mit AdHoc von heute, Gruss E.
FDA Approves ABIOMED's New AB5000 Heart Assist Ventricle
THURSDAY, SEPTEMBER 25, 2003 11:58 AM
DANVERS, Mass., Sep 25, 2003 (BUSINESS WIRE) -- ABIOMED, Inc., (ABMD) announced today that it has received FDA approval to begin commercial distribution of the Company's new AB5000(TM) Ventricle, the first in a planned series of additions to its new AB5000(TM) heart assist product line. The AB5000 Ventricle can provide temporary support for one or both sides of the natural heart in circumstances where the heart has failed but has the potential to recover. It is driven and controlled by the AB5000(TM) Circulatory Support System Console that ABIOMED recently introduced into the U.S. market.
"The AB5000 Ventricle is an exciting addition to our product offerings," said Gene Rabe, Senior Vice President for Sales and Services. "It will provide significant benefits to patients with regard to mobility and comfort, and should thereby aid the process of recovery. In conjunction with the AB5000 Console, the new Ventricle provides a total circulatory support system that we believe will provide the ease of use and reliability that our physician and hospital customers have told us they value. Our research tells us that the AB5000 Ventricle should be well-received in the market, and our sales force is eager to begin introducing it to their accounts."
"Approval of the AB5000 Ventricle, following the recent FDA approval and introduction of ABIOMED's new AB5000 Console, is an important business milestone for ABIOMED," said Chief Executive Officer Dr. David M. Lederman. "This is our first significant addition to our commercial product portfolio since the original introduction of the BVS(R) product line, and it solidifies the new AB5000(TM) platform as one focal point for our growth over the next year and beyond. This example of successful execution of one of our business objectives exemplifies the commitment to commercial success of dozens of members of our product development, clinical and regulatory teams. They executed with excellence in record time.
"In April of this year," Lederman continued, "we announced an ambitious program timetable of product introductions planned for the next several years, including those related to the AbioCor(R) Implantable Replacement Heart. Today's announcement of a critical regulatory approval for our new product platform demonstrates that we are executing according to that timetable. We intend to continue to meet those milestones, and our entire organization remains focused on that purpose."
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. ABIOMED, which currently sells the BVS 5000(R) Biventricular Support System and the AB5000 Circulatory Support System, is the market leader in devices for the temporary support of patients with failing but potentially recoverable hearts. The Company's first generation AbioCor Implantable Replacement Heart is the subject of an initial clinical trial being conducted under an Investigational Device Exemption from the United States Food and Drug Administration. The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial.
This Release contains forward-looking statements, including statements regarding the likely market acceptance of the AB5000 Ventricle, the future market introduction of additional new circulatory support and heart replacement products, and ABIOMED's future performance. ABIOMED's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing and other risks detailed in the Company's filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any 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 that occur after the date of this Release or to reflect the occurrence of unanticipated events.
SOURCE: ABIOMED, Inc.
Edward E. Berger, Ph.D., 978-646-1419
Lippert/Heilshorn & Associates, Inc.
Kim Sutton-Golodetz, 212-838-3777
Bruce Voss, 310-691-7100