Advanced Neuromodulation Systems Announces Expanded Market Launch of Its Eon(TM) Rechargeable Neurostimulation System
June 21 2005 - 8:30AM
PR Newswire (US)
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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