-----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, AcG42b1iwv9ISDcos9qt6QFy+OEP727uKBayb2TMok9nhu/j2CREMrhUqLcpf6pU 88a3VQN8FS0NIem3VFVARw== 0001157523-08-002573.txt : 20080328 0001157523-08-002573.hdr.sgml : 20080328 20080328130952 ACCESSION NUMBER: 0001157523-08-002573 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080328 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080328 DATE AS OF CHANGE: 20080328 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: 08718114 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 a5644544.htm 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: March 28, 2008

 

 

(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 March 28, 2008, we issued a press release announcing an update on our submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of 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 March 28, 2008




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:

March 28, 2008

EX-99.1 2 a5644544-ex991.htm EXHIBIT 99.1

Exhibit 99.1

Abiomed Announces Update on 510(k) Clearance Process for Impella 2.5 Circulatory Support Device

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD) today announced an update on the 510(k) clearance process related to its Impella® 2.5 circulatory support device.

While there are no guarantees, the Company remains confident that the Impella 2.5 device is on the substantially equivalent (SE) path based on informal feedback from the U.S. Food and Drug Administration (FDA). Abiomed is currently in an interactive review with the FDA on bench testing results of the Impella 2.5, the remaining area of concern. The Company does not anticipate additional bench testing studies at this time, but remains prepared to answer any questions from the FDA during the ongoing discussions.

Abiomed believes that the review of the bench testing results will not be completed by the FDA before March 31, 2008, as originally estimated by the Company in November 2006. This estimate was a Company forecast and not an FDA timeline or deadline. Abiomed now estimates that the review of the bench testing results by the FDA will be completed some time during the quarter ending June 30, 2008.

"While we had hoped this would be completed before the end of our fiscal year, we remain confident that we are on a 510(k) clearance path for the Impella 2.5," stated Michael R. Minogue, Chairman, President and CEO of Abiomed.


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 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 risk factors contained in the Company’s 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, 978-777-5410
Chief Financial Officer
ir@abiomed.com
or
For Abiomed, Inc.
Brodeur
Heather Nevers, 617-587-2814
Media Relations
hnevers@brodeur.com

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