HOUSTON, April 28 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that 22 medical centers from across the country are actively enrolling patients in a landmark patient registry of treatment- resistant depression (TRD) and Vagus Nerve Stimulation (VNS) Therapy. Among the centers participating so far in the TRD Registry are Columbia University/New York Presbyterian Hospital, Massachusetts General Hospital, Sheppard Pratt Health System, UT Southwestern Medical Center at Dallas, Medical University of South Carolina, University of Connecticut Health Center, SUNY Upstate Medical University at Syracuse, Oregon Health & Science University, University of Florida, University of South Florida, Wake Forest University, Florida Atlantic University, University of Mississippi Medical Center, Buffalo Medical Group, University of Pittsburgh, Henry Ford Health System, University of Massachusetts, University of Utah, Medical College of Virginia and Rush-Presbyterian Chicago.
The TRD Registry is overseen by the TRD Registry Advisory Board led by Martin B. Keller, M.D., Mary E. Zucker Professor and Chairman, Department of Psychiatry and Human Behavior, Brown Medical School, Providence, RI. The objective of the TRD Registry is to follow the clinical course and outcome for patients with TRD treated with and without adjunctive VNS Therapy. This is a longitudinal, prospective, observational, multi-site patient outcome registry. The TRD Registry will enroll 2,000 patients with chronic or recurrent depression who are experiencing a major depressive episode and have not had an adequate response to four or more adequate treatments. Half of the patients in the registry will receive adjunctive VNS Therapy. Thirty patients, of which 25 receive VNS Therapy, have already been enrolled in the registry.
In all, up to 100 centers will enroll and follow patients for up to five years. In addition to the 22 sites now enrolling patients, an additional 20 sites are in the final stages of approval to participate. The TRD Registry will greatly enhance understanding of TRD as well as VNS Therapy among psychiatrists, patients and payers. It is estimated that more than four million Americans experience TRD.
“Cyberonics is extremely proud to launch the first TRD patient registry, part of our ongoing commitment to post-market development,” said Richard L. Rudolph, M.D., Cyberonics’ Vice President, Clinical and Medical Affairs and Chief Medical Officer. “We have been working closely with Dr. Keller and the TRD Registry Advisory Board to develop a comprehensive TRD registry that will enhance the medical community’s understanding of TRD, predictors of response and remission and long-term patient outcomes for this severely ill subset of patients with major depressive disorder. We are confident that our TRD objectives will be achieved based on our experience with the first refractory epilepsy registry, which Cyberonics started in 1998.”
“I am pleased to lead the effort to capture patient experience with TRD and VNS Therapy for the TRD patient registry. Our goal is to improve our collective insight into this debilitating and difficult-to-treat condition and improve our understanding of patient outcomes with TRD and VNS Therapy. We finally have an FDA-approved therapy to offer patients with TRD as an alternative to or in addition to medications and I’m looking forward to working closely with the TRD Registry Advisory Board on this important research initiative,” said Dr. Keller.
The FDA approved 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 FDA-approved implantable device-based treatment for depression and the first treatment developed, studied, approved and labeled specifically for patients with TRD. Recent peer-reviewed data published in Biological Psychiatry and the Journal of Clinical Psychiatry confirm the association of VNS Therapy with significant antidepressant benefits that are sustained and/or increase over time for patients with chronic or recurrent treatment-resistant depression.
ABOUT VNS THERAPY AND CYBERONICS
Information on Cyberonics, Inc. and VNS Therapy is available at http://www.cyberonics.com and http://www.vnstherapy.com .
SAFE HARBOR STATEMENT
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. 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. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning the number of registry sites and the number of and timing for enrollment of patients in the registry. 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 Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to Cyberonics’ most recent filings with the SEC, including its Form 10-K for the fiscal year ended April 29, 2005.
Cyberonics, Inc.
CONTACT: Investor Relations of Cyberonics, Inc., +1-281-228-7262, or fax,+1-281-218-9332, or ir@cyberonics.com ; or Helen Shik, Vice President ofSchwartz Communications, +1-781-684-0770, or fax, +1-781-684-6500, orhshik@schwartz-pr.com , for Cyberonics, Inc.
