ABIOMED Provides Update on AbioCor Trial Enrollment; Tenth Patient Implanted at Texas Heart Institute; Periodic Announcements to Replace Individual Patient Reports.Business Editors/Health/Medical Writers DANVERS, Mass.--(BUSINESS WIRE)--March 10, 2003 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 ) today provided an update on the status of patient enrollment in the AbioCor(R) Implantable Replacement Heart clinical trial. As of this date, a total of 10 patients have been enrolled in the AbioCor initial clinical trial. Three patients are currently on AbioCor support. These include previously-announced patients (the eighth and ninth enrollees) implanted on January 7, 2003 and January 22, 2003 respectively at Jewish Hospital Jewish Hospital can refer to:
St. in Houston, TX on February 24, 2003. No further information will be made available by ABIOMED at this time. The patients and their families have requested that their confidentiality be maintained, including names, personal information, and any reports of their medical condition. "We are very pleased with the rate of enrollment in the AbioCor clinical trial since the beginning of the calendar year," said Dr. Robert T. V. Kung, ABIOMED's Chief Scientific Officer. "We believe we have recaptured the momentum lost in 2002, and are working diligently to maintain that momentum. We are excited to be moving forward into the final third of the 15 implants authorized by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for the clinical trial of the first generation AbioCor implantable heart." "Going forward," said Dr. Edward E. Berger, Vice President for Strategic Planning Strategic planning is an organization's process of defining its strategy, or direction, and making decisions on allocating its resources to pursue this strategy, including its capital and people. and Policy, "ABIOMED will be providing only monthly updates on the status of the clinical trial in order to keep our investors and the public informed of our progress. These updates will include any significant events that have occurred within the month. It is our goal to eliminate special announcement of individual implants and or patient-specific events -- either positive or negative -- as they occur. We believe that the trial has advanced to a point where monthly updates should be sufficient to keep all interested parties adequately informed of material developments. Furthermore, elimination of the expectation of company announcements on individual patients will be beneficial to the processes of care within the trial, the patients and their families, and the overall management of the trial." ABIOMED will next update the progress of the AbioCor trial in a presentation at the Banc of America Securities Healthcare Conference on March 25, 2003 in Las Vegas Las Vegas (läs vā`gəs), city (1990 pop. 258,295), seat of Clark co., S Nev.; inc. 1911. It is the largest city in Nevada and the center of one of the fastest-growing urban areas in the United States. , Nevada. Information about how investors will be informed about the content of this presentation will be made available prior to the event. 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 the subject 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) (R), a heart assist device for the temporary support of all patients with failing but potentially recoverable hearts. This Release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. , including statements regarding the progress of the clinical trial of the AbioCor and the public release of information about the trial. 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. |
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