currently enrolling patients to evaluate the effectiveness of the CardiAMP Cell Therapy System in improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for patients.
- The trial is scheduled to have a prespecified formal Data Safety Monitoring Board Review, which will assess both the safety and futility of the trial on February 8, 2022.
- Price Action: BCDA shares are trading 26.1% higher at $1.98 during the market session on the last check Thursday.
