Mortality and SUDEP (Sudden, Unexpected, Unexplained Death) Rates Drop Significantly Among Epilepsy Patients Treated With Vagus Nerve Stimulation (VNS(TM)), New Research Shows

Re-release of June 2000 Study Results



Apr 11, 2001, 01:00 ET from Cyberonics, Inc.

    HOUSTON, April 11 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq:   CYBX) today
 announced that results from a recent study published in the current issue of
 Epilepsia show that the mortality and SUDEP (sudden, unexpected, unexplained
 death) rates among epilepsy patients treated with VNS for more than two years
 have decreased significantly compared to patients treated for less than two
 years with VNS.  The first VNS mortality and SUDEP study, the results of which
 were published in Epilepsia in 1997, involved 791 patients treated with VNS
 for a total of 1,335 years.  This recent follow-up study involved all patients
 from the original study plus another 1,028 for a total of 1,819 patients
 treated with VNS for a total of 3,176 years.  Mortality rates as measured by
 the Standard Mortality Ratio decreased as the duration of active VNS treatment
 increased.  Mortality rates declined from 5.3 in the first study to 2.0 in the
 second study.  SUDEP rates were similar in the two studies at 4.5 per 1,000
 patient years in the first study and 4.1 per thousand patient years in the
 second.  However, when the SUDEP rates of patients treated with VNS for less
 than two years were compared with those treated for two or more years, a
 statistically significant drop in SUDEP was observed from 5.5 per 1,000
 patient years for those patients treated for less than two years to 1.7 per
 1,000 for those patients treated with VNS for more than two years.
     "The VNS cohort is disproportionately weighted towards patients with
 intractable epilepsy who are at a higher risk of SUDEP.  These patients failed
 multiple medications and in many cases had or were considered for epilepsy
 surgery.  The results from this second study are quite significant for this
 patient population.  The lower mortality and SUDEP rates for the patients
 treated with vagus nerve stimulation may be a result of improved seizure
 control," explains Dr. W. A. Hauser, professor at the G. H. Sergievsky Center,
 College of Physicians and Surgeons, Columbia University, co-author of the
 study.  "These results are extremely encouraging and additional research
 should be done to further confirm our initial findings that VNS is in part
 responsible for the decreased mortality and SUDEP rates."
     Robert P. Cummins, Cyberonics' President and Chief Executive Officer,
 today commented, "Cyberonics' mission is to improve the lives of people
 touched by epilepsy and other disorders that may prove to be treatable with
 VNS.  We are extremely proud of the progress we have made toward the
 achievement of that mission including the improvements in mortality and SUDEP
 noted in this study of over 1,800 patients treated with VNS for over 3,000
 total years.  Incomplete and misleading reporting regarding the FDA MDR
 warning letter we recently received has obviously raised concerns among
 patients, clinicians and Cyberonics' shareholders.  As a result, we are re-
 releasing these important findings which were submitted to FDA last year."
     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.  In March 2001, Cyberonics received CE Mark Approval to
 sell VNS in the member countries of the European Union as a treatment for
 patients with treatment resistant or recurrent 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:  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 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 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.
 
 

SOURCE Cyberonics, Inc.
    HOUSTON, April 11 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq:   CYBX) today
 announced that results from a recent study published in the current issue of
 Epilepsia show that the mortality and SUDEP (sudden, unexpected, unexplained
 death) rates among epilepsy patients treated with VNS for more than two years
 have decreased significantly compared to patients treated for less than two
 years with VNS.  The first VNS mortality and SUDEP study, the results of which
 were published in Epilepsia in 1997, involved 791 patients treated with VNS
 for a total of 1,335 years.  This recent follow-up study involved all patients
 from the original study plus another 1,028 for a total of 1,819 patients
 treated with VNS for a total of 3,176 years.  Mortality rates as measured by
 the Standard Mortality Ratio decreased as the duration of active VNS treatment
 increased.  Mortality rates declined from 5.3 in the first study to 2.0 in the
 second study.  SUDEP rates were similar in the two studies at 4.5 per 1,000
 patient years in the first study and 4.1 per thousand patient years in the
 second.  However, when the SUDEP rates of patients treated with VNS for less
 than two years were compared with those treated for two or more years, a
 statistically significant drop in SUDEP was observed from 5.5 per 1,000
 patient years for those patients treated for less than two years to 1.7 per
 1,000 for those patients treated with VNS for more than two years.
     "The VNS cohort is disproportionately weighted towards patients with
 intractable epilepsy who are at a higher risk of SUDEP.  These patients failed
 multiple medications and in many cases had or were considered for epilepsy
 surgery.  The results from this second study are quite significant for this
 patient population.  The lower mortality and SUDEP rates for the patients
 treated with vagus nerve stimulation may be a result of improved seizure
 control," explains Dr. W. A. Hauser, professor at the G. H. Sergievsky Center,
 College of Physicians and Surgeons, Columbia University, co-author of the
 study.  "These results are extremely encouraging and additional research
 should be done to further confirm our initial findings that VNS is in part
 responsible for the decreased mortality and SUDEP rates."
     Robert P. Cummins, Cyberonics' President and Chief Executive Officer,
 today commented, "Cyberonics' mission is to improve the lives of people
 touched by epilepsy and other disorders that may prove to be treatable with
 VNS.  We are extremely proud of the progress we have made toward the
 achievement of that mission including the improvements in mortality and SUDEP
 noted in this study of over 1,800 patients treated with VNS for over 3,000
 total years.  Incomplete and misleading reporting regarding the FDA MDR
 warning letter we recently received has obviously raised concerns among
 patients, clinicians and Cyberonics' shareholders.  As a result, we are re-
 releasing these important findings which were submitted to FDA last year."
     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.  In March 2001, Cyberonics received CE Mark Approval to
 sell VNS in the member countries of the European Union as a treatment for
 patients with treatment resistant or recurrent 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:  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 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 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.
 
 SOURCE  Cyberonics, Inc.