-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, JnjydmIi5obtCfBIeoZkhSR0VM8DVjYLYfsZfMn2TlJOcLbqcDQdlma6cy4z8qd9 iL5BTVH5btJBeOX2QHjW4Q== 0001157523-06-005602.txt : 20060525 0001157523-06-005602.hdr.sgml : 20060525 20060525155257 ACCESSION NUMBER: 0001157523-06-005602 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060525 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060525 DATE AS OF CHANGE: 20060525 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ABIOMED INC CENTRAL INDEX KEY: 0000815094 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 042743260 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09585 FILM NUMBER: 06867206 BUSINESS ADDRESS: STREET 1: 22 CHERRY HILL DR CITY: DANVERS STATE: MA ZIP: 01923 BUSINESS PHONE: 9787775410 MAIL ADDRESS: STREET 1: 22 CHERRY HILL DRIVE CITY: DANVERS STATE: MA ZIP: 01923 8-K 1 a5157424.txt ABIOMED, INC. 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report: May 25, 2006 - -------------------------------------------------------------------------------- (Date of earliest event reported) ABIOMED, Inc. - -------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) Delaware 04-2743260 (State or other Jurisdiction (IRS Employer of Incorporation) Identification Number) 0-20584 (Commission File Number) 22 Cherry Hill Drive Danvers, MA 01923 (Address of Principal Executive Offices, including Zip Code) (978) 777-5410 (Registrant's Telephone Number, including Area Code) Not Applicable (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c) Item 8.01 Other Events Attached and incorporated herein by reference as Exhibit 99.01 is a copy of a press release of ABIOMED, Inc. dated May 25, 2006, announcing the Company's receipt of FDA approval to commence its pilot clinical trial immediately in the United States for the IMPELLA(R) 2.5 minimally invasive ventricular assist device (VAD). The approval is conditioned upon the Company's submission of additional information to the FDA over the next 45 days. The indication for use is support during "high-risk" angioplasty for up to five days as a left ventricular assist device. Item 9.01 Financial Statements and Exhibits (c) Exhibits 99.01 Press release dated May 25, 2006 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. ABIOMED, Inc. By: /s/ Daniel J. Sutherby ---------------------------- Daniel J. Sutherby Principal Financial Officer Date: May 25, 2006 Exhibit Index Exhibit Number Description 99.01 Press release dated May 25, 2006 EX-99.01 2 a5157424ex99_01.txt EXHIBIT 99.01 Exhibit 99.01 ABIOMED Receives FDA Approval to Commence IMPELLA 2.5 U.S. Trial; Indication for Use is Support During High-Risk Angioplasty DANVERS, Mass.--(BUSINESS WIRE)--May 25, 2006--ABIOMED, Inc. (NASDAQ: ABMD) today announced that the U.S. Food and Drug Administration (FDA) granted approval for the Company to commence its pilot clinical trial immediately in the United States for the IMPELLA(R) 2.5 minimally invasive ventricular assist device (VAD). The approval is conditioned upon the Company's submission of additional information to the FDA over the next 45 days. The indication for use is support during "high-risk" angioplasty for up to five days as a left ventricular assist device. Angioplasty, performed in the catheterization lab, is the insertion of a catheter-guided balloon and is used to open a narrowed coronary artery. A stent (a wire-mesh tube that expands to hold the artery open) is usually placed at the narrowed section. High-risk angioplasty is defined as patients undergoing angioplasty on an unprotected left main coronary artery lesion, or the last patent coronary conduit, and poor cardiac function. "We are very excited to receive this approval to begin the trial for our breakthrough IMPELLA 2.5 product. We believe IMPELLA will change the standard of care in the cath lab," stated Michael R. Minogue, Chairman, President and CEO of ABIOMED. "Our results in Europe for high-risk patients have been outstanding. We estimate that approximately 5%-10% of the one million U.S. angioplasty patients could benefit in the future from IMPELLA technologies." "The IMPELLA 2.5 is a highly advanced, minimally invasive VAD that can be utilized in the cath lab to provide patients support during a procedure," stated William O'Neill, Corporate Director of Cardiology, William Beaumont Hospital System. "We hope to demonstrate that the IMPELLA system, with its unique capability to unload the left ventricle and enhance flow to the body, will improve the safety of complex, high-risk angioplasty procedures." The Company intends to conduct the pilot investigation on the IMPELLA 2.5 with no more than seven hospitals and 20 patients. Based on the Centers for Medicare and Medicaid (CMS) category B2 status, the hospitals could be eligible for full reimbursement during the trial. ABIOMED will conduct a conference call in the future to outline the details of the trial. ABOUT ABIOMED Based in Danvers, Massachusetts, ABIOMED, Inc. is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. ABIOMED currently manufactures and sells the AB5000(TM) Circulatory Support System and the BVS(R) 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. In Europe, ABIOMED offers the IMPELLA(R) RECOVER(R) minimally invasive cardiovascular support systems under CE Mark approval. The IMPELLA(R) 2.5 is an investigational device limited by Federal Law solely to investigational use in the United States. Other IMPELLA devices are not yet available for sale in the United States. The Company's AbioCor(R) Implantable Replacement Heart was the subject of an initial clinical trial 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. For additional information please visit: www.abiomed.com. FORWARD-LOOKING STATEMENTS This Release contains forward-looking statements, including statements regarding development of ABIOMED's existing and new products, the Company's progress toward commercial growth, and future opportunities. The Company'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 and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K. 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. Daniel Sutherby, 978-646-1812 Chief Financial Officer ir@abiomed.com or ABIOMED, INC. Liza Heapes, 978-646-1668 Media Relations mediarelations@abiomed.com -----END PRIVACY-ENHANCED MESSAGE-----