ABIOMED Issues Update on AbioCor Heart Program Status; Clinical Trial To Begin Soon
ABIOMED, Inc. (NASDAQ:ABMD) announced today that while device and team readiness have been demonstrated for several weeks, the first human implantation of the AbioCor(TM) Implantable Replacement Heart has not yet taken place.
ABIOMED further indicated that all that is reasonably possible is being done to identify the right patients through a prudent and cautious process designed to insure the ultimate success for both the initial patients and the entire trial. During the past weeks, the program has focussed on screening appropriate candidates. ABIOMED is confident that the initial clinical trial will begin soon.
In order to protect patient confidentiality and provide the best possible medical care, ABIOMED will continue its policy of pursuing a “quiet period” during patient selection and implantation for the AbioCor clinical trial.
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 first generation AbioCor Implantable Replacement Heart is ready for implantation in selected patients as part of an initial clinical trial conducted under an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA). 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.
