HOUSTON, Feb. 17 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that the first patient was enrolled in its E20 Phase IV epilepsy study of patients with less chronic and less resistant medically refractory partial onset seizures. The E20 study is a Phase IV, post- approval, multi-center, open-label, parallel-group, active treatment control trial comparing patients who have partial seizures refractory to at least two, but not more than five, anticonvulsant medications treated with adjunctive VNS Therapy(TM) plus standard of care treatment-as-usual to patients treated with only standard of care treatment-as-usual (no VNS) over a one-year period. The E20 study will enroll up to 360 patients over the age of 12 at 40 study sites. Nineteen of the forty study sites are under contract and five of those sites have IRB approvals.
"The combination of final approval of the proposed treatment-resistant depression indication, if and when received, and new post-approval studies will increase the clinical knowledge of VNS Therapy and facilitate a repositioning of VNS in a unique market position in epilepsy, seven years after launch," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "We expect that patient enrollments and the number of study sites under contract and with IRB approval will not only accelerate in E20, but also in E21, a comparison of VNS Therapy and treatment-as-usual in epilepsy patients who are not epilepsy surgery candidates, in the coming months. These are the first large scale epilepsy studies that Cyberonics has sponsored since approval in 1997. Similar to the MADIT and AVID cardiac defibrillator studies done in the late nineties, we believe that these new epilepsy studies will not only increase clinical knowledge but also increase the awareness and acceptance of VNS as a treatment for patients who are today infrequently treated with VNS, although their illness is within the VNS indication for use."
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 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 in the patient's neck 24 hours a day. The Company's initial market is 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 member countries of the European Economic Area, Canada, Australia and other markets. To date, more than 30,000 epilepsy patients in 24 countries have accumulated over 79,000 patient years of experience using VNS Therapy. The VNS Therapy System was deemed approvable in writing by the FDA on February 2, 2005 as an adjunctive treatment for chronic treatment-resistant depression for adults over the age of 18. According to FDA's approvable letter, final approval was conditional on final labeling, final protocols for a post-approval dosing optimization study and patient registry, satisfactory compliance with the Quality System Regulations (QSR) and satisfactory resolution of any outstanding bioresearch monitoring issues. 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). 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/ .
FORWARD LOOKING STATEMENTS
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 obtaining final FDA approval for the treatment-resistant depression indication, enrolling additional patients in the E20 and E21 clinical studies, contracting with additional study sites, obtaining IRB approval at additional study sites, repositioning of VNS Therapy in a unique market position in epilepsy, and increasing clinical knowledge, awareness, and acceptance of VNS Therapy as a treatment for its labeled indications. 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 and/or regulatory approval 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.
"The combination of final approval of the proposed treatment-resistant depression indication, if and when received, and new post-approval studies will increase the clinical knowledge of VNS Therapy and facilitate a repositioning of VNS in a unique market position in epilepsy, seven years after launch," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "We expect that patient enrollments and the number of study sites under contract and with IRB approval will not only accelerate in E20, but also in E21, a comparison of VNS Therapy and treatment-as-usual in epilepsy patients who are not epilepsy surgery candidates, in the coming months. These are the first large scale epilepsy studies that Cyberonics has sponsored since approval in 1997. Similar to the MADIT and AVID cardiac defibrillator studies done in the late nineties, we believe that these new epilepsy studies will not only increase clinical knowledge but also increase the awareness and acceptance of VNS as a treatment for patients who are today infrequently treated with VNS, although their illness is within the VNS indication for use."
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 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 in the patient's neck 24 hours a day. The Company's initial market is 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 member countries of the European Economic Area, Canada, Australia and other markets. To date, more than 30,000 epilepsy patients in 24 countries have accumulated over 79,000 patient years of experience using VNS Therapy. The VNS Therapy System was deemed approvable in writing by the FDA on February 2, 2005 as an adjunctive treatment for chronic treatment-resistant depression for adults over the age of 18. According to FDA's approvable letter, final approval was conditional on final labeling, final protocols for a post-approval dosing optimization study and patient registry, satisfactory compliance with the Quality System Regulations (QSR) and satisfactory resolution of any outstanding bioresearch monitoring issues. 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). 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/ .
FORWARD LOOKING STATEMENTS
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 obtaining final FDA approval for the treatment-resistant depression indication, enrolling additional patients in the E20 and E21 clinical studies, contracting with additional study sites, obtaining IRB approval at additional study sites, repositioning of VNS Therapy in a unique market position in epilepsy, and increasing clinical knowledge, awareness, and acceptance of VNS Therapy as a treatment for its labeled indications. 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 and/or regulatory approval 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.
