Advanced Neuromodulation (NASDAQ:ANSI)
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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/