Biocardia Inc Stock Price, News & Analysis

BioCardia, Inc. (Nasdaq: BCDA) announced leadership changes in its clinical team, effective February 15, 2021. Dr. Sujith Shetty has been appointed as Chief Medical Officer, succeeding Dr. Eric Duckers, who resigned to explore new opportunities but will remain as a consultant. Ms. Debby Holmes-Higgin retains her position as Vice President of Clinical with broader responsibilities. The changes follow a successful Data Safety Monitoring Board Review of the CardiAMP Heart Failure Trial, aimed at enhancing the trial's success.

BioCardia, Inc. (Nasdaq: BCDA) announced the election of Krisztina Zsebo, Ph.D., to its Board of Directors during the 2020 Annual Meeting of Stockholders. With over 30 years in biotech, Dr. Zsebo has raised more than $200 million and launched products generating over $3.5 billion in annual sales. She replaces Fernando L. Fernandez, who completed his term. Dr. Zsebo is expected to chair the Science and Technology Committee, enhancing BioCardia's product development initiatives. The company focuses on regenerative therapies for cardiovascular and respiratory diseases.

BioCardia, Inc. (Nasdaq: BCDA) has announced the issuance of U.S. Patent No. 10,874,831 for a new device designed to enhance the delivery of biotherapeutics in cardiovascular treatments. This technology is expected to improve physician control during procedures involving complex vascular anatomy. The patented design is incorporated in the company’s recently approved products, Morph DNA and AVANCE steerable catheters, which could bolster clinical programs for heart failure and chronic ischemia. CEO Peter Altman emphasizes the importance of delivery systems in therapeutic success.

BioCardia, Inc. (Nasdaq: BCDA) announced the sale of 2,038,836 shares of common stock at $5.15 per share in a registered direct offering, expected to close around December 18, 2020. A.G.P./Alliance Global Partners serves as the sole placement agent. This transaction is executed under an effective shelf registration statement previously filed with the SEC. Investors are encouraged to review the upcoming prospectus supplement for further details.

BioCardia, Inc. (Nasdaq: BCDA) announced a registered direct offering of 1,789,474 shares of common stock at $4.75 per share, totaling approximately $8.5 million. The offering is expected to close around December 16, 2020, subject to customary conditions. A.G.P./Alliance Global Partners is the sole placement agent. The offering is made under an effective shelf registration statement with the SEC. Investors are encouraged to review the prospectus supplement and related documents for complete details.

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.