Recent Updates — BCDA

On October 1, 2026, BioCardia, Inc. announced the completion of a revised Pre-Submission to the FDA Center for Devices and Radiological Health (CDRH) under its Q-Submission program regarding the approval of its Helix Catheter for therapeutic and diagnostic agent delivery to the heart. The submission incorporates advice from an initial meeting in May 2026, where the FDA identified two pathways for marketing clearance and raised no concerns regarding safety data or device performance. The FDA targets providing written feedback within 70 calendar days. BioCardia operates in the biotechnology industry, developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases.

BioCardia, Inc. reported financial results for the quarter ended June 30, 2026, announcing a net loss of $1.6 million compared to $2.0 million in the prior year period. The company raised approximately $4.9 million in net proceeds through its At-the-Market facility and held cash reserves of $4.1 million at quarter-end. Research and development expenses decreased to $0.9 million from $1.4 million, primarily due to the close-out of the CardiAMP HF Trial. BioCardia highlighted positive regulatory interactions, noting that Japan’s PMDA supports a Shonin pre-market submission for CardiAMP Cell Therapy in Q4 2026 and the FDA indicated ongoing trials may support U.S. approval. The company operates in the biotechnology industry, developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases.

BioCardia, Inc. issued a press release on June 18, 2026, providing a business strategy update and highlighting business development opportunities. BioCardia, Inc. is a biotechnology company focused on developing and delivering cell therapy products.