Epilepsy - VNS Therapy(TM) System as a Treatment for Refractory Epilepsy in Korea and Brazil

Main Category: Neurology / Neuroscience
Article Date: 05 Mar 2005 - 9:00 PDT

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Cyberonics, Inc (Nasdaq: CYBX) today announced that it received approval from the regulatory agencies in Korea and Brazil to market the VNS Therapy Models 102 and 102R Generators, and the VNS Therapy Model 302 Leads in Korea and Brazil for the treatment of pharmacoresistant epilepsy. The Models 102 and 102R Generators are slimmer, lighter and easier to implant than their predecessor, the Model 101 Generator. The Model 102R Generator is a dual connector version of the Model 102 Generator for use as a replacement for Model 100 and 101 Generators with dual connector Model 300 leads that have reached end of service.

"Part of Cyberonics' plan to become the global neuromodulation market leader following final depression approval is to increase our investments and penetration of international markets," commented Michael A. Cheney, Cyberonics' Vice President, Marketing. "These approvals provide improved commercial access to our patented VNS Therapy Systems for the safe and effective treatment of medically refractory epilepsy in Korea and Brazil. We have already received sales orders for these newly approved products and plan immediate shipment into these markets. We are pleased to have the opportunity to improve the lives of people in Korea and Brazil suffering from pharmacoresistant epilepsy and look forward to continuing the expansion of our global VNS Therapy franchise."

ABOUT VNS THERAPY AND CYBERONICS

Cyberonics, Inc. was founded in 1987 to design, develop and market medical devices for the long-term treatment of epilepsy, depression and other chronic neurological disorders using a unique therapy, vagus nerve stimulation (VNS). Stimulation is delivered by the VNS Therapy System, an implantable generator similar to a cardiac pacemaker. The VNS Therapy System delivers preprogrammed intermittent mild electrical pulses to the vagus nerve in the patient's neck 24 hours a day. The Company's initial market is epilepsy, a disorder characterized by recurrent seizures. Epilepsy is the second most prevalent neurological disorder. The Cyberonics VNS Therapy System was approved by the FDA on July 16, 1997 for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. The VNS Therapy System is also approved for sale as a treatment for epilepsy in all the member countries of the European Economic Area, Canada, Australia and other markets. To date, more than 30,000 epilepsy patients in 24 countries have accumulated over 79,000 patient years of experience using VNS Therapy. The VNS Therapy System was deemed approvable in writing by the FDA on February 2, 2005 as an adjunctive treatment for chronic treatment-resistant depression for adults over the age of 18. According to FDA's approvable letter, final approval was conditional on final labeling, final protocols for a post- approval dosing optimization study and patient registry, satisfactory compliance with the Quality System Regulations (QSR) and satisfactory resolution of any outstanding bioresearch monitoring issues. The VNS Therapy System is approved for sale in the European Economic Area and in Canada as a treatment for depression in patients with treatment-resistant or treatment- intolerant major depressive episodes, including unipolar depression and bipolar disorder (manic depression). VNS Therapy is at various levels of investigational clinical study as a potential treatment for anxiety disorders, Alzheimer's disease, chronic headache/migraine and bulimia. The Company is headquartered in Houston, Texas and has an office in Brussels, Belgium. For additional information please visit us at http://www.cyberonics.com .

FORWARD LOOKING STATEMENTS

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," and "forecast," or other similar words. Such forward-looking statements include statements concerning obtaining final regulatory approval for the depression indication, becoming the global neuromodulation market leader and increasing investment and penetration in international markets. Statements contained in this press release are based upon information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information should those facts change or should we no longer believe the assumptions to be reasonable. 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 Therapy and sales of our product; the development and satisfactory completion of clinical trials and/or market test and/or regulatory approval of VNS Therapy for the treatment of depression, Alzheimer's disease, anxiety, or other indications; 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 applications; 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; and other risks detailed in from time to time in the Company's filings with the SEC.

SOURCE Cyberonics, Inc.
Web Site: http://www.cyberonics.com

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