-- Approval Enables Commercial Launch in the United States
-- AbioCor the Only Treatment Option for Bi-Ventricular Heart
Failure Patients Not Eligible for Transplant
DANVERS, Mass.--(BUSINESS WIRE)--Jan. 22, 2008--Abiomed, Inc.
(NASDAQ: ABMD) today announced that it has received U.S. Food and Drug
Administration (FDA) Humanitarian Device Exemption (HDE) supplement
approval on system upgrades for its AbioCor(R) Implantable Replacement
Heart (AbioCor). The AbioCor is intended to replace the severely
damaged native heart for patients who are not eligible for a
transplant and have no other treatment alternative. The AbioCor
sustains the body's circulation and is designed to extend the lives of
patients who would otherwise die of heart failure, while also offering
a probable benefit for a satisfactory quality of life. The AbioCor is
the first completely self-contained artificial heart that may allow
patients more time at home, without wires or tubes piercing through
their skin. This technology provides patients with complete mobility
and remote diagnostics.
"This is a momentous day for Abiomed and advanced heart failure
patients who cannot recover their natural heart or receive a
transplant. We have selected leading U.S. hospitals committed to the
AbioCor program and expect patient implants with AbioCor to commence
in early 2008," said Michael R. Minogue, Chairman, CEO and President
Abiomed has selected four sites to date as AbioCor Centers
including: The Johns Hopkins Hospital in Baltimore, MD; Robert Wood
Johnson University Hospital in New Brunswick, NJ; Texas Heart
Institute at St Luke's Episcopal Hospital in Houston, TX; and St.
Vincent's Hospital in Indianapolis, IN.
HDE approval allows the AbioCor to be made available to a limited
patient population, with no more than 4,000 patients receiving the
technology in the United States each year. Abiomed expects to charge
$250,000 per AbioCor unit in a controlled roll-out at up to five U.S.
ABOUT THE ABIOCOR
The AbioCor(R)Implantable Replacement Heart is one of the most
sophisticated medical devices ever developed and is designed to extend
the lives of patients who would otherwise die of heart failure. The
AbioCor can potentially offer an improved quality of life so that a
patient can be mobile and continue a productive lifestyle. The AbioCor
is the only artificial heart without wires piercing through the skin,
reducing the chance of infection. Its remote diagnostics allow
patients to return home where they can resume normal activities
including bathing. The AbioCor is able to pump blood through the body,
simulating the rhythm of a heartbeat. The complete AbioCor system
consists internally of a thoracic unit, a rechargeable battery, a
miniaturized electronics package, a power receiver coil, and
externally, a power transmitter coil, power and battery pack, handheld
alarm monitor and sophisticated computer console.
Abiomed continues to develop next-generation total artificial
heart technology, the AbioCor II, in order to provide life-saving
circulatory support to more patients in bi-ventricular heart failure.
Currently in preclinical evaluation, this technology has the potential
to last up to five years and is approximately 30 percent smaller than
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading
provider of medical devices that provide circulatory support to acute
heart failure patients across the continuum of care in heart recovery.
Our products are designed to enable the heart to rest, heal and
recover by improving blood flow and/or performing the pumping of the
heart. For additional information please visit: www.abiomed.com.
This Release contains forward-looking statements, including
statements regarding development of Abiomed's existing and new
products, the Company's progress toward commercial growth, and future
opportunities. The Company's actual results may differ materially from
those anticipated in these forward-looking statements based upon a
number of factors, uncertainties associated with development, testing
and related regulatory approvals, anticipated future losses, complex
manufacturing, high quality requirements, dependence on limited
sources of supply, competition, technological change, government
regulation, future capital needs and uncertainty of additional
financing, and other risks and challenges detailed in the Company's
filings with the Securities and Exchange Commission, including the
risk factors contained in the Company's Annual Report filed on Form
10-K and recently filed Form 10-Q. Readers are cautioned not to place
undue reliance on any forward-looking statements, which speak only as
of the date of this Release. The Company undertakes no obligation to
publicly release the results of any revisions to these forward-looking
statements that may be made to reflect events or circumstances that
occur after the date of this Release or to reflect the occurrence of
CONTACT: Abiomed, Inc.
Daniel J. Sutherby, 978-777-5410
Chief Financial Officer
For Abiomed, Inc.
Heather Nevers, 617-587-2814