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®, iPulseTM and AB5000® 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® 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 iPulseTM 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®5000 and AB5000® 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.
Contacts:
Daniel J. Sutherby, 978-646-1812
Chief Financial
Officer
ir@abiomed.com
or
Brodeur,
for Abiomed
Heather Nevers, 617-587-2814
Media Relations
hnevers@brodeur.com
