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Advanced Neuromodulation Systems Announces FDA Approval of First Generation Rechargeable Neurostimulation Systems.


DALLAS -- Advanced Neuromodulation Systems Advanced Neuromodulation System is a subsidiary of St. Jude Medical, Inc based in Plano, Texas. Among the products ANS makes and sells include spinal cord stimulators for intractable pain. , Inc. (ANS (ANS Communications, Inc, Purchase, NY) An ISP, Internet backbone and provider of private data network services, founded in 1990 as Advanced Network & Services, Inc., by IBM, MCI and Merit (consortium of Michigan universities). ) (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:ANSI (American National Standards Institute, New York, www.ansi.org) A membership organization founded in 1918 that coordinates the development of U.S. voluntary national standards in both the private and public sectors. It is the U.S. member body to ISO and IEC. ) announced today that it has received FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval to market and sell its first generation rechargeable re·charge  
tr.v. re·charged, re·charg·ing, re·charg·es
To charge again, especially to reenergize a storage battery.



re
 spinal cord spinal cord, the part of the nervous system occupying the hollow interior (vertebral canal) of the series of vertebrae that form the spinal column, technically known as the vertebral column.  stimulation systems, the Genesis(R) RC and Genesis(R) RC Dual (IPG IPG Implantable pulse generator, see there ) Neurostimulation Systems.

"Pain practitioners want the flexibility to apply the right system to the right indication -- one size does not fit all. Rechargeable IPGs represent a natural extension of our product line. ANS is now the only company in the world that offers a full array of spinal cord stimulation devices, including radio-frequency (RF), non-rechargeable IPGs, and now rechargeable IPGs," said Chris Chavez, ANS' President and Chief Executive Officer.

"Improvements in battery technology and circuit efficiency will make conventional IPGs increasingly effective, which is why we believe that conventional IPGs will continue to hold a dominant place in neuromodulation therapy. But we also expect rechargeable products to claim an important share of the total market over time," Chavez said.

"We currently are building inventory to support a limited market test of our Genesis RCs, to be followed by a broader launch. Simultaneously, we are preparing to file for approval of smaller and even more powerful second-generation rechargeable IPGs," Chavez added.

"ANS continues to innovate and invest in developing new generators, leads and programming systems. In addition to introducing rechargeable IPGs into our expanding family of products, we recently announced FDA approval and market launch of our Lamitrode(R) lead with the Tripole 8(TM) configuration, market launch of our new Axxess(R) lead, and market launch of our C Series(TM) curved lead. We are also launching a significant upgrade to our MTS (1) See Microsoft Transaction Server.

(2) (Modular TV System) The stereo channel added to the NTSC standard, which includes the SAP audio channel for special use.

1. MTS - Message Transport System.
2.
(TM) trial system. ANS has the broadest and most advanced product offering in the industry to address the diverse needs of interventional pain physicians, pain patients and the expanding neurostimulation market," Chavez said.

"The neuromodulation market remains large -- approaching $1 billion -- is under-penetrated and is growing rapidly. This market promises to become a multi-indication and multi-billion dollar segment of an expanding medical technology industry. ANS continues to identify and develop other indications for its neuromodulation technology," Chavez concluded.

About Advanced Neuromodulation Systems

Advanced Neuromodulation Systems designs, develops, manufactures and markets implantable systems used to manage chronic intractable pain intractable pain Refractory pain Pain medicine Persistent pain which does not respond to at least 3 dosease of parenteral analgesics given over a 12-24 hr period; pain that does not respond to appropriate doses of opioid analgesics.  and other disorders of the central nervous system. Additional information is available at www.ans-medical.com. For a third consecutive year, ANS has been recognized in the annual Forbes ranking of the 200 Best Small Companies. Up from 95 last year, ANS ranked 81 on the 2004 list. In addition, ANS has been recognized by FORTUNE Small Business for the second consecutive year as one of the fastest-growing small public companies in America. Of the FORTUNE Small Business 100, ANS ranked 8th, reflecting strong financial performance over the past three years.

"Safe harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
" statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995:

Statements contained in this document that are not based on historical facts are "forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
." 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 nonrechargeable IPGs and radio-frequency powered SCS systems; filing for and obtaining necessary government approvals for the Company's second-generation rechargeable IPG and other new products or applications and maintaining compliance with FDA product and manufacturing requirements; 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; 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 against Advanced Bionics; 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.
COPYRIGHT 2004 Business Wire
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Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Dec 10, 2004
Words:804
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