Advanced Neuromodulation Systems Announces Supply and Development Agreement for Batteries; ANS to File Application to Market Rechargeable IPG.Business Editors/Health/Medical Writers DALLAS--(BUSINESS WIRE)--April 7, 2004 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: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. ) today announced a long-term supply agreement with EaglePicher Technologies, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control under which EaglePicher will supply ANS with rechargeable lithium ion A rechargeable battery technology introduced in 1991 that provides greater charge per pound than nickel metal hydride. In 1993, Toshiba introduced the first notebook in the U.S. with a Li-ion battery. batteries, as well as the lithium thionyl chloride Thionyl chloride (or thionyl dichloride) is an inorganic compound with the formula SOCl2. SOCl2 is a reactive chemical reagent used in chlorination reactions. batteries ANS uses today in its Genesis(R) and Genesis XP(TM) Totally Implantable Pulse Generator implantable pulse generator Cardiac pacing A pacemaker used for permanent pacing, which is placed inside a pocket under the skin; the leads are positioned in or on the heart (IPG IPG Implantable pulse generator, see there ) Spinal Cord Stimulators Spinal Cord Stimulator (SCS) or Dorsal Column Stimulator (DCS) is an implantable medical device used to treat chronic pain of neurologic origin. An electric impulse generated by the device near the dorsal surface of the spinal cord provides a paresthesia ("tingling") . Under the agreement, EaglePicher will also continue to develop certain future generation batteries for ANS. Specific terms of the agreement were not disclosed. ANS simultaneously announced that it will file for approval of its first generation rechargeable IPG with the 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. this quarter. "We hope to receive approval to market this new product in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. later this year," said Chris Chavez, President and Chief Executive Officer of Advanced Neuromodulation Systems, Inc. The supply and development agreement assures ANS a reliable source and predictable pricing for batteries used in its Genesis(R) and Genesis XP(TM) IPGs, as well as the rechargeable batteries to be used in its new family of rechargeable IPGs. This agreement strengthens an earlier agreement between the two companies, and enables both companies to leverage their respective technology strengths to develop new products that are clinically compelling. "ANS has built its reputation on technology innovation and designing advanced neuromodulation devices that address a diverse set of clinician and patient needs," said Mr. Chavez. "No single system or solution is optimal for addressing the broad range of our customer's diverse needs. A rechargeable IPG will add another important product to our growing family of neuromodulation products. This supports our strategy of offering our customers the opportunity to select the right systems solution for each unique clinical need. We believe that clinicians will continue to need both radio-frequency (RF) powered SCS and nonrechargeable IPG products for most applications. "We have worked with EaglePicher for the last five years under a prior supply and development agreement, through which EaglePicher demonstrated its commitment to developing and building high quality and reliable batteries for use in medical applications. We look forward to continuing our relationship with EaglePicher to develop advanced technology implantable devices," Mr. Chavez added. 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. Forbes magazine recently recognized ANS as one of America's 200 Best Small Companies and Fortune magazine recently recognized ANS as one of Fortune's Top 100 Fastest-Growing Small Companies in the United States. 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 www.ans-medical.com. "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 related to ANS 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: continued market acceptance of the Genesis(R) IPG and GenesisXP(TM) IPG; competition from Medtronic, Inc. and future competitors; continued market acceptance of our Renew(R) system following the launches of the Genesis IPG and GenesisXP IPG; 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 our rechargeable IPGs and 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; 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. |
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