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SUNNYVALE, Calif. - BioCardia (NASDAQ:BCDA), Inc. [Nasdaq: BCDA], a clinical-stage biotechnology company with a current market capitalization of $9.6 million, has announced the completion of its Phase 3 CardiAMP Heart Failure (HF) study’s primary outcomes data verification and freezing process. According to InvestingPro data, the company’s stock has experienced significant volatility, declining over 72% in the past year. The study is significant for being one of the largest ischemic heart failure of reduced ejection fraction (HFrEF) patient cohorts in a randomized trial of an autologous cell therapy.
The trial involved 115 randomized patients, and the data has now been transferred to the Statistical Data Analysis Center core laboratory for analysis. The results are expected to be presented at the American College of Cardiology ( ACC (NSE:ACC)) 2025 Scientific Sessions in Chicago on March 30, 2025. With the next earnings report due on March 28, 2025, InvestingPro subscribers can access detailed financial analysis and 12 additional ProTips about BioCardia’s performance and outlook. If the results align with the interim analysis, it could indicate a meaningful therapeutic benefit for HFrEF patients who have not responded adequately to medication.
Peter Altman, PhD, President and CEO of BioCardia, stated that the clinical study aims to support the safety and efficacy of their CardiAMP cell therapy system for future approvals in the United States and Japan. Additionally, the company anticipates that the results will back the safety and effectiveness of the Helix biotherapeutic delivery system for standalone approval for intramyocardial delivery to the heart.
CardiAMP Cell Therapy, which has received FDA Breakthrough designation, uses a patient’s own marrow cells in a catheter-based procedure to potentially stimulate the body’s natural healing response. The therapy targets mechanisms leading to microvascular dysfunction, which includes fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, through the production of various growth factors and cytokines.
The development of the CardiAMP clinical program for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). However, it is important to note that the therapy is currently limited by United States law to investigational use.
This announcement is based on a press release statement from BioCardia, Inc. The company, headquartered in Sunnyvale, California, is advancing its biotherapeutic platforms with three clinical stage product candidates, enabled by its Helix and Morph vascular navigation product platforms. InvestingPro analysis shows the company maintains a healthy current ratio of 1.78 and holds more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn. For comprehensive insights into BioCardia’s financial health and future prospects, investors can access the detailed Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, BioCardia, Inc. has completed enrollment and dosing for the low-dose cohort in its Phase I/II trial of CardiALLO™ Allogeneic Mesenchymal Cell Therapy. This trial focuses on patients with ischemic heart failure with reduced ejection fraction, aiming to establish the safety and efficacy of this innovative cell therapy. The study involves a nine-patient dose escalation cohort followed by a thirty-patient randomized double-blinded placebo-controlled cohort. BioCardia’s CEO, Peter Altman, Ph.D., expressed confidence in the program’s potential to lead to pivotal clinical studies in the U.S. and conditional approval in Japan. Additionally, BioCardia is making strides in Japan with its BCDA-01 therapy, as the country’s Pharmaceutical (TADAWUL:2070) and Medical (TASE:BLWV) Device Agency has invited the company for further consultation. This follows the submission of final clinical data, which includes a two-year follow-up for the CardiAMP Heart Failure Trial involving 125 patients. The trial results are being considered as evidence for the registration of the CardiAMP Cell Therapy System in Japan. BioCardia’s BCDA-01 has also received Breakthrough Designation from the FDA, supported by the Maryland Stem Cell Research Fund.
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