Biocardia, Inc. products

The AVANCE steerable introducer leverages technology from BioCardia`s Morph family of access catheters. The 8.5 F AVANCE Steerable Introducer is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. Designed to be virtually whipless around curves, due to its helically arranged pull-wires, the AVANCE bi-directional introducer provides exceptional torsional stiffness to enable greater predictability, stability and control during procedures.

The investigational CardiAMP™ Cell Therapy is designed to be a comprehensive biotherapeutic heart failure solution, incorporating: a proprietary molecular diagnostic to characterize the potency of a patient’s own bone marrow cells and determine if they are an optimal candidate for therapy. a point of care processing platform to prepare cells at the patient’s bedside. an optimized therapeutic formulation that builds on the total experience in the cardiac stem cell field to-date. a proprietary interventional delivery system that easily navigates a patient’s vasculature to securely deliver the specific dosage of cells in a routine cardiac catheterization procedure.

Where the CardiAMP Cell Therapy System uses a patient’s own cells, the CardiALLO system uses culture-expanded, bone marrow-derived mesenchymal stem cells from a universal donor. This allows the cells to be obtained "off the shelf" from a pharmacy, negating the need for a bone marrow aspirate for the patient and providing an option for patients identified as sub-optimal for the CardiAMP treatment. This “off the shelf” dose, which uses neurokinin-1 receptor positive mesenchymal stem cells, is then processed into a proprietary dosage for delivery with the Helix transendocardial delivery system for the treatment of cardiac and pulmonary disease.

Leading physicians have described the current Helix Biotherapeutic Delivery System as elegant in its simplicity. BioCardia’s Helix Biotherapeutic Delivery System is the leading percutaneous catheter delivery system for cardiovascular regenerative medicine. It enables local delivery of cell and gene based therapies to treat heart failure, myocardial infarction, ischemia, and cardiac conduction disorders.