ANSI Advanced Neuromodulation Systems (MM)

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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