HOUSTON, Nov. 29 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced major upgrades to the TRD Insurance Coverage and Reimbursement Section of http://www.VNSTherapy.com . The website, http://www.VNSTherapy.com , was created to facilitate well-informed decisions by patients, families, healthcare professionals and payers regarding VNS Therapy(TM) for treatment-resistant depression (TRD) and epilepsy. The upgraded "TRD Insurance and Reimbursement" section, http://www.vnstherapy.com/depression/hcp/ReimbursementIns/default.aspx , specifically provides to the public, and most importantly to payers, psychiatrists, patients, families and hospitals, the most up-to-date information regarding case-by-case approvals and national coverage policies for VNS Therapy, the first and only FDA-approved treatment for TRD. The "TRD Insurance and Reimbursement" section includes all of the relevant FDA submissions which resulted in approval, links to important publications in peer-reviewed journals, FDA documents including FDA's Summary of Safety and Effectiveness, a list of payers that have approved and/or reimbursed at least one TRD implant and communications to/from payers, Cyberonics and psychiatrists regarding coverage policies and technology assessments.
"People whose lives are touched by TRD need, want and deserve non- discriminatory parity with people suffering from similarly life-threatening, disabling and expensive illnesses when it comes to access to FDA-approved treatments, including VNS Therapy," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "Americans with pharmaco-resistant epilepsy and their neurologists today have universal access to VNS Therapy, one of many FDA-approved treatments for medically refractory partial onset seizures, regardless of whether their insurance provider is Medicare, Medicaid or private payers. Such is not yet the case in TRD where Americans with TRD and their psychiatrists today have only limited access to VNS Therapy, the first and only treatment for TRD. Since approval in July of this year, over 1,200 well-informed and trained psychiatrists have sought Cyberonics' assistance in obtaining access to VNS Therapy for some 4,500 Americans with chronic or recurrent treatment-resistant depression as defined by VNS Therapy's FDA-approved indication for use. To date, less than 300 of those 4,500 Americans with TRD have received insurance approvals and/or been treated with VNS, the first and only FDA-approved treatment for their specific illness. Had the diagnosis of those 4,500 Americans with TRD been pharmaco-resistant epilepsy, access would be universal and largely automatic, and over 3,000 of them would have likely received VNS Therapy. Clearly this is not parity in access and is not acceptable to people whose lives are touched by TRD.
"The primary purpose of the new TRD Coverage and Reimbursement section of the VNS Therapy website is to facilitate and accelerate parity in access to VNS for Americans with TRD and their psychiatrists," continued Mr. Cummins. "Most payers make their case-by-case decisions, technology assessments and national coverage policies based primarily on publicly available information. Many payers refuse to meet with independent experts and/or listen to non- public presentations by experts, even in cases where there is only one FDA- approved treatment for a very specific and poorly understood life-threatening illness such as chronic or recurrent treatment-resistant depression. The new TRD Coverage and Reimbursement website not only makes all relevant information publicly available, but also provides unprecedented parity in access to VNS TRD coverage and reimbursement information to all stakeholders including payers' coverage policy makers and medical directors making case-by-case decisions, psychiatrists, patients, families, hospitals, patient advocacy organizations, state insurance commissioners, etc."
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 94,000 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.
VNS Therapy is at various levels of investigational clinical study as a potential treatment for anxiety disorders, Alzheimer's disease, chronic headache/migraine and bulimia. 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 .
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 epilepsy patients maintaining universal access to VNS Therapy and TRD patients gaining access to VNS Therapy through case-by-case approvals or national coverage policies. Our actual results may differ materially. 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, 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.
