AtriCure Announces Tentative Settlement with the Department of Justice

Wed Nov 4, 2009 8:10am EST
 
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WEST CHESTER, Ohio--(Business Wire)--
AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac
surgical ablation systems, today announced that it has reached a tentative
agreement, subject to completion and approval of a written settlement agreement,
with the Department of Justice (DOJ) to resolve the issues raised in the DOJ`s
investigation and the related qui tam complaint regarding the marketing of the
Company`s surgical ablation devices. The agreement includes AtriCure`s assertion
that the Company and its employees have not engaged in any wrongdoing or illegal
activity. 

Pursuant to the tentative agreement, AtriCure would pay $3.8 million plus
interest over a five-year period. Payments during the five-year period,
inclusive of interest, would be $0.5 million, $0.5 million, $0.65 million, $1.0
million and $1.5 million, respectively. AtriCure has recorded a settlement
reserve of $3.8 million related to the agreement in its financial statements for
its quarter ended September 30, 2009. Further, as is typical of settlements of
this nature, AtriCure has agreed, subject to completion and approval of a
written agreement, to enter into a corporate integrity agreement with the Office
of Inspector General of the Department of Health and Human Services. 

About AtriCure, Inc.
AtriCure, Inc. is a medical device company and a leader in developing,
manufacturing and selling innovative cardiac surgical ablation systems designed
to create precise lesions, or scars, in cardiac, or heart, tissue. Medical
journals have described the adoption by leading cardiothoracic surgeons of the
AtriCure Isolator® bipolar ablation system as a treatment alternative during
open-heart surgical procedures to create lesions in cardiac tissue to block the
abnormal electrical impulses that cause atrial fibrillation, or AF, a rapid,
irregular quivering of the upper chambers of the heart. Additionally, medical
journals and leading cardiothoracic surgeons have described the AtriCure
Isolator system as a promising treatment alternative for patients who may be
candidates for sole-therapy minimally invasive procedures. AF affects more than
5.5 million people worldwide and predisposes them to a five-fold increased risk
of stroke. The FDA has cleared the AtriCure Isolator system and AtriCure`s
multifunctional pen and CoolrailTM linear ablation device, for the ablation, or
destruction, of cardiac tissue during surgical procedures. Additionally, the FDA
has cleared AtriCure`s multifunctional pen for temporary pacing, sensing,
stimulating and recording during the evaluation of cardiac arrhythmias and
AtriCure`s Cryo1TM system for the cryosurgical treatment of cardiac arrhythmias.
To date, the FDA has not cleared or approved AtriCure`s products for the
treatment of AF. 

Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Forward-looking statements
include statements that address activities, events or developments that AtriCure
expects, believes or anticipates will or may occur in the future, such as
earnings estimates, other predictions of financial performance, launches by
AtriCure of new products and market acceptance of AtriCure`s products.
Forward-looking statements are based on AtriCure`s experience and perception of
current conditions, trends, expected future developments and other factors it
believes are appropriate under the circumstances and are subject to numerous
risks and uncertainties, many of which are beyond AtriCure`s control. These
risks and uncertainties include the rate and degree of market acceptance of
AtriCure`s products, AtriCure`s ability to develop and market new and enhanced
products, the timing of and ability to obtain and maintain regulatory clearances
and approvals for its products, the timing of and ability to obtain
reimbursement of procedures utilizing AtriCure`s products, competition from
existing and new products and procedures or AtriCure`s ability to effectively
react to other risks and uncertainties described from time to time in AtriCure`s
SEC filings, such as fluctuation of quarterly financial results, reliance on
third party manufacturers and suppliers, litigation (including the purported
class action lawsuits, qui tam complaint and Department of Justice
investigation) or other proceedings, government regulation and stock price
volatility. AtriCure does not guarantee any forward-looking statement, and
actual results may differ materially from those projected. AtriCure undertakes
no obligation to publicly update any forward-looking statement, whether as a
result of new information, future events or otherwise.

AtriCure, Inc.
Julie A. Piton, 513-755-4561
Vice President and Chief Financial Officer
jpiton@atricure.com

Copyright Business Wire 2009

 

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