BCDA news

BioCardia finalized regulatory consultations with Japan's PMDA for its CardiAMP cell therapy, moving closer to a commercial launch and potential market entry in 2028.

BioCardia announced FDA acceptance of its revised submission for the Helix catheter, marking the start of substantive review expected this quarter. The approval paves the way for expanded partnerships related to heart disease therapies.

BioCardia completed a revised pre-submission for its Helix Catheter based on FDA guidance, aiming for approval as a unique therapeutic delivery device. This clearance could significantly expand partnership opportunities in cardiology.

BioCardia updated on its regulatory submission timelines, noting a Q4 2026 PMDA Shonin application and a Q4 2026 De Novo pre-submission for its Helix platform.

BioCardia announced CEO Peter Altman will present at the H.C. Wainwright Global Investment Conference, covering regulatory progress for CardiAMP and other business developments.

BioCardia announced the FDA has accepted meeting minutes for the Helix Transendocardial Delivery Catheter, which supports a follow-on De Novo pre-submission to potentially clear the device for market.

BioCardia sold 3.5M shares at $1.279 per share on June 5, 2026, raising $4.4M in net proceeds. The capital is intended to fund operations through Q1 2027 and support the company's Japan PMDA submission for its CardiAMP cell therapy platform.

BioCardia received FDA confirmation that its ongoing CardiAMP Heart Failure II trial may support premarket approval for its cell therapy treating ischemic heart failure. The positive FDA feedback potentially clears a major regulatory hurdle for a therapy targeting over one million U.S. patients.