Cyberonics, Inc. (NASDAQ: CYBX) today announced the 100,000th patient implant of its Vagus Nerve Stimulation (VNS) Therapy system. The announcement comes as Cyberonics recognizes a milestone year marking the 25th anniversary of the company's founding. The VNS Therapy System for the treatment of epilepsy received CE Mark approval 18 years ago, and this year marks the 15th anniversary of approval by the United States Food and Drug Administration (FDA).
According to an Institute of Medicine Report released earlier this year, approximately one in 26 people will develop epilepsy at some point during their lives. VNS Therapy is a unique device-based treatment option specifically developed for people with refractory epilepsy. Epilepsy is considered refractory when seizures are not adequately controlled by medications alone or when the side effects associated with seizure medications are intolerable.
Recently-published data from New York University clinician researchers show that more than 60 percent of people with refractory epilepsy treated with adjunctive VNS Therapy experience 50 percent or greater reduction in seizures. Clinician researchers from Emory University have also shown in a recent publication that adding VNS Therapy to the treatment regimen of patients experiencing refractory epilepsy is associated with significant reductions in resource utilization (ER visits, hospitalizations, and inpatient days) and epilepsy-related clinical events, as well as a net cost savings after 1.5 years.
"Cyberonics is proud to acknowledge this important milestone and the impact VNS Therapy has made on the lives of so many people with epilepsy and their families," said Dan Moore, Cyberonics' President and Chief Executive Officer. "We look forward to expanding access to VNS Therapy and innovating new therapeutic options for patients around the world." VNS Therapy device technology has evolved over time to become smaller, have a longer battery life and offer new programming functionalities.
The latest model of VNS Therapy, the AspireHC@ generator, is available in the U.S. and in Europe. The AspireHC generator offers physicians and patients additional options, such as longer battery life, improved electronics and enhanced programming features.
Cyberonics continues to develop new device-based solutions for epilepsy, including the ProGuardianT system, an innovative, in-home monitoring system; the AspireSRT generator, a VNS Therapy system featuring automatic magnet-mode stimulation; and RelayT, a wireless-enabled generator.
About Cyberonics, Inc. and the VNS Therapy@ System Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation. The company developed and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy System uses an implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.
Additional information on Cyberonics and the VNS Therapy System is available at www.cyberonics.com.
Safe harbor statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words. Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning developing and commercially releasing new device-based solutions for epilepsy, including the ProGuardianT system, the AspireSRT generator and the RelayT generator.
Our actual results may differ materially. Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of VNS TherapyT and sales of our products; the development and satisfactory completion of clinical trials and/or market test and/or regulatory approval of new products, including VNS TherapyT for the treatment of other indications; satisfactory completion of the post-market registry required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; adverse changes in coverage or reimbursement amounts by third-parties; intellectual property protection and potential infringement claims; maintaining compliance with government regulations and obtaining necessary government approvals for new products and indications; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; the potential identification of material weaknesses in our internal controls over financial reporting; and other risks detailed from time to time in our filings with the Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 27, 2012 and our Quarterly Report on Form 10-Q for fiscal quarters ended July 27, 2012 and October 26, 2012.
Contact Information Greg Browne, CFO Cyberonics, Inc. 100 Cyberonics Blvd. Houston, TX 77058 Main: (281) 228-7262 Fax: (281) 218-9332 firstname.lastname@example.org SOURCE Cyberonics, Inc.
-0- 12/20/2012 /Web Site: http://www.cyberonics.com (NASDAQ-NMS:CYBX) / CO: Cyberonics, Inc.
ST: Texas IN: MTC SPM HEA CPR SU: PDT PRN -- DA33463 -- 0000 12/20/2012 20:05:08 EDT http://www.prnewswire.c