Long Term Results From Vagus Nerve Stimulation (VNS(TM)) Depression Pilot Study to Be Presented at Society of Biological Psychiatry and American Psychiatric Association Meetings

91% of Acute Responders Maintained Response After One Year of VNS;

18% of Acute Non-Responders Were Responders After One Year of VNS;

Statistically Significant Improvements in Long-Term Remission Rates Reported;

Improvements in Physical, Cognitive and Social Function Noted



Apr 30, 2001, 01:00 ET from Cyberonics, Inc.

    HOUSTON, April 30 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq:   CYBX) today
 announced results of the long-term follow up study of VNS for treatment-
 resistant depression.  The 30-patient D-01 long-term results indicate that
 response rates were sustained and remission rates were significantly increased
 nine months after the ten-week acute study period or one year after patients
 were implanted.  Additional improvements in patients overall functioning were
 also observed.  The study results will be presented at the Society of
 Biological Psychiatry and the American Psychiatric Association meetings in New
 Orleans beginning later this week.  Dr. Lauren Marangell of Baylor College of
 Medicine, the lead author of the study, will present the study results at the
 Society of Biological Psychiatry Conference on May 4, 2001, and Dr. Mark
 George of the Medical University of South Carolina will present the results as
 part of a symposium presentation at the American Psychiatric Association on
 May 7, 2001.
     The D-01 study was conducted at the University of Texas Southwestern
 Medical Center, the Medical University of South Carolina, the Columbia (New
 York) College of Physicians and Surgeons/New York State Psychiatric Institute
 and Baylor College of Medicine.  Following ten weeks of acute treatment with
 VNS, the 30 adult patients with treatment-resistant depression received an
 additional nine months of long-term maintenance treatment.  Patients were seen
 at three months, six months and nine months after exiting the acute study
 period.  Response to VNS treatment in this evaluation was defined as a
 50 percent or greater improvement in depression according to the Hamilton
 Rating Scale for Depression (HRSD).  Remission was defined as being "complete
 responders" with an HRSD score of less than or equal to ten.  At the
 conclusion of the acute study, 12 of the 30 patients (40%) were responders,
 including 5 patients (17% of the 30 patients) who were in remission.  At nine
 months, the response rate rose to 46 percent, including a statistically
 significant increase in the remission rate to 29 percent.  Ninety-one percent
 of the responders at the end of the acute study maintained their response at
 nine months of long-term follow-up (one year after implantation).
 Additionally, of the 17 non-responders at the end of the acute study,
 18 percent were responders at nine months.
     "There is a considerable body of evidence indicating VNS for epilepsy has
 sustained and improving effects with long-term treatment, as patients are
 experiencing continued and increasing seizure control.  It was logical for us
 to evaluate the long-term effects of VNS for depression after the encouraging
 acute study results," said Dr. Lauren Marangell, lead study author and
 Director of the Mood Disorder Center at Baylor College of Medicine.  "The
 findings in the VNS depression study long-term follow up are very promising.
 In the longer-term VNS study, changes in medications and device settings were
 allowed.  This and other study design issues make direct comparison with other
 treatments preliminary.  However, relapse rates for patients with depression
 and treatment-resistant patients seeking pharmacotherapy can run between
 20 and 37 percent and can be as high as 70% for patients after receiving ECT.
 In contrast, the patients in the VNS study exhibited sustained improvements
 and improved remission rates.  The improvements in physical, cognitive and
 social function are remarkable."
     These one year long-term follow-up results on the first 30 D-01 patients
 and the acute study results of the expanded 60 patient D-01 study were
 presented to regulatory agencies in Europe and Canada and have lead to
 approval to sell the NeuroCybernetic Prosthesis (NCP(R)) System for the
 treatment of depression in the member countries of the European Union and in
 Canada.
     During the course of the initial phase of the D-01 study, 30 adult
 patients with non-psychotic, chronic or recurrent treatment-resistant
 depression were treated with VNS.  Each patient either was in the midst of a
 Major Depressive Episode (MDE) that had lasted longer than two years or they
 had at least four MDEs in their lifetime.  The mean duration of the current
 depressive episode for the first 30 study patients was 10 years.  All patients
 had also not responded to at least two robust medication trials in the
 treatment of their current MDE, and more than half had not responded to at
 least four medication trials.  Fifty-seven percent of the patients had also
 been non-responsive to ECT or had been unable to tolerate it.  The 30 patients
 had a pacemaker-like generator implanted under the skin in the upper chest and
 a stimulation electrode tunneled from the chest to the neck where it was
 attached to the vagus nerve.  Following a two-week recovery period,
 stimulation parameters were adjusted, and for the next eight weeks,
 intermittent VNS was provided at a fixed (maximum comfortably tolerated) dose.
 The device used in the study, the implant location and technique, the
 intermittent stimulation parameters and the side-effects reported during the
 D-01 study were similar to those for VNS in patients with epilepsy, with the
 most common side-effects being voice alteration and surgically-related pain.
     The NCP System that delivers VNS is approved in Canada and the European
 Union for "the treatment of chronic or recurrent depression in patients that
 are in a treatment-resistant or treatment-intolerant major depressive
 episode," which includes treatment of patients with major depressive disorder
 (unipolar depression) as well as patients with bipolar disorder (manic
 depression).
     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 target market is epilepsy, the world's second most prevalent
 neurological disorder, which is characterized by recurrent seizures.  VNS 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 and
 Alzheimer's disease.  Earlier this year, Cyberonics received CE Mark Approval
 to sell VNS in the member countries of the European Union and Canada as a
 treatment for patients with 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:  sales projections for epilepsy for
 fiscal 2002; budget projections for expenditures for fiscal 2002; maintaining
 and obtaining appropriate regulatory approvals; transitioning VNS therapy from
 a revolutionary treatment to a standard of care in epilepsy; developing VNS as
 a treatment for depression, Alzheimer's Disease, obesity and other
 indications; the timing and outcome of clinical studies; improving our
 productivity and efficiencies; increasing our sales and achieving
 profitability.  These predications 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 with the
 Cyberonics NeuroCybernetic Prosthesis (NCP(R)) 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 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; 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 the
 Company's Quarterly Report on Form 10Q for the three months ended September
 30, 2000 and December 31, 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/11690X32263787
 
 

SOURCE Cyberonics, Inc.
    HOUSTON, April 30 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq:   CYBX) today
 announced results of the long-term follow up study of VNS for treatment-
 resistant depression.  The 30-patient D-01 long-term results indicate that
 response rates were sustained and remission rates were significantly increased
 nine months after the ten-week acute study period or one year after patients
 were implanted.  Additional improvements in patients overall functioning were
 also observed.  The study results will be presented at the Society of
 Biological Psychiatry and the American Psychiatric Association meetings in New
 Orleans beginning later this week.  Dr. Lauren Marangell of Baylor College of
 Medicine, the lead author of the study, will present the study results at the
 Society of Biological Psychiatry Conference on May 4, 2001, and Dr. Mark
 George of the Medical University of South Carolina will present the results as
 part of a symposium presentation at the American Psychiatric Association on
 May 7, 2001.
     The D-01 study was conducted at the University of Texas Southwestern
 Medical Center, the Medical University of South Carolina, the Columbia (New
 York) College of Physicians and Surgeons/New York State Psychiatric Institute
 and Baylor College of Medicine.  Following ten weeks of acute treatment with
 VNS, the 30 adult patients with treatment-resistant depression received an
 additional nine months of long-term maintenance treatment.  Patients were seen
 at three months, six months and nine months after exiting the acute study
 period.  Response to VNS treatment in this evaluation was defined as a
 50 percent or greater improvement in depression according to the Hamilton
 Rating Scale for Depression (HRSD).  Remission was defined as being "complete
 responders" with an HRSD score of less than or equal to ten.  At the
 conclusion of the acute study, 12 of the 30 patients (40%) were responders,
 including 5 patients (17% of the 30 patients) who were in remission.  At nine
 months, the response rate rose to 46 percent, including a statistically
 significant increase in the remission rate to 29 percent.  Ninety-one percent
 of the responders at the end of the acute study maintained their response at
 nine months of long-term follow-up (one year after implantation).
 Additionally, of the 17 non-responders at the end of the acute study,
 18 percent were responders at nine months.
     "There is a considerable body of evidence indicating VNS for epilepsy has
 sustained and improving effects with long-term treatment, as patients are
 experiencing continued and increasing seizure control.  It was logical for us
 to evaluate the long-term effects of VNS for depression after the encouraging
 acute study results," said Dr. Lauren Marangell, lead study author and
 Director of the Mood Disorder Center at Baylor College of Medicine.  "The
 findings in the VNS depression study long-term follow up are very promising.
 In the longer-term VNS study, changes in medications and device settings were
 allowed.  This and other study design issues make direct comparison with other
 treatments preliminary.  However, relapse rates for patients with depression
 and treatment-resistant patients seeking pharmacotherapy can run between
 20 and 37 percent and can be as high as 70% for patients after receiving ECT.
 In contrast, the patients in the VNS study exhibited sustained improvements
 and improved remission rates.  The improvements in physical, cognitive and
 social function are remarkable."
     These one year long-term follow-up results on the first 30 D-01 patients
 and the acute study results of the expanded 60 patient D-01 study were
 presented to regulatory agencies in Europe and Canada and have lead to
 approval to sell the NeuroCybernetic Prosthesis (NCP(R)) System for the
 treatment of depression in the member countries of the European Union and in
 Canada.
     During the course of the initial phase of the D-01 study, 30 adult
 patients with non-psychotic, chronic or recurrent treatment-resistant
 depression were treated with VNS.  Each patient either was in the midst of a
 Major Depressive Episode (MDE) that had lasted longer than two years or they
 had at least four MDEs in their lifetime.  The mean duration of the current
 depressive episode for the first 30 study patients was 10 years.  All patients
 had also not responded to at least two robust medication trials in the
 treatment of their current MDE, and more than half had not responded to at
 least four medication trials.  Fifty-seven percent of the patients had also
 been non-responsive to ECT or had been unable to tolerate it.  The 30 patients
 had a pacemaker-like generator implanted under the skin in the upper chest and
 a stimulation electrode tunneled from the chest to the neck where it was
 attached to the vagus nerve.  Following a two-week recovery period,
 stimulation parameters were adjusted, and for the next eight weeks,
 intermittent VNS was provided at a fixed (maximum comfortably tolerated) dose.
 The device used in the study, the implant location and technique, the
 intermittent stimulation parameters and the side-effects reported during the
 D-01 study were similar to those for VNS in patients with epilepsy, with the
 most common side-effects being voice alteration and surgically-related pain.
     The NCP System that delivers VNS is approved in Canada and the European
 Union for "the treatment of chronic or recurrent depression in patients that
 are in a treatment-resistant or treatment-intolerant major depressive
 episode," which includes treatment of patients with major depressive disorder
 (unipolar depression) as well as patients with bipolar disorder (manic
 depression).
     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 target market is epilepsy, the world's second most prevalent
 neurological disorder, which is characterized by recurrent seizures.  VNS 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 and
 Alzheimer's disease.  Earlier this year, Cyberonics received CE Mark Approval
 to sell VNS in the member countries of the European Union and Canada as a
 treatment for patients with 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:  sales projections for epilepsy for
 fiscal 2002; budget projections for expenditures for fiscal 2002; maintaining
 and obtaining appropriate regulatory approvals; transitioning VNS therapy from
 a revolutionary treatment to a standard of care in epilepsy; developing VNS as
 a treatment for depression, Alzheimer's Disease, obesity and other
 indications; the timing and outcome of clinical studies; improving our
 productivity and efficiencies; increasing our sales and achieving
 profitability.  These predications 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 with the
 Cyberonics NeuroCybernetic Prosthesis (NCP(R)) 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 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; 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 the
 Company's Quarterly Report on Form 10Q for the three months ended September
 30, 2000 and December 31, 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/11690X32263787
 
 SOURCE  Cyberonics, Inc.