BioCardia is focused on developing innovative cellular and cell-derived therapeutics aimed at addressing unmet needs in cardiovascular and pulmonary diseases. Their lead product, CardiAMP® autologous mononuclear cell therapy, is designed for the treatment of ischemic heart failure with reduced ejection fraction (HFrEF). This therapy utilizes a proprietary molecular diagnostic to assess the potency of a patient’s bone marrow cells, ensuring optimal candidates for treatment. The process involves a minimally invasive procedure where bone marrow is harvested, processed at the bedside, and then delivered using a specialized interventional delivery system during a routine cardiac catheterization.

In addition to CardiAMP, BioCardia is advancing other therapies such as CardiALLO™ and PulmALLO™, which are allogeneic cell therapies that provide immunomodulatory benefits for inflammatory diseases. The company is actively conducting clinical trials to evaluate the efficacy of these therapies, including ongoing studies for inflammatory ischemic heart failure and Acute Respiratory Distress Syndrome (ARDS). Preclinical and clinical research has shown promising results, including trends toward reduced mortality and improved quality of life for patients receiving these treatments, highlighting BioCardia's commitment to enhancing patient outcomes through advanced cellular medicine.

United States

We are a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. BioCardia is developing proprietary comprehensive biotherapeutic solutions for cardiovascular disease in its CardiAMP™ and CardiALLO™ therapies. Clinical results supporting both therapeutic programs are compelling and build upon the most rigorous data in the field to date with intramyocardial delivery of marrow-derived cells.

These programs are enabled by the Company's Helix™ transendocardial delivery systems and Morph® vascular access products, which are partnered to enable other promising biotherapeutic programs.

Cardiovascular Diseases

BioCardia

Heart failure

Ischemic stroke

Autologous BCDA-01 CardiAMP

Biologics

Cell Therapies

<p class="font_8">CardiAMP Cell Therapy – FDA designated as a Breakthrough therapy – uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP HF trial is supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services. The proprietary CardiAMP cell procedure kits and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California.&nbsp;CAUTION - Limited by United States law to investigational use.</p>

BCDA-01 CardiAMP cell therapy

Myocardial ischemia

BCDA-02 CardiAMP cell therapy

<p class="font_8">CardiALLO™ Allogeneic Cell Therapy provides an “off the shelf” mesenchymal stem cells (MSC) typically from a younger donor. These cells are immunomodulatory with potential for impact on inflammatory processes in heart failure and have been shown to release multiple critical angiogenic factors that can enhance microvascular function and capillary networks in ischemic tissues. The CardiALLO study is a dose escalation Phase I safety study to be followed by a Phase II randomized double-blind controlled study to assess therapeutic benefit or efficacy. The proprietary CardiALLO human cells and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California.&nbsp;CAUTION - Limited by United States law to investigational use.</p>

BioCardia

Company Details