HOUSTON, May 27 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that Cyberonics and its Chairman of the Board and Chief Executive Officer, Robert P. ("Skip") Cummins, were honored at the Epilepsy Foundation's Distinguished Achievement Awards Gala at Chelsea Piers in New York City on Thursday, May 26, 2005. In attendance were more than 500 thought-leaders and advocates in the epilepsy community. Actress Garcelle Beauvais-Nilon hosted the event and presented the Distinguished Achievement Award to Robert Cummins. Cyberonics and the Epilepsy Foundation are dedicated partners in the battle to improve the quality of life of people with epilepsy. The Distinguished Achievement Award honors Cyberonics and Mr. Cummins for their Innovation and creativity in the development of new treatment options to improve the lives of people touched by epilepsy.
"Cyberonics and its Chairman, Skip Cummins are to be commended for their commitment and perseverance in improving the lives of people touched by epilepsy. This award is our way of honoring these achievements," said Eric Hargis, CEO of The National Epilepsy Foundation.
Cyberonics Chairman and CEO Robert Cummins stated, "We are honored to be the recipient of the Epilepsy Foundation Distinguished Achievement Award and to be recognized for Cyberonics' unwavering commitment to people with refractory epilepsy. Since FDA approval in 1997, more than 32,000 Americans have accumulated over 80,000 patient years of experience with our patented therapy. VNS Therapy has clearly not just survived, but thrived in commercial use considering that (1) the commercial safety and effectiveness of VNS Therapy is equivalent to or better than the safety and effectiveness data from the studies found in our epilepsy labeling and (2) approximately 75% of patients elect generator replacement at the end of battery life.
"Cyberonics is looking forward to FDA's final treatment-resistant depression approval decision, so that VNS Therapy can begin to have a similar positive effect on the lives of millions of Americans touched by TRD," continued Mr. Cummins. "If the VNS that was deemed approvable in early February is approved, (1) it will be the first FDA approved treatment specifically for TRD, (2) it will be the only antidepressant that has proven safety and effectiveness over a two-year period, and (3) it will be the first antidepressant with fully informative labeling and rigorous post-market surveillance. Final approval will benefit not only millions of Americans with TRD, but also hundreds of thousands of Americans with refractory epilepsy, who also suffer from depression, the most common comorbidity in epilepsy."
The Epilepsy Foundation is the national, nonprofit, voluntary organization that leads the fight to ensure that people with epilepsy are able to participate in all life experiences. The Epilepsy Foundation is committed to the prevention, control and cure of epilepsy through research, education, advocacy and patient services. They strive for a positive quality of life for everyone whose life is touched by seizures. Nationwide, their work is carried out by a network of local Epilepsy Foundations serving 125 communities.
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 FDA approval of VNS Therapy for treatment-resistant depression. 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 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; our ability to hire, train and retain personnel; the accuracy of management's estimates of future events, sales, expenses and earnings; and other risks detailed from time to time in the Company's filings with the SEC.
CONTACT: Pamela B. Westbrook, Vice President of Finance and CFO ofCyberonics, Inc., +1-281-228-7200, or fax, +1-281-218-9332, firstname.lastname@example.org ; or Helen Shik, Vice President of SchwartzCommunications, +1-781-684-0770, or fax, +1-781-684-6500, email@example.com , for Cyberonics, Inc.