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ABIOMED INC
FORM
8-K
(Current report filing)
Filed 04/23/09 for the Period Ending 04/20/09
Address
Telephone
CIK
Symbol
SIC Code
Industry
Sector
Fiscal Year
22 CHERRY HILL DR
DANVERS, MA 01923
9787775410
0000815094
ABMD
3841 - Surgical and Medical Instruments and Apparatus
Medical Equipment & Supplies
Healthcare
03/31
http://www.edgar-online.com
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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, 2009
(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 April 22, 2009, we issued a press release announcing we received 510(k) clearance from the U.S. Food and Drug Administration
(FDA) for our Impella 5.0 Cardiac Assist Device. 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.
Exhibit
Description
99.1
Press release dated April 22, 2009.
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 Michael R Minogue
Michael R. Minogue
President and Chief Executive Officer
Date: April 23, 2009
Exhibit Index
Exhibit
Description
99.1
Press release dated April 22, 2009.
EXHIBIT 99.1
FOR IMMEDIATE RELEASE
Abiomed receives FDA 510(k) Clearance for Impella ® 5.0 and Impella ® LD
•
Abiomed Will Host Brief 30-Minute Conference Call on April 23, 2009 at 8:30 a.m. ET
DANVERS, Mass. — April 22, 2009 — Abiomed, Inc. (NASDAQ: ABMD), a leading provider of break-through heart support technologies
enabling safer revascularization, heart recovery and cost-effective patient care, today announced it has received 510(k) clearance from the U.S.
Food and Drug Administration (FDA) for its Impella ® 5.0 and Impella ® LD Circulatory Support Devices. This 510(k) clearance designates
Impella 5.0 and Impella LD to provide circulatory support for periods of up to six hours.
Similar to the Impella 2.5, which received 510(k) clearance on June 2, 2008 for partial circulatory support for periods of up to six hours, the
Impella 5.0 and Impella LD devices are minimally invasive catheter-based pumps, designed to provide temporary circulatory support and
reduce the workload of the heart muscle. The pump is approximately the size of a pencil with a small nine French catheter, which drives up to
five liters of blood flow per minute, a flow rate typically adequate to fully support the average adult.
“Formerly, only patients with a grave prognosis received aggressive circulatory support due to the invasiveness and potential complications
associated with conventional surgery devices,” said Anson Cheung, M.D., Surgical Director of Heart Transplantation at St. Paul’s Hospital in
Vancouver, British Columbia. “The availability of the Impella 5.0 and Impella LD has reduced our threshold to implanting patients with a
temporary circulatory support device and offers a potential benefit to reduce the likelihood of escalating therapy, such as implantable devices or
heart transplantation. We have already seen patient success from Impella 5.0 and LD in providing the therapeutic benefit of ventricular
unloading, which helps to interrupt the progression of heart muscle damage and potentially repair reversible damage.”
The Impella 5.0 further enhances Abiomed’s heart recovery portfolio, providing cardiologists and surgeons with the clinical flexibility to select
and deploy circulatory support devices for patients based on the severity of cardiac dysfunction, the amount of flow needed while addressing
the dysfunction, and the preferred implant approach. In application, Impella is intended to increase the flow delivered by the heart, which can
potentially reduce the work of the heart and augment coronary flow.
“Now, both cardiologists and surgeons can use the minimally invasive Impella 5.0 and Impella LD devices for critical patients whose
conditions require high-flow circulatory support,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed.
“This FDA clearance represents Abiomed’s ability to create new heart support technologies and execute on the regulatory path. This is the
eighth FDA regulatory clearance or approval in the past four years.”
The Company will hold a brief 30-minute conference call at 8:30 a.m. ET on April 23, 2009 to discuss the clearance of the Impella 5.0 and
Impella LD circulatory support devices. Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed, will host the
conference call.
To listen to the call live, please tune into the webcast via http://investor.abiomed.com or dial 800.599.9816; the international number is
617.847.8705. The access code is 54282866. A replay of this conference call will be available beginning at 11:30 a.m. ET on April 23, 2009
through April 27, 2009. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is
16166003.
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 and expected regulatory approvals. 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, including 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 most recently filed Quarterly Report on 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.
For further information please contact:
Aimee Maillett
Public Relations Specialist
978-646-1553
[email protected]