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I-Flow Corporation Announces Preliminary Results of ON-Q(R) Colorectal Infection Study at Annual Surgical Infection Society Meeting

Posted on: Thursday, 19 April 2007, 09:00 CDT

I-Flow Corporation (NASDAQ:IFLO) announced today that preliminary results of an ON-Q prospective human study in colorectal surgery were presented at the annual meeting of the Surgical Infection Society (SIS) in Toronto. This trial was designed to evaluate the effects of ON-Q PainBuster with ON-Q SilverSoaker Antimicrobial Catheter on surgical site infections. The early results of the ongoing study indicate a statistically significant reduction in the rate of surgical site infections and a statistically significant decrease in length of hospital stay for patients who received ON-Q versus those who received only narcotics, today's standard of care for pain relief after surgery.

The preliminary findings captured the outcomes of 120 patients undergoing abdominal colorectal surgery, 72 of whom received continuous local anesthetic using ON-Q and 48 who received traditional pain relief treatment. The results revealed that at 30 days after their surgery, patients who received ON-Q had a statistically significant lower risk of developing surgical site infections -- 0% -- than the control group -- 22.9%. Additionally, patients treated with ON-Q had statistically significant shorter hospital stays -- 5.1 days -- than the control group -- 6.9 days. This multi-center study is ongoing and is expected to be completed by year-end.

"We are excited that the early data from the colorectal study has indicated that ON-Q may have potential benefits in reducing the incidence of surgical site infections," said Donald M. Earhart, President and CEO of I-Flow Corporation. "This study is the next step in potentially expanding ON-Q's therapeutic benefits beyond pain relief into the area of surgical site care, and is potentially important as we continuously strive to get more and more patients back to normal faster following surgery. We look forward to completing the trial and understanding the overall results."

The initial results from the colorectal study are consistent with findings seen in a recently completed meta-analysis, spanning nearly 10 different surgical specialties, that was also presented at the SIS annual meeting. The meta-analysis, consisting of a systematic review of 50 studies and encompassing 4,030 patients, for whom ON-Q Soaker Catheters were used instead of the newer ON-Q SilverSoaker Antimicrobial Catheters, was done to determine the effect ON-Q had on the incidence of surgical site infections. The results showed that the reported surgical site infection rate in clinical trials with ON-Q versus standard pain relief treatments was approximately one-third -- 0.7% -- as compared to the national average -- 2.1%. It appears that ON-Q's ability to relieve post-surgical pain may be accompanied by additional benefits that possibly result from factors like anti-microbial effects, an increase in tissue oxygen delivery and improved immune response because of reduced narcotic intake.

According to the Centers for Disease Control and Prevention's (CDC's) National Nosocomial Infections Surveillance (NNIS) system, surgical site infections often increase patient length of stay in the hospital by an average of seven or more days and cost the healthcare system hundreds of millions of dollars each year.

About ON-Q

ON-Q is now labeled to significantly reduce pain better than narcotics and to significantly reduce narcotics intake after surgery. ON-Q therapy was recently upheld as a best practice for post-surgical pain relief and its widespread use was encouraged in an independent study published in the prestigious Journal of American College of Surgeons. The large-scale pain relief meta-analysis included 2,141 patients across a wide range of surgical procedures.

ON-Q is a simple yet elegant device that consists of a small balloon pump that holds a local anesthetic (a pain-numbing medicine) and delivers it automatically through a specially designed catheter to provide even distribution of local anesthetic over a wider area, as compared to other catheters, because of its patented wicking capabilities.

Currently, more than 55 studies on the use of ON-Q have been completed and published or presented and more are underway to demonstrate the benefits of ON-Q in additional areas such as reduced infection risk, combination therapies (e.g., local anesthetic and antibiotic mixtures, a combination of a local anesthetic and an anti-inflammatory), pediatrics and chronic pain. In addition, effective January 1, 2007, Medicare recognized the ON-Q therapy 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 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-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: successful consummation of the previously announced sale of InfuSystem, Inc; physician acceptance of infusion-based therapeutic regimens; implementation of our direct sales strategy; 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 the Medicare's and 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 and acceptance; 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 release or elsewhere, should be considered in context with the various disclosures made by the Company about its business.

Source: Business Wire

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