Abiomed Announces Update on European Growth Strategy
Abiomed, Inc. (NASDAQ: ABMD) today announced an update on its
European strategy to drive growth by establishing recovery as the goal
for patients experiencing acute cardiac events.
There are over 200,000 deaths annually in Germany, France, UK,
Spain, Italy and Russia from acute myocardial infarction (AMI).(1)
Abiomed´s portfolio of circulatory care products including Impella(R),
iPulse(TM) and AB5000(R) are approved in 27 European Union (EU)
countries through CE-Mark approval, and Impella is now approved in
over 40 countries outside the United States. Abiomed announced that it
has continued to invest in its sales, clinical, marketing and field
service teams in Europe, now totaling over 30 individuals, to promote
recovery for acute heart failure patients and increase revenue growth.
Revenue in Europe for the first two quarters of Abiomed´s fiscal year
2008 represented the highest six months revenue total for the region
in Abiomed´s history. The Impella technology has been the subject of
more than 40 publications.
"We are pleased with our European revenue growth and progress in
major initiatives such as expansion of distribution resources and
company offices into major EU markets, improved reimbursement for
hospitals, positive clinical studies, and continued investment in our
German manufacturing capabilities to prepare for future growth in the
U.S.," said Michael R. Minogue, Chairman, CEO and President of
Abiomed.
France & UK Subsidiaries; Positive Patient Experience
"We are increasing our distribution network to drive continued
penetration and growth in the European markets," commented Paul Krell,
Vice President and General Manager, Abiomed Europe Operations. "The
favorable patient experiences and positive clinical data are fueling
European interest in the Impella and iPulse platforms, and we are
pleased that reimbursement is now established in Germany and Italy."
Abiomed´s European headquarters is located in Aachen, Germany, and
all Impella products are manufactured at this facility. Abiomed has
formed subsidiaries and has appointed experienced country managers in
France and the UK. The Company announced that over 50 patients have
already been treated in France with Abiomed technologies since the
opening of its office there.
The Company opened its office in the UK in November 2007 and
announced today that the first Impella 2.5 patient was recently
treated. "The Impella 2.5 provided effective support during a
high-risk PCI procedure for the patient who had low ejection
fraction," said Dr. Farzin Fath-Ordoubadi of the Manchester Royal
Infirmary. "The clinical outcome was favorable and we believe that
Impella improved the safety of this procedure."
Abiomed´s Impella technologies are now at EU centers in Austria,
Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Italy, Luxembourg, Netherlands, Spain and the United Kingdom.
ABOUT ABIOMED
Based in Danvers, Massachusetts with European Headquarters in
Aachen, Germany, 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.
About Impella
Abiomed´s Impella(R) 2.5 and 5.0 catheters are percutaneous micro
heart pumps with integrated motors and sensors for use in
interventional cardiology and heart surgery. The devices are designed
for use by interventional cardiologists to support pre-shock patients
in the cath lab who may not require as much support as patients in the
surgery suite. Impella catheters are also designed to provide
ventricular support for patients requiring hemodynamic stabilization
or suffering from reduced cardiac output, and can aid in recovering
the hearts of patients following a heart attack. These products
increase flow to the heart and organs without the need for drugs such
as inotropes while reducing the workload of the heart. The Impella
products are currently the subject of clinical trials in the United
States and have not yet been approved for sale by the Food and Drug
Administration.
About iPulse
The iPulse(TM) Circulatory Support System is designed to treat
patients suffering from acute heart failure by offering various levels
of cardiac support, whether minimal, moderate, or full bi-ventricular,
to potentially recover the patient´s native heart. The iPulse
combination console drives Abiomed and other manufacturers
intra-aortic balloons (IAB), Abiomed´s BVS(R)5000 and AB5000(R)
Ventricular Assist Devices (VAD), as well as new products Abiomed may
offer in the future. The iPulse is the first console with the
capability to provide either VAD or IAB support in the catheterization
lab and surgery suite.
About AB5000
The AB5000 Circulatory Support System provides temporary support
of acute heart patients in profound shock, including patients
suffering from cardiogenic shock after a heart attack, post-cardiotomy
cardiogenic shock, or myocarditis. The AB5000 VADs are surgery suite
products and can assume the full pumping function of a patient´s
failing heart, allowing the heart to rest, heal and potentially
recover. AB5000 is designed to provide either univentricular or
biventricular support.
(1) Source: Espicom Ltd., Data Report 2002
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 its most recently filed annual report on Form 10-K and
quarterly report on 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
unanticipated events.