Advanced Neuromodulation (NASDAQ:ANSI)
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Advanced Neuromodulation Systems Announces FDA Approval of ANS'
Second Rechargeable IPG
DALLAS, March 15 /PRNewswire-FirstCall/ -- Advanced Neuromodulation Systems,
Inc. (ANS) (NASDAQ:ANSI) 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.
DATASOURCE: Advanced Neuromodulation Systems
CONTACT: Chris Chavez, President & CEO of Advanced Neuromodulation
Systems, +1-972-309-8000; or Investor: Neil Berkman Associates,
+1-310-277-5162, or
Web site: http://www.ans-medical.com/