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February 21, 2014
12:45 EDTCYBXCyberonics discloses qui tam action unsealed, U.S. declined to intervene
Cyberonics disclosed in a regulatory filing that on December 5, 2013, after the United States declined to intervene, the U.S. District Court for the District of Massachusetts unsealed a qui tam action, or a lawsuit brought by a private individual purporting to act on behalf of the government, filed against the company under the Federal False Claims Act and the false claims statutes of 28 different states and the District of Columbia. The qui tam action was filed under seal in February 2013 by former employee Andrew Hagerty. Previously, in August 2012, Hagerty filed a related lawsuit in the same court and then voluntarily dismissed that lawsuit immediately prior to filing this qui tam action. In addition to his claims for wrongful and retaliatory discharge stated in the first lawsuit, the qui tam lawsuit alleges that the company violated the FCA and various state false claims statutes while marketing its VNS Therapy System and seeks an unspecified amount consisting of treble damages, civil penalties, and attorneys’ fees and expenses, Cyberonics stated.
News For CYBX From The Last 14 Days
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December 8, 2014
11:51 EDTCYBXCyberonics reports new results from E-36, E-37 studies
Cyberonics announced new results from two multi-site clinical studies of the AspireSR generator, E-36 and E-37, at the AES Annual Meeting in Seattle, Washington. Investigators presented results from the European E-36 study and the U.S. E-37 study, which assessed the acute impact of the AspireSR generator on seizure duration and termination, as well as the long-term evaluation of safety, clinical benefit of the automatic stimulation feature, and quality of life. Assessments of seizure severity and quality of life were made using validated scales scored by patients and physicians. The acute impact of the AspireSR generator on seizure duration and termination was evaluated during the Epilepsy Monitoring Unit stay period experienced by all patients in both studies. Seizure activity was recorded using concurrent video-EEG and ECG monitoring. Patients in both studies experienced termination of seizures as well as reduced seizure duration during automatic stimulation compared to historical controls. The AspireSR generator is currently investigational in the U.S. and not approved for commercial use. The AspireSR generator attained the CE Mark and is now available in an increasing number of European countries.
December 5, 2014
11:57 EDTCYBXCyberonics management to meet with Sidoti
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09:45 EDTCYBXBrown Capital reports 5.61% passive stake in Cyberonics

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