TABMMI Heart Failure Study Published in EuroIntervention

BioCardia, developer of devices for delivery of biologic therapies for treatment of heart failure and chronic myocardial ischemia announced today two year study results in the EuroIntervention Journal

FOR IMMEDIATE RELEASE
(Free-Press-Release.com) December 6, 2011 --San Carlos, CA – December 6, 2011
BioCardia, Inc., a leader in the development of devices for the delivery of biologic therapies for the treatment of heart failure and chronic myocardial ischemia announced today the publication in the December issue of EuroIntervention of the two year follow-up safety data on the Helical Infusion System from the Transendocardial Autologous Bone Marrow in Myocardial Infarction Induced Heart Failure (TABMMI) study.

The Helical Infusion System is a two catheter system which includes BioCardia’s FDA cleared Morph® Universal Deflectable Guide catheter and the Helical Infusion Catheter™. Each has received CE Mark approval. The Helical Infusion System enables a catheter to be advanced to within the heart chamber to enable stem cell delivery directly into the muscle. This direct delivery has potential advantages over delivery into the coronary arteries by providing for enhanced cell retention in target tissues, the avoidance of obstruction of the microcirculation, and the ability to target selected regions of interest directly, particularly those with poor perfusion.

The TABMMI study is an open-label Phase I safety study of adult stem cells for patients with heart failure resulting from coronary artery disease but without having documented myocardial ischemia initiated under the leadership of Dr. Luis de la Fuente, and sponsored by BioCardia. TABMMI shows an excellent safety profile for the Helical Infusion System delivery platform and the patient’s own stem cells derived from their bone marrow. Although not an efficacy study, results include statistically significant increases in cardiac ejection fraction and exercise tolerance, non statistically significant trend in decreased cardiac diastolic dimension, and reduced patient mortality as compared to historical controls.
Heart failure is a condition that can result from any structural or functional cardiac disorder that weakens or damages the heart and impairs its ability to fill with blood or pump a sufficient amount of blood throughout the body. Those over 40 years of age have a 1 in 5 chance of developing heart failure and there is a 20% mortality rate at 2 years which increases to 50% at 5 years. Myocardial ischemia affects an even larger patient population, results from poor blood flow to the heart muscle, and often results in heart failure.
“In addition to compelling results for the autologous cells delivered, results support the ease and safety of the Helical Infusion Catheter System that is likely to enable many advances in cardiac cell and gene therapy that are underway today.” said Peter Altman, president and chief executive officer of BioCardia. “This work has led to multiple ongoing trials around the world and we are thankful to both the patients who participated and to the investigative team who performed this study under Dr. de la Fuente’s leadership.”
About BioCardia
BioCardia, Inc. (San Carlos, Calif.) was incorporated in 2002 to design, develop, manufacture, and market innovate devices to enable percutaneous delivery of biologics to treat cardiovascular disease. The company's initial products are intended to provide a new therapeutic option for patients with heart failure and chronic myocardial ischemia.

More information can be found online at http://www.biocardia.com

clinical study     heart failure     myocardial ischemia     treatment