Exhibit 99.1
Abiomed Receives FDA Approval of The
AbioCor(R), the World's First Completely Self-Contained, Implantable
Artificial Heart; AbioCor Granted Humanitarian Device Exemption
DANVERS, Mass.--(BUSINESS WIRE)--Sept. 5, 2006--
-- Conference Call Scheduled for September 5, 2006 at 3 PM Eastern
Abiomed, Inc. (NASDAQ: ABMD) announced today it has received
Humanitarian Device Exemption (HDE) approval from the U.S. Food and
Drug Administration (FDA) for its AbioCor(R) Implantable Replacement
Heart (AbioCor). This landmark approval will provide patients
suffering from heart failure on both sides of their heart
(bi-ventricular) and who have no other alternative, a viable option
for extending the quality of their 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.
According to the American Heart Association's 2006 Statistics,
each year 57,000 patients in the United States die from chronic heart
failure. While roughly 2,200 donor hearts are transplanted into
patients suffering from heart failure, there are many more patients
awaiting a second chance at life, for whom a heart transplant is not
an option. Patients with advanced age, organ failure or cancer are, in
most circumstances, ineligible for a heart transplant and are
potential candidates to receive the AbioCor implantable heart. The
Humanitarian Device Exemption (HDE) approval of the AbioCor signifies
that no comparable alternative therapy exists for patients facing
imminent death without the technology, and that it has proven to be
safe and have probable benefit for patients.
"FDA approval of the AbioCor provides new hope for heart failure
patients who cannot recover their natural heart or receive a
transplant. Abiomed has been a leader in recovering patients' hearts
following an acute event and with this approval, we have expanded our
product portfolio to treat patients with chronic heart failure as
well," said Michael R. Minogue, Chairman, CEO and President of
Abiomed. "We are pleased with this landmark decision and extremely
proud of the extensive efforts of our employees, scientists, numerous
healthcare professionals, FDA staff and individuals and families who
have been actively involved in the clinical study of the AbioCor to
advance the future of medical technology."
"This is a momentous day for Abiomed and for all the key
contributors to the development and advancement of the AbioCor. In
1964, the National Heart Institute (NHI), now the National Heart, Lung
and Blood Institute (NHLBI), created its Artificial Heart Program to
reduce death and disability from heart disease through the development
of reliable cardiac assist and total replacement heart systems. Today
marks the realization of that mission, which Abiomed has worked
towards since the company's founding in 1981," said Robert T.V. Kung,
Ph.D., Chief Scientific Officer and Senior Vice President of Abiomed.
Dr. Kung led the evolution of the Abiocor technology over the past 25
years.
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
circulatory system 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. A post-market study is
planned to allow Abiomed to monitor and optimize the introduction of
the AbioCor into clinical use.
The FDA decision was completed after extensive review of the
clinical testing, beginning with clinical trials starting in 2001
under an Investigational Device Exemption (IDE). The AbioCor would be
available under an HDE to a limited patient population in the United
States under this approval, with no more than 4,000 patients receiving
the technology each year. In order to ensure the highest standards of
patient care, Abiomed intends to make the AbioCor available through a
controlled roll-out at approximately five to ten heart hospitals in
the United States, including qualified clinical trial sites and
additional qualified centers once they have completed a comprehensive
and rigorous training program which may take six to eight months.
Under HDE approval, the FDA may request a panel review of the
post-approval study data. In addition, Abiomed is working with the
Centers for Medicare and Medicaid Services (CMS) and private insurers
to establish reimbursement policies for the AbioCor.
Jewish Hospital in Louisville, KY, an AbioCor clinical trial site,
will be among the first U.S. hospitals to offer patients the AbioCor.
The Jewish Hospital/University of Louisville team, led by surgeons
Laman Gray, M.D., and Rob Dowling, M.D., performed the first and
second AbioCor implantable replacement heart procedures in the world
and a total of seven implants since 2001. Two other hospitals are
entering into a letter of intent. They are: The Johns Hopkins Hospital
in Baltimore, MD, with Dr. John Conte, and Robert Wood Johnson
University Hospital in New Brunswick, NJ, with Dr. Mark Anderson.
"The AbioCor has the potential to fill a very real void. Patients
in bi-ventricular heart failure who were not candidates for a heart
transplant often do not have adequate support with drug therapy or
even other destination-therapy ventricular assist devices that are
designed to boost only one side of the heart. Now we can continue to
treat these severely ill heart failure patients," said Dr. Laman Gray,
Jr., Professor of Surgery and Director of the Division of Thoracic and
Cardiovascular Surgery at the University of Louisville School of
Medicine.
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
the AbioCor.
CONFERENCE CALL
A conference call to discuss the HDE approval of the AbioCor will
occur at 3 PM Eastern Time on September 5, 2006. The conference call
may be accessed by dialing 800-811-0667 (if dialing from within the
U.S.) or 913-981-5581 (if dialing from outside the U.S.). Please
reference Abiomed. A replay of the conference call will be available 3
hours after the completion of the conference call by dialing
888-203-1112 (if dialing from within the U.S.) or 719-457-0820 (if
dialing outside the U.S.). The replay conference ID access code is
5939154.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading
developer, manufacturer and marketer of medical products designed to
assist or replace the pumping function of the failing heart. Abiomed
currently manufactures and sells the AB5000(TM) Circulatory Support
System and the BVS(R) 5000 Biventricular Support System for the
temporary support of all patients with failing but potentially
recoverable hearts. In Europe, Abiomed offers the IMPELLA(R)
RECOVER(R) minimally invasive cardiovascular support systems under CE
Mark approval. The IMPELLA(R) 5.0 and 2.5 are investigational devices
limited by Federal Law solely to investigational use in the United
States. Other IMPELLA devices are not yet available for sale in the
United States. The Company's AbioCor(R) Implantable Replacement Heart
is now available under a Humanitarian Device Exemption granted by the
United States Food and Drug Administration. For additional information
please visit: www.abiomed.com.
FORWARD-LOOKING STATEMENTS
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, including 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 Annual Report filed on Form 10-K. 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 unanticipated events.
CONTACT: Abiomed, Inc.
Daniel J. Sutherby, 978-646-1812
Chief Financial Officer
ir@abiomed.com
or
Abiomed, Inc.
Liza Heapes, 978-646-1668
Media Relations
mediarelations@abiomed.com
or
Brodeur
Elizabeth Dumm, 617-817-7951
AbioCor Media Relations
edumm@brodeur.com