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Results of Study Published in The Journal of Antimicrobial Chemotherapy Confirm That Silver Nanoparticles May Be Useful in Reducing Infections
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® PainBuster® with ON-Q SilverSoaker® 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®, 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.
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 Corporation
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.
¹Singh, 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.
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Orlando Rodrigues, 949-206-2619 (direct)
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