Positive Preliminary Clinical Consultation in Japan
BioCardia announced a positive preliminary clinical consultation with Japan's pharmaceutical and medical device agency (PMDA) for the CardiAmp system, indicating potential for market entry in Japan.
Advancement of CardiAmp Heart Failure II Trial
The CardiAmp Heart Failure II confirmatory Phase III trial is accelerating with four centers actively enrolling and showing promising results in patients with elevated NT proBNP.
CardiAmp Cell Therapy Receives FDA Breakthrough Designation
The CardiAmp system has received FDA breakthrough designation based on clinical results, highlighting its potential to treat ischemic heart failure patients effectively.
Partnership for Heart 3D Fusion Imaging
BioCardia announced a partnership with CAR TECH for developing and commercializing Heart 3D Fusion Imaging, showing promising results in animal studies.
Non-Dilutive Funding Expectations
BioCardia expects non-dilutive funding to complete the Phase I-II trial for its BCDA-03 program in 2026, with promising federal grant funding discussions.