DALLAS, March 15 /PRNewswire-FirstCall/ -- Advanced Neuromodulation Systems, Inc. (ANS) announced today that it has received FDA approval to market and sell its second rechargeable implantable pulse generator (IPG), the Eon(TM) Neurostimulation System.
"We received FDA approval for our Eon system earlier than anticipated," said Chris Chavez, ANS' President and Chief Executive Officer. "This is ANS' second rechargeable system to be approved by the FDA within the past four months, and I want to thank the agency for their prompt, professional review and approval of our application. With approval for our new Eon system now in hand, we will begin to manufacture product to support a limited launch late in the second quarter and a full market launch in the second half of 2005."
ANS' Eon system features an IPG roughly the same size as the company's Genesis(R) IPG. Eon also can power up to 16 electrodes in a dual 8-electrode lead configuration, similar to ANS' flagship Renew(R) radio-frequency external battery system. 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 surgical (laminectomy) leads, the Eon system features constant current stimulation delivery and a high-capacity rechargeable battery. And while the FDA-approved labeling claim for this device estimates seven years of battery life at high power settings (compared to the competitor's five years at moderate usage), we are considering submitting data to the FDA in the future to support an even longer battery life claim. Additionally, Eon offers the longest projected usage time between battery charges and the fastest recharge rate of any rechargeable IPG on the market, for greater patient convenience. 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) capabilities," Chavez said.
"The pain practitioner's choice of a neuromodulation system is driven by considerations of product breadth and depth, superior technology, and knowledgeable and experienced field service support. Pain practitioners want the flexibility to apply the right product to the right indication -- one size does not fit all, nor does one system at one price adequately address the broad and complex clinical and economic needs of the market.
"ANS has the broadest, most advanced product offering in the industry to address the diverse needs of interventional pain physicians and their pain patients who suffer from chronic pain. ANS is the only company in the world that offers a full array of spinal cord stimulation devices to meet this demand, including two radio-frequency powered stimulators, four conventionally powered IPGs and now three rechargeable IPGs. We firmly believe that each kind of system has its place in the treatment armamentarium. With our impressive list of generators and equally impressive list of leads and programmers, ANS is uniquely positioned to address the broad needs of the market at many different price points," Chavez added.
The CEO concluded, "Neuromodulation promises to be a multi-billion dollar, multi-indication modality. The interventional neuromodulation market now exceeds one billion dollars and continues to expand. Neuromodulation, which was the subject of a cover story in the March 7, 2005, edition of Business Week, continues to grow in visibility and promise. The clinical indications that neuromodulation can address are large, underserved 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. We are excited about our mission to develop ever-improving neuromodulation technologies to address an expanding set of clinical indications."
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 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 the intellectual property 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; the satisfactory completion of clinical trials and/or market tests prior to the introduction of new products; successful integration of acquired businesses, products and technologies; the cost, uncertainty and other risks inherent in patent and intellectual property litigation; 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.
Advanced Neuromodulation Systems