Results of Study Published in The Journal of Antimicrobial
Chemotherapy Confirm That Silver Nanoparticles May Be Useful in
Reducing Infections
LAKE FOREST, Calif.--(BUSINESS WIRE)--March 11, 2008--I-Flow
Corporation (NASDAQ:IFLO) is leading and helping to define a rapidly
emerging trend of using silver as an antimicrobial agent to help
reduce infections with its ON-Q(R) PainBuster(R) with ON-Q
SilverSoaker(R) Antimicrobial Catheter combination. This approach was
supported in a recent study published in The Journal of Antimicrobial
Chemotherapy (Roe et al), entitled "Antimicrobial surface
functionalization of plastic catheters by silver nanoparticles." The
study confirmed the potential usefulness of plastic catheters coated
with proprietary silver nanoparticles, because of their demonstrated
antimicrobial properties, and concluded that the treated catheters may
be useful in reducing infectious complications in patients with
indwelling catheters.
Since early 2006 patients have benefited from I-Flow's foresight
to market and sell the ON-Q SilverSoaker, a patented Soaker catheter
that is treated with SilvaGard(R), a specially-formulated
antimicrobial silver agent developed by AcryMed, Inc, an I-Flow
subsidiary. SilvaGard is an established antimicrobial coating that is
effective against a wide variety of microorganisms and common
pathogens, including MRSA (methicillin-resistant Staphylococcus
aureus), that may cause surgical site infections (SSI).
The Roe et al study, published in February, measured microbial and
biofilm formation against pathogens most commonly involved in
catheter-related infections. The surface of the catheters was coated
with a thin layer of sustained-release silver nanoparticles which then
eluted over a period of 10 days. The coated catheters showed
significant in vitro antimicrobial activity and inhibited biofilm
formation of Escherichia coli, Enterococcus, Staphylococcus aureaus,
and other strains of bacteria.
"Hospital-acquired infections, especially those caused by MRSA,
are a contemporary and critical healthcare concern. I-Flow is leading
a trend to help reduce dangerous and potentially deadly infections.
The use of SilvaGard as an antimicrobial agent is a tremendous benefit
to patients because it combats pathogens that may cause infections,"
said President and CEO, Donald M. Earhart of I-Flow Corporation, the
manufacturer of ON-Q. "This exciting silver nanoparticle technology
coupled with our infection prevention focus is a key reason that we
recently acquired AcryMed," he continued.
ON-Q is already labeled to significantly reduce pain better than
narcotics alone and to significantly reduce narcotics intake following
surgery. Results from a multi-center colorectal study conducted in
2007 showed that patients who received ON-Q PainBuster with ON-Q
SilverSoaker to relieve post-surgical pain in the study had
significantly less risk of developing an SSI and had a significant
reduction in hospital length of stay.(1) ON-Q patients often do not
experience the immune-suppressive response of narcotics, which can
essentially weaken patients and make it more difficult for their
bodies to fight an infection.
Mr. Earhart continued, "ON-Q is the only pain relief pump to
include a catheter coated with SilvaGard and the first and only to
document an infection reduction capability. This type of technology
redefines recovery for patients and will help to establish guidelines
for surgical site care in the future. This is especially relevant in
view of the announcement by the Centers for Medicare & Medicaid
Services (CMS) that for discharges occurring on or after October 1,
2008, hospitals will not receive additional payment for patients in
which certain conditions were not present on admission, such as
hospital-acquired infections."
Staph infections, such as MRSA, are resistant to certain
antibiotics and thus may be hard to treat. According to the Centers
for Disease Control and Prevention (CDC), nearly 100,000 people a year
develop a serious hospital-acquired MRSA infection and it is blamed
for almost 20,000 deaths annually. This is more deaths in the U.S. per
year than is attributed to HIV/AIDS.
About ON-Q
ON-Q PainBuster from I-Flow Corporation (NASDAQ: IFLO) is the
market leader in continuous surgical-site pain relief systems -
commonly known as "pain pumps" or "pain relief pumps." It consists of
a small balloon pump that holds local anesthetic (a pain-numbing
medicine) and delivers it automatically through its proprietary ON-Q
SilverSoaker catheter treated with an antimicrobial silver agent to
provide even distribution of local anesthesia over a wider area than
competitive devices. ON-Q is the only pain relief pump to include an
antimicrobial catheter and the first and only to document an infection
reduction capability.
ON-Q is labeled to significantly reduce pain better than narcotics
alone and to significantly reduce narcotics intake after surgery. ON-Q
was upheld as a best practice for post-surgical pain relief and its
widespread use was encouraged as part of an independent study
published in the prestigious Journal of American College of Surgeons.
Currently, more than 55 studies on the use of ON-Q have been completed
and published or presented, and more research is being conducted to
explore the benefits of ON-Q in such areas as infection prevention,
combination therapies (e.g., local anesthetic and antibiotic mixtures,
a combination of a local anesthetic and an anti-inflammatory),
pediatrics and chronic pain. Medicare recognizes ON-Q as a payable
covered benefit and therefore medically necessary.
To learn more about the benefits of ON-Q visit
www.AskYourSurgeon.com.
About I-Flow
I-Flow Corporation (www.IFLO.com) designs, develops and markets
technically advanced, low cost drug delivery systems and services that
are redefining the standard of care by providing life enhancing, cost
effective solutions for pain relief.
"Safe Harbor" Statement
Statements by the Company in this press release and in other
reports and statements released by the Company are and will be
forward-looking in nature and express the Company's current opinions
about trends and factors that may impact future operating results.
Statements that use words such as "may," "will," "should," "believes,"
"predicts," "estimates," "projects," "anticipates" or "expects" or use
similar expressions are intended to identify forward-looking
statements. Forward-looking statements are subject to material risks,
assumptions and uncertainties, which could cause actual results to
differ materially from those currently expected, and readers are
cautioned not to place undue reliance on these forward-looking
statements. Except as required by applicable law, the Company
undertakes no obligation to publish revised forward-looking statements
to reflect the occurrence of unanticipated or subsequent events.
Readers are also urged to carefully review and consider the various
disclosures made by the Company in this press release that seek to
advise interested parties of the risks and other factors that affect
the Company's business. Interested parties should also review the
Company's reports on Forms 10-K, 10-Q and 8-K and other reports that
are periodically filed with or furnished to the Securities and
Exchange Commission. The risks affecting the Company's business
include, among others: physician acceptance of infusion-based
therapeutic regimens; implementation of the Company's direct sales
strategy; successful integration of the Company's recent acquisition
of AcryMed Incorporated and further development and commercialization
of AcryMed's technologies; dependence on the Company's suppliers and
distributors; the Company's continuing compliance with applicable laws
and regulations, such as the Medicare Supplier Standards and the Food,
Drug and Cosmetic Act, and Medicare's and the FDA's concurrence with
management's subjective judgment on compliance issues; the
reimbursement system currently in place and future changes to that
system; product availability, acceptance and safety; competition in
the industry; technological changes; intellectual property challenges
and claims; economic and political conditions in foreign countries;
currency exchange rates; inadequacy of booked reserves; and reliance
on the success of the home health care industry. All forward-looking
statements, whether made in this press release or elsewhere, should be
considered in context with the various disclosures made by the Company
about its business.
I-Flow, ON-Q and PainBuster are registered trademarks of I-Flow
Corporation.
SilverSoaker is a trademark of I-Flow Corporation.
SilvaGard is a registered trademark of AcryMed, Inc.
(1)Singh, J et al. Multicenter infection surveillance study
comparing two types of postoperative pain management, surgical site
using ON-Q SilverSoaker and local anesthetics vs. systemic narcotics
following colorectal procedures. Paper presented at: 47th Annual
Interscience Conference on Antimicrobial Agents and Chemotherapy;
September 2007; Chicago IL.
CONTACT: I-Flow Corporation
Orlando Rodrigues, 949-206-2619 (direct)
orlandorodrigues@iflo.com
SOURCE: I-Flow Corporation
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