The Company is
headquartered in Houston,
Texas and has an office in Brussels, Belgium. The Company's initial market is epilepsy, a
disorder
characterized by recurrent seizures. 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.
neurological stimulator
com .deaths intractable
Cyberonics Announces Approval of 2005 Stock Plan;
Senate Finance Committee (SFC) Contact Information on Cyberonics Website
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.
"Cyberonics is today more confident than ever that final FDA approval of
the
treatment-resistant depression indication will facilitate a U. 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
.booklet talking
shetland someone
HOUSTON, Cyberonics, Inc.cyberonics.com .
The sites provide information and resources.
myoclonic nerve
"The
Stock Plan will provide the necessary
equity incentives for Cyberonics to attract, retain and motivate
key personnel
essential for the accomplishment of Cyberonics' mission of improving the lives
of
people touched by epilepsy, depression and other chronic, treatment-
resistant illnesses that prove
to be treatable with our patented therapy,
Vagus Nerve Stimulation.
Stimulation is delivered by
the VNS Therapy System, an implantable generator
similar to a cardiac pacemaker. 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.
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. Our actual results
may
differ materially.deaths someone
cyberonics.myoclonic sudep
Sites in this category serve the support needs of people with Epilepsy
or similar conditions.
myoclonic penarth
The VNS Therapy System delivers preprogrammed
intermittent mild electrical
pulses to the vagus nerve in the patient's neck
24 hours a day.S.cyberonics. Such forward-looking
statements include
statements concerning obtaining regulatory approval for use of VNS Therapy for
treatment-resistant depression, implementing our long-term strategic plan,
realizing the potential
of our intellectual property, regulatory and market
franchises in epilepsy, depression and other
chronic, treatment resistant
disorders, and hiring, retaining, and motivating key personnel. Statements
contained in this press release are based upon information presently available
to us and assumptions
that we believe to be reasonable.shetland epilepsy
Cummins. To date, more than 30,000 epilepsy patients in 24 countries
have accumulated over 79,000 patient years of experience using VNS Therapy. HOUSTON, Cyberonics
, Inc. Cyberonics must hire
over 200 new, and retain over 400 existing, key personnel to realize
the
enormous potential of our intellectual property, regulatory and market
franchises in epilepsy
, depression and other chronic, treatment-resistant
disorders that prove to be treatable with our
patented therapy, VNS. 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).minuet bereavement
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). For
additional information please visit us at http:
//www. Statements contained
in this press release are based upon information presently available
to us and
assumptions that we believe to be reasonable.nerve talking
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
hiring, retention and motivation of key personnel requires
competitive
compensation packages, most importantly equity ownership that is issued at
fair market
value and is earned (vested) over years of service. The VNS Therapy System delivers
preprogrammed
intermittent mild electrical pulses to the vagus nerve in the
patient's neck 24 hours a day.
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.diagnosed minuet
Epilepsy is the second most prevalent
neurological disorder. Such forward-looking statements
include
statements concerning attracting, retaining and motivating key personnel
essential for
the accomplishment of Cyberonics' mission. Our actual results may differ
materially. The special
shareholder meeting will be held
on Thursday, May 19, 2005 at 10:00 AM CDT at the Company's Houston
headquarters.
Stimulation is delivered by the VNS Therapy System(TM), an implantable
generator
similar to a cardiac pacemaker.talking minuet
(Nasdaq: CYBX)
today announced that the Company's 2005 Stock Plan
was approved at a Special
Meeting of Shareholders on May 19, 2005. The Company's initial market
is epilepsy, a disorder
characterized by recurrent seizures.
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).vagus nerve
com ."
ABOUT VNS THERAPY AND CYBERONICS
Cyberonics
, Inc. 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). The
Company is headquartered in Houston, Texas and has an office in Brussels,
Belgium.severe minuet
"Cyberonics
is grateful for shareholders' support and approval of the 2005
Stock Plan," commented Robert P.intractable myoclonic
The 2005 Stock Plan provides up to
one million shares for the issuance of Restricted Stock or options
to purchase
common stock to qualified employees and board members at fair market value on
the
date of grant or issuance.
"Yesterday we received numerous calls from Americans concerned about
the
Senate Finance Committee's 'examination' of FDA's February 2, 2005 approvable
decision regarding
Cyberonics' Expedited Review PMA-Supplement for patients
with chronic or recurrent treatment-resistant
depression that was (1)
submitted in October 2003, (2) recommended for approval by a specially chosen
FDA Advisory Panel of experts in June 2004, and (3) amended by a PMA-S
Amendment submitted in
September 2004," continued Mr. 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.Cyberonics Seeks Shareholder Approval of 2005 Stock
Plan to Facilitate the Hiring and Retention of Key Personnel
A Definitive Proxy Statement on Schedule
14A has been filed
with the U. 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
. 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.vagus penarth
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.
bereavement disorder
"In response
to those calls, the contact information for SFC is now available on our
website
, http://www. 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 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; our ability to
hire, train and retain personnel; the accuracy of management
's estimates of
future events, sales, expenses and earnings; and other risks detailed from
time
to time in the Company's filings with the SEC. Epilepsy is the second most
prevalent neurological
disorder.stimulator minuet
("Skip") Cummins, Cyberonics' Chairman of the
Board and Chief Executive Officer. Securities
and Exchange Commission and is available on the
Company's website. For additional information please
visit us at
http://www.vagus supportive
S. launch at
the American Psychiatric Association meeting in late May,
" commented Robert P.
("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive
Officer
.
All sites listed are interactive - you will find message boards
myoclonic talking
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. The 2005 Stock Plan provides up to
one million
shares for the issuance of Restricted Stock or options to purchase
common stock to qualified employees
and board members at fair market value on
the date of grant or issuance. 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. 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 from
time to time in the Company's filings
with the SEC.talking intractable
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.
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. "Final FDA approval will enable
Cyberonics to properly scale our
organization and fully implement our plan to become the market leader
in
neuromodulation, the next frontier for medical devices. To date, more than 30,000 epilepsy
patients
in 24 countries have accumulated over 79,000 patient years of
experience using VNS Therapy.severe deaths
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.
(Nasdaq: CYBX) today announced
its plans to hold a special shareholder meeting
to approve the Company's 2005 Stock Plan. Considering
that Cyberonics' existing stock and option plans do not presently have
adequate shares, Cyberonics
is requesting shareholder approval of the 2005
Stock Plan to facilitate the hiring and retention
of key personnel to
implement Cyberonics' long-term strategic plan."
ABOUT VNS THERAPY
AND CYBERONICS
Cyberonics, Inc.
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