BioCardia completed a third preliminary clinical consultation with Japan's PMDA on CardiAMP Cell Therapy for Heart Failure with Reduced Ejection Fraction.
PMDA agreed to advance to formal clinical consultation based on positive outcomes in clinical efficacy endpoints.
CardiAMP Cell Therapy utilizes autologous minimally invasive cell therapy for microvascular repair in heart failure patients.
Positive Clinical Outcomes
Phase I, II, and III trials showed improved survival, reduced adverse events, and enhanced heart function in patients receiving CardiAMP Cell Therapy.
Breakthrough Designation
CardiAMP Cell Therapy has been granted FDA Breakthrough designation for its innovative approach using a patient's own bone marrow cells for heart treatment.
Regulatory Progress
The existing clinical data supporting CardiAMP Cell Therapy's safety and efficacy is under regulatory discussions in Japan and the United States.
Clinical Development
Clinical trials demonstrated improved left ventricular ejection fraction, exercise tolerance, and quality of life measures in treated heart failure patients.
- BioCardia's progression to formal consultation with PMDA marks a significant step in the regulatory pathway for CardiAMP Cell Therapy in Japan.
- The positive clinical outcomes and breakthrough designation highlight the potential of CardiAMP Cell Therapy to address microvascular dysfunction in heart failure patients.
BioCardia's CardiAMP Cell Therapy shows promise in addressing the unmet need for treatment options in ischemic heart failure patients. The ongoing regulatory discussions and positive clinical outcomes pave the way for potential regulatory approval in Japan and the United States.