ABIOMED Updates Implantable Heart Program Status; AbioCor Heart Reaches Important Milestone.Business Editors and Health/Medical Writers DANVERS, Mass.--(BW HealthWire)--Nov. 14, 2000 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 its AbioCor(TM) Implantable Replacement Heart has met an important system durability milestone critical for commencement of human trials, pending regulatory approval. The AbioCor has been undergoing system and component level testing in the Company's test facility to validate its performance and to demonstrate the required durability and reliability. This testing needs to be completed and documented as part of the submission for 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 (IDE). Approval of the IDE is necessary to begin human trials in the U.S. With the achievement of this program milestone, the Company is moving closer to this goal. Commenting on the state of readiness See: defense readiness condition; weapons readiness state. of the AbioCor for initial trials in humans, Dr. Robert T.V. Kung, ABIOMED's Senior Vice President for Research and Chief Scientific Officer, stated: "reaching this reliability program milestone has been on our critical path to clinical trials with the AbioCor. Demonstration of the system durability required for the initial patient population has been the primary program focus over the past several years. To reach this stage, many AbioCor systems have been operated under a range of simulated physiological conditions Noun 1. physiological condition - the condition or state of the body or bodily functions physical condition, physiological state wakefulness - a periodic state during which you are conscious and aware of the world; "consciousness during wakefulness in a sane over extended periods of time. Assuming no unfavorable surprises prior to completion of all the tests, we should complete our IDE submission before the end of 2000." 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 and BeneCor(TM) implantable replacement hearts are in advanced stages of development and the AbioCor is moving into a state of preparedness for 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. This News 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 development, performance and timing to initial human trials of the AbioCor Implantable Replacement Heart. The Company's actual timing and results may differ materially based on a number of factors, including uncertainty of successfully meeting product development milestones and obtaining regulatory approvals for clinical trials, complex manufacturing, unproven unproven Dubious, nonscientific, not proven, quack, questionable, unscientific adjective Relating to that which has not been validated by reproducible experiments or other scientific methods for determining effect or efficacy markets for products under development, dependence on key personnel, competition and technological change, uncertainty in the ability to recruit required personnel on a timely basis, government regulations, dependence on limited sources of supply, dependence on third-party reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. , potential inadequacy of product liability insurance, dependence on patents and proprietary rights and other risks detailed in the Company's filings with the Securities and Exchange Commission. Investors are cautioned that all such statements involve risks and uncertainties. Readers are cautioned not to place undue reliance on these 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 after the date hereof or to reflect the occurrence of unanticipated events. |
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