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Advanced Neuromodulation Systems (ANSI) Announces IDE Approval To Investigate Libra(TM) DBS System For Essential Tremor


10/19/2005 5:13:05 PM

DALLAS, March 22 /PRNewswire-FirstCall/ -- Advanced Neuromodulation Systems, Inc. (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.

Advanced Neuromodulation Systems, Inc.

CONTACT: investors, Neil Berkman Associates, +1-310-277-5162, orinfo@BerkmanAssociates.com , for Advanced Neuromodulation Systems, Inc.; orChris Chavez, President & CEO of Advanced Neuromodulation Systems, Inc.,+1-972-309-8000



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