Posted by jrbecker on July 23, 2003, at 11:07:29
http://www.biospace.com/news_story.cfm?StoryID=13289720&full=1
Cyberonics Inc. (CYBX) To Announce Depression Causality Results On Wednesday, July 23, 2003
HOUSTON, July 18 /PRNewswire-FirstCall/ -- Cyberonics, Inc. intends to announce the results from its depression pivotal study causality analysis plan on Wednesday, July 23, 2003 before the market opens. The causal relationship between VNS Therapy(TM) and the D-02 study patients' highly statistically significant and clinically significant one-year outcomes reported in January 2003 will be determined using a repeated measures linear regression analysis to compare depression improvements over one year in the D-02 patients receiving VNS Therapy and treatment as usual with the outcomes of patients in a companion study, D-04, receiving only treatment as usual (no VNS). In D-04, patients with chronic or recurrent treatment resistant depression who met the critical D-02 inclusion criteria were treated with standard medical management at 13 total study sites including 12 of the 21 D-02 study sites.A conference call to discuss the results will be held at 9:00 AM EDT on Wednesday, July 23, 2003. The depression results, a revised U.S. regulatory plan and a revised long-term Cyberonics business plan will be presented and discussed by Robert P. ("Skip") Cummins, Chairman of the Board and Chief Executive Officer; Richard L. Rudolph, M.D., Vice President, Clinical Medical Affairs and Chief Medical Officer; Alan D. Totah, Vice President, Regulatory Affairs and Quality; Michael A. Cheney, Senior Vice President, Marketing and Sales; and Pamela B. Westbrook, Vice President, Finance and Administration and Chief Financial Officer.
Conference Call Instructions
Two separate phone lines are necessary to access the conference call and Internet presentation. The audio portion of the conference call may be accessed by dialing 877-451-8943 (if dialing from within the U.S.) or 706-679-3062 (if dialing from outside the U.S.). The conference ID is 1590979; the leader is Pam Westbrook. A replay of the audio portion of the conference call will be available two hours after the completion of the conference call on Wednesday, July 23, 2003 through Wednesday, August 6, 2003 by dialing 800-642-1687 (if dialing from within the U.S.) or 706-645-9291 (if dialing outside the U.S.). The replay conference ID access code is 1590979.
You may access the Cyberonics Internet presentation site via the PresentPLUS Gateway address http://www.presentplus.com/conference/gateway.html . To test your system in advance, take the instant system check by clicking on the PresentPLUS Gateway link above, then select Browser Check from the available options. If you encounter difficulty, support solutions will be provided, or you may call PresentPLUS toll-free at 877-549-3137 or email support@presentplus.com with your telephone number for an immediate call back. Once proper compatibility is confirmed, the presentation site can be accessed 10 minutes prior to the scheduled start, beginning at 8:50 AM EDT on Wednesday, July 23, 2003. Click on the link http://www.presentplus.com/conference/gateway.html , then click on "Attendee Login" from the available options. The event name and password is xcyberonics.
ABOUT VNS AND CYBERONICS
Cyberonics, Inc. was founded in 1987 to design, develop and market medical devices for the long-term treatment of epilepsy 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 24 hours a day. The Company's initial market is epilepsy, which is 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 22,000 epilepsy patients in 24 countries have accumulated over 56,000 patient years of experience using VNS Therapy. VNS Therapy is at various levels of investigational clinical study as a potential treatment for depression, anxiety disorders, Alzheimer's disease, and chronic headache/migraine. 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). 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/ .
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 our anticipated announcement of recent depression clinical study results. We can provide no assurances as to the outcome of such studies, any follow up studies, nor to our ultimate ability to commercialize VNS as a treatment for depression or any other indication. Important factors that could materially impact such application include the results of the depression study which we expect to announce on July 23, 2003; the results of any future depression clinical trials and/or market studies 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.
CONTACT: Pamela Westbrook, Vice President of Finance and CFO of Cyberonics, Inc., +1-281-228-7200, or fax, +1-281-218-9332, orpbw@cyberonics.com ; or Helen Shik, Vice President of Schwartz Communications, +1-781-684-0770, ext. 6587, or fax, +1-781-684-6500, orhshik@schwartz-pr.com , for Cyberonics, Inc.Web site: http://www.presentplus.com/conference/gateway.html
http://www.cyberonics.com/
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