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BioCardia Announces FDA Approval for Groundbreaking Heart Failure Treatment

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BioCardia, Inc., a prominent player in the development of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has recently announced a significant milestone. The U.S. Food and Drug Administration (FDA) has approved the Phase III clinical trial protocol for BioCardia’s CardiAMP autologous cell therapy. This therapy is designed for patients suffering from ischemic heart failure.

The CardiAMP Heart Failure II study protocol, now approved by the FDA, follows the ongoing CardiAMP Heart Failure trial, which has completed enrollment. The final data from this trial is expected to be reported in the fourth quarter of 2024.

An interim analysis of the ongoing study has shown promising results. Patients with N-terminal pro B-type natriuretic peptide (NT-proBNP) levels indicative of heart failure showed significant clinical improvements compared to controls. These improvements include a 59% relative risk reduction in heart death and a 54% relative risk reduction in Major Adverse Cardiovascular or Cerebrovascular events (MACCE).

The therapy has shown several benefits, including improved quality of life, reduced NT-proBNP levels, increased walk distance, and improved cardiac measures such as left ventricular ejection fraction and volumes. The FDA-approved CardiAMP Heart Failure II study includes specific eligibility criteria based on NT-proBNP levels and a modified primary efficacy endpoint compared to the ongoing study.

The CardiAMP Cell Therapy Program, designated as a Breakthrough therapy by the FDA, uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive procedure. This therapy aims to stimulate the body’s natural healing response. The upcoming trial, supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services, is expected to provide primary evidence for FDA approval and marketing registration.

BioCardia, headquartered in Sunnyvale, California, is also developing other cell therapies and partnering with various biotherapeutic companies to advance treatments for heart failure, chronic myocardial ischemia, and acute myocardial infarction.

Key Takeaways

  1. FDA Approval of CardiAMP Heart Failure II Protocol: This marks a significant step forward in the treatment of ischemic heart failure using autologous cell therapy.
  2. Promising Interim Results: The ongoing CardiAMP Heart Failure trial shows substantial improvements in patients, indicating the potential effectiveness of this therapy.
  3. Future Prospects: The success of this trial could lead to FDA approval and widespread use of this innovative treatment, offering hope to many patients with heart failure.

For more information, visit BioCardia’s website.

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