ABIOMED Expands AbioCor Clinical Trial Sites to Include University Medical Center, Tucson, Arizona.Business Editors and Health/Medical Writers DANVERS, Mass.--(BUSINESS WIRE)--Nov. 7, 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 ) announced today that University Medical Center, Tucson, AZ and ABIOMED, Inc. have reached agreement and have regulatory permission for University Medical Center to participate as a clinical site in the initial U. S. clinical trial for ABIOMED's AbioCor(TM)Implantable Replacement Heart. "The University Medical Center clinical team, led by Drs. Jack G. Copeland and Francisco Arabia, is the most experienced in the world in the clinical management of patients bridged to transplantation by means of temporary artificial hearts," stated ABIOMED CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Dr. David M. Lederman. "We believe that the unique capabilities of the UMC UMC United Methodist Church UMC United Microelectronics Corporation UMC University Medical Center UMC United Microelectronics Corp (Republic of China) UMC University of Missouri-Columbia team will provide an excellent complement to the other leading U.S. medical centers in this initial clinical trial and will further strengthen our joint effort. We look forward to working with them." More than 50 patients have been bridged to transplantation with artificial hearts at UMC. "We are pleased to join the ongoing AbioCor clinical trial," said UMC's Dr. Jack G. Copeland. "The AbioCor technology is an exciting step forward, and the potential benefit for people with end stage heart disease for long-term support with a totally implantable device is great. We have a long road ahead of us, with many things to evaluate and to prove. I am optimistic op·ti·mist n. 1. One who usually expects a favorable outcome. 2. A believer in philosophical optimism. op that this device will ultimately prove to be beneficial and that it has the potential to help fill the gap between the tens of thousands of people who require heart replacement each year and the extremely limited supply of human hearts for transplantation." University Medical Center is a 365-bed teaching hospital associated with the University of Arizona (body, education) University of Arizona - The University was founded in 1885 as a Land Grant institution with a three-fold mission of teaching, research and public service. and the Sarver Heart Center. UMC surgeons have performed more than 600 heart transplants since their first in 1979, and they are among the world's leaders in artificial heart technology. In July, UMC was rated among the top 50 hospitals in the nation for heart care in U.S. News & World Report's annual "Best Hospitals" survey (#25). 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 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 anticipated timing and results of clinical trials for the AbioCor. 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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