BioCardia completes enrollment in Phase III CardiAMP HF trial

BioCardia announces completion of enrollment in its CardiAMP Heart Failure Trial and initiation of a discussion with the FDA on a second pivotal study protocol adapted for the responders in the initial trial with the objective of gaining FDA marketing approval. As previously disclosed, interim trial results reviewed by the Data Safety Monitoring Board in July 2023 indicated that the Phase III CardiAMP Heart Failure trial is not likely to meet the primary endpoint for efficacy at 12 months, in part, because both study groups of randomized patients have had good outcomes. There were no treatment emergent safety concerns by the DSMB. Notably, patients receiving CardiAMP Cell Therapy followed up to 24 months showed a 37% relative risk reduction of cardiac death equivalents and an 18% relative risk reduction in major adverse cardiac and cerebrovascular events.