SUNNYVALE, Calif. - BioCardia, Inc. (NASDAQ:BCDA), a biotechnology company specializing in cellular therapies for cardiovascular diseases, has announced the activation of a pivotal trial for its CardiAMP autologous cell therapy. The trial targets patients with ischemic heart failure and has been approved by the FDA to proceed after receiving study-wide Institutional Review Board (IRB) approval.
The CardiAMP HF II trial is a randomized controlled study designed to assess the efficacy of CardiAMP therapy in individuals with heart failure of reduced ejection fraction (HFrEF) due to ischemic etiology. The trial follows the interim results of the CardiAMP Heart Failure study, which enrolled 125 patients. These interim results are scheduled to be presented at the Technology and Heart Failure Therapeutics meeting on March 4, 2024.
The primary endpoint of the study is based on a composite score that includes all-cause heart death, major adverse cardiac and cerebrovascular events, and quality of life measurements. The trial aims to enroll 250 patients and boasts a statistical probability of success greater than 90 percent. BioCardia aims to complete patient enrollment within 24 months of the first patient randomization.
CardiAMP Cell Therapy, designated by the FDA as a Breakthrough therapy, involves using a patient's own bone marrow cells, delivered to the heart via a minimally invasive procedure. The therapy includes a proprietary cell analysis for patient selection, a high dosage of cells, and a delivery system that has shown to be safer and more effective in cell retention compared to other methods.
The company's CEO, Dr. Peter Altman, expressed optimism regarding the trial's potential for rapid enrollment, citing operational benefits from previous experience with their interventional heart failure network and the motivation of both physicians and patients based on the forthcoming clinical results.
BioCardia's proprietary cell procedure kits and catheter delivery system are manufactured in Sunnyvale, California. The CardiAMP HF trial has received support from the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services.
The information in this article is based on a press release statement from BioCardia, Inc.
InvestingPro Insights
As BioCardia, Inc. (NASDAQ:BCDA) embarks on a pivotal trial for its CardiAMP autologous cell therapy, the company's financial health and market performance are crucial for investors monitoring its progress. According to real-time data from InvestingPro, BioCardia's market capitalization stands at a modest 9.5M USD, reflecting the scale of the company within the biotechnology sector. The firm's revenue for the last twelve months as of Q3 2023 was reported at 0.57M USD, highlighting the challenges faced in generating sales. This is further evidenced by a significant revenue decline of 56.98% over the same period.
Moreover, the company's stock has experienced high price volatility and has seen a substantial price drop of 81.89% over the last year. This could be indicative of market sentiment and investor expectations regarding the company's performance and future prospects. An InvestingPro Tip suggests that analysts are not optimistic about sales in the current year, which could be a concern for potential investors.
For those considering an investment in BioCardia, it's notable that the company has been operating with a moderate level of debt and has been quickly burning through cash. The balance sheet shows that short-term obligations exceed liquid assets, which may pose liquidity risks. Additionally, gross profit margins have been weak, with gross profit reported at -8.2M USD, and the company has not been profitable over the last twelve months. These factors could be crucial for investors assessing the risk profile of the company.
For further insights and additional InvestingPro Tips, such as the company's anticipated sales decline and its high price volatility, interested readers can explore more at https://www.investing.com/pro/BCDA. There are 12 additional tips listed in InvestingPro that could provide a deeper understanding of BioCardia's financial and market status. To enhance your research, use coupon code "SFY24" to get an additional 10% off a 2-year InvestingPro+ subscription, or "SFY241" to get an additional 10% off a 1-year InvestingPro+ subscription.
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