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Ikaria® Commences Global Registration Trial for Bioabsorbable Cardiac Matrix
Date:1/3/2012

nature of BCM, as well as the fact that it provides structural support to the heart without any metabolic affect on the body, we believe the medical device pathway is the most appropriate regulatory approval pathway," stated Douglas Greene, MD, Executive Vice President of Research & Development of Ikaria.

PRESERVATION I is a placebo-controlled, multi-center, randomized double-blind clinical trial involving approximately 300 patients which evaluates the safety and effectiveness of BCM when administered to patients who had successful percutaneous coronary intervention (PCI) following acute ST-segment elevation myocardial infarction (STEMI).

It is estimated that of the more than approximately 690,000 patients throughout Europe, Australia and Israel who are hospitalized for AMI, approximately 40% experience the more serious STEMI.  According to published estimates, approximately 30% to 40% of patients with AMI later suffer from CHF.  Moreover, the cost of re-hospitalization and other long-term treatments for CHF can be significant.  For example, the American Heart Association estimates that in 2008 the direct and indirect cost of CHF was $20 billion to $30 billion, of which approximately half was related to AMI.

The major endpoints for the PRESERVATION I trial are: 1) Left ventricular end diastolic volume index (anatomic measurement of left ventricular end diastolic volume index will be assessed through echocardiogram); 2) a validated, disease-specific, self-administered, questionnaire to quantify symptoms, function, and the quality-of-life of subjects, and; 3) an exercise tolerance test to measure the response to treatment in subjects with moderate to severe heart disease.

The trial aims to recruit patients across 45 sites.  Approximately 50 Australian patients will be recruited at 11 clinical trial sites. 

Ikaria acquired the exclusive worldwide license to develop and commercialize BCM from BioLineRx
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SOURCE Ikaria, Inc.
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