Key Developments For AtriCure, Inc.
AtriCure, Inc. (ATRC.O) (Consolidated Issue listed on NASDAQ Global Market)
AtriCure, Inc. Announces Tentative Settlement With The Department Of Justice
AtriCure, Inc. 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. The Company 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, the Company 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.
AtriCure, Inc. Announces European Approval For AtriClip System
AtriCure, Inc. announced CE Mark approval for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion System. The AtriClip System is designed to safely and effectively exclude the left atrial appendage and is being launched in Europe through a phased approach during the fourth quarter.
AtriCure, Inc. Announces New $10 Million Credit Facility
AtriCure, Inc. announced that on May 1, 2009 the Company has entered into a $10 million credit facility with Silicon Valley Bank. The three year facility provides for a maximum borrowing capacity of $10 million and consists of a $6.5 million term loan, which was funded at closing and bears interest at 10%, and a $10 million revolving loan facility. The existing credit facility with National City Bank, which did not have any amounts outstanding currently or as of March 31, 2009, has been terminated.
AtriCure, Inc. Receives FDA 510(k) Clearance
AtriCure, Inc. announced that its new innovative disposable cryoablation system, Cryo1, received 510(k) clearance from the Food and Drug Administration, or FDA, for the cryosurgical treatment of cardiac arrhythmias. Additionally, the first patient was successfully treated using the Cryo1 system by Dr. Niv Ad, the Chief of Cardiac Surgery at Inova Fairfax Hospital Department of Cardiovascular and Thoracic Surgery in Falls Church, Virginia. Dr. Ad, an internationally recognized thought leader in the field of cardiac surgery and the surgical treatment of cardiac arrhythmias, successfully used the AtriCure Frigitronics CCS-200 console and the Cryo1 linear disposable ablation probe to perform a minimally invasive, sole therapy cardiac ablation procedure. The Cryo1 system offers several important benefits, including a long, malleable yet rigid design to achieve consistent contact, superior thermal dynamics and an active defrost mode which increases ease of use. In addition, the AtriCure Frigitronics CCS-200 console supports both our Cryo1 disposable probe and our well-established line of reusable cryoablation probes. The Frigitronics CCS-200 console and reusable probes have a strong market presence and a documented track record of safety and efficacy resulting from more than thirty years of use in cardiac arrhythmia procedures.
Saxena White P.A. Files Securities Fraud Class Action Against AtriCure, Inc.
Saxena White P.A. announced that it has filed suit on behalf of shareholders of AtriCure, Inc. in the United States District Court for the Southern District of Ohio. The complaint seeks damages for violations of federal securities laws on behalf of all investors who purchased AtriCure stock between May 10, 2007 and October 31, 2008, inclusive (the Class Period). AtriCure is a medical device company engaged in the development, manufacture and sale of cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac tissue. During the Class Period, the complaint alleges that defendants fraudulently inflated AtriCure's securities prices by improperly promoting its products to physicians and improperly causing the filing of false claims for reimbursement. On October 31, 2008, AtriCure shocked investors when the Company revealed that it had received a letter from the U.S. Department of Justice - Civil Division (the DOJ) informing the Company that the DOJ was conducting an investigation for potential False Claims Act and common law violations relating to the Company's surgical ablation devices.
