ABIOMED Investor Conference Call Provides Clinical Trial Update.Business Editors & Health/Medical Writers DANVERS Danvers, town (1990 pop. 24,174), Essex co., NE Mass.; settled in the 1630s, set off from Salem 1752, inc. as a town 1757. Danvers has light manufacturing, including electronic equipment, chemicals, machinery, and apparel. , Mass.--(BUSINESS WIRE)--Oct. 16, 2002 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 ) in a conference call with investors yesterday, provided an update on the status of its ongoing clinical trial of the AbioCor(TM) Implantable Replacement Heart, the world's first replacement heart designed to allow patients to leave the hospital and lead a reasonably good quality of life. A complete replay of yesterday's conference call can be heard via ABIOMED's website at www.abiomed.com. The Company highlighted the following points: -- The trial is ongoing and in good regulatory standing; -- There are no known technical impediments to implantation; -- The AbioCor has performed exceptionally -- the AbioCor has fully supported patients for an aggregate of 2.8 years without any mechanical malfunction; -- Positives clearly outweigh negatives with regard to the overall clinical trial experience; -- The overall complication rate to date is very encouraging and ABIOMED believes that what has been learned from the early patients in this trial will improve performance moving forward. Significantly, there have been no mechanical malfunctions and no device-related infections, and the rate of severe strokes is comparable on average to devices currently in clinical use; -- Increasing efforts are being made to enroll additional patients into the clinical trial. For ethical reasons, the Company's approach has been, and remains, to gain experience with the sickest of patients, while increasingly targeting patients with fewer non-cardiac complications; -- We are excited, extremely eager to proceed and remain very optimistic about the success of the clinical trial. ABIOMED has also indicated that the Company will be presenting at the Salomon Smith Barney Smith Barney is a division of Citigroup Global Capital Markets Inc., a global, full-service financial firm, that provides brokerage, investment banking and asset management services to corporations, governments and individuals around the world. Healthcare Conference on October 28, 2002. 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 im·plant v. im·plant·ed, im·plant·ing, im·plants v.tr. 1. To set in firmly, as into the ground: implant fence posts. 2. 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) , the most widely used heart assist device for the temporary support of patients with failing but potentially recoverable hearts. This Release contains references to clinical trials for the AbioCor. Clinical trials are subject to significant risks. ABIOMED's actual results may differ materially from those anticipated for the clinical trials 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. Investors are encouraged to consider these risks and cautioned not to place undue reliance on any 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. regarding these clinical trials. |
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