ROSHOLT INTERNATIONAL
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AbioMed, Inc.



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AbioCor
Implantable Replacement Heart

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AbioMed

Fundamentals

AbioMed is engaged in the research, development, manufacture and sale of sophisticated products for people with varying degrees of life-impairing or life-threatening heart failure. They believe that a significant number of people can benefit from our cardiac assist and heart replacement technologies.

Cardiac Assistance: Bridge-to-Recovery

AbioMed's BVS 5000, cardiac support system, provides a patient's failing heart with full circulatory assistance while allowing the heart to rest, heal and recover its function. The BVS 5000 has been approved by the U. S. Food and Drug Administration (FDA) as a bridge-to-recovery device for the treatment of all patients with potentially reversible heart failure. It is now the most widely used advanced cardiac assist system in the world. It is installed in hundreds of leading medical centers worldwide. The BVS 5000 is most frequently used with patients whose hearts do not immediately recover their function following heart surgery.

Heart Replacement

They are currently developing the AbioCor Implantable Replacement Heart, a totally implantable, battery-powered heart replacement device intended for patients with irreparably damaged hearts who are at risk of death due to acute myocardial infarction, chronic ischemic disease or some form of end-stage congestive heart failure, but whose vital organs otherwise remain viable. The AbioCor is in an advanced stage of development and they are devoting significant resources to help ensure that the AbioCor is the first replacement heart to reach the market.

Marketing and Sales

AbioMed sells and supports the BVS 5000 in the United States through direct sales and clinical support teams. Their field teams are responsible for sales to new customers, supporting usage by existing customers, and training in order to improve clinical outcomes. They are currently shifting from an indirect sales and support organization outside the United States to a mix of direct and indirect teams. The majority of the Company's product revenues are derived from reorders by existing customers.

Markets

With more than 700,000 cardiac deaths per year, heart disease is the leading cause of death in the U.S. and one of the leading chronic conditions affecting the U.S. population.

AbioMed is a pioneer in the use of mechanical cardiac intervention for patients whose needs have exceeded the limits of pharmaceutical therapies, cardiological intervention and surgical correction. Mechanical cardiac assist involves the use of devices for those patients whose natural hearts are unable to maintain the normal circulation and sustain life without cardiac assistance.

Mechanical cardiac assist can be divided into three groups of devices, each addressing important segments of the heart failure market: 1) temporary cardiac assist; 2) permanent cardiac assist; and, 3) heart replacement. ABIOMED is working on devices for each of these three groups. For example, thousands of patients with potentially recoverable hearts die each year in the U.S. following heart surgery despite inotropic support and intra-aortic balloon pumps. With their BVS 5000 temporary cardiac assist system, they are confident many of these patients can be saved.

Examples of even larger patient populations in need of cardiac assist or heart replacement include people who die in the U.S. due to heart attacks and end-stage congestive heart failure. ABIOMED is working to address these patients' needs with the AbioCor Implantable Replacement Heart and believes that over 100,000 of these patients might eventually benefit from a replacement heart every year.


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