Advanced Neuromodulation Systems Announces IDE Approval to Investigate Libra(TM) DBS System for Parkinson's Disease
15 April 2005 - 10:30PM
PR Newswire (US)
Advanced Neuromodulation Systems Announces IDE Approval to
Investigate Libra(TM) DBS System for Parkinson's Disease DALLAS,
April 15 /PRNewswire-FirstCall/ -- Advanced Neuromodulation
Systems, Inc. (NASDAQ:ANSI) (ANS) announced today that it has
received an FDA Investigational Device Exemption (IDE) approval to
implant 136 patients at 12 sites to investigate the safety and
efficacy of the ANS Libra(TM) Deep Brain Stimulation (DBS) System
to treat Parkinson's disease. 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. "This approval represents another major milestone for ANS.
Less than a month ago, we announced FDA approval of our IDE
application to investigate the use of our DBS system to treat
Essential Tremor. With these two approvals, we have the opportunity
to move into the deep brain stimulation arena, which presents
numerous new growth opportunities for our platform technologies to
address various neurological conditions. We are excited about our
prospects in this emerging field," said Chris Chavez, ANS'
President and CEO. "Estimates of the prevalence of these conditions
vary significantly, but it is generally estimated that
approximately 1.9 million people in the U.S. alone suffer from
Parkinson's disease, while approximately 5 million people in the
U.S. suffer from 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 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. We have proactive
efforts and capability in place to identify, qualify and acquire a
rich and growing portfolio of applications for our technology. 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 and Traumatic Brain Injury. 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," Chavez said. On March 22,
2005, ANS announced it had received FDA IDE approval to implant 160
patients at 12 sites to investigate the safety and efficacy of the
ANS Libra DBS System to treat Essential Tremor. In that press
release, ANS also reported its proprietary interest in a unique
method of treating chronic treatment-resistant depression through
DBS that has shown "a striking and sustained remission of
depression in four of six patients" according to researchers in a
pilot study. The specific purpose of ANS' study for Parkinson's
disease is to demonstrate the safety and efficacy of bilateral
stimulation of the subthalamic nucleus (STN) when using the ANS
Libra DBS System as an adjunctive treatment for reducing some of
the symptoms of advanced, levodopa-responsive Parkinson's disease
that are not adequately controlled with medication. "ANS selected
the brand name 'Libra' for its DBS systems because we believe that
neuromodulation in its many evolving forms attempts to restore
balance to the central nervous system that has been lost due to
trauma, disease, mechanical impairment or other dysfunctions. The
word "Libra" is derived from the Latin term for a pair of scales
and connotes balance and equilibrium," said Mr. Chavez. 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; 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. 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/
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