| Conference
Call Scheduled for June 24, 2005 at 11:00 A.M. EASTERN
Danvers, Mass., June 23, 2005—ABIOMED,
Inc. (NASDAQ: ABMD) announced that after several rounds of voting,
the Circulatory System Devices Panel of the FDA today requested
additional information on ABIOMED's AbioCor® total artificial
heart. The submission of the AbioCor to the U.S. Food and Drug Administration
(FDA) under the Humanitarian Device Exemption (HDE), along with
the transcript and proceedings, will be further reviewed by the
FDA. ABIOMED is committed to working with the FDA to submit additional
data regarding patients' anti-coagulation and quality of life information.
FDA approval of the AbioCor would provide patients who have serious
heart failure and who have no other alternative, the option for
the first completely self-contained artificial heart.
Panel proceedings included a vote against a ";non-approvable" recommendation.
The panel then voted seven to six, with one abstention, that the
submission did not meet HDE requirements.
";While we are disappointed in the Panel's recommendation, there
is more work to be done to clarify our submission and HDE requirements.
The Company today is stronger than it has ever been, with 48 percent
growth last year, 110 patents or patents pending, and $44 million
in cash," said Michael R. Minogue, ABIOMED's Chairman, Chief Executive
Officer and President.
ABIOMED initially submitted the AbioCor for marketing approval
under HDE to the FDA in September 2004. Approval under an HDE would
make the AbioCor commercially available to treat a defined subset
of not more than 4,000 irreversible end-stage heart failure patients.
The AbioCor is designed to sustain the body's circulatory system
and to extend the lives of patients who would otherwise die of heart
failure. Its unique design allows it to be totally implanted within
the body. Unlike the artificial hearts of the past, patients are
not tethered to a large, air-pumping console nor do they have wires
or tubes piercing their skin. The AbioCor 2 is currently being implanted
in animal studies and has the potential to last longer, with a 35
percent reduction in size.
CONFERENCE CALL
A conference call to discuss the panel meeting and vote will occur
at 11:00am Eastern Time on Friday, June 24, 2005. A live webcast
of the conference will be available on ABIOMED's website at www.abiomed.com.
The call may also be accessed by dialing (800) 500-3170 (within
the U.S. and Canada) or (719) 457-2733 (outside the U.S. and Canada).
The conference ID/confirmation code is 4880535. A replay of the
conference call will be available from 2:00pm on Friday, June 24,
2005 through midnight on July 22nd by dialing (888) 203-1112 (within
the U.S. and Canada) or (719) 457-0820 (outside the U.S. and Canada).
The replay conference passcode is 4880535.
ABOUT ABIOMED
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 currently manufactures and sells the AB5000™
Circulatory Support System and the BVS® 5000 Biventricular Support
System for the temporary support of all patients with failing but
potentially recoverable hearts. The Company’s AbioCor®
Implantable Replacement Heart is the subject of an initial clinical
trial being conducted under an Investigational Device Exemption
from the United States Food and Drug Administration. The AbioCor
has not been approved for commercial distribution, and is not available
for use or sale outside of the initial clinical trial. For additional
information please visit: www.abiomed.com.
Contacts:
Liza Heapes
ABIOMED, INC.
Communications Specialist
(978) 646-1668
mediarelations@abiomed.com
Investor Relations Contact:
RX Communications Group
Pat Garrison/Tony Ho Loke (Media Inquiries)
917-322-2567/917-322-2164
Melody Carey/Paula Schwartz (Investor Inquiries)
917-322-2571/917-322-2216
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.
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