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ABIOMED Strengthens Management Team with Appointments in R&D, Manufacturing, and Clinical and Regulatory Affairs.


Business Editors and Health/Medical Writers

DANVERS, Mass.--(BW HealthWire)--April 24, 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
) today announced three key management appointments. Fred Zarinetchi, Ph.D. has been promoted to Vice President for Research and Development, Karen A. Heffernan has been named Director of Manufacturing Operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations. , and Zvi Ladin, Ph.D. has joined the Company as Vice President for Clinical, Regulatory Affairs and Quality Assurance.

Dr. Fred Zarinetchi is an eight-year veteran of ABIOMED, with an extensive background in medical device development. Dr. Zarinetchi has been an integral contributor to the development of the AbioCor(TM) Implantable Replacement Heart, and has since August of last year directed the development of ABIOMED's smaller replacement heart based upon technology acquired in 2000 from The Pennsylvania State University Pennsylvania State University, main campus at University Park, State College; land-grant and state supported; coeducational; chartered 1855, opened 1859 as Farmers' High School. . Dr. Zarinetchi received his Doctorate in Electrical Engineering and Computer Sciences from the Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business,  (MIT MIT - Massachusetts Institute of Technology ), and conducted his post-doctoral work at Harvard University. He will continue to direct development of the smaller replacement heart, and will assume overall responsibility for leading and managing ABIOMED's research and development efforts. Those efforts will focus on technologies with potential commercial applications in cardiovascular medicine.

Karen A. Heffernan's new appointment follows a highly productive three-year assignment in Quality Control and Quality Assurance management at ABIOMED. Prior to joining ABIOMED, Ms. Heffernan worked with Medtronic AVE (formerly C.R. Bard, Inc.) for twenty years TWENTY YEARS. The lapse of twenty years raises a presumption of certain facts, and after such a time, the party against whom the presumption has been raised, will be required to prove a negative to establish his rights.
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, holding successively more responsible positions in Manufacturing, Quality and Regulatory functions. As Director of Manufacturing Operations, Ms. Heffernan currently oversees all manufacturing for ABIOMED's 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) 5000 product line and will increasingly contribute to the manufacturing scale-up of the AbioCor product as that system moves from clinical trials into future commercial distribution.

Dr. Zvi Ladin joins ABIOMED from ESC See escape character and escape key. See also ESC/P.

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 Medical Systems, where he was Corporate Vice President for Clinical and Regulatory Affairs. Prior to his six years at ESC, Dr. Ladin was a member of the faculty of Boston University's Department of Biomedical Engineering Biomedical engineering

An interdisciplinary field in which the principles, laws, and techniques of engineering, physics, chemistry, and other physical sciences are applied to facilitate progress in medicine, biology, and other life sciences.
. Concurrent with his teaching, Zvi received a federal appointment as a Science Advisor for the 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.
. Dr. Ladin holds a Doctorate in Medical Engineering from the joint Health Sciences and Technology Program of Harvard Medical School/MIT. He will have full responsibility for ABIOMED's clinical and regulatory affairs and quality assurance functions, including management of clinical trials.

"I'm extraordinarily pleased to announce these appointments," said Dr. David M. Lederman, President and Chief Executive Officer. "It is particularly gratifying grat·i·fy  
tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies
1. To please or satisfy: His achievement gratified his father. See Synonyms at please.

2.
 to be able to fill key positions by promotion from within. The promotions of Karen Heffernan and Fred Zarinetchi recognize the very significant past contributions both have made to ABIOMED, and position them to exercise greater responsibility and to more fully utilize their full range of talents and capabilities. The opportunities afforded them have been well-earned and we look forward to even greater future contributions."

"We are extremely pleased that Dr. Zvi Ladin has agreed to join ABIOMED," Dr. Lederman continued. "He brings leadership and organizational strengths to areas that are critical to our future success, and will help to sharpen our focus and strategic capabilities in those areas. In addition to adding to the strength of our management team, Dr. Ladin's appointment will allow Senior Vice President and Chief Scientific Officer Robert T.V. Kung to devote more of his time and energy to long-range advanced technology initiatives. Dr. Kung will also continue his invaluable work as a senior scientific resource across all of ABIOMED's technical programs, and especially in support of the initial AbioCor clinical trial to provide continuity through its successful completion."

Based in Danvers, Massachusetts, 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, including statements regarding future commercialization of 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.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 24, 2002
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