Posted by jrbecker on June 11, 2003, at 11:07:32
In reply to VNS study results to be released soon, posted by jrbecker on June 11, 2003, at 10:50:12
Well, I guess the preliminary results are have already just been released...according to Jim McManamy of McMan's Depression and Bipolar Web, the response rate was 31 percent for actual completers of the 12-month study.
http://www.mcmanweb.com/news.htm> 06/09/2003
>
> Cyberonics Announces Depression Disclosure Timetable
>
> HOUSTON, June 9 /PRNewswire-FirstCall/ -- Cyberonics, Inc. expects to announce the results of its depression pivotal study causality analysis, and release a revised U.S.
>
> PR via NewsEdge Corporation : HOUSTON, June 9 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX) expects to announce the results of its depression pivotal study causality analysis, and release a revised U.S. depression regulatory plan and a revised five-year business plan in July 2003. The Company will host a dinner program for investors and analysts, "The Future of VNS Therapy(tm)," on Wednesday, September 24, 2003 at the Plaza Hotel in New York City from 5:00 PM to 10:00 PM during the UBS Warburg Healthcare Conference. A conference call to discuss the depression disclosure timetable and the recent redeployment and realignment of U.S. sales resources will be held at 4:00 PM EDT today.
>
> "Cyberonics will provide investors with clarity on our five year business plan and the future of VNS Therapy immediately following final determination of depression causality," commented Robert P. Cummins, Cyberonics' Chairman and Chief Executive Officer. "Today on the conference call, we will discuss the depression timetable and Michael Cheney, Senior Vice President Marketing and Sales and Steve Jennings, our new Vice President Sales, both of whom were at our national sales meeting during last week's conference call, will provide investors with an update on the redeployment of our U.S. sales resources into a classic specialty pharmaceutical sales model. We will enter the pre- causality quiet period on June 16, 2003."
>
> The causal relationship between VNS Therapy and the depression pivotal study patients' highly statistically significant and clinically significant one-year outcomes will be determined in July 2003 using a repeated measures linear regression analysis to compare depression improvements over one year in approximately 190 D-02 patients receiving VNS Therapy and treatment as usual with the outcomes of approximately 100 patients in a companion study, D-04, receiving only treatment as usual. 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. Cyberonics' revised U.S. depression regulatory plan and a revised five-year corporate business plan will be released at the same time as the causality results.
>
> "The Future of VNS Therapy" dinner program will occur on Wednesday, September 24, 2003 at the Plaza Hotel in New York City from 5:00 PM to 10:00 PM during the UBS Warburg Healthcare Conference. Presentations will be made by Cyberonics management and by epileptologists and psychiatrists involved in the VNS Therapy clinical studies. The VNS dinner program is open to the public and registration is available online at www.cyberonics.com .
>
> Scheduled speakers at the VNS dinner program include:
>
> -- A. John Rush, M.D., Professor and Vice Chairman of Research, Department of Psychiatry, University of Texas Southwestern
>
> -- Mark S. George, M.D., Professor of Psychiatry, Radiology and Neurology; Director, Functional Neuroimaging Division, Psychiatry; Director, Brain Stimulation Laboratory, Medical University of South Carolina
>
> -- Harold A. Sackeim, Ph.D., Professor of Clinical Psychology in Psychiatry & Radiology, Columbia University; Chief, Department of Biological Psychiatry, New York State Psychiatric Institute
>
> -- Lauren B. Marangell, M.D., Associate Professor of Psychiatry; Director, Mood Disorder Center, Baylor College of Medicine
>
> -- James Wheless, M.D., Professor of Neurology and Pediatrics, Department of Neurology; Director, Texas Comprehensive Epilepsy Program, The University of Texas Health Science Center at Houston; Director, Epilepsy Monitoring Unit, Memorial Hermann Children's Hospital
>
> -- Robert P. ("Skip") Cummins, Chairman and Chief Executive Officer, Cyberonics
>
> -- Michael A. Cheney, Senior Vice President Marketing and Sales, Cyberonics
>
> -- W. Steve Jennings, Vice President Sales, Cyberonics
>
> -- Richard L. Rudolph, M.D., Vice President Clinical and Medical Affairs, Cyberonics
>
> -- Pamela B. Westbrook, Vice President Finance, Cyberonics
>
> 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 1210032; 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 Monday, June 9, 2003 through Monday, June 23, 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 1210032.
>
> 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 3:50 PM EDT on Monday, June 9, 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 Union, Canada, Australia and other markets. To date, more than 20,000 epilepsy patients in 24 countries have accumulated over 50,000 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 Union 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 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 the timing of the release of the final determination of depression causality and our five year business plan. 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; 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.
>
> SOURCE Cyberonics, Inc.
>
> -0- 06/09/2003
>
> /CONTACT: Pamela Westbrook, Vice President of Finance and CFO of Cyberonics, Inc., +1-281-228-7200, or fax, +1-281-218-9332, or pbw
>
> cyberonics.com ; or Helen Shik, Vice President of Schwartz Communications, +1-781-684-0770 ext. 6587, or fax, +1-781-684-6500, or hshik
>
> schwartz-pr.com , for Cyberonics, Inc./
>
> /Web site: http://www.presentplus.com/conference/gateway.html http://www.cyberonics.com /
>
> (CYBX)
>
> CO: Cyberonics, Inc.; UBS Warburg
>
> ST: Texas, New York
>
> IN: HEA MTC BIO SPM FIN
>
> SU: CCA MAV
>
> JS-CD
>
> -- DAM027 --
>
> 0658 06/09/2003 10:13 EDT http://www.prnewswire.com
>
>
> << Copyright ©2003 PR Newswire >>
>
> http://www.psychiatry24x7.com/news/detail.jhtml?itemname=p0609044.8rw0
>
poster:jrbecker
thread:233159
URL: http://www.dr-bob.org/babble/20030609/msgs/233163.html