HOUSTON, Jan. 18 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that FDA recently approved its request to officially close Investigational Device Exemption (IDE) G980099 covering all pre-market studies of VNS Therapy(TM) in chronic or recurrent treatment-resistant depression including the D-01 pilot study, the D-02 Pivotal Study and the D-20 Treatment IDE. No additional depression studies under an Investigational Device Exemption are currently underway or being planned by Cyberonics. To ensure that all TRD IDE study patients continue to have access to VNS Therapy, Cyberonics also announced today that it is providing a lifetime reimbursement guarantee to all study patients and VNS Therapy service providers, whereby Cyberonics will provide reimbursement for VNS Therapy services at standard rates in the event that third party payers deny post-approval coverage to patients in the D-01, D-02 and D-20 studies. Lastly, Cyberonics also announced a $15 million TRD Indigent Access Program, similar to its B.J. Wilder Therapy Access Program in epilepsy, to provide indigent Americans with TRD access to VNS Therapy. Cyberonics will provide up to 200 VNS Therapy Systems per year over a five year period in this program to qualified patients through experienced hospitals and trained psychiatrists.
“Cyberonics’ mission is to improve the lives of people touched by pharmaco-resistant epilepsy and treatment-resistant depression,” commented Robert P. (“Skip”) Cummins, Cyberonics’ Chairman of the Board and Chief Executive Officer. “Official closure by FDA of all TRD studies conducted under an Investigational Device Exemption, the lifetime reimbursement guarantee for TRD IDE study patients and the $15 million TRD Indigent Access Program will facilitate accomplishment of that mission by providing more Americans with TRD access to the first and only FDA-approved treatment option for their lifelong and life-threatening illness.
“All Americans with TRD should have access to VNS Therapy for its FDA-approved indication,” continued Mr. Cummins. “Although over 85 different third party payers, including 19 different Blue Cross/Blue Shield plans, United Healthcare, CIGNA, Aetna, Humana and several regional Medicare carriers have to date granted at least one American with TRD access to VNS Therapy (http://www.vnstherapy.com/depression/hcp/ReimbursementIns/casebycase.aspx ) and several State Medicaid programs now have the same coverage policy for both epilepsy and depression, all Americans with TRD do not yet have the same immediate, universal access to VNS Therapy that Americans with pharmaco- resistant epilepsy have had for at least the past five years. The combination of FDA approval, FDA’s Summary of Safety and Effectiveness, the official closure by FDA of all VNS Therapy TRD investigational studies, the rapidly building body of peer-reviewed evidence and post-approval appropriate use and favorable patient outcomes should convince all third party payers that VNS Therapy, the first and only treatment specifically developed, studied, approved and labeled for TRD, should be a covered benefit as indicated for fully-informed use. Lack of access to the only FDA-approved treatment option for TRD can, unfortunately, have tragic implications for Americans and their families. Cyberonics was recently made aware of one person with three children who had suffered from treatment-resistant depression for over 25 years who committed suicide following a VNS Therapy coverage denial by a major private payer. Cyberonics has taken the unprecedented steps with its lifetime reimbursement guarantee for study patients and its $15 million TRD Indigent Access Program, to ensure that study patients and indigent Americans with TRD have fully informed access to VNS Therapy. We continue to work diligently with all third party payers to provide them with all the information they need to follow our lead and give Americans with health insurance suffering from TRD the same universal access to VNS Therapy that Americans with epilepsy have had for over five years and that Cyberonics is now providing to TRD study patients and indigent Americans with no insurance.
“Official closure of the TRD IDE confirms that VNS Therapy for its approved indication for use, is neither experimental nor investigational,” concluded Mr. Cummins. “Studies under an Investigational Device Exemption are done to demonstrate the safety and effectiveness of devices for a proposed indication for use. We have no plans and there are no FDA requirements for Cyberonics to conduct further depression studies of VNS Therapy as an investigational device for its approved indication. Consistent with the post-market requirements of the majority of device approvals over the past five years, Cyberonics is required by FDA to conduct post-market studies. In our case, we originally planned, and were subsequently required by FDA’s approval order, to conduct a dosing study and long-term patient outcome registry to elucidate the optimal dosing, predictors of response and long-term outcomes of patients treated with post-approval VNS Therapy. Similar to our track record in epilepsy, Cyberonics’ post-approval TRD development plan goes well beyond the FDA approval requirements and includes mechanism of action research and several clinical studies all within the TRD approved indication for use. The purpose of these post-approval studies is to facilitate fully-informed use of VNS Therapy for the approved indication consistent with our mission to improve the lives of people touched by TRD.”
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, TRD patients gaining access to VNS Therapy through case-by-case approvals or national coverage policies, TRD patients gaining similar insurance coverage for VNS Therapy services as Americans with epilepsy and/or Cyberonics’ funding or completing post-approval TRD studies. 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 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.
