Advanced Neuromodulation (NASDAQ:ANSI)
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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/