SUNNYVALE, Calif. - BioCardia (NASDAQ:BCDA), Inc. [Nasdaq: BCDA] has announced the completion of the final protocol-specified follow-up visit in its CardiAMP HF Trial, a key clinical trial targeting heart failure with reduced ejection fraction (HFrEF). The study, which is a prospective, randomized, double-blinded, and placebo-controlled trial, has enrolled 115 patients and aims to assess the safety and efficacy of the CardiAMP Cell Therapy System.
The trial included patients with advanced HFrEF who were already on guideline-directed medical therapy. They were randomized at a 3:2 ratio to receive either the CardiAMP autologous cell therapy treatment or a placebo. The trial spanned eighteen U.S. hospitals, and the primary effectiveness follow-up ranged from 12 to 24 months, including an additional open-label cohort of ten patients.
The CardiAMP Cell Therapy System, which is currently considered investigational and has received the FDA's Breakthrough Device Designation, involves a minimally invasive procedure where a patient's own cells are delivered to the heart. This is theorized to promote microvascular repair, potentially reducing fibrosis and increasing capillary density. Phase I and II trials, as well as interim Phase III results, have indicated potential patient benefits.
BioCardia's CEO, Peter Altman, Ph.D., expressed optimism about the therapy's promise based on the trends observed in various outcome measures. The company is preparing for data lock and will transfer final data to the University of Wisconsin's independent Statistical Data Analysis Core. Top line results are anticipated for release in the first quarter of 2025.
In addition to the trial's progress, BioCardia has submitted an Annual Report for the CardiAMP Heart Failure Trial to the FDA and plans to request a meeting to discuss the system's approvability. A supplementary submission to Japan's Pharmaceutical and Medical Device Agency (PMDA) has also been completed, with a consultation scheduled for late November.
The CardiAMP Cell Therapy System targets microvascular dysfunction, a condition associated with fibrotic, inflammatory, and endothelial autonomic dysfunction, by potentially stimulating the body's natural healing response. The therapy includes a pre-procedural cell population analysis, a high dosage of cells, and a proprietary delivery system.
This report is based on a press release statement from BioCardia, Inc. and contains no endorsement of claims. The information provided is intended to inform about the recent developments in BioCardia's clinical trials and regulatory communications.
In other recent news, BioCardia, Inc. has regained compliance with Nasdaq Capital Market's listing requirements, following strategic financial efforts including a successful $7.2 million financing round. The company's securities will continue to be listed on the Nasdaq Stock Market. In addition, BioCardia has made notable advancements in its therapeutic programs, including FDA approval of an amendment to the CardiAMP Cell Therapy Heart Failure II protocol and completion of patient treatment in the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial by the University of Wisconsin.
BioCardia also secured FDA market clearance for its Morph DNA product family, designed for commercial use. Furthermore, the company's partner, CellProthera, had a positive pre-IND meeting with the FDA regarding their cell therapy for acute myocardial infarction. A.G.P./Alliance Global Partners (NYSE:GLP) has been closely monitoring these developments as the sole placement agent for BioCardia's public offering.
BioCardia's recent financial performance showed a decrease in net loss to $1.6 million and a 53% reduction in expenses for Q2 2024, despite minimal revenues of $3,000. The company also priced an upsized public offering at $3 per share, expected to generate gross proceeds of $7.2 million. These developments reflect BioCardia's commitment to advancing heart failure treatments and exploring growth opportunities.
InvestingPro Insights
As BioCardia, Inc. [Nasdaq: BCDA] reaches a significant milestone in its CardiAMP HF Trial, investors should be aware of some key financial metrics and insights provided by InvestingPro.
According to InvestingPro data, BioCardia's market capitalization stands at a modest $8.47 million, reflecting its status as a small-cap biotech company. This valuation should be considered in the context of the company's revenue, which was reported at $0.43 million for the last twelve months as of Q2 2024. The low revenue figure aligns with the company's current stage of clinical development and pre-commercialization status.
InvestingPro Tips highlight that BioCardia is "quickly burning through cash" and "not profitable over the last twelve months." These points are particularly relevant given the company's ongoing clinical trials and regulatory activities, which typically require significant financial resources. The tip indicating that "short-term obligations exceed liquid assets" further underscores the financial challenges faced by the company as it progresses through the costly drug development process.
It's worth noting that BioCardia's stock has experienced significant volatility, with InvestingPro reporting a 57.16% price decline over the past six months. This volatility is not uncommon for biotech companies awaiting critical trial results, as investor sentiment can fluctuate based on expectations and interim data.
Despite these challenges, analysts have set a fair value target of $25 per share, significantly higher than the current trading price. This disparity suggests that there may be potential upside if the CardiAMP Cell Therapy System proves successful in its clinical trials and gains regulatory approval.
For investors considering BioCardia, it's important to note that InvestingPro offers 12 additional tips that could provide further insights into the company's financial health and market position. These tips, along with real-time metrics, can be valuable tools for making informed investment decisions in the volatile biotech sector.
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