May 1, 2004

For Immediate Release

Heart Failure on the Rise, But is Under Siege by Multiple Therapeutic Alternatives and Approaches, According to New Report from MedMarket Diligence

FOOTHILL RANCH, CA— Nearly five million people in the U.S. suffer with heart failure, the inability of the heart to pump sufficient blood, and over 400,000 patients are newly diagnosed each year, but improvements in understanding, development of therapeutics and overall management of heart failure is creating dramatic progress, according to a new report from MedMarket Diligence.

“Heart failure is a multifactorial disease, so it is fitting that we are seeing such progress with the disease as a result of taking multiple approaches,” says Patrick Driscoll, of MedMarket Diligence. According to Driscoll, as many as half of all heart failure patients die within five years, despite a cost of $16,000 per patient per year, including medications at an average coat of $6,000 per year. However, the disease is being confronted by advances in understanding and development of multiple alternatives that are demonstrating the potentially to alleviate symptoms and eventually cure heart failure. These include steady increase in understanding of the disease’s underlying pathologies, the better understood effects of drugs alone or in combination with each other or with other therapies, the availability of proven surgical, interventional and device therapies, and the development of patient management and monitoring services across the spectrum of care sites from the home to the hospital.

The advances in heart failure stem from the following:

-- The majority of heart failure-focused pharmacologic interventions currently used or under development represents a shift in thought, and these are based on the now-proven neurohormonal model.

-- Clinical trials have determined and now confirmed that biventricular pacemakers, implantable cardioverter defibrillators (collectively, cardiac resynchronization therapy) and ventricular assist devices have significant benefit for the heart failure patient.  Cardiomyoplasty and associated products are also under development to reduce cardiac hypertrophy and improve cardiac performance for select HF patients.

-- Investigated and developed as an alternative to intravenous diuretic therapy in heart failure, ultrafiltration (a process of hemofiltration designed to remove plasma water through a semi-permeable membrane) has emerged as an additional therapeutic method that has displayed benefits for the CHF patient beyond fluid removal.

-- An individual’s hemodynamics (which includes heart rate and cardiac output) play a significant role in risk for cardiovascular diseases including heart failure. The use of external counterpulsation (ECP) methods to increase the blood flow to the heart, and decrease the pressure that the heart must pump against has improved clinical manifestations including decreasing recurrent chest pain, decreasing heart size and lessening of the progression to cardiac failure.

-- The surges in the blood pressure and heart rate of individuals suffering from sleep apnea result in hemodynamics that may particularly aggravate heart failure, and studies have shown as much as up to one-third of heart failure patients may also have obstructive sleep apnea. Continuous positive airway pressure (CPAP), shown as an effective treatment for sleep apnea, has shown evidence of improved ventricular function, improvements in ejection fraction (EF) and disturbed heart rhythms in heart failure patients who responded to it in studies. ECP, and CPAP for the treatment of sleep apnea, are therefore covered within this report as adjunctive treatments in heart failure

-- Better understanding in HF pathology and have improved the ability of clinicians to prescribe of combinations of drugs that slow disease progression and improve quality of life.  These include ACE inhibitors; Angiotensin II receptor blockers; Beta-blockers; blood thinners (anticoagulants); Digoxin; diuretics, loop diuretics, thiazides; inotropic therapy; spironolactone (aldosterone agonist); and vasodilators

-- It is evident that both current and future strategies for treatment of heart failure are moving rapidly toward a multidimensional approach that focuses not only on the neurohormonal component of the disease but will most likely involve therapeutic strategies that are designed to prevent or minimize the remodeling processes in the heart and vasculature at early stages of cardiac dysfunction.

The MedMarket Diligence report on Heart Failure (published April 2004) details the current approaches applied by physicians (primary care & cardiologists) and healthcare systems to heart failure. The report addresses clinician and system approaches, detailing the practices, products, and services in use and under development. Products addressed include monitoring, medicines/drugs and devices. The report provides a detailed review of heart failure programs in place through disease management companies, and hospital, home care and outpatient programs. The report details the status of research toward improving heart failure programs. The report details the market outlook for products in heart failure management encompassing diagnostics, monitoring products, drugs/medicines and devices. Details of the report are available at http://www.mediligence.com/rpt-c301.htm.

MedMarket Diligence provides tactical decision-making solutions on medical technology to the medical products and investment industries.  The company publishes the “MedMarkets” newsletter, a monthly analysis of the market implications of new medical technology and dedicated reports on technology markets.  For more information on MedMarket Diligence, LLC, contact Patrick Driscoll at (949) 859-3401, e-mail, or visit http://www.mediligence.com.