Journal of Clinical Psychiatry Publishes Two-Year Results From Cyberonics' Depression Pilot Study

42% Response and 22% Remission Rates Seen After Two Years of Adjunctive VNS



Sep 13, 2005, 01:00 ET from Cyberonics, Inc.

    HOUSTON, Sept. 13 /PRNewswire-FirstCall/ -- Cyberonics, Inc.
 (Nasdaq:   CYBX) today announced that the peer-reviewed two-year results from
 its treatment-resistant depression D-01 pilot study were published in the
 September 2005 issue of the Journal of Clinical Psychiatry (J. Clin Psychiatry
 66:9, September 2005).  The article, entitled "Two-Year Outcome of Vagus Nerve
 Stimulation (VNS) for Treatment of Major Depressive Episodes," by Ziad Nahas,
 M.D., Associate Professor at Medical University of South Carolina (MUSC);
 Medical Director of Brain Stimulation Lab at MUSC; and Director of Mood
 Disorder Program at MUSC, et al, presents the three-month, one-year and two-
 year response and remission rates from the 60-patient VNS pilot study
 conducted at Medical University of South Carolina, Baylor College of Medicine,
 University of Texas Southwestern Medical Center and Columbia University.
 Based on last observation carried forward analyses, HAM-D response rates were
 42% and HAM-D remission rates were 22% after two years of adjunctive VNS
 Therapy(TM) in patients that had received a mean of 15.7 unsuccessful clinical
 treatments in the current depressive episode, the median of which was 6.8
 years.  At two years, 81% of the study participants were still receiving VNS
 Therapy.
     "The two-year results from the D-01 pilot study for VNS Therapy found
 short-term and long-term benefits for more than one-third of treatment-
 resistant depression patients in the trial.  Benefits seen at one year were
 largely sustained for the group at two years, and one of two initial
 responders continued to evidence response after two years," commented senior
 author Mark George, M.D., Distinguished Professor of Psychiatry, Radiology and
 Neurosciences at the Medical University of South Carolina, who oversaw the
 first VNS implant for depression at MUSC in 1998.  "These long-term data on
 these initial patients are part of a growing body of peer-reviewed literature
 further confirming the significant relationship between VNS Therapy and long-
 term improvements in overall presence of depression and its symptoms.  VNS
 Therapy's availability for treatment-resistant depression patients provides a
 new option to try when first-line treatments are unable to provide relief from
 chronic depression."
     "Publication of the scientific evidence that was the foundation for FDA
 approval in respected peer-reviewed journals such as Journal of Clinical
 Psychiatry facilitates well-informed decisions by psychiatrists and payers and
 accomplishment of Cyberonics' mission to improve the lives of people touched
 by treatment-resistant depression," commented Robert P. ("Skip") Cummins,
 Cyberonics' Chairman of the Board and Chief Executive Officer.  "This
 publication follows the recent publication of important long-term data from
 the D-02 pivotal study showing sustained and/or improving response and
 remission rates in three peer-reviewed articles in Biological Psychiatry.  We
 expect that the body of compelling, peer-reviewed evidence supporting the use
 and third-party payer coverage of VNS Therapy in treatment-resistant
 depression will grow rapidly in the coming months.
     "The momentum in peer-reviewed publications is consistent with the overall
 momentum that has been built in the physician, payer and patient communities
 in first month of the TRD launch," continued Mr. Cummins.  "Almost 3,000 TRD
 patients have requested information from Cyberonics and over 1,000 of those
 are actively moving through our education and insurance verification and prior
 authorization processes.  Interestingly, the number of TRD patients identified
 by their psychiatrists as VNS candidates quarter to date is essentially the
 same as the number of epilepsy candidates identified by neurologists.  We are
 also making good progress with physician education.  We plan to educate over
 5,000 psychiatrists and VNS surgeons in fiscal 2006 and so far our regional
 education and training programs have been largely oversubscribed.  In terms of
 TRD coverage, coding and reimbursement, with AMA's approval of the VNS
 programming codes for use in TRD, the remaining challenge is obtaining case-
 by-case and regional and national coverage.  While there is much work to be
 done, we are pleased with our progress towards national coverage policies and
 with the favorable case-by-case coverage decisions obtained from a variety of
 payers by our Case Management team.  Although VNS Therapy clearly has momentum
 in TRD, we expect that at least three quarters will be required for us to have
 a clear understanding of TRD patient conversion rates and cycle times from
 identification to implant."
     The publication of peer-reviewed data follows FDA approval of 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 implantable device-based treatment for depression
 and the first treatment specifically developed, studied, approved and labeled
 for treatment-resistant depression.  In addition to treatment-resistant
 depression and pharmacoresistant epilepsy indications, VNS Therapy is at
 various stages of investigational clinical studies as a potential treatment
 for anxiety disorders, Alzheimer's disease, bulimia and chronic
 headache/migraine.
 
     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 100,000 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.
     Company is headquartered in Houston, Texas and has an office in Brussels,
 Belgium.  For additional information please visit us at
 http://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 future publication of important peer-reviewed journal
 articles related to VNS Therapy for treatment-resistant depression and the
 need for at least three quarters for us to have a clear understanding of TRD
 patient conversion rates and cycle times from identification to implant.
 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 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 SEC.
 
 

SOURCE Cyberonics, Inc.
    HOUSTON, Sept. 13 /PRNewswire-FirstCall/ -- Cyberonics, Inc.
 (Nasdaq:   CYBX) today announced that the peer-reviewed two-year results from
 its treatment-resistant depression D-01 pilot study were published in the
 September 2005 issue of the Journal of Clinical Psychiatry (J. Clin Psychiatry
 66:9, September 2005).  The article, entitled "Two-Year Outcome of Vagus Nerve
 Stimulation (VNS) for Treatment of Major Depressive Episodes," by Ziad Nahas,
 M.D., Associate Professor at Medical University of South Carolina (MUSC);
 Medical Director of Brain Stimulation Lab at MUSC; and Director of Mood
 Disorder Program at MUSC, et al, presents the three-month, one-year and two-
 year response and remission rates from the 60-patient VNS pilot study
 conducted at Medical University of South Carolina, Baylor College of Medicine,
 University of Texas Southwestern Medical Center and Columbia University.
 Based on last observation carried forward analyses, HAM-D response rates were
 42% and HAM-D remission rates were 22% after two years of adjunctive VNS
 Therapy(TM) in patients that had received a mean of 15.7 unsuccessful clinical
 treatments in the current depressive episode, the median of which was 6.8
 years.  At two years, 81% of the study participants were still receiving VNS
 Therapy.
     "The two-year results from the D-01 pilot study for VNS Therapy found
 short-term and long-term benefits for more than one-third of treatment-
 resistant depression patients in the trial.  Benefits seen at one year were
 largely sustained for the group at two years, and one of two initial
 responders continued to evidence response after two years," commented senior
 author Mark George, M.D., Distinguished Professor of Psychiatry, Radiology and
 Neurosciences at the Medical University of South Carolina, who oversaw the
 first VNS implant for depression at MUSC in 1998.  "These long-term data on
 these initial patients are part of a growing body of peer-reviewed literature
 further confirming the significant relationship between VNS Therapy and long-
 term improvements in overall presence of depression and its symptoms.  VNS
 Therapy's availability for treatment-resistant depression patients provides a
 new option to try when first-line treatments are unable to provide relief from
 chronic depression."
     "Publication of the scientific evidence that was the foundation for FDA
 approval in respected peer-reviewed journals such as Journal of Clinical
 Psychiatry facilitates well-informed decisions by psychiatrists and payers and
 accomplishment of Cyberonics' mission to improve the lives of people touched
 by treatment-resistant depression," commented Robert P. ("Skip") Cummins,
 Cyberonics' Chairman of the Board and Chief Executive Officer.  "This
 publication follows the recent publication of important long-term data from
 the D-02 pivotal study showing sustained and/or improving response and
 remission rates in three peer-reviewed articles in Biological Psychiatry.  We
 expect that the body of compelling, peer-reviewed evidence supporting the use
 and third-party payer coverage of VNS Therapy in treatment-resistant
 depression will grow rapidly in the coming months.
     "The momentum in peer-reviewed publications is consistent with the overall
 momentum that has been built in the physician, payer and patient communities
 in first month of the TRD launch," continued Mr. Cummins.  "Almost 3,000 TRD
 patients have requested information from Cyberonics and over 1,000 of those
 are actively moving through our education and insurance verification and prior
 authorization processes.  Interestingly, the number of TRD patients identified
 by their psychiatrists as VNS candidates quarter to date is essentially the
 same as the number of epilepsy candidates identified by neurologists.  We are
 also making good progress with physician education.  We plan to educate over
 5,000 psychiatrists and VNS surgeons in fiscal 2006 and so far our regional
 education and training programs have been largely oversubscribed.  In terms of
 TRD coverage, coding and reimbursement, with AMA's approval of the VNS
 programming codes for use in TRD, the remaining challenge is obtaining case-
 by-case and regional and national coverage.  While there is much work to be
 done, we are pleased with our progress towards national coverage policies and
 with the favorable case-by-case coverage decisions obtained from a variety of
 payers by our Case Management team.  Although VNS Therapy clearly has momentum
 in TRD, we expect that at least three quarters will be required for us to have
 a clear understanding of TRD patient conversion rates and cycle times from
 identification to implant."
     The publication of peer-reviewed data follows FDA approval of 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 implantable device-based treatment for depression
 and the first treatment specifically developed, studied, approved and labeled
 for treatment-resistant depression.  In addition to treatment-resistant
 depression and pharmacoresistant epilepsy indications, VNS Therapy is at
 various stages of investigational clinical studies as a potential treatment
 for anxiety disorders, Alzheimer's disease, bulimia and chronic
 headache/migraine.
 
     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 100,000 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.
     Company is headquartered in Houston, Texas and has an office in Brussels,
 Belgium.  For additional information please visit us at
 http://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 future publication of important peer-reviewed journal
 articles related to VNS Therapy for treatment-resistant depression and the
 need for at least three quarters for us to have a clear understanding of TRD
 patient conversion rates and cycle times from identification to implant.
 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 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 SEC.
 
 SOURCE  Cyberonics, Inc.