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First Two AbioCor Patients Continue to Recover.


Business/Technology Editors & Health/Medical Writers

DANVERS, Mass.--(BW HealthWire)--Sept. 19, 2001

ABIOMED, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ABMD ABMD areal bone mineral density
ABMD AEGIS Ballistic Missile Defense (US Navy)
ABMD Advanced Ballistic Missile Defense
) alerts investors that Jewish Hospital Jewish Hospital can refer to:
  • Barnes-Jewish Hospital, St. Louis, Missouri
  • Jewish Hospital, Cincinnati, Ohio http://www.jewishhospitalcincinnati.com/
  • Long Island Jewish Hospital, Long Island, New York
  • Jewish Hospital, Louisville, Kentucky http://www.jhhs.org/
 and the University of Louisville See also
  • The University of Louisville Cardinal Singers
  • The University of Louisville Collegiate Chorale
  • History of Louisville, Kentucky
  • McConnell Center
References

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 today announced an update on the status of the first two patients to receive ABIOMED's AbioCor Implantable Replacement Heart. In that announcement, the medical team reported that that they remain encouraged by the continuing progress shown by both patients, Mr. Robert Tools Robert L. Tools (July 31 1942 - November 30 2001), was the world's first recipient of a fully self-contained artificial heart called AbioCor. The operation took place on July 2, 2001. He survived for 151 days without a living heart. Dr.  and Mr. Tom Christerson.

Consistent with previously announced ABIOMED policy for the AbioCor initial clinical trial, additional information about the patients will be made available when the clinical team deems it to be clinically significant or a patient's family deems it to be appropriate.

Concurrent with this alert, ABIOMED stated that it expects, consistent with its plan that at least five patients will be implanted with the AbioCor before the end of 2001. In addition, ABIOMED management reiterated to investors that it has over $80 million in cash and short-term investments which, together with the Company's other resources, are deemed to be sufficient to meet the needs of the Company's operations for the foreseeable future.

Based in Danvers, Massachusetts Danvers is a town in Essex County, Massachusetts, United States. Located on the Danvers River near the northeastern coast of Massachusetts, Danvers is most widely known for its association with the 1692 Salem witch trials. , 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. The Company's AbioCor Implantable Replacement Heart is being implanted in patients as part of an initial clinical trial conducted under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  from the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
. The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. ABIOMED currently manufactures and sells the BVS BVS Biblioteca Virtual em Saúde (Brazil)
BVS Bureau of Vital Statistics
BVS Brethren Volunteer Service (Church of the Brethren)
BVS Boston Vegetarian Society (Cambridge, MA) 
, a heart assist device for the temporary support of all patients with failing but potentially recoverable hearts.

This Release contains forward-looking statements, including statements regarding the anticipated timing and results of clinical trials for the AbioCor and adequacy of financial resources. ABIOMED'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 detailed in the Company's filings with the Securities and Exchange Commission. 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.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 19, 2001
Words:451
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