ABIOMED Announces Completion of Human Fit Optimization of Its Implantable Replacement Heart.

DANVERS, Mass.--(BUSINESS WIRE)--Oct. 26, 1999--

- Production of clinically configured AbioCor(TM) devices has now

started -

ABIOMED, Inc. (NASDAQ:ABMD) today announced that it has completed its efforts to optimize the human fit of its AbioCor(TM) implantable replacement heart in preparation for its use in initial human trials, subject to regulatory approvals.

"Finalizing the clinical configuration of the AbioCor(TM) heart and starting production of clinically configured devices are both very significant milestones," commented Dr. David M. Lederman, President and CEO of ABIOMED. "These represent two of the six pre-clinical milestones identified at the beginning of the current fiscal year on the path to initial human trials scheduled to begin next year. Additional milestones include successful completion of reliability goals, formal in-vivo studies, training of all the initial centers, and approvals by the appropriate regulatory authorities. Significant progress was made toward each of these milestones in the past fiscal quarter."

Dr. Lederman concluded: "While we have much to do over the next year, we are now clearly heading down the homestretch toward the day when we begin clinical trials of this exciting life-extending technology."

About the AbioCor(TM) implantable replacement heart

Building on more than three decades of research, the AbioCor heart has been developed to fully sustain the body's blood circulation requirements. It is a true replacement heart. Deceptively simple in its concept, the AbioCor heart is one of the most sophisticated implantable medical devices ever developed. It is designed to overcome the limitations of early air-driven replacement hearts and implantable ventricular assist devices (VADs). These devices, currently in the clinic, require cables or tubes piercing the skin increasing the risk of infection. Further, implantable VADs support only one ventricle and cannot help the thousands of patients who need replacement or support to both ventricles. Sealed within the chest cavity, and powered without the need of wires across the intact skin, the AbioCor's titanium and smooth plastic construction and unique design are specifically engineered to reduce the likelihood of damage to blood components. The AbioCor heart is designed to operate quietly and is expected to allow recipients to eventually move about freely and to live productive lives.

Based in Danvers, Massachusetts, ABIOMED, Inc. develops, manufactures and markets innovative cardiovascular products and is a leader in the research and development of advanced devices to assist or replace the failing heart. The Company's BVS-5000(R) is the most widely used FDA-approved cardiac assist device and the only device approved by the FDA for all patients with recoverable failing hearts. The Company's AbioCor implantable replacement heart is in an advanced stage of development and intended to extend the duration and quality of the lives of patients who would otherwise die from acute or chronic heart failure.

This News Release contains forward-looking statements, including statements regarding development, performance characteristics and timing to initial clinical trials of the AbioCor implantable replacement heart. The Company's actual results, including the development and timing of the AbioCor, may differ materially based on a number of factors, including uncertainty of product development and clinical trials, anticipated future losses, complex manufacturing, high quality requirements, unproven markets for products under development, dependence on key personnel, risks associated with growing number of employees, competition and technological change, government regulations, reliance on government contracts, dependence on limited sources of supply, future capital needs and uncertainty of additional funding, dependence on third-party reimbursement, 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.