
Profile
Cyberonics designs, develops and markets implantable medical devices for the long-term treatment of epilepsy, depression, and other chronic disorders using the unique patented therapy, vagus nerve stimulation (VNS Therapy™)
Ownership
Public Company (NASDAQ: CYBX) founded in 1987.
Offices
With approximately 500+ full-time employees, corporate headquarters are in Houston, Texas, with an international subsidiary, Cyberonics Europe, S.A., located in Brussels, Belgium.
Management:
Daniel. J. Moore, President and Chief Executive Officer
Gregory H. Browne, Vice President, Finance and Chief Financial Officer
George E. Parker III, VP, Human Resources and Depression General Manager
James A. Reinstein, VP, Sales and Marketing and International General Manager
Richard L. Rudolph M.D., VP, Clinical, Regulatory and Medical Affairs and CMO
Randal L. Simpson, VP, Quality, Operations and R&D
David S. Wise, VP,General Counsel and Secretary
Principal Product
Cyberonics manufactures one product, the VNS Therapy System. The 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 seizures which are refractory to antiepileptic medications.
On July 15, 2005 , FDA approved VNS Therapy as a long-term adjunctive treatment for patients 18 years of age or older with chronic or recurrent treatment-resistant depression in a major depressive episode and have not responded to at least four adequate antidepressant treatments. Chronic treatment-resistant depression is defined as being in the current depressive episode for more than two years. Recurrent treatment-resistant depression is defined as having a history of multiple prior episodes of depression. The approved indication for use includes patients with unipolar or bipolar depression in a major depressive episode.
VNS Therapy consists of an implanted pacemaker-like device that delivers mild, intermittently pulsed electrical signals to the patient’s left vagus nerve, which then activates various areas of the brain. Stimulation of the left vagus nerve has been shown to induce widespread bilateral effects in areas of the brain implicated in seizures.
In addition to the U.S., the VNS Therapy System is currently approved for sale as a treatment for epilepsy in all the member countries of the European Union, Canada, Australia and other markets. VNS Therapy is also approved for sale in the European Union and in Canada as a treatment of depression in patients with treatment-resistant or treatment-intolerant major depressive episodes including unipolar depression and bipolar disorder, also known as manic depression.
To date, more than 32,000 patients in 24 countries have accumulated over 94,000 patient years of experience using VNS Therapy.
Other Research Initiatives
The VNS Therapy System is at various levels of investigational clinical study as a potential treatment Alzheimer’s Disease, anxiety, chronic migraine headache and bulimia.
Patent Portfolio
Cyberonics holds the rights to numerous device patents, covering the generator and electrode, as well as method patents, covering the application of a pulsed electrical signal to the vagus, trigeminal and glossopharyngeal nerves.
Media Contacts
Helen Shik or Sherry Feldberg
Schwartz Communications, Inc.
781.684.0770
cyberonics@schwartz-pr.com
Investor Relations
Cyberonics, Inc.
800.332.1375
ir@cyberonics.com
|