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September 15, 2005
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Journal of Clinical Psychiatry Publishes Two-Year Results From Cyberonics' Depression Pilot Study.
PR Newswire; 9/13/2005
42% Response and 22% Remission Rates Seen After Two Years of Adjunctive VNS
HOUSTON, Sept. 13 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that the peer-reviewed two-year results from its treatment-resistant depression D-01 pilot study were published in the September 2005 issue of the Journal of Clinical Psychiatry (J. Clin Psychiatry 66:9, September 2005). The article, entitled "Two-Year Outcome of Vagus Nerve Stimulation (VNS) for Treatment of Major Depressive Episodes," by Ziad Nahas, M.D., Associate Professor at Medical University of South Carolina (MUSC); Medical Director of Brain Stimulation Lab at MUSC; and Director of Mood Disorder Program at MUSC, et al, presents the three-month, one-year and two- year response and remission rates from the 60-patient VNS pilot study conducted at Medical University of South Carolina, Baylor College of Medicine, University of Texas Southwestern Medical Center and Columbia University. Based on last observation carried forward analyses, HAM-D response rates were 42% and HAM-D remission rates were 22% after two years of adjunctive VNS Therapy(TM) in patients that had received a mean of 15.7 unsuccessful clinical treatments in the current depressive episode, the median of which was 6.8 years. At two years, 81% of the study participants were still receiving VNS Therapy.
"The two-year results from the D-01 pilot study for VNS Therapy found short-term and long-term benefits for more than one-third of treatment- resistant depression patients in the trial. Benefits seen at one year were largely sustained for the group at two years, and one of two initial responders continued to evidence response after two years," commented senior author Mark George, M.D., Distinguished Professor of Psychiatry, Radiology and Neurosciences at the Medical University of South Carolina, who oversaw the first VNS implant for depression at MUSC in 1998. "These long-term data on these initial patients are part of a growing body of peer-reviewed literature further confirming the significant relationship between VNS Therapy and long- term improvements in overall presence of depression and its symptoms. VNS Therapy's availability for treatment-resistant depression patients provides a new option to try when first-line treatments are unable to provide relief from chronic depression."
"Publication of the scientific evidence that was the foundation for FDA approval in respected peer-reviewed journals such as Journal of Clinical Psychiatry facilitates well-informed decisions by psychiatrists and payers and accomplishment of Cyberonics' mission to improve the lives of people touched by treatment-resistant depression," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "This publication follows the recent publication of important long-term data from the D-02 pivotal study showing sustained and/or improving response and remission rates in three peer-reviewed articles in Biological Psychiatry. We expect that the body of compelling, peer-reviewed evidence supporting the use and third-party payer coverage of VNS Therapy in treatment-resistant depression will grow rapidly in the coming months.
"The momentum in peer-reviewed publications is consistent with the overall momentum that has been built in the physician, payer and patient communities in first month of the TRD launch," continued Mr. Cummins. "Almost 3,000 TRD patients have requested information from Cyberonics and over 1,000 of those are actively moving through our education and insurance verification and prior authorization processes. Interestingly, the number of TRD patients identified by their psychiatrists as VNS candidates quarter to date is essentially the same as the number of epilepsy candidates identified by neurologists. We are also making good progress with physician education. We plan to educate over 5,000 psychiatrists and VNS surgeons in fiscal 2006 and so far our regional education and training programs have been largely oversubscribed. In terms of TRD coverage, coding and reimbursement, with AMA's approval of the VNS programming codes for use in TRD, the remaining challenge is obtaining case- by-case and regional and national coverage. While there is much work to be done, we are pleased with our progress towards national coverage policies and with the favorable case-by-case coverage decisions obtained from a variety of payers by our Case Management team. Although VNS Therapy clearly has momentum in TRD, we expect that at least three quarters will be required for us to have a clear understanding of TRD patient conversion rates and cycle times from identification to implant."
The publication of peer-reviewed data follows FDA approval of VNS Therapy as an adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
VNS Therapy is the first implantable device-based treatment for depression and the first treatment specifically developed, studied, approved and labeled for treatment-resistant depression. In addition to treatment-resistant depression and pharmacoresistant epilepsy indications, VNS Therapy is at various stages of investigational clinical studies as a potential treatment for anxiety disorders, Alzheimer's disease, bulimia and chronic headache/migraine.
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 treatment-resistant disorders using a unique therapy, vagus nerve stimulation (VNS). Stimulation is delivered by the VNS Therapy System(TM), 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 was 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 European Economic Area, Canada, Australia and other markets. To date, more than 32,000 epilepsy patients in 24 countries have accumulated over 100,000 patient years of experience using VNS Therapy.
The VNS Therapy System was approved by the FDA on July 15, 2005 "as an adjunctive long-term treatment for chronic or recurrent depression for patients 18 years of age and older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments." As part of FDA's approval order, Cyberonics is required to conduct a 450-patient post-market dosing study and a 1,000- patient, five-year patient outcome registry. For more information on VNS Therapy for treatment-resistant depression, including the contraindications, warnings and precautions, see the Physician's and Patient's Manuals and other information at http://www.cyberonics.com/ or http://www.vnstherapy.com/ or call 1-877-NOW 4 VNS.
The VNS Therapy System has been 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) since 2001.
Company is headquartered in Houston, Texas and has an office in Brussels, Belgium. For additional information please visit us at http://www.cyberonics.com/ .
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 future publication of important peer-reviewed journal articles related to VNS Therapy for treatment-resistant depression and the need for at least three quarters for us to have a clear understanding of TRD patient conversion rates and cycle times from identification to implant. 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 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 from time to time in the Company's filings with the SEC.
CONTACT: Pamela B. Westbrook, Vice President of Finance and CFO of Cyberonics, Inc., +1-281-228-7200, or fax, +1-281-218-9332, or firstname.lastname@example.org ; or Helen Shik, Vice President of Schwartz Communications, +1-781-684-0770, or fax, +1-781-684-6500, or email@example.com , for Cyberonics, Inc.
Web site: http://www.cyberonics.com/ http://www.vnstherapy.com/
COPYRIGHT 2005 PR Newswire Association LLC
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The Warning Signs Of An Impending Bipolar Disorder Manic Episode
Bipolar disorder - as the name implies - involves two distinct set of symptoms. One set throws the individual down into the depths of a massive depression. The other places the individual who suffers with bipolar disorder at the top of a peak manic episode.
Most everyone can eventually recognize the warning signs of an impending depressive episode related to bipolar disorder. More likely than not, individuals with bipolar disorder try very hard to avoid it.
However, for many individuals with bipolar disorder, it's more difficult to recognize the signs of an impending manic episode. After all, a manic episode of bipolar disorder can be mistaken in some cases - especially in the very early formation -- for the lifting of the corresponding mood swing of the depression.
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