ANSI Advanced Neuromodulation Systems (MM)

Advanced Neuromodulation Systems Announces Expanded Market Launch of Its Eon(TM) Rechargeable Neurostimulation System DALLAS, June 21 /PRNewswire-FirstCall/ -- Advanced Neuromodulation Systems, Inc. (NASDAQ:ANSI) (ANS) today announced an expanded U.S. market launch of its new flagship rechargeable implantable pulse generator (IPG) system, the Eon(TM) Neurostimulation System. After successfully completing a market test and increasing inventory levels, the company is expanding market availability of Eon. "Eon offers a significant step-up in IPG capability, including high power, longer recharge intervals, broad programming capability and, we believe, best-in-class systems configuration flexibility," said Chris Chavez, ANS President and CEO. The Eon IPG can also power up to 16 independent electrodes in a dual 8-electrode lead configuration, similar to ANS' flagship Renew(R) radio-frequency external power system. Quick and easy to implant, the Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. "Compatible with all ANS percutaneous and paddle leads, the Eon system can also be configured to drive up to four separate leads with four independent electrodes on each lead to offer broad flexibility in dealing with complex multi-focal pain. Eon is slightly larger than the company's Genesis(R) IPG and features a high capacity rechargeable battery and a constant current stimulation capability. And while the FDA-approved labeling claim for this device estimates seven years of battery life at high power settings, we are considering submitting data to the FDA in the future to support an even longer battery life claim. Additionally, the Eon system is very efficient and offers longer projected usage time between battery charges and fast recharge rates, for greater patient convenience. Simply put, Eon has the largest gas tank and a very efficient engine, which translates into longer intervals between recharge (up to two months at moderate usage and six months at low usage) and quick and efficient recharge time. It also features impressive programming ranges for pulse width and frequency, similar to our Renew system. And like other ANS systems, it offers both MultiStim(R) and PC-Stim(R) (patient-controlled stimulation) technologies to empower clinicians with the capability to deal with the broad range of clinical needs," Chavez said. The CEO added, "ANS enjoys the broadest, most advanced product offering in the industry to address the needs of interventional pain physicians and their pain patients. With Eon now added to our impressive list of generators and an equally impressive list of leads and programmers, we believe we are uniquely positioned to address the diverse needs of the market at many different price points. We expect our expanded product range, combined with our excellent sales representation in the field and our dedication to providing excellent customer service, to sustain ANS' highly competitive position in the interventional neuromodulation market, a market which now exceeds one billion dollars and which promises to become a multi-billion dollar, multi-indication segment of the expanding medical technology industry in the years ahead. "As described in recent feature stories in Business Week, Time and the Wall Street Journal and in a week-long segment on the Today Show, the clinical indications that neuromodulation can address are large, under-served and under-penetrated. Now more than ever, neuromodulation holds the promise to improve the quality of life for millions of people who suffer from chronic pain and other chronic diseases. With the growing awareness of the benefits of neuromodulation, we are increasingly excited about our mission to develop ever-improving neuromodulation technologies to address an expanding set of clinical indications," Mr. Chavez added. 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. Fortune magazine recently ranked ANS as the 36th fastest growing small company in its annual list of the Top 200 Fastest Growing Small Companies in the United States. Forbes magazine recently recognized ANS as one of America's 200 Best Small Companies. Frost & Sullivan, an international strategic market research firm, also recently presented ANS with its Product Innovation Award, recognizing ANS as the technology innovation leader in the neurostimulation market and ANS' Genesis(R) Implantable Pulse Generator system as the most advanced fully implantable spinal cord stimulator on the market. 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 market acceptance of our new rechargeable IPGs, as well as continued market acceptance of our conventional IPGs and radio-frequency powered SCS systems; 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 IPG and RF systems, 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; the cost, uncertainty and other risks inherent in litigation generally, including without limitation the intellectual property and patent litigation against Advanced Bionics; 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; successful patient enrollment in and timely implementation of IDE clinical studies for migraine headache, Essential Tremor and Parkinson's disease; physician and patient acceptance of our Libra DBS system for Essential Tremor and Parkinson's disease 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 applications following the completion of the clinical trials; the satisfactory completion of feasibility, pilot and pivotal studies and/or market tests prior to the introduction of new products generally; successful integration of acquired businesses, products and technologies; international trade risks; 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 company, Chris Chavez, President & CEO of Advanced Neuromodulation Systems, Inc., +1-972-309-8000 Web site: http://www.ans-medical.com/

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