ABIOMED Informs Investors of Media Seminar on AbioCor Clinical Trial; Remains on Track for First Implant Prior to June 30, 2001.Business/Technology Editors DANVERS, Mass.--(BUSINESS WIRE)--April 12, 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 it has scheduled a Media Seminar on the upcoming initial clinical trial of the AbioCor Implantable Replacement Heart. The Seminar, scheduled for the National Press Club in Washington, D.C. on Wednesday, April 18 from 8:30 - 10:30 am, is intended to provide general information concerning ABIOMED, the AbioCor Implantable Replacement Heart, the design of the AbioCor clinical trial and the need for this important technology. This Media Seminar is part of an ongoing program by ABIOMED to ensure that its efforts to introduce the world's first implantable replacement heart are accurately understood and that expectations for such trials are realistic. The April 18 Seminar was scheduled independently of any AbioCor clinical trial implant. ABIOMED announced 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. approval of the 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 (IDE (1) (Integrated Development Environment) A set of programs run from a single user interface. For example, programming languages often include a text editor, compiler and debugger, which are all activated and function from a common menu. ) for the AbioCor clinical trial in January 2001, and has said that the first trial implant will occur in the first half of the year (prior to June 30, 2001). The company remains committed to that schedule and preparations for the trial are continuing according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. plan. Due to space limitations, attendance at the April 18 Seminar is by invitation only. The event will be simultaneously webcast for interested parties unable to attend. The webcast may be accessed through http://www.ConnectLive.com/events/abiomed, and will remain available online for at least 30 days. ABIOMED shareholders or potential investors are welcome to listen to the Seminar webcast. Investors are cautioned that this announcement 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. regarding the timing of AbioCor initial clinical trials and that the Seminar will likely contain forward-looking statements regarding the potential timing, design and outcome of the AbioCor initial clinical trials. All such statements involve risks and uncertainties, and the Company's actual results may differ materially based on a number of factors. Many of the factors and risks that could affect the Company's performance with respect to such forward-looking statements are described in the Company's Forms 10-K and 10-Q as filed with the Securities and Exchange Commission. Investors are recommended to familiarize themselves with such factors and risks and are cautioned not to place undue reliance on any forward-looking statement as all such statements speak only of the date of this announcement or the date of the Seminar, respectively. The Company undertakes no obligation to publicly release any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date of such statements. 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 in an advanced stage of development and has received approval to begin initial human trials. 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 temporary heart assist device, for the support of all patients with failing but potentially recoverable hearts. |
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