ABIOMED Provides Information on Plans for U.S. Market Entry With AbioCor and Heart Assist Product Line Enhancements.

Business Editors/Health/Medical Writers

LAS VEGAS--(BUSINESS WIRE)--March 25, 2003

ABIOMED, Inc. (Nasdaq:ABMD) today provided new information on how it seeks to initially enter the U.S. market with its AbioCor(R) Implantable Replacement Heart, and disclosed that it plans to seek stepwise approvals for the introduction of a family of heart assist device product line enhancements and additions.

In a presentation to the Banc of America Securities Healthcare Conference in Las Vegas, Nevada, (Webcast at www.abiomed.com), ABIOMED said that it would seek FDA approval for a Humanitarian Device Exemption (HDE) to allow sale of the AbioCor for use in a clearly defined subset of patients who qualify for heart replacement. An HDE will allow ABIOMED to create an installed base of trained and experienced AbioCor users at some of the country's leading centers of excellence and provide the clinical experience that will be essential to assure long-term maximization of the AbioCor's potential. It will also allow the Company to begin to derive revenues from the current AbioCor while it continues the process of implementing and testing incremental system capabilities in next generation devices designed to address expanding groups of patients. Contingent upon patient experience in the ongoing clinical trial of the first generation AbioCor, and on FDA approval of a qualifying population, ABIOMED anticipates submitting an HDE application to the FDA near the end of the current calendar year, and to be ready for its U.S. launch by mid-2004.

Under U.S. Federal rules, an HDE may be granted for a device which has been shown to be safe, which is applicable to treat a defined patient population of fewer than 4,000 per year, for which no approved alternative devices exist and for which the potential benefits outweigh the risks. While the Company estimates the total addressable U.S. patient population for a replacement heart to exceed this number by a factor of between 10 and 20 times, the first generation AbioCor addresses a small portion of the potential market by virtue of some constraints such as size. ABIOMED expects to address these constraints, and seek expansion beyond the initial approval via sequential IDE/PMA applications for next generation devices, before the addressable market provided under an HDE becomes a practical limitation on AbioCor penetration in the USA.

ABIOMED also disclosed that it plans to expand its product offerings in the heart assist device market. The Company said that it plans to introduce a family of ventricular assist devices, under varying stages of development and testing, to meet patient needs across a broad spectrum of temporary heart assist applications. The first of the new single-use blood pumps, currently under review by the FDA, is intended to improve upon the ease of use, quality of life, and mobility offered for post-cardiotomy and other short-term bridge-to-recovery patients by the current BVS 5000 blood pump. Subject to regulatory approvals, ABIOMED expects to begin selling the system, designated as the AB5000, before the end of the current calendar year. Subsequent additions to the Company's temporary heart assist offerings will follow as the regulatory submissions and approvals permit. The existing BVS blood pumps as well as all of the new product line enhancements and additions are designed to operate with the new AB5000 circulatory assist console, which was determined to be "approvable" by the FDA and announced by the Company on March 10, 2003.

The Company also indicated that, barring a strategic collaboration, it anticipates its current cash resources to be sufficient to execute on its plans to grow revenues and achieve profitability based on its own internally-developed products.

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 the subject of an initial clinical trial conducted under an Investigational Device Exemption from the United States Food and Drug Administration. 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 the anticipated timing and results of clinical trials for the AbioCor, the timing of sequential AbioCor market entries, and the timing of extensions and additions to ABIOMED's heart assist device product offerings. 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.