ABIOMED Reports Progress With Its Replacement Heart.

NEW YORK--(BW HealthWire)--Feb. 11, 1999--ABIOMED, Inc. (pronounced "AB-EE-O-MED"), (NASDAQ:ABMD) announced today that its Implantable Replacement Heart has reached an important milestone under the Company's ongoing reliability growth program. Full systems, including internal batteries and electronics, belonging to the second pilot production lot placed under formal testing, have met the Company's reliability criteria for their use in some bridge-to-transplant indications, should the Company elect to pursue this patient category. Actual use for these indications would require FDA approval. The announcement was made at the ING Baring Furman Selz Conference on Emerging Medical Technology.

Dr. David M. Lederman, Chief Executive Officer, indicated at the Conference that "the ABIOMED Reliability Growth and Qualification Program began in 1998." He explained that "it is a formal testing program intended to demonstrate performance and durability of the full system under a range of simulated physiological conditions over increasing periods of time. The ongoing tests are conducted in an intensely monitored laboratory environment. The reliability growth data are derived from tests of multiple systems belonging to continuously improving successive production lots. Each successive generation incorporates improvements learned from the previous generation. Under this program, each successive lot is expected to yield increasing reliability milestones."

Dr. Lederman added: "as the various reliability milestones are reached, the Company, in consultation with independent medical advisors, intends to define patient indications that are medically and ethically appropriate and will apply for regulatory permission to begin clinical trials under approved protocols." He concluded that: "the next production lot to enter reliability evaluation will incorporate, among others, configurational refinements for optimal human fit. Positive results from these tests are critical toward achieving the Company's goal of initial human trials in the year 2000."

The ABIOMED Replacement Heart is intended to restore the lives of patients who would otherwise die from heart failure from various causes. The Company estimates that there are more than 100,000 people dying each year in the USA from acute myocardial infarction, chronic ischemic disease or congestive heart failure who could benefit from this device. In contrast to other implantable cardiac assist devices, which leave failing or diseased natural hearts in place, the ABIOMED Replacement Heart replaces the severely diseased heart.

Based in Danvers, Massachusetts, ABIOMED, Inc. develops, manufactures and markets innovative cardiovascular products and is a leader in the research and development of advanced heart assist and replacement systems. The Company's BVS-5000 is the most widely used FDA-approved cardiac assist device and the only FDA-approved device for all patients with reversible heart failure. The Company's Implantable Replacement Heart is in an advanced stage of development and intended to extend the lives of patients who would otherwise die from heart failure.

This News Release contains forward-looking statements, including statements regarding development of an implantable battery-powered replacement heart and timing of its initial implantation in humans. Actual results, events or performance may differ materially based on a number of factors, both known and unknown, including: uncertainty of product development and clinical trials, complex manufacturing, high quality requirements, unproven demonstration of required reliability of products under development, dependence on key personnel, risks associated with growing number of employees, inability to recruit required human resources on schedule, competition and technological change, government regulations including the FDA and other regulatory agencies, dependence on limited sources of supply, future capital needs and uncertainty of additional funding, potential inadequacy of product liability insurance and dependence on patents and proprietary rights. 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.