Advanced Neuromodulation (NASDAQ:ANSI)
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Advanced Neuromodulation Systems Announces IDE Approval to
Investigate Libra(TM) DBS System for Essential Tremor
DALLAS, March 22 /PRNewswire-FirstCall/ -- Advanced Neuromodulation Systems,
Inc. (NASDAQ:ANSI) (ANS) announced today that it has 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. The company has identified
a number of sites for the clinical study. The first implants of the Libra IPG
System are anticipated to occur in the second quarter of this year.
The company also announced the submission to the FDA of an amendment to its IDE
application to investigate the ANS Libra DBS System to treat Parkinson's
disease. ANS anticipates receiving this IDE approval from the FDA in the
second quarter.
"This approval represents a major milestone for ANS. Historically, we have
focused on neurostimulation to treat chronic pain, and we intend to continue to
grow that core franchise. With this approval, we now have the opportunity to
move into the deep brain stimulation arena. DBS presents numerous new growth
opportunities for our platform technologies to address various neurological
conditions. We've been working on our DBS project for a long time, and it is
exciting and satisfying to see it coming to fruition," said Chris Chavez, ANS'
President and CEO.
"Estimates of the prevalence of these conditions vary significantly, but it is
generally estimated that approximately 5 million people in the United States
alone suffer from Essential Tremor, and approximately 1.9 million people in the
U.S. suffer from Parkinson's disease. An independent market research firm
estimates that the market for DBS for these 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 neuromodulation market as a whole is expected to surpass the
billion-dollar milestone this year, and promises to become a multi-billion
dollar, multi-indication segment of the medical device industry. We are
aggressively investing in both product development and clinical trials to
leverage our platform technologies into emerging clinical applications for
neuromodulation, applications that we believe will fuel strong organic growth
for years to come. In addition to Essential Tremor and Parkinson's disease, we
are systematically incubating such promising new indications as Migraine,
Depression, Pelvic Pain, Obesity, Tinnitus and Traumatic Brain Injury," Chavez
said.
DBS for Depression
The company recently announced that it has acquired exclusive rights to
intellectual property covering a unique method of treating chronic
treatment-resistant depression through DBS. The highly-respected neuroscience
journal Neuron recently reported clinical results in a depression research
study using this method of deep brain neurostimulation. Authored by noted
clinical researchers including the inventors, the article reports "a striking
and sustained remission of depression in four of six patients." ANS acquired
the exclusive rights to this intellectual property over a year ago.
The research study was conducted independent of ANS and without ANS funding at
the University of Toronto using the Medtronic DBS device. Based on their
preliminary observations that a particular region of the brain (the subgenual
cingulate region, or Broadmann area 25) is metabolically overactive in
treatment-resistant depression, the investigators studied whether electrical
stimulation of that region could reduce the elevated activity and produce
clinical benefit. Six patients with refractory depression were implanted and
followed for six months.
Continuous stimulation of these specific brain structures "demonstrated that
high-frequency DBS of the [target area] can produce striking behavioral changes
in patients with TRD," the article reports. In addition, "sustained clinical
improvement decreased with blinded discontinuation of chronic DBS and were
recaptured with reinstitution of stimulation, providing evidence as to the
specificity of DBS-mediated changes." The investigators noted that the
antidepressant effects were accompanied by a marked reduction in local cerebral
blood flow as well as changes in downstream limbic and cortical sites that were
measured using PET scans, meaning that the effects of stimulation can be
visually observed and recorded. The investigators stated that the study
suggests that disrupting brain circuitry in this region by using electrical
stimulation "can effectively reverse symptoms in otherwise treatment-resistant
depression."
Treatment-resistant depression, or TRD, is a severely disabling disorder with
very limited proven treatment options once multiple medications, psychotherapy
and electroconvulsive therapy have failed. The National Institutes of Health
(NIH) estimate that 9.9 million adult Americans suffer from major depressive
disorder. Research indicates that approximately 20% of these patients are
resistant to existing treatments. Approximately 100,000 people in the United
States are treated with electroconvulsive therapy (ECT) each year.
"We will be quick to caution that these results cover only six patients,
follow-up was limited, and no sham surgery or systematic placebo control arm
was used. Despite these and other limitations in this research study, 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. What is particularly impressive is the sustained response in four of
the six patients. Based on the strength of this research 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," said Chris Chavez, President and Chief
Executive Officer of ANS.
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. Additional information is available at
http://www.ans-medical.com/ .
"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." 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. Such
statements are by nature subject to uncertainties and risks, including but not
limited to successful patient enrollment in and timely implementation of the
IDE clinical studies for Essential Tremor and Parkinson's disease; receipt of
an IDE approval to conduct the Parkinson's disease study, which is not assured;
physician and patient acceptance of the Libra DBS system for these DBS 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 DBS products
or applications following the completion of the clinical trials; 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 products, 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; 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; the satisfactory completion of clinical trials
and/or market tests prior to the introduction of new products; the cost,
uncertainty and other risks inherent in patent and intellectual property
litigation; and other risks detailed from time to time in the Company's SEC
filings. In addition, despite the encouraging results reported in the Neuron
article, there are limitations to this first study of DBS for
treatment-resistant depression. Sample size was small, follow-up was limited,
and no sham surgery or systematic placebo control arm was used. There were also
limitations on identifying markers that might predict response. Differences in
electrode targeting and placement may have also contributed to the observed
response variance. The mechanisms of action of DBS are incompletely
understood. These and other factions require testing of additional subjects.
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. 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.
DATASOURCE: Advanced Neuromodulation Systems, Inc.
CONTACT: investors, Neil Berkman Associates, +1-310-277-5162, or
, for Advanced Neuromodulation Systems, Inc.; or
Chris Chavez, President & CEO of Advanced Neuromodulation Systems, Inc.,
+1-972-309-8000
Web site: http://www.ans-medical.com/