OT twister: I'm obviously not Ken, but ABMD is **really** cooking today, up over 19%--and this is not the high for the day. It was just announced that, "ABIOMED Gets O.K. From FDA to Begin Human Implants of Artificial Heart:"
DANVERS, Mass.--(BW HealthWire)--Jan. 30, 2001--ABIOMED, Inc. (NASDAQ:ABMD - news), a
leader in heart assist and replacement technology, announced today that it has received permission from the
Food and Drug Administration (FDA) to begin the initial clinical trial of its AbioCor(TM) Replacement
Heart. The AbioCor, the world's first implantable artificial heart, is intended as a destination therapy for
end-stage heart failure patients who are at risk of imminent death, are not transplantable, and cannot be
helped by other available therapies.
The Investigational Device Exemption (IDE) granted by the FDA allows for the implantation of the AbioCor
in the first five patients of the clinical trial. Success of the trial will be based upon periodic review of the
survival of AbioCor patients and their quality of life as measured by a variety of assessment instruments
previously validated for end stage heart failure patients. FDA's letter authorizing the trial requires
ABIOMED to respond to a number of questions within 45 days, but initiation of the trial is not contingent
upon those responses.
``This is a great day for everyone who has worked with so much dedication and spirit to make the AbioCor
a reality'' said Dr. David M. Lederman, ABIOMED's President and Chief Executive Officer. ``Dozens and
dozens of people have been major contributors to ABIOMED's effort, under the leadership of Chief
Scientific Officer Dr. Robert T. V. Kung, Chief Regulatory Officer Janice T. Piasecki, and AbioCor
Program Director and Chief Engineering Officer William J. Bolt. We will take a moment to celebrate, but
only a moment. This FDA action will further energize us as we make final preparations, at ABIOMED and
at the collaborating centers, for the initial human implants of the AbioCor.''
``Our IDE submission for the AbioCor clinical trial was extraordinarily comprehensive,'' Dr. Lederman
continued, ``totaling thousands of pages of highly technical material in eighteen volumes. It is a testimony to
the commitment and professionalism of the FDA staff that they reviewed this material, submitted to them just
before the December holiday, so quickly, thoroughly and expertly. Our interactions with members of FDA's
Office of Device Evaluation over the past several years have given us important direction in improving our
testing protocols and have thereby helped us to reach this landmark point in AbioCor's development.''
``We have benefited immensely from the enthusiastic support and the many contributions of all of our
collaborating centers and the members of our Medical Replacement Heart Advisory Board. Special mention
needs to be made of Dr. O. H. (Bud) Frazier of the Texas Heart Institute, who has lent his clinical insight to
the AbioCor program for over a decade. The team at Jewish Hospital in Louisville, Kentucky, led by Dr.
Laman A. Gray and Dr. Robert D. Dowling, has made major contributions over the past three years to the
advancement of our preclinical testing program and to our current state of preparedness.'' He concluded:
``We thank and acknowledge the vital support and encouragement from the National Heart, Lung and Blood
Institutes, who have sponsored the development of AbioCor since 1988.''
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 preparing for initial human trials. ABIOMED currently manufactures and sells the
BVS®, a temporary heart assist device, for the support of all patients with failing but potentially
recoverable hearts.
The Company's AbioCor performance, timing and results may differ materially based on a number of
factors, including uncertainty of successfully meeting product development milestones, manufacturing
milestones in light of complex manufacturing processes, obtaining and maintaining regulatory approvals for
clinical trials, ability to train the clinical teams on a timely basis and to obtain IRB approvals from the
participating institutions, 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.
Contact:
ABIOMED, Inc.
Investor Contact:
John Thero, (978)777-5410
OR
Media Contact:
Edward E. Berger, Ph.D., (978)777-5410
biz.yahoo.com
Lynn |
