Cyberonics, Inc. Announces Depression Advisory Board

Apr 27, 2001, 01:00 ET from Cyberonics, Inc.

    HOUSTON, April 27 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq: CYBX) today
 announced the formation of a VNS Depression Advisory Board.  The Board's
 mission will be to advise Cyberonics on a variety of corporate and clinical
 issues including clinical trials, mechanism of action research, health
 economics and cost effectiveness studies, publications, product positioning
 and sales and marketing strategies and tactics.  A. John Rush, M.D., Professor
 and Vice Chairman for Research at the Department of Psychiatry at University
 of Texas Southwestern Medical Center at Dallas, and lead investigator in the
 D-01 study of VNS for depression, will chair the board, which consists of the
 following thought leaders from the psychiatric community:
 
     --  Mark George, M.D., Distinguished Professor of Psychiatry, Radiology
         and Neurology, Director, Center for Advanced Imaging Research and
         Brain Stimulation Laboratory, Medical University of South Carolina
         (MUSC)
     --  Leighton Huey, M.D., Chair, Department of  Psychiatry, University of
         Connecticut
     --  Lauren Marangell, M.D., Director, Mood Disorder Research, Director of
         Clinical Psychopharmacology and Associate Professor of Psychiatry,
         Baylor College of Medicine
     --  John McIntyre, M.D., Chair, Department of Psychiatry & Behavioral
         Health, Unity Health System and Clinical Professor of Psychiatry,
         University of Rochester (past president American Psychiatric
         Association)
     --  Jerrold F. Rosenbaum, M.D., Professor of Psychiatry, Harvard Medical
         School, Chief of Psychiatry (Interim), Massachusetts General Hospital,
         President and Executive Director, MGH Mood and Anxiety Disorders
         Institute (MADI)
     --  Harold Sackeim, Ph.D., Chief, Department of Biological Psychiatry, New
         York State Psychiatric Institute/Columbia University
     --  Alan Schatzberg, M.D., Professor and Chair, Department of Psychiatry,
         Stanford University
     --  Michael E. Thase, M.D., Professor, Department of Psychiatry,
         University of Pittsburgh School of Medicine
     --  David Tyler, MD, psychiatrist in private practice, Dallas, Texas
 
     "It is an honor to be chairing this group of esteemed psychiatrists as we
 work with Cyberonics to further explore the potential of Vagus Nerve
 Stimulation for depression," said Advisory Board Chairman Dr. A. John Rush,
 Betty Jo Hay Distinguished Chair in Mental Health and Professor and Vice
 Chairman for Research at the Department of Psychiatry at University of Texas
 Southwestern Medical Center at Dallas.  "The results from the preliminary
 clinical research of VNS from the D-01 study for patients with depression are
 extremely encouraging and I am confident that the extensive experience of the
 VNS Depression Advisory Board will help Cyberonics achieve its mission of
 improving the lives of patients and their families, psychiatrists, surgeons,
 hospital personnel and payers touched by chronic or recurrent depression."
     Robert P. ("Skip") Cummins, Cyberonics' President and Chief Executive
 Officer, commented, "Cyberonics' mission in depression is to improve the lives
 of people touched by chronic or recurrent depression by partnering with
 preeminent psychiatrists to develop FDA-approved therapies which satisfy the
 needs of psychiatrists, patients and payers for an effective long term or
 maintenance therapy.  The goal of our depression pivotal study program in the
 United States is to within two years have the acute and long term clinical
 study data, the neurotransmitter, neuroimaging and sleep mechanism of action
 data and the health economics and cost effectiveness data which demonstrates
 to FDA, psychiatrists, payers and patients and their families that VNS is a
 safe and effective treatment for over one million Americans with treatment-
 resistant depression.  We are extremely privileged to have the opportunity to
 work with such a prestigious group of depression advisors to help us
 accomplish our depression mission and our U.S. pivotal study program
 objectives."
     Cyberonics, Inc. (www.cyberonics.com) was founded in 1987 to design,
 develop and market medical devices for the treatment of epilepsy and other
 debilitating disorders using a unique therapy, vagus nerve stimulation.  The
 Company's initial market is epilepsy, the world's second most prevalent
 neurological disorder, which is characterized by recurrent seizures.  Vagus
 Nerve Stimulation (VNS(TM)) with the Cyberonics NeuroCybernetic Prosthesis
 (NCP(R)) 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 medically refractory partial onset
 seizures.  In addition to the U.S., the NCP System is currently approved for
 sale as a treatment for epilepsy in all the member countries of the European
 Union, Canada, Australia and other markets.  VNS delivered by the NCP System
 is at various levels of investigational clinical study as a potential
 treatment for depression, obesity, anxiety disorders and Alzheimer's disease.
 VNS with the Cyberonics NCP System was recently approved for sale in the
 European Union and in Canada as a treatment of depression in patients with
 treatment resistant or treatment intolerant major depressive episodes
 including unipolar depression and bipolar disorder (manic depression).
     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.  Such forward-looking
 statements include statements concerning: developing VNS therapy as a
 treatment for depression; FDA approvals of VNS with the Cyberonics NCP System
 as a treatment for depression; the timing and completion of future clinical
 study activities; developing and completing our depression launch plan and
 FY02 goals and objectives; and planned presentations of clinical pilot study
 data.  These predictions 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: ongoing safety and efficacy of VNS therapy with the Cyberonics NCP
 System; the overall rate of demand for the Company's products; the Company's
 ability to hire, train and retain key personnel; the Company's ability to
 obtain and maintain all appropriate regulatory approvals; the Company's
 ability to develop and maintain adequate manufacturing capacities and sources
 of supply; the timing and results of future clinical studies; the rate at
 which overall corporate infrastructure will be developed and the amount of
 timing of expenditures related to those and other activities; and management's
 ability to accurately forecast future events.  For further discussion of these
 and other important factors that could affect the Company's activities and
 results, please refer to the Company's Annual Report on Form 10-K for the year
 ended June 30, 2000 and quarterly reports for the periods ended September 30
 and December 30, 2000.
     NCP is a registered trademark of Cyberonics, Inc.  VNS is a trademark of
 Cyberonics, Inc.
 
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SOURCE Cyberonics, Inc.
    HOUSTON, April 27 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq: CYBX) today
 announced the formation of a VNS Depression Advisory Board.  The Board's
 mission will be to advise Cyberonics on a variety of corporate and clinical
 issues including clinical trials, mechanism of action research, health
 economics and cost effectiveness studies, publications, product positioning
 and sales and marketing strategies and tactics.  A. John Rush, M.D., Professor
 and Vice Chairman for Research at the Department of Psychiatry at University
 of Texas Southwestern Medical Center at Dallas, and lead investigator in the
 D-01 study of VNS for depression, will chair the board, which consists of the
 following thought leaders from the psychiatric community:
 
     --  Mark George, M.D., Distinguished Professor of Psychiatry, Radiology
         and Neurology, Director, Center for Advanced Imaging Research and
         Brain Stimulation Laboratory, Medical University of South Carolina
         (MUSC)
     --  Leighton Huey, M.D., Chair, Department of  Psychiatry, University of
         Connecticut
     --  Lauren Marangell, M.D., Director, Mood Disorder Research, Director of
         Clinical Psychopharmacology and Associate Professor of Psychiatry,
         Baylor College of Medicine
     --  John McIntyre, M.D., Chair, Department of Psychiatry & Behavioral
         Health, Unity Health System and Clinical Professor of Psychiatry,
         University of Rochester (past president American Psychiatric
         Association)
     --  Jerrold F. Rosenbaum, M.D., Professor of Psychiatry, Harvard Medical
         School, Chief of Psychiatry (Interim), Massachusetts General Hospital,
         President and Executive Director, MGH Mood and Anxiety Disorders
         Institute (MADI)
     --  Harold Sackeim, Ph.D., Chief, Department of Biological Psychiatry, New
         York State Psychiatric Institute/Columbia University
     --  Alan Schatzberg, M.D., Professor and Chair, Department of Psychiatry,
         Stanford University
     --  Michael E. Thase, M.D., Professor, Department of Psychiatry,
         University of Pittsburgh School of Medicine
     --  David Tyler, MD, psychiatrist in private practice, Dallas, Texas
 
     "It is an honor to be chairing this group of esteemed psychiatrists as we
 work with Cyberonics to further explore the potential of Vagus Nerve
 Stimulation for depression," said Advisory Board Chairman Dr. A. John Rush,
 Betty Jo Hay Distinguished Chair in Mental Health and Professor and Vice
 Chairman for Research at the Department of Psychiatry at University of Texas
 Southwestern Medical Center at Dallas.  "The results from the preliminary
 clinical research of VNS from the D-01 study for patients with depression are
 extremely encouraging and I am confident that the extensive experience of the
 VNS Depression Advisory Board will help Cyberonics achieve its mission of
 improving the lives of patients and their families, psychiatrists, surgeons,
 hospital personnel and payers touched by chronic or recurrent depression."
     Robert P. ("Skip") Cummins, Cyberonics' President and Chief Executive
 Officer, commented, "Cyberonics' mission in depression is to improve the lives
 of people touched by chronic or recurrent depression by partnering with
 preeminent psychiatrists to develop FDA-approved therapies which satisfy the
 needs of psychiatrists, patients and payers for an effective long term or
 maintenance therapy.  The goal of our depression pivotal study program in the
 United States is to within two years have the acute and long term clinical
 study data, the neurotransmitter, neuroimaging and sleep mechanism of action
 data and the health economics and cost effectiveness data which demonstrates
 to FDA, psychiatrists, payers and patients and their families that VNS is a
 safe and effective treatment for over one million Americans with treatment-
 resistant depression.  We are extremely privileged to have the opportunity to
 work with such a prestigious group of depression advisors to help us
 accomplish our depression mission and our U.S. pivotal study program
 objectives."
     Cyberonics, Inc. (www.cyberonics.com) was founded in 1987 to design,
 develop and market medical devices for the treatment of epilepsy and other
 debilitating disorders using a unique therapy, vagus nerve stimulation.  The
 Company's initial market is epilepsy, the world's second most prevalent
 neurological disorder, which is characterized by recurrent seizures.  Vagus
 Nerve Stimulation (VNS(TM)) with the Cyberonics NeuroCybernetic Prosthesis
 (NCP(R)) 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 medically refractory partial onset
 seizures.  In addition to the U.S., the NCP System is currently approved for
 sale as a treatment for epilepsy in all the member countries of the European
 Union, Canada, Australia and other markets.  VNS delivered by the NCP System
 is at various levels of investigational clinical study as a potential
 treatment for depression, obesity, anxiety disorders and Alzheimer's disease.
 VNS with the Cyberonics NCP System was recently approved for sale in the
 European Union and in Canada as a treatment of depression in patients with
 treatment resistant or treatment intolerant major depressive episodes
 including unipolar depression and bipolar disorder (manic depression).
     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.  Such forward-looking
 statements include statements concerning: developing VNS therapy as a
 treatment for depression; FDA approvals of VNS with the Cyberonics NCP System
 as a treatment for depression; the timing and completion of future clinical
 study activities; developing and completing our depression launch plan and
 FY02 goals and objectives; and planned presentations of clinical pilot study
 data.  These predictions 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: ongoing safety and efficacy of VNS therapy with the Cyberonics NCP
 System; the overall rate of demand for the Company's products; the Company's
 ability to hire, train and retain key personnel; the Company's ability to
 obtain and maintain all appropriate regulatory approvals; the Company's
 ability to develop and maintain adequate manufacturing capacities and sources
 of supply; the timing and results of future clinical studies; the rate at
 which overall corporate infrastructure will be developed and the amount of
 timing of expenditures related to those and other activities; and management's
 ability to accurately forecast future events.  For further discussion of these
 and other important factors that could affect the Company's activities and
 results, please refer to the Company's Annual Report on Form 10-K for the year
 ended June 30, 2000 and quarterly reports for the periods ended September 30
 and December 30, 2000.
     NCP is a registered trademark of Cyberonics, Inc.  VNS is a trademark of
 Cyberonics, Inc.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X63237882
 
 SOURCE  Cyberonics, Inc.