ABIOMED Announces Organizational Changes.Business Editors & Health/Medical Writers DANVERS, Mass.--(BUSINESS WIRE)--Jan. 14, 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 announced implementation of organizational changes consistent with the Company's need to achieve its short and long term goals. The actions follow a yearlong year·long adj. Lasting one year. Adj. 1. yearlong - lasting through a year; "attending yearlong courses" long - primarily temporal sense; being or indicating a relatively great or greater than average duration or comprehensive review of the Company's organizational structure To comply with Wikipedia's lead section guidelines, one should be written. , business processes, and staff resources. The Company also said that as a result of the organizational realignment re·a·lign tr.v. re·a·ligned, re·a·lign·ing, re·a·ligns 1. To put back into proper order or alignment. 2. To make new groupings of or working arrangements between. , effective January 14, 2003, it has reduced its current staff by 21 positions. At the same time, ABIOMED expects new recruitment efforts in certain functional areas where different skills are needed to meet the strategic focus of the Company. Key elements of ABIOMED's changes include: -- Outsourcing of all, but pilot-scale, manufacturing of electronics components for all product lines, in order to increase scale-up capabilities and reduce costs; -- Centralization of proprietary plastics manufacturing, retained in-house, within a single integrated group, which serves all product lines; -- Restructuring of the Design Assurance, Quality Assurance, Materials Management, and Engineering departments; and -- Improvements of internal systems for budgeting, project management, and financial performance metrics. "With regard to staff reductions associated with these changes, our decision has not been made lightly," said Dr. David M. Lederman, ABIOMED's Chief Executive Officer. "ABIOMED has made every effort to provide assistance to all affected individuals." He continued, "these actions prepare us for the next stage of ABIOMED's business growth. The challenges ahead are changing, and our resource requirements The components of a system that are required by software or hardware. It refers to resources that have finite limits such as memory and disk. In a PC, it may also refer to the resources required to install a new peripheral device, namely IRQs, DMA channels, I/O addresses and memory are evolving. Our management and staff are now increasingly deployed to achieve our principal goals, which include: clinical and commercial introduction of the AbioCor(R) Implantable Replacement Heart; development and commercial introduction of substantive add-ons to our 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) product line; and development of our next generation, smaller replacement heart, to fit a larger proportion of the population. We believe that these initiatives put us firmly on a path, during 2003 and 2004, toward business growth and profitability." 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, 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 achievement of strategic and operational goals, including but not limited to introduction of add-ons to the BVS product line, the development of a next generation replacement heart and the success of the AbioCor program. 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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