NEWS OF THE YEAR........SO FAR.....
biz.yahoo.com
ABIOMED Requests FDA Approval to Begin Human
Trials of AbioCor Replacement Heart
DANVERS, Mass.--(BW HealthWire)--Dec. 22, 2000--ABIOMED, Inc. (NASDAQ: ABMD - news), leader in heart assist and replacement technology, announced today that it has completed its IDE submission to the U.S. Food and Drug Administration (FDA), requesting approval to commence initial human trials of its AbioCor(TM) Implantable Replacement Heart.
``The completion of the AbioCor IDE submission is a major milestone on the path to bringing heart replacement technology to the tens of thousands of people in heart failure who have little hope of receiving a human heart transplant.'' said Dr. David M. Lederman, President and CEO of ABIOMED.
``This IDE submission is the culmination of years of development and testing. I want to acknowledge all the hard work and important contributions made by our team of dedicated employees and our clinical partners in achieving this important milestone.'' Dr. Lederman added.
Dr. Robert T.V. Kung, ABIOMED's Chief Scientific Officer explained, ``Our testing of the AbioCor in preparation for initial human trials has been extensive and the results of this testing have been very encouraging. While we expect questions from the FDA as they review our IDE application, we believe that a thorough review of our submission should lead to the conclusion that the AbioCor is ready for initial human trials in select patient populations. Subject to regulatory approval, we hope for the first human implant of the AbioCor to occur in the U.S. during the first half of 2001. In the interim, we are working diligently to produce sufficient quantities of devices and interacting closely with members of our clinical centers to insure that we are all fully trained and ready.''
ABIOMED's U.S. clinical centers are: Brigham and Women's Hospital teamed with Massachusetts General Hospital in Boston, MA; Hahnemann University Hospital in Philadelphia, PA; Jewish Heart and Lung Hospital in Louisville, KY; Texas Heart Institute in Houston, TX; and UCLA Medical Center in Los Angeles, CA. The Company anticipates that international trials of the AbioCor will commence after the U.S. trials are underway.
Dr. Kung added, ``the proposed goals of the initial AbioCor human trials will be to demonstrate improved life expectancy with a reasonable quality of life for selected patients who are in end-stage heart failure and who are not candidates for heart transplantation or any other available therapy. Ultimately, the successful completion of clinical trials should generate the clinical data necessary to submit to the corresponding Regulatory Authorities for approval to market the AbioCor in the U.S. and internationally. We are very excited about this important step toward making this life-saving technology available for human use.''
An IDE, or Investigational Device Exemption, is an application that must be approved by the FDA prior to commencing human clinical trials with a new medical device. An IDE must be supported by significant data that describe the medical device's design, operational function and pre-clinical test results. An IDE also describes the nature, purpose and justification of the proposed clinical study.
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 in an advanced stage of development and moving into a state of preparedness for initial human trials. ABIOMED currently manufactures and sells the BVS(R), a temporary heart assist device, for the support of all patients with failing but potentially recoverable hearts.
This News Release contains forward-looking statements, including statements regarding development, performance and timing to initial human trials of the AbioCor Implantable Replacement Heart. The Company's actual timing and results may differ materially based on a number of factors, including uncertainty of successfully meeting product development milestones and obtaining regulatory approvals for clinical trials, complex manufacturing, unproven markets for products under development, dependence on key personnel, competition and technological change, uncertainty in the ability to recruit required personnel on a timely basis, government regulations, dependence on limited sources of supply, 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. |
