08:41 AM EDT, 06/05/2026 (MT Newswires) -- BioCardia ( BCDA ) has received confirmation from the US Food and Drug Administration that its ongoing heart failure trial may support a premarket approval of the CardiAMP Cell Therapy System for the treatment of ischemic heart failure with reduced ejection fraction, the company said Friday.

The FDA provided the feedback following a Q-Sub meeting with the agency's Center for Biologics Evaluation and Research, BioCardia ( BCDA ) said.

Shares of BioCardia ( BCDA ) were up more than nearly 26% in Friday premarket activity.