Cyberonics, Inc. Receives FDA Approval for a 30 Patient Pilot Study of VNS as a Treatment for Chronic Migraine Headache; Up to 28 Million Americans Suffer from Migraine Headache.

Business Editors & Health/Medical Writers

HOUSTON--(BUSINESS WIRE)--July 19, 2001

Cyberonics, Inc. (NASDAQ/NMS:CYBX) today announced that the United States Food and Drug Administration (FDA) has granted Cyberonics an Investigational Device Exemption (IDE) for a 30 patient pilot study to assess the preliminary safety and efficacy of Vagus Nerve Stimulation (VNS) with the Cyberonics NeuroCybernetic Prosthesis (NCP(R)) System in treating patients with chronic migraine headache.

Up to 30 patients at four study sites will be implanted with the NCP System and treated with left cervical (neck area) vagus nerve stimulation similar to the VNS being used to treat patients with epilepsy, depression and Alzheimer's Disease.

According to the National Headache Foundation (www.headaches.org/factsheet.html), over 45 million Americans suffer from chronic, recurring headaches. Of these, 28 million annually suffer from migraines. Seventy percent of all migraine headache sufferers are women. Chronic migraine headache patients are treated with a wide variety of chronic prescription treatments including antidepressants, beta blockers, calcium channel blockers, and anticonvulsants. Despite the availability of effective treatments for acute migraine headache, patients who suffer from chronic migraine headache seldom experience complete relief of their migraine headache pain. It is estimated that migraine headache costs U.S. employers a total of $50 billion per year including medical expenses and more than 157 million lost workdays each year. In excess of $4 billion are spent annually on over-the-counter pain relievers for headache. Many of these treatments are ineffective for the headache sufferer.

"Cyberonics is committed to the timely development of new indications covered by our extensive method patent portfolio," said Robert P. ("Skip") Cummins, Cyberonics' Chairman and Chief Executive Officer. "Observations from VNS mechanism of action research and anecdotal reports of improvement in headaches in epilepsy and depression patients suggest that VNS may be an effective treatment for chronic migraine headache. We expect to begin the chronic migraine headache pilot within the next few months. Once the chronic migraine headache pilot study is underway, our new indications development pipeline will include the depression phase III pivotal study, phase II pilot studies of left cervical (neck area) VNS as a treatment for anxiety, Alzheimer's Disease and headache and a phase I pilot study of bilateral chest area VNS as a treatment for obesity."

Vagus Nerve Stimulation was approved by the FDA in 1997 for the treatment of refractory partial onset seizures in epilepsy patients. Positive effects on the moods of epilepsy patients treated with VNS led researchers to study the therapy as a possible treatment for depression. Preliminary clinical results showed VNS to be a promising treatment option for low to moderate treatment-resistant depression. Lifetime prevalence of major depression is approximately three times higher in persons with migraines and in persons with severe headaches compared with controls. Antidepressant medications, such as the serotonin reuptake inhibitors (SSRIs) and anticonvulsants, such as valproic acid, are commonly used in the treatment of chronic migraine headache. The successful use of anticonvulsants and antidepressants in the treatment of chronic migraine headache and the demonstration of VNS as an anticonvulsant and preliminarily as an antidepressant was one of the main rationales for the initiation of this study of VNS in patients with chronic migraine headache.

The NCP System, also referred to as a "pacemaker for the brain" consists of a pocket watch sized generator implanted under the skin in a patient's chest. A lead wire from the device is then tunneled up the neck, and coils at the end of the wire are wrapped around the vagus nerve in the neck. Using a laptop computer and programming wand, the neurologist programs the NCP System to deliver regular, mild electrical stimulation to the vagus nerve. The NCP System has been clinically proven to decrease the frequency of, and in some patients completely eliminate, partial onset seizures. Patients may also pass a magnet over the device when they sense a seizure coming up for an extra dose of stimulation to decrease the severity or stop a seizure in its tracks.

About Cyberonics

Cyberonics, Inc. was founded in 1987 to design, develop and market medical devices for the treatment of patients with epilepsy and other debilitating disorders using a unique therapy, vagus nerve stimulation (VNS). VNS therapy is delivered by the Cyberonics NeuroCybernetic Prosthesis (NCP(R)) System, a pacemaker-like implantable medical device which delivers mild electrical stimulation to the left vagus nerve in the patient's neck. The NCP System is approved as a treatment for epilepsy in all the member countries of the European Union, Canada, Australia, the United States and other markets, as well as for treatment of depression in patients with treatment resistant or treatment intolerant major depressive episodes including unipolar depression and bipolar disorder (manic depression) in the European Union and Canada. A 235 patient randomized phase III pivotal study of VNS for chronic and recurrent depression is currently underway in the United States. Investigations of VNS as a potential treatment for obesity, anxiety disorders and Alzheimer's Disease are ongoing. The NCP System and VNS therapy are covered by a variety of method and device patents. Cyberonics is headquartered in Houston, Texas, USA, with an office in Belgium. For additional information please visit us at www.cyberonics.com.

NCP is a registered trademark of Cyberonics, Inc.

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. Such forward-looking statements include statements concerning: developing VNS as a treatment for depression, obtaining reimbursement for the treatment of depression in approved markets and gaining market acceptance in the European depression market. These predictions 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: ongoing safety and efficacy of VNS with the Cyberonics NCP System; the overall rate of demand for the Company's products; the Company's ability to hire, train and retain key personnel; the Company's ability to maintain all appropriate regulatory approvals; and management's ability to accurately forecast future events. For further discussion of these and other important factors that could affect the Company's activities and results, please refer to the Company's Annual Report on Form 10-K for the year ended June 30, 2000 and the Company's Quarterly Reports on Forms 10-Q for the three months ended September 30, 2000, December 31, 2000 and March 31, 2001.