Cardiomedics Announces Breakthrough in the Treatment of Heart Failure.

IRVINE, Calif. -- Cardiomedics Inc. today announced a clinical study on the use of its non-invasive CardiAssist(TM) External Counter Pulsation (ECP) System in the treatment of congestive heart failure (CHF) was published in Congestive Heart Failure, a peer-reviewed journal. The study showed a 90% reduction in mortality in the treatment of heart failure and an 87.5% reduction in the number of hospitalizations in the year following the ECP therapy. The treatment of heart failure is Medicare's largest single cost, about $40 billion per year. The paper can be accessed at the publisher's Web site, www.lejacq.com.

The study was conducted at six clinical sites in the United States and employed Cardiomedics' CardiAssist ECP System and new Graduated(TM) Pressure Regimen (patent-pending) in the treatment of 127 New York Heart Association (NYHA) Class II, III and IV CHF patients. The CardiAssist ECP System uses a series of cuffs fastened with Velcro around the patient's calves, thighs and buttocks. The cuffs are sequentially inflated, synchronized with the patient's electrocardiogram, forcing blood up the veins and arteries to the heart between heartbeats, significantly increasing perfusion of the heart muscle. The therapy is painless and non-invasive.

The patients were divided into three groups, Low, Medium and High, depending on their diastolic to systolic pressure ratio (D/S Ratio) resulting from the amount of pressure applied during the ECP therapy. Under Cardiomedics' new Regimen, the D/S Ratios are gradually increased over the 35-hour ECP treatment program (one hour per day, five days a week for seven weeks).

In the 54 CHF patients of the Low D/S Ratio Group, in the year following ECP therapy, mortality was only 1.85%, a statistically significant reduction from mortality of 7.69% in the 39 patients of the Mid D/S Ratio Group and mortality of 8.82% in the 34 patients in the High D/S Ratio Group. According to the American Heart Association, mortality from heart failure is typically 18.8% per year, ten times the mortality in Cardiomedics' Low D/S Ratio Group. CHF affects more than 2 million Americans, and about 400,000 die each year, more than from all types of cancer combined.

No drug or device has come close to equaling Cardiomedics' results. In two published studies on the use of surgically implanted cardiac resynchronization pacemakers and/or defibrillators made by Guidant Corp. (NYSE:GDT), the annual mortality rates were 8.5% in NYHA Class II and III CHF and 12.2% in NYHA Class III and IV CHF. In Cardiomedics' Low D/S Ratio Group, annual mortality was zero in NYHA Class II and III CHF and 2.1% in NYHA Class III and IV CHF, both statistically significant reductions from those of the above studies.

In the Low D/S Ratio Group, the average number of hospital admissions was reduced by 87.5%, from 2.8 hospitalizations per patient in the year before to 0.35 hospitalizations in the year following the ECP therapy. The patients' average left ventricular ejection fractions, an indicator of the heart's pumping efficiency, increased by 23%, and their average NYHA CHF Class (severity of disease) declined by 36.6%, both statistically significant improvements from those of the other Groups.

Kris Vijay, M.D., Director of Research of the Scottsdale Cardiovascular Center, Scottsdale, Ariz., and the lead author of the paper, commenting on the effect of ECP on the patients in this study, said, "Their shortness of breath decreased, it reduced the number of hospitalizations and there was a dramatic reduction in mortality."

Lawrence Santora, M.D., Chief Cardiologist of the Orange County Heart Institute, Orange, Calif., and a participant in the study, commenting on the use of ECP, added, "This will open a whole new world of treatment for heart failure patients."

Cardiomedics filed an application for Medicare coverage of ECP for the treatment of heart failure and requested that Medicare limit coverage to ECP devices which have demonstrated in clinical studies, reductions in mortality and hospital admissions in the year following ECP treatment equivalent to Cardiomedics' results, which no other ECP device has been able to produce.

Cardiomedics, which is privately held, pioneered the development of ECP and received the first FDA clearance to market an ECP System in the United States. Its advanced ECP System is small, portable and cleared for sale by the FDA for the treatment of Heart Failure, Angina and Heart Attacks. U.S. patent applications were filed in 2003 and 2004 on Cardiomedics' Graduated Pressure Regimen.

Publication References

(a) Congestive Heart Failure; 2005; 11:147-152.

(b) American Heart Association, Dallas, Texas, Heart Failure and
    Stroke 2004 Statistical Update, Pages 22-23.

Physician References

(a) Kris Vijay, M.D., Phone: [phone], Mobile: [phone]

(b) Lawrence Santora, M.D., Phone: [phone]