With an estimated
2.
nostrum lend
ANS-medical.ans-medical. The mechanisms of action of DBS are incompletely understood. These
and
other factions require testing of additional subjects. NEW YORK, What do Barbara Streisand, Donny
Osmond, Carly Simon, and 17 million Americans have in common? They have all
suffered from an
anxiety disorder, one of America's most common mental
illnesses.
Mary Guardino
http://profnet
.phobia phobics
2 million people in the U.
"With these two approvals for essential tremor and Parkinson's, we
are
moving into the deep brain stimulation arena, which presents many new growth
opportunities
for our platform technologies to address various neurological
conditions," Chavez said. While we
will
remain focused on profitable bottom-line performance and growth in our core
pain business
, we continue to expect to significantly increase our investment
in clinical studies, regulatory and
R+D in 2005 compared to 2004.
About Advanced Neuromodulation Systems
Advanced Neuromodulation
Systems designs, develops, manufactures and
markets implantable systems used to manage chronic intractable
pain and other
disorders of the central nervous system." Terms such as "plan," "should,"
"would
," "anticipate," "believe," "intend," "estimate," "expect," "predict,"
"scheduled," "new market,"
"potential market applications" and similar
expressions are intended to identify forward-looking
statements.5% was
adjusted to 34."
For additional information, or to find
a screening site in your area,
please call toll free, 1-888-442-2022, or visit our Web site at
http:
//www.coping araneum
(Nasdaq: ANSI) (ANS) today announced operating results for the
first quarter, provided a review
of its strategy and recent accomplishments,
and updated guidance for 2005. Gross
margin was 74
% for both periods. The highly-respected neuroscience journal
Neuron recently reported clinical results
in a depression research study using
this method of deep brain neurostimulation.
Advanced Neuromodulation Systems, Inc.22
Note: The Company believes that the Non-GAAP
measurement of net income
before the gain on sale of Cyberonics, Inc. investment assists
investors in understanding the impact on the Company's diluted
earnings
per share of the gain on sale of Cyberonics, Inc.panic nostrum
prnewswire.sufferers phobics
Sales of
neuro products increased 18
.5% to $28,717,000 for this year's first quarter
compared to $24,228,000 a year earlier, as sales
of ANS' Genesis(R) and
GenesisXP(TM) implantable spinal cord stimulation (SCS) systems for the
treatment
of chronic pain continued to perform well in the marketplace.
Received IDE to Investigate
DBS System For Parkinson's Disease
ANS also received IDE approval from the FDA to implant 136
patients at
12 sites to investigate the safety and efficacy of the ANS Libra DBS System to
treat
Parkinson's disease.9 million adult Americans suffer from major depressive disorder.
"We caution
that these results cover only six patients, follow-up was
limited, and no sham surgery or systematic
placebo control arm was used.49 to $3.Free Help Available for Anxiety Sufferers on National Anxiety
Disorders Screening Day May 4 2005
givers coping
Net income for the first quarter of 2005 was
$58,568,000
, or $2.8 million
issued and outstanding shares. As described in the cover story in
the March
7, 2005 edition of Business Week, as well as in recent feature
stories in Time, the Wall Street Journal
, and in a week-long segment on the
Today Show, the clinical indications that neuromodulation can
address are
large, under-served and under-penetrated. "With approval of our new Eon system now in
hand, we are
manufacturing product to support a limited launch in the second quarter and a
full
market launch in the third quarter of 2005," Chavez said. "We expect
the results of this pivotal
trial to support a future PMA submission for
chronic headache.S. Frost +
Sullivan, an international
strategic market research firm, also recently
presented ANS with its Product Innovation Award, recognizing
ANS as the
technology innovation leader in the neurostimulation market and ANS'
Genesis(R) Implantable
Pulse Generator system as the most advanced fully
implantable spinal cord stimulator on the market
.
"Safe harbor" statement under the Private Securities Litigation Reform Act
of 1995:
Statements contained in this document that are not based on historical
facts are "forward-looking
statements.88 $.
Press Contact: Jeanine Christiana May 2005
Facility
Name: Freedom From Fear
Phone: 718-351-1717
Available Topic Expert(s): For information
on the listed expert(s), click
appropriate link.panic nostrum
Following its repurchases to date, ANS currently
has about 19.
Despite these and other limitations in this research, the response rate in
these
patients is striking given their extreme resistance to other treatments
and the well-documented low
placebo response in these patients. EDT. Anxiety disorders include: Panic Disorder,
Generalized Anxiety
Disorder (GAD), Social Phobia, and Obsessive Compulsive
Disorder (OCD).jsp?userid=351342
sufferers disorder
Board Increases Share Repurchase Authorization to 2,000,000 Shares
To date, the
company has repurchased 923,674 shares of its common stock
under a 1,000,000-share repurchase authorization
. Authored by noted clinical
researchers including the inventors, the article reports "a striking
and
sustained remission of depression in four of six patients. Approximately 100,000 people in the
United States are treated
with electroconvulsive therapy (ECT) each year.
With respect to
the earnings outlook for 2005, the CEO continued, "As
previously announced, we have decided to accelerate
our pursuit of new
indications for our technology more aggressively, by accelerating clinical
studies
, regulatory approval efforts and product development. EDT. Consequently, if
such management assumptions
prove to be incorrect or such risks or
uncertainties materialize, anticipated results could differ
materially from
those forecast in forward-looking statements. and SUBSIDIARIES
Condensed
Consolidated Balance Sheets (Unaudited)
March
31, December 31,
2005 2004
Assets
Current assets:
Cash and marketable securities $180,676,803
$124,016,064
Receivable, trade net 25,598,912 25,322,813
Receivable, interest and other 1,106,898 638,987
Inventories
24,754,210 23,923,851
Deferred income taxes
1,994,747 2,029,091
Prepaid expenses and other current assets 1,357,241
1,888,957
Total current assets 235,488,811 177,819,763
Net property, equipment and fixtures 33,277,977 33,175,329
Minority equity investments
in preferred
stock 1,104,000 1,104,000
Goodwill
, patents, tradenames, purchased
technology + other assets, net 35,342,461
35,388,049
Total assets $305,213,249 $247,487,141
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$2,688,037 $3,206,516
Accrued salary and employee benefit costs
1,933,556 2,390,721
Accrued commissions 1,579,853 2,656
,112
Income taxes payable 33,526,811 708,412
Deferred
revenue 107,028 165,861
Other accrued expenses
445,318 342,075
Total current liabilities 40,280
,603 9,469,697
Deferred income taxes 6,056,418 14,734,487
Non-current deferred revenue 670,362 718,820
Total stockholders
' equity 258,205,866 222,564,137
Total liabilities and stockholders'
equity $305,213,249 $247,487,141
Advanced
Neuromodulation Systems, Inc.4%.disorder generalised
This was ANS' second rechargeable system to be approved by the FDA
since December 2004. Differences in electrode
targeting and placement may have also contributed
to the observed response
variance. investment,
net of acquisition costs
(85,244,301)
Income before gain on sale of Cyberonics, Inc.panic coping
First Quarter Results
For the three months ended March 31, 2005, revenue increased 21.19 per diluted share. ANS announced
today that
the Board of Directors has increased the repurchase authorization to a total
of 2,000
,000 shares. ANS also recently
acquired exclusive intellectual property rights to stimulate a specific
target
in the brain to treat Obsessive Compulsive Disorder (OCD), and we hope to
initiate a pilot
study to further evaluate safety and efficacy for this
indication. The first implants of the Libra
DBS System to treat
Parkinson's disease are anticipated to occur in the second quarter.9 million
people in the U. A
replay will be available at this same Internet address, or at (800) 633-8284
,
reservation #21244484, after 1:00 p. Gain
Income before income taxes
$92,233,706
Gain on sale of Cyberonics, Inc.
investment.suffer compulsive
"The Board of
Directors believes that ANS
common stock is an attractive investment, and repurchasing shares is
a sound
use of working capital under the right circumstances," said President and CEO
Chris Chavez
. The first implants of the Libra DBS System to treat essential
tremor are anticipated to occur in
the second quarter. "Estimates of the prevalence of these two
conditions vary significantly, but
it is generally estimated that
approximately 1.com . In addition, despite the encouraging results
reported
in the Neuron article, there are limitations to this first study of DBS for
TRD. and
Subsidiaries
Condensed Consolidated Statements of Income (Unaudited)
Three Months Ended
March 31,
2005
2004
Net revenue $32,335,463 $26,632,863
Cost
of revenue 8,446,834 6,965,532
Gross profit
23,888,629 19,667,331
Operating expenses:
Sales and marketing
10,090,319 8,564,046
Research and development
3,324,707 2,314,950
General and administrative 3,343,454 2
,316,740
Amortization of intangibles 639,980 574,874
17,398,460 13,770,610
Income from operations
6,490,169 5,896,721
Other income (expense):
Gain on sale
of marketable securities 85,244,301 ---
Foreign currency transaction loss
(47,625) (29,347)
Investment income 546,861
251,329
85,743,537 221,982
Income before income taxes 92,233,706 6,118,703
Income taxes
33,665,303 2,150,112
Net income
$58,568,403 $3,968,591
Basic income per share:
Net income
$2.affirmations moderated
alone suffer from Parkinson's
disease, while approximately 5 million
people in the U. Based on the
strength of this study, we are pursuing a multi-center feasibility
study to
further evaluate efficacy, and if the expanded study continues to impress, ANS
intends
to pursue a pivotal trial for this important application," Chavez
said.19
Number of diluted
shares 21,192,297 21,187,163
ADVANCED NEUROMODULATION SYSTEMS
, INC. "That's the sad news; the good news is these
illnesses can quickly and effectively be treated
.ocd suffer
Advanced Neuromodulation Systems Reports First Quarter Results
Additionally, ANS' Axxess(R) neurostimulation
leads,
designed for superior handling and precise placement, recently received a 2005
Medical
Design Excellence Award (MDEA)."
Acquired Exclusive Rights For Method To Treat Depression
Through DBS
ANS also recently announced that it has acquired exclusive rights to
intellectual
property covering a unique method of treating chronic treatment-
resistant depression through DBS
.m.com/investors . Such
statements are by nature subject to uncertainties and risks, including but
not
limited to market acceptance of our new rechargeable IPGs, as well as
continued market acceptance
of our conventional IPGs and radio-frequency
powered SCS systems; competition from and the launch
of new competitive
products by Medtronic, Advanced Bionics/Boston Scientific or others, as well
as
other market factors that could impede growth in or reduce sales of the
Company's IPG and RF systems
, which could adversely affect revenues and
profitability; patient or physician selection of less
invasive or less
expensive alternatives; adverse changes in coverage or reimbursement amounts
by
Medicare, Medicaid, private insurers, managed care organizations or
workers' comp programs; intellectual
property protection and potential
infringement issues; the cost, uncertainty and other risks inherent
in
litigation generally, including without limitation the intellectual property
and patent litigation
against Advanced Bionics; obtaining necessary government
approvals for other new products or applications
and maintaining compliance
with FDA product and manufacturing requirements; product liability; reliance
on single suppliers for certain components; completion of research and
development projects in
an efficient and timely manner; successful patient
enrollment in and timely implementation of the
IDE clinical studies for
migraine headache, Essential Tremor and Parkinson's disease; physician and
patient acceptance of the Libra DBS system for the Essential Tremor and
Parkinson's disease studies
, for which already-approved products are already
available on the market; the uncertainty of clinical
results that may ensue
from these clinical studies; the risk that the FDA may not approve our PMA
applications for these applications following the completion of the clinical
trials; the satisfactory
completion of feasibility, pilot and pivotal studies
and/or market tests prior to the introduction
of new products generally;
successful integration of acquired businesses, products and technologies;
international trade risks; and other risks detailed from time to time in the
Company's SEC filings
. Participating in the
screening day on May 4, 2005, is the first step in finding help.org.depressive phobia
"
Received FDA Approval Of Its Second Rechargeable IPG
ANS recently received FDA approval to
market and sell its second
rechargeable implantable pulse generator (IPG), the Eon(TM) Neurostimulation
System.
Received FDA Approval For Pivotal Study of Migraine Headache
ANS also has
received approval from the FDA to expand its feasibility
study to a pivotal study of neurostimulation
for the treatment of migraine
headache.S.S."
Treatment-resistant depression, or TRD, is a
severely disabling disorder
with very limited proven treatment options once multiple medications
,
psychotherapy have failed and electroconvulsive therapy has either been
declined or failed.
Management Updates Guidance for 2005
Chavez said that management continues to expect revenue
for 2005 of
approximately $145 million.m. Such forward-looking statements
speak only as of the
date on which they are made, and the Company does not
undertake any obligation to update any forward
-looking statement to reflect
events or circumstances after the date of this release.76
$.phobia compulsive
The company has identified a number of sites for
the clinical study. Including
the impact
of these increases, we currently expect net income for 2005 in the
range of $3. Additional information
is
available at http://www.3% for purposes of the Non-GAAP measurement above,
which
closely approximates the Company's 2004 effective tax rate
of 34.lend ocd
76 per diluted share
. who suffer
from severe migraines, we believe that this application has significant
clinical potential
," Chavez said.
Received IDE to Investigate DBS System For Essential Tremor
ANS recently
received an FDA Investigational Device Exemption (IDE)
approval to implant 160 patients at 12 sites
to investigate the safety and
efficacy of the ANS Libra(TM) Deep Brain Stimulation (DBS) System to
treat
essential tremor. An independent market research firm estimates that the
market for DBS
for these specific indications will grow to approximately
$180 million by 2008 and will continue
to grow as improvements in the
procedure and stereotactic targeting are made. The National Institutes
of Health (NIH) estimate that
9. The Company's effective tax rate of 36.generalised coping
Strategic Review
Chavez continued: "The interventional neuromodulation market now exceeds
one billion dollars
, and promises to become a multi-billion dollar, multi-
indication modality in the years ahead. With
the increasing
awareness of the benefits of neuromodulation, we are increasingly excited
about
our mission to develop ever-improving neuromodulation technologies to
address an expanding set of
clinical indications. With our impressive list
of generators and equally impressive list of leads
and programmers, ANS is
uniquely positioned to address the broad needs of the market at many different
price points," Chavez added. Research
indicates that approximately 20% of these patients are
resistant to existing
treatments. Forbes magazine
recently recognized ANS as one of America's
200 Best Small Companies. There were also limitations on
identifying markers that might predict
response. To help individuals learn about anxiety disorders, their
symptoms, and effective treatments
, mental health professionals are available
for this screening as part of a free national outreach
program.
"Anxiety disorders bring tremendous suffering and pain to millions of
Americans each
year," says Mary Guardino, founder of the National Anxiety
Disorders Screening Project.traumatic anxiety
Net income
for this year's first quarter included a pre-tax gain of $85,244,000 from the
previously announced
sale of Cyberonics common stock acquired in August 2004.22 per diluted share.
"We believe that
ANS has the broadest, most advanced product offering in
the industry to address the diverse needs
of interventional pain physicians
and their pain patients who suffer from chronic pain. We firmly
believe that each kind of
system has its place in the treatment armamentarium. The company has identified
a number of sites for the
clinical study. The
simultaneous webcast is available at http://www
. Fortune magazine recently ranked ANS
as the 8th fastest growing small company in its annual list
of the Top 200
Fastest Growing Small Companies in the United States.20
Number of basic shares
20,366,990 19,928,946
Diluted income per share:
Net
income $2. investment $4,592,039
Number of diluted shares 21,192,297
Diluted income per share
$.ocd agoraphobia
Revenue Increases 21%
Management Updates 2005 Guidance
DALLAS, Advanced Neuromodulation
Systems
, Inc.
"As we announced last quarter, we have decided to pursue new indications
for our technology
more aggressively, by accelerating clinical studies,
regulatory approval efforts and product development
. We are leveraging our
platform technologies into emerging clinical applications that we believe
will
fuel strong organic growth for years to come.com/ud_public.
coping suffering
2,397,366
Net income before gain on sale of Cyberonics,
Inc. The program
includes
viewing a video, completing a screening questionnaire, meeting a
doctor or mental health professional
to review the questionnaire, and
receiving information about various anxiety disorders and mental
illnesses.A listing of web sites offering support to those suffering from (or care-givers) Anxiety and
Panic.
moderated sufferers
This compares to net income for the
first quarter of 2004 of $3,969,000, or $0.
Excluding
the effects of this gain as reconciled in the attached table,
earnings for this year's first quarter
were $0. ANS has no debt.
investment and income taxes 6,989,405
Income tax expense 33,665,303
Impact of gain on sale of
Cyberonics investment (31,267,937)
Income tax expense before gain on sale of
Cyberonics
, Inc.anxiety generalised
At March 31, 2005, ANS had total cash and marketable securities of
approximately $181
million. The first implants are expected in the second quarter. suffer from
essential tremor.52
per diluted share. Sample size was small, follow-up was limited, and no sham surgery or
systematic
placebo control arm was used. and Subsidiaries
Non-GAAP Reconciliation
(Unaudited)
Three
Months Ended
March 31,
2005
Impact of Cyberonics, Inc.
phobics agoraphobia
4% to a
record $32,335,000 from $26
,633,000 for the first quarter of 2004. Repurchases may be made from time to time in open market
or
privately negotiated transactions, subject to price and availability, and
financed out of working
capital. Now more than ever, neuromodulation
holds the promise to improve the quality of life for
millions of people who
suffer from chronic pain and other chronic diseases."
Conference
Call
ANS has scheduled a conference call today at 11:00 a. Individuals who suffer from an anxiety
disorder experience a
variety of symptoms that can include spontaneous panic attacks, endlessly
checking
and rechecking their actions, persistent and uncontrollable worry,
and anxiety in social situations
.
With the increase of environmental disasters in the world such as
hurricanes, earthquakes
, the Iraq war, and September 11, psychiatric
researchers have noted an increase in Post-traumatic
Stress Disorder (PTSD)
after individuals experienced any severely distressing or traumatic event
.
Untreated anxiety disorders often can lead to substance abuse, depression,
and even suicide
.freedomfromfear.agoraphobia alli
In addition to planned pivotal
studies to treat migraine headaches, essential tremor
and Parkinson's disease,
we are systematically incubating such promising new indications as depression
,
pelvic pain, obesity, tinnitus, angina, ischemic pain associated with
peripheral vascular disease
, and traumatic brain injury. ANS offers a full array
of spinal cord stimulation devices to meet
this demand, including two
rechargeable IPGs, five conventionally powered IPGs and radio-frequency
powered stimulators.phobia disorder
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