FDA Clears BioCardia to Seek PMA for CardiAMP HF II Cell Therapy, Shares Jump (BCDA)

BioCardia Inc. (NASDAQ: BCDA) shares rallied on June 5, 2026, after the U.S. Food and Drug Administration confirmed the company may pursue a Premarket Approval application for its CardiAMP HF II cell therapy in ischemic heart failure with reduced ejection fraction. The positive regulatory feedback allows BioCardia to forego an additional pivotal trial, directly filing for the PMA. CardiAMP HF II uses a patient’s own bone marrow cells to stimulate cardiac repair. The streamlined pathway accelerates the therapy’s potential market entry, addressing a significant unmet need in advanced heart failure. BioCardia plans to submit the application in the coming months.