-----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, INj2F2VnUlfIMeTO0ynX8eum3PxVZ9teBsVHVe577xSj7TTPD7wEIHMX+m9S23hB drYQazBLIQEq9ekzgIMVOg== 0001157523-06-006437.txt : 20060628 0001157523-06-006437.hdr.sgml : 20060628 20060628083211 ACCESSION NUMBER: 0001157523-06-006437 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060627 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060628 DATE AS OF CHANGE: 20060628 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: 06928406 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 a5178865.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: June 27, 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 Identification of Incorporation) 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 June 27, 2006, announcing conditional approval by the U.S. Food and Drug Administration (FDA) of its Investigational Device Exemption (IDE) for the IMPELLA 5.0 unique, catheter-based Circulatory Support Systems. Clinical trials in the U.S. are to begin immediately. Item 9.01 Financial Statements and Exhibits (c) Exhibits 99.01 Press release dated June 27, 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 Chief Financial Officer Date: June 28, 2006 EX-99.01 2 a5178865ex99_01.txt EXHIBIT 99.01 Exhibit 99.01 FDA Approves Abiomed's IDE for IMPELLA 5.0 Minimally Invasive Cardiac Support Systems; Advanced Medical Technology Indicated for Use with Low Cardiac Output after Cardiac Surgery DANVERS, Mass.--(BUSINESS WIRE)--June 27, 2006--Abiomed, Inc. (NASDAQ: ABMD) today announced conditional approval by the U.S. Food and Drug Administration (FDA) of its Investigational Device Exemption (IDE) for the IMPELLA 5.0 unique, catheter-based Circulatory Support Systems. Clinical trials in the U.S. are to begin immediately. The IMPELLA(R) RECOVER 5.0 devices are already available in Europe under CE Mark approval and have been used to treat more than 250 patients in Europe in need of cardiac support resulting from postcardiotomy cardiogenic shock, myocarditis, low cardiac output post-acute myocardial infarction, or post-coronary intervention procedures, or as a bridge to other circulatory support devices, including Abiomed's AB5000(TM) and BVS(R) 5000 Circulatory Support Systems. The pilot study in the United States for the IMPELLA 5.0 will enroll up to 20 patients at seven U.S. sites including: the University of Maryland, Massachusetts General Hospital, Lankenau Hospital in Philadelphia, Robert Wood Johnson Hospital in New Jersey, New York Presbyterian Hospital, Texas Heart Institute and Penn State Milton S. Hershey Medical Center in Pennsylvania. The study will include postcardiotomy patients who have been weaned from heart-lung machines and whose hearts require added support to maintain good blood flow. The study will enroll those patients that would typically need more flow and hemodynamic support than provided by an Intra-Aortic Balloon Pump (IABP). "The IMPELLA micro-VAD technology is likely a window into the future where heart assist is headed. We look forward to evaluating the safety of this device in patients whose hearts are weakened after heart surgery. Because of the small size, they are assembled on a catheter that can be placed through an artery and into the heart," said Bartley Griffith, M.D., Chief of Cardiac Surgery and Heart & Lung Transplantation at the University of Maryland School of Medicine and Principal Investigator of the study. "We are excited to receive this approval for the IMPELLA 5.0 as we believe this technology will provide surgeons with a potent, minimally invasive, circulatory support system. Abiomed's results with the IMPELLA 5.0 in Europe have been excellent and we look forward to ultimately bringing this technology to the United States through this study," said Michael R. Minogue, Chairman, CEO and President of Abiomed. ABOUT THE IMPELLA 5.0 The IMPELLA 5.0 technology consists of catheters that can be introduced percutaneously through a cut-down and surgically. Other IMPELLA devices currently available in Europe under CE Mark approval include the IMPELLA(R) 2.5, and the IMPELLA(R) RD. The IMPELLA 5.0 Pumps can achieve flows of up to 5.0 liters per minute, and actively unload the ventricle, reducing myocardial workload and oxygen consumption while increasing cardiac output and coronary and end-organ perfusion. IMPELLA 5.0 devices have been the subject of more than 10 clinical papers reporting European experiences. Recent studies have shown that the IMPELLA 5.0 can provide effective and adequate support for high-risk surgery patients, as well as patients presenting with marginal cardiac output as well as severe cardiogenic shock. The IMPELLA 5.0 Support Systems are intended to be used for up to seven days as left ventricular cardiac assist devices. The systems are comprised of the IMPELLA mobile console, the IMPELLA bearing purger and the IMPELLA 5.0 catheter based rotary blood pumps. 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) 5.0 and 2.5 are investigational devices 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 Liza Heapes, 978-646-1668 Media Relations mediarelations@abiomed.com -----END PRIVACY-ENHANCED MESSAGE-----