BioCardia, Inc. develops cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. Its recurring company updates center on the CardiAMP autologous cell therapy platform, CardiALLO allogeneic cell therapy programs, and device and software technologies used to deliver therapies to the heart, including the Helix transendocardial delivery catheter and Heart3D Fusion Imaging software.
News about BCDA commonly covers clinical results in ischemic heart failure with reduced ejection fraction, FDA and Japan PMDA regulatory interactions, patent protection for procedure-planning and navigation technology, and annual financial results. Company communications also address the role of Helix and related vascular navigation platforms in minimally invasive intramyocardial delivery of therapeutic and diagnostic agents.
BioCardia (Nasdaq: BCDA) has announced a registered direct offering of 1,888,889 shares of its common stock at $4.75 per share. The offering, priced at-the-market, is expected to close around December 16, 2020, pending customary conditions. A.G.P./Alliance Global Partners is the sole placement agent for this transaction. This initiative is part of an effective shelf registration statement filed with the SEC. Investors are encouraged to review the forthcoming prospectus supplement for detailed terms of the offering.
BioCardia, Inc. (Nasdaq: BCDA) announces it expects feedback from the data safety monitoring board (DSMB) by December 15, 2020, on interim data from its pivotal Phase 3 CardiAMP Heart Failure Trial. This trial aims to assess the safety and efficacy of CardiAMP autologous cell therapy for ischemic heart failure, approved by the FDA to enroll up to 260 patients across 40 centers. BioCardia plans to release a summary of the DSMB feedback on December 17, 2020, which will help determine the next steps in the trial.
BioCardia, Inc. (Nasdaq: BCDA) announced that its Helix Biotherapeutic Delivery System showed the best safety profile among cardiac cell therapy delivery systems in a study published in Cardiovascular Revascularization Medicine. The analysis involved 1,789 patients and found the Helix System had a serious adverse event (SAE) rate of just 1.1%, significantly lower than competing systems, which had rates as high as 8.3%. This efficiency may enhance the potential for BioCardia’s CardiAMP cell therapy to treat millions of cardiac disease patients.
BioCardia, Inc. (NASDAQ: BCDA) announced the activation of the pivotal CardiAMP Chronic Myocardial Ischemia Trial, studying the safety and efficacy of CardiAMP cell therapy for patients with refractory angina. The FDA has approved the trial, which will enroll up to 343 patients across 40 sites. The first site initiation occurred at the University of Florida, with patient recruitment expected soon. The CMS will reimburse investigational sites similar to the CardiAMP Heart Failure Trial. This trial aims to address a significant unmet clinical need affecting 600,000 to 1.8 million patients in the U.S.
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