-----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, ITKRsOhFP4PJKY5MC09/mlr2uq+DlUzlR9xAE2YdXP6UyP3H8VT6cNvPNWuws+lX olnW3uRkS4PRKqYKBXsaBw== 0001104659-05-018120.txt : 20050426 0001104659-05-018120.hdr.sgml : 20050426 20050426151722 ACCESSION NUMBER: 0001104659-05-018120 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050420 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050426 DATE AS OF CHANGE: 20050426 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: 05772836 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 a05-7238_18k.htm 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:  April 20, 2005
(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) 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:

 

o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o   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 April 20, 2005, we issued a press release announcing that the U.S. Food and Drug Administration will convene an expert panel of cardiovascular surgeons and cardiologists to review the technologies and clinical trial data behind the AbioCor artificial heart.

 

                The full text of the press release is attached as Exhibit  99.01 to this report and incorporated herein by reference.

 

 

Item 9.01               Other Events

 

(c) Exhibits

 

 

 

 

 

99.01

 

Press release dated April 20, 2005

 

 



 

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/ Charles B. Haaser

 

 

Charles B. Haaser

 

 

Controller

 

 

Principal Accounting Officer

 

 

Principal Financial Officer

 

Date:  April 26, 2005

 



 

Exhibit Index

 

 

 

Exhibit Number

 

Description

 

 

 

99.01

 

Press release dated April 20, 2005

 

 


EX-99.01 2 a05-7238_1ex99d01.htm EX-99.01

Exhibit 99.01

 

 

 

Contact:

Jane Petrino

Noonan Russo

(212) 845-4274

jane.petrino@eurorscg.com

 

FOR IMMEDIATE RELEASE

 

FDA Expert Panel to Review ABIOMED’s Fully Self-Contained Artificial Heart

Ground Breaking Artificial Heart is First-Ever to Come Before FDA Review

 

DANVERS, Mass. (April 20, 2005) - ABIOMED, Inc. (NASDAQ: ABMD) a manufacturer of products for circulatory care and support, today announced that the U.S. Food and Drug Administration (FDA) will convene an expert panel of cardiovascular surgeons and cardiologists to review the groundbreaking technologies and clinical trial data behind the AbioCor artificial heart.  The special expert review panel is expected to decide on June 23, 2005 on the potential approval for AbioCor under a Humanitarian Device Exemption (HDE).  This is the first-ever completely self-contained artificial heart to come before the FDA for review.

 

The technology behind the AbioCor artificial heart is the result of over 20 years of design, research, and testing conducted by ABIOMED, Inc. and its collaborators, with the support of the National Heart, Lung and Blood Institute.  The AbioCor is driven by a high-precision electro-hydraulic system pumping seamlessly to drive consistent and stable circulation, similar to a patient’s natural heart.  This device also contains a microprocessor chip and internal diagnostics that continuously monitor patient vitals.  The complete system is powered by a small external battery that transmits power across the skin without wires, eliminating risk of infection and allowing for a better quality of life.  Additionally, with the use of the internal battery, which lasts over 60 minutes, patients can enjoy swimming or bathing.  The AbioCor is truly a unique break-through product with over 50 patents, numerous trade secrets and over $100 million invested in its development.

 

Although tens of thousands are in need, only about 2,000 people in the U.S. will be able to receive donor hearts every year.  This consistent shortage in the supply of donor hearts in the U.S. demonstrates the need for an alternative to heart transplantation. Under the HDE application, up to four thousand patients a year who are not eligible for a heart transplant, will have the potential to be eligible for an AbioCor. These patients currently have no other options available and are suffering from bi-ventricular heart failure.  Subject to HDE approval, ABIOMED will select 15 centers worldwide to perform the procedure with the AbioCor.

 





 

-more-

 

“The elegance of the AbioCor technology makes this device groundbreaking and represents a new level of science never before seen in heart treatment,” stated Dr. Laman Gray, Professor of Surgery and Director of the Division of Thoracic and Cardiovascular Surgery at the University of Louisville School of Medicine.  “We are very excited to have the AbioCor reviewed by a FDA panel comprised of industry experts, as they can truly appreciate the level of medical advancement that the AbioCor brings to modern patient care.”

 

“We believe that this panel will give us immediate exposure to the experts in heart failure, as well as the general public. Our surgeons are very passionate about this technology and look forward to having the ability to offer this solution under an HDE to their patients,” commented Michael R. Minogue, Chief Executive Officer and President.

 

ABIOMED initially submitted the AbioCor for marketing approval under HDE to the FDA in September 2004.  Approval under an HDE would make the AbioCor commercially available to treat a defined subset of not more than 4,000 irreversible end-stage heart failure patients.  The AbioCor is designed to sustain the body’s circulatory system and to extend the lives of patients who would otherwise die of heart failure. Its unique design allows it to be totally implanted within the body. Unlike the artificial hearts of the past, patients are not tethered to a large, air-pumping console nor do they have wires or tubes piercing their skin. The AbioCor 2 is currently being implanted in animal studies and has the potential to last longer with a 35 percent reduction in size.

 

About ABIOMED

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.  ABIOMED, which currently sells the BVS® 5000 Biventricular Support System and the AB5000™ Circulatory Support System, is the market leader in devices for the temporary support of patients with failing but potentially recoverable hearts.  In September 2004, ABIOMED applied for initial FDA market approval for the AbioCor® Implantable Replacement Heart to treat a defined subset of irreversible end-stage heart failure patients under a Humanitarian Device Exemption.

 

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 earnings or 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.

 # # #

 

 




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