FDA Advisory Panel Voted ABIOMED's AbioCor(R) Submission Did Not
Yet Meet HDE Standards; Additional Data is Requested
Conference Call Scheduled for June 24, 2005 at 11:00 A.M. EASTERN
DANVERS, Mass., June 23 /PRNewswire-FirstCall/ -- 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(R)
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 http://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(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. The Company's AbioCor(R)
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:
http://www.abiomed.com/.
Contacts:
Liza Heapes
ABIOMED, INC. Communications Specialist
(978) 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. DATASOURCE: ABIOMED, Inc.
CONTACT: Liza Heapes, Communications Specialist of ABIOMED, Inc., +1-978-646-1668, ; or Media, Pat Garrison, +1-917-322-2567, or Tony Ho Loke, +1-917-322-2164, both of RX Communications Group for ABIOMED, Inc.; or Investors, Melody Carey, +1-917-322-2571, or Paula Schwartz +1-917-322-2216, both for ABIOMED, Inc.
Web site: http://www.abiomed.com/
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