Promising Results for Cyberonics' VNS Therapy(TM) in Patients With Bulimia, University of Minnesota Researchers Report

Main Category: Eating Disorders
Article Date: 05 Mar 2005 - 5:00 PDT

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Cyberonics, Inc (Nasdaq: CYBX) today announced promising initial pilot study results from a study of VNS Therapy in patients with bulimia nervosa at the University of Minnesota's Neuroscience Research Center. The pilot study is designed to evaluate whether or not VNS Therapy reduces the episodes of binging and vomiting that are the hallmark of bulimia by reversing the physiological changes that occur in the function of the vagus nerve. The National Institutes of Health provided a $300,000 grant to the University of Minnesota to fund the study. To date, six patients have been treated with VNS Therapy. All reported significant reductions in episodes of binging/vomiting.

According to Patricia Faris, Ph.D., Associate Professor and the study's principal investigator, "All six patients have experienced dramatic results.

What's most impressive about these early results is that the women taking part had severe bulimia and had not responded to numerous traditional treatments.

If these results hold up in a larger study, this will be the first real hope for severely ill individuals to have a complete remission of symptoms."

"Cyberonics' mission is to improve the lives of people touched by epilepsy, depression and other treatment-resistant chronic disorders," commented Robert P. ("Skip") Cummins, Chairman of the Board and Chief Executive Officer. "Part of Cyberonics' plan to accomplish that mission and become the neuromodulation market leader following final depression approval is to accelerate the development of several new patent-protected VNS indications. To date we have completed or have currently underway several pilot studies in potential new VNS indications such as Alzheimer's Disease, anxiety, chronic headache and bulimia. We plan to begin a pivotal trial in one new VNS indication in the next year and a second new indication the year after. An estimated one million Americans suffer from treatment-resistant bulimia nervosa and today have no safe and effective treatment for their chronic and debilitating illness. We are very encouraged by Dr. Faris' important findings."

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 FDA approval for the treatment-resistant depression indication, becoming the neuromodulation market leader, developing potential new VNS indications such as Alzheimer's Disease, anxiety, chronic headache and bulimia, and commencing new pivotal trials for new indications and the timetable for the new trials. 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.

Cyberonics, Inc.
http://www.cyberonics.com

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