ABIOMED Wins Federal Grant
DANVERS, Mass.–(BW HealthWire)–Oct. 21, 1998–
— to Develop Next Generation of Implantable Replacement Heart —
ABIOMED, Inc. (pronounced “AB-EE-O-MED”), (NASDAQ:ABMD) today announced that it has won a two-year research grant for approximately $740,000 from the National Institutes of Health to develop technology which would allow ABIOMED to miniaturize the Company’s Implantable Replacement Heart device currently in development. The grant was awarded under the Small Business Innovation Research Program.
Dr. Fred Zarinetchi, Principal Investigator on the project, commented; “ABIOMED is already in an advanced stage of pre-clinical development of an Implantable Replacement Heart device aimed at saving approximately 100,000 people who die annually in the U.S.A. from various end stage heart ailments. Although the current device will address a large portion of this patient population, we believe that a smaller device will allow the replacement heart technology to serve the entire patient population. This grant adds resources for further technology innovation without affecting the current development schedule.”
The ABIOMED Implantable Replacement Heart is intended for the replacement of the severely diseased natural heart of a patient with end-stage chronic or acute heart failure. It is battery-driven and designed to give patients mobility to carry-out normal life activities. Power to drive the device is transmitted without wires piercing the skin.
The base technology used in the ABIOMED Implantable Replacement Heart has been under development since 1977 with significant financial support from the National Institutes of Health. Certain elements of this technology are today being used to save human lives as components of ABIOMED’s BVS-5000(R), a temporary heart assist system. The BVS-5000 is the only device approved by the FDA as a bridge-to-recovery device for the treatment of all patients with reversibly failing hearts.
Earlier this year the Company announced that it has selected the five U.S. Medical Teams that will perform the first human implantations of the ABIOMED Implantable Replacement Heart. ABIOMED and these medical teams have collaborative agreements to prepare for demonstration of device and team readiness for clinical trials.
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 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 products under development. The Company’s actual results, including its ability to develop and commercially introduce new products, may differ materially based on a number of factors, including dependence on BVS product line, stage of BVS market development, uncertainty of product development and clinical trials, anticipated future losses, complex manufacturing, high quality requirements, risk of market withdrawal or product recall, 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.
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