The ACCLAIM trial enrolled 2,414 patients at 176 cardiac centers throughout North America, Europe, and Israel. The study was a double-blind, placebo-controlled trial designed to definitively assess the impact of Vasogen's Celacade(TM) technology on the risk of death and cardiovascular hospitalizations in patients with advanced chronic heart failure. ACCLAIM enrolled patients with New York Heart Association (NYHA) Class II, III, or IV chronic heart failure and a mean left ventricular ejection fraction (LVEF) of less than 30%, indicating patients with advanced disease. Patients who participated in the ACCLAIM trial were taking pharmaceuticals that reflect the current standard-of-care and many had implanted cardiac defibrillators and/or cardiac resynchronization devices as clinically indicated. Study patients received monthly Celacade treatments in an outpatient clinic.
About Heart Failure
Chronic HF is a major public health problem that imposes a significant burden in terms of morbidity, mortality, and the utilization of health care services. It is one of the most commonly diagnosed medical conditions affecting nearly 5 million Americans and 6.5 million Europeans. Each year, in the U.S. alone, 550,000 new cases of HF are diagnosed and nearly 300,000 deaths are associated with this condition. The five-year survival rate for patients with heart failure is only 50%. Approximately 6.5 million hospital days and up to 15 million office visits are for HF care each year in the United States alone. The health care costs associated with HF are staggering, with $29.6 billion in direct and indirect costs in the United States projected for 2006. Almost 72% ($21.3 billion) of this total represents costs associated with hospital and nursing home care, and physician and other health care professionals. More Medicare dollars are spent for the diagnosis and treatment of HF than for any other diagnosis.
Vasogen will conduct a conference call on Monday, June 26, 2006 at 8:30 a.m. EST. David Elsley, President and CEO of Vasogen, and Dr. James Young, Chairman, Division of Medicine at the Cleveland Clinic Foundation and Global Principal Investigator and Chairman of the Steering Committee for the ACCLAIM trial will host the call.
The conference call can be accessed at 617-213-8854 or 1-866-831-6234, pin code 61349936 ten minutes prior to the call. An audio web cast of the event will also be available at www.vasogen.com
. A re-broadcast of the conference call will be available by dialing 1-617-801-6888 or 1-888-286-8010, pin code 92365502 and will also be available at www.vasogen.com