Thursday, January 27, 2005

Abiomed


This is not an offer to buy or sell. This in not a solicitation of business. The following is for informational purposes only. I own the stock.

COMPANY DESCRIPTION

Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced "AB'-EE-O-MED") is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. ABIOMED, which currently sells the BVS(R) 5000 Biventricular Support System and the AB5000(TM) Circulatory Support System, is the market leader in devices for the temporary support of patients with failing but potentially recoverable hearts. In September 2004, ABIOMED applied for initial FDA market approval for the AbioCor(R) Implantable Replacement Heart to treat a defined subset of irreversible end-stage heart failure patients under a Humanitarian Device Exemption.

The company has two very interesting products.

AB5000(TM) Circulatory Support System

ABIOMED, Inc. (Nasdaq: ABMD) a manufacturer of products for circulatory care and support, today provided a clinical update for the AB5000 Circulatory Support System. Formally launched in April 2004, outcomes have continued to improve as the system has gone into wider use. ABIOMED's ventricular assist devices, the AB5000 and the BVS(R) 5000, are the only devices approved for Bridge-to- Recovery treatment following AMI-cardiogenic shock (shock following a heart attack). The systems are also used to support the heart and allow for potential recovery following other acute events including post cardiotomy cardiogenic shock (shock following coronary bypass surgery), and viral myocarditis, a virus that attacks the heart.

Key facts on AB5000 usage and outcomes, based on ABIOMED's voluntary data registry:

* More than seventy percent of survivors have been able to go home with their own hearts. In addition, recovery of kidney function has allowed some heart patients to avoid planned kidney transplants.

* One in four patients have been transitioned from the BVS 5000 to the AB5000. This transition took place without re-opening the chest,
avoiding bleeding and other risks associated with additional surgery to change out to other devices.

* Mean duration of support on the AB5000 is three times longer than on the BVS5000, with many patients requiring support beyond 30 or 60 days and some beyond 90 days. In bench testing, the AB5000 Ventricle has operated nearly a year and is continuing.

* While patients are implanted with the AB5000 with the goal of recovering the heart, there have been some instances in which, after giving a patient's heart a full opportunity to recover, doctors have determined that recovery will not occur. Nearly thirty percent of survivors have received heart transplants after it was determined that native heart function would not return; their average duration of support on the AB5000 was nearly 40 days.

* 20 percent of all AB5000 patients were supported following AMI-
Cardiogenic shock.

* 47 percent of all AB5000 patients required support on both sides of the heart.

* Nineteen patients have ambulated while on AB5000 support, walking
hospital grounds as well as using treadmills and stationary bicycles.

The AbioCor

The AbioCor is the world’s first completely self-contained replacement heart. A product of three decades of research, development and testing, the AbioCor is central to ABIOMED’s mission to make real the day when heart failure need not mean the end of life or the ability to enjoy life. Designed to fully sustain the body's circulatory system, the AbioCor is intended for end-stage heart failure patients whose other treatment options have been exhausted.

In 2001, ABIOMED made history when Mr. Robert Tools, a 58-year-old telephone company employee and teacher suffering from end stage heart failure was successfully implanted with the first AbioCor. The initial clinical trial is continuing with the aim of gaining approval to market the AbioCor to support patients with irreversible end-stage heart failure. The company also recently submitted to the FDA for commercial approval for the AbioCor under a Humanitarian Device Exemption.

ABIOMED is also working on the next generation implantable replacement heart, the AbioCor II. Incorporating technology both from ABIOMED and Penn State, the AbioCor II is smaller and is being designed with a goal of five year reliability.

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