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Acorn Cardiovascular Announces Positive Clinical Trial Results at American Heart Association Scientific Sessions.

ST. PAUL, Minn. -- Study Shows CorCap Cardiac Support Device Reverses Heart Failure Progression and Improves Quality of Life

Acorn Cardiovascular(TM) announced that data presented at the Late Breaking Clinical Trials Session of the American Heart Association (AHA) 2004 Scientific Sessions indicates that the company's CorCap(TM) Cardiac Support Device (CSD) reversed heart failure progression and improved patient quality of life. The CorCap CSD is the first medical device specifically designed to address the problem of enlargement of the heart, a major contributing factor to heart failure progression. Results from the Acorn Clinical Trial of the CorCap CSD were presented by principal investigator, Dr. Douglas Mann of the Michael E. DeBakey VA Medical Center and Baylor College of Medicine.

"The CorCap Cardiac Support Device helps an enlarged heart recover a more normal size and shape. As a result, patients feel better and require fewer costly medical interventions to treat their heart failure," commented Dr. Mann. "These clinical trial results should bring hope to thousands of heart failure patients whose lives have been severely affected by this debilitating disease. CorCap CSD therapy could improve outcomes for the many patients who are not helped by drugs alone."

The CorCap CSD is a proprietary mesh wrap that is implanted around the heart to provide gentle support, relieving the stress that is caused by an unhealthy increase in heart size. In comparison with control patients, clinical trial data revealed that patients treated with the CorCap CSD:

--Demonstrated sustained improvements in heart size and shape.

--Showed significant improvements in quality of life using standardized evaluation methods.

--Were 50 percent less likely to require additional cardiac procedures for worsening heart failure such as transplants and implants of ventricular assist or electrical stimulation devices.

Acorn Cardiovascular President and Chief Executive Officer Rich Lunsford stated, "The presentation of promising results from our Acorn Clinical Trial marks the beginning of a new era in heart failure therapy. In the past, patients with enlarged hearts had very few treatment options. The positive trial results bring us one step closer to making a breakthrough therapy widely available to heart failure patients."

The Acorn Clinical Trial is a scientific evaluation comparing treatment with the CorCap CSD versus traditional therapies. The trial involved 300 patients at 29 centers across North America, making it the most extensive controlled evaluation of a surgical treatment for heart failure ever conducted. Patients participating in the Acorn Clinical Trial had symptomatic heart failure with enlargement of the heart and were being treated with optimal drug therapy, including beta-blockers and ACE inhibitors.

About Heart Failure

Heart failure is a progressive and debilitating disease that stems from heart muscle damage, often caused by heart attacks, valvular disorders or uncontrolled high blood pressure. As the heart attempts to supply the body with adequate blood, the stress on the heart builds in a degenerative cycle of muscle damage, often leading to an unhealthy dilation of the heart. An oversized heart cannot efficiently pump blood to meet the body's needs, leading patients to become fatigued and short of breath, even with activities such as climbing stairs or walking short distances.

Up to 50 percent of patients with advanced heart failure die within five years of diagnosis. Heart failure affects more than five million people in the United States and 25 million people worldwide. The alarming growth rate -- an estimated 550,000 new cases are diagnosed each year in the United States alone -- led the U.S. National Heart, Lung and Blood Institute to categorize heart failure as an epidemic.

About Acorn Cardiovascular

Acorn Cardiovascular is a privately held medical device company located in St. Paul, Minn. Incorporated in 1996, Acorn Cardiovascular develops innovative and effective treatments for patients with heart failure. The company's introductory product, the CorCap(TM) Cardiac Support Device (CSD), is intended to improve the heart's structure and function, leading to potential improvements in the quality and duration of a patient's life. For more information about Acorn Cardiovascular and the CorCap CSD, visit www.acorncv.com.

CAUTION: The CorCap CSD is an investigational device. Limited by USA law to investigational use.
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Publication:Business Wire
Date:Nov 8, 2004
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