News | May 21, 2009

Biotronik Supplies ICDs to Cardio3 BioSciences for C-Cure Stem Cell Clinical Trial

May 22, 2009 – Biotronik said today it is partnering with Belgian biotechnology company Cardio3 BioSciences in its C-Cure stem cell clinical trial, where it will provide implantable cardioverter defibrillators (ICDs) with home monitoring.

This pivotal trial is designed to evaluate the safety and efficacy of Cardio3 BioSciences’ second-generation stem cell therapy in patients with heart failure. The first patient was treated in March 2009. The ICDs will help ensure an optimal standard of care for patients with severe cardiac conditions. Biotronik Home Monitoring offers remote monitoring for cardiac patients and reduces the need for conventional in-office visits, while improving follow-up adherence, and enables earlier evaluation of clinically relevant cardiovascular events.

C-Cure is a second generation cell therapy for the treatment of heart failure that involves taking a patient’s own stem cells from bone marrow and through a proprietary culturing technology generating differentiated “cardiopoietic” cells which can regenerate damaged heart muscle. Unlike previous cell therapies for this indication, C-Cure is designed to produce new autologous heart muscle cells, which behave identically to those lost in infarction without carrying the risk of rejection.

In the two-phase, multicenter trial, 240 patients suffering from ischemic cardiomyopathy at 35 sites in eleven countries will be treated with C-Cure. The primary endpoint is a change in left-ventricular ejection fraction at six months post treatment.

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