-----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, FR3atsan7hGaT7qRGkOw670oBkDESLqvFdS4093JoXqUdWdyhneMVCLlMMn+Zqvf 2hnRBM0uAosB9jeT5b/YpA== 0001157523-07-009746.txt : 20071011 0001157523-07-009746.hdr.sgml : 20071011 20071011094655 ACCESSION NUMBER: 0001157523-07-009746 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071011 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071011 DATE AS OF CHANGE: 20071011 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: 071166443 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 a5515639.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: October 11, 2007 (Date of earliest event reported) - -------------------------------------------------------------------------------- ABIOMED, Inc. (Exact name of registrant as specified in its charter) Delaware 04-2743260 (State or other Jurisdiction of Incorporation) (IRS Employer Identification Number) 0-20584 (Commission File Number) 22 Cherry Hill Drive Danvers, MA 01923 (Address of Principal Executive Offices, including Zip Code) (978) 646-1400 (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. On October 11, 2007 we issued a press release announcing an update on the 510k clearance process for our Impella 2.5 product. A copy of the press release is set forth as Exhibit 99.1 and is incorporated by reference herein. Item 9.01 Financial Statements and Exhibits. (d) Exhibits Number Title - -------- ------------------------------------------------------------------- 99.1 Press Release dated October 11, 2007. - -------------------------------------------------------------------------------- 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: October 11, 2007 EX-99.1 2 a5515639ex99_1.txt EXHIBIT 99.1 Exhibit 99.1 Abiomed Announces Update on Impella(R) 2.5 510(k) Process DANVERS, Mass.--(BUSINESS WIRE)--Oct. 11, 2007--Abiomed, Inc. (NASDAQ: ABMD) today announced it recently received a written response from the U.S. Food and Drug Administration (FDA) outlining four areas of concern for which they requested additional information related to the company's submission for 510(k) clearance of the Impella 2.5. Two of the questions requested clarification and additional information related to labeling within the 510(k) submission. A third question requested additional information related to bench-testing of the device. A fourth question requested that the company provide an updated clinical review of the global experience with the Impella 2.5 since the original 510(k) submission, including up to date information from the U.S. safety pilot clinical trial for the Impella 2.5. The company plans to respond to this recent request for information. "We continue to work diligently with the FDA to provide clarification on existing data and additional information related to our 510(k) clearance submission for the Impella 2.5," stated Michael R. Minogue, Chairman, President and CEO of Abiomed. "While there are no guarantees for a 510(k) clearance, we remain confident that we are on a 510(k) path with a potential clearance sometime between November 2007 and March 2008." The clinical experience to-date with Impella 2.5 has been favorable, including its recently completed U.S. safety pilot clinical trial. The technology is now approved in more than 40 countries, and is available in Europe under the CE Mark. Impella has been the subject of more than 20 peer reviewed publications. ABOUT ABIOMED Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. 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 the Company's ability to provide the FDA with the additional information it has requested, the results of the Company's pivotal study, 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 and recently filed Form 10-Q. 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 J. Sutherby, 978-646-1812 Chief Financial Officer ir@abiomed.com or Brodeur Elizabeth Dumm, 617-817-7951 Media Relations edumm@brodeur.com -----END PRIVACY-ENHANCED MESSAGE-----