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SUNNYVALE, Calif. - BioCardia, Inc. [Nasdaq: BCDA], a company specializing in cellular therapies for cardiovascular and pulmonary diseases, announced that Emory University School of Medicine has begun enrolling patients for the CardiAMP HF II trial. This pivotal Phase III study is evaluating BioCardia's lead product candidate, the CardiAMP Cell Therapy system, for treating ischemic heart failure with reduced ejection fraction and elevated cardiac stress markers. According to InvestingPro data, BioCardia maintains a healthy balance sheet with more cash than debt, though the company is currently experiencing rapid cash utilization as it advances its clinical programs.
The CardiAMP Cell Therapy has demonstrated promising benefits in trial results, as noted by Dr. Arshed Quyyumi, Professor of Medicine at Emory University. He expressed confidence in the trial's design and its alignment with previous research that suggests potential improvements for patients undergoing the treatment. With a market capitalization of just $9 million and analyst price targets ranging from $6 to $25, InvestingPro analysis suggests the stock is currently undervalued relative to its Fair Value.
BioCardia's CEO, Peter Altman, Ph.D., highlighted the significance of Emory University's participation, anticipating that their involvement will expedite patient enrollment, aiming for trial completion by 2027.
Heart failure of reduced ejection fraction (HFrEF) affects millions and is characterized by the heart's inability to pump sufficient blood, leading to a decline in quality of life and potential progression to advanced heart failure. Current treatments often fail to halt disease progression effectively.
The CardiAMP therapy, which has received FDA Breakthrough Designation, involves using a patient's own bone marrow cells in a catheter-based procedure to stimulate natural healing. It is designed to improve microvascular density and reduce fibrosis. Preliminary data from the CardiAMP Heart Failure Study presented in March 2025 showed increased survival, fewer adverse cardiac events, and improved quality of life, particularly in patients with active heart stress.
BioCardia's clinical and regulatory team is working to share these results with the FDA and Japan's Pharmaceutical and Medical Device Agency, aiming for approval of the CardiAMP Cell Therapy and the Helix transendocardial biotherapeutic delivery system.
The information reported is based on a press release statement. BioCardia's forward-looking statements are not guarantees of future performance, and actual results may differ materially. The company cautions that these statements are subject to risks and uncertainties. InvestingPro analysis reveals the company's overall financial health score is currently rated as WEAK, with analysts anticipating continued sales decline in the current year. For deeper insights into BioCardia's financial metrics and growth potential, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, along with 12 additional ProTips and extensive financial analysis tools.
In other recent news, BioCardia Inc. reported a significant reduction in expenses for the fourth quarter of 2024, with total expenses decreasing by 35% year-over-year. The company also announced promising results from its Cardiamp heart failure trial, which showed a 47% relative risk reduction in heart death equivalents and a 16% reduction in major adverse cardiac events. Despite these positive developments, BioCardia's stock experienced a decline in aftermarket trading. The company completed enrollment for its Mercardiallo therapy low-dose cohort and is preparing for regulatory submissions and new trial activations. BioCardia's CEO, Peter Altman, highlighted the strong data supporting the Cardiamp Heart Failure II trial, emphasizing the ongoing regulatory discussions in the U.S. and Japan. CFO David McClung noted the company's financial discipline, with R&D expenses decreasing by 43% and SG&A expenses by 16% year-over-year. BioCardia anticipates a modest increase in R&D expenses in 2025 while maintaining SG&A expenses close to 2024 levels.
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