ABIOMED Announces First European Site for AbioCor Implantable Replacement Heart Clinical Trial
ABIOMED, Inc. (NASDAQ:ABMD) today announced that the North Rhine-Westphalia Heart Center, Bad Oeynhausen, Germany will serve as a European clinical trial site for the AbioCor Implantable Replacement Heart. The European trial of the AbioCor is expected to begin within the next six months.
“We are very pleased to have reached this agreement with North Rhine-Westphalia” said Dr. David M. Lederman, ABIOMED’s Chief Executive Officer. “It is our goal to work with the very best and most experienced heart transplant and mechanical heart assistance programs in the world in bringing the AbioCor Implantable Replacement Heart through clinical trials and into the clinical setting. The program at Bad Oeynhausen is distinguished by the quality and efficiency of its work, and by the breadth of its experience with advanced heart assist systems. We look forward to a close and mutually rewarding working relationship with Prof. Dr. med. R. Korfer and his team.”
“I’m very pleased and proud that we are now in the start-up phase for the clinical trial of the AbioCor,” said Prof. Dr. med. Reiner Korfer, Director of the heart surgery program of the Heart Center North Rhine-Westphalia. “ABIOMED’s choice of our center is for me an acknowledgement of our successful work during the past years. We are committed to the development of the replacement heart as a widely available clinical option made necessary by limitations in the availability and applicability of transplantation, and we share with ABIOMED a continuous focus on improving the quality of life of our patients.”
The Heart Center North Rhine-Westphalia, founded in l984, is the largest cardiac surgery facility in Europe, and is widely recognized as an experienced center in advanced cardiac assist systems. It has been the site of more than 50,000 open heart surgeries, more than 1,000 heart transplants, and more than 550 implantations of advanced heart assist devices.
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 being implanted in patients as part of an initial clinical trial 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. ABIOMED currently manufactures and sells the BVS, a heart assist advice for the temporary support of all patients with failing but potentially recoverable hearts.
This Release contains forward-looking statements, including statements regarding the anticipated timing and results of clinical trials for the AbioCor. 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.
CONTACT: ABIOMED, Inc. | Investor Contact: | John F. Thero, (978) 777-5410 | or | Media Contact: | Edward E. Berger, Ph.D., (978) 777-5410
