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I-Flow Announces ON-Q Study Published in Prestigious Journal of the American College of Surgeons

Posted on: Tuesday, 21 March 2006, 09:00 CST

I-Flow Corporation (NASDAQ:IFLO) announced today that a key ON-Q colorectal study conducted at the Cleveland Clinic Florida was published in the Journal of the American College of Surgeons (JACS). This latest publication complements the more than 50 published and presented ON-Q studies to date. The published results reflect the improved outcomes seen in previous studies and go a step further in demonstrating how ON-Q may even result in a lower infection rate than expected for this type of surgery.

JACS is a monthly peer-reviewed journal that features original scientific articles and collective reviews and is the official scientific publication of the American College of Surgeons. The Cleveland Clinic Florida is a national sponsor for continuing medical education courses and annually publishes results of hundreds of clinical trials.

The ON-Q study was conducted with a prospective, randomized, double-blind design at the Cleveland Clinic Florida and consisted of 70 colorectal surgery patients; 35 of which received an ON-Q delivering a local anesthetic and 35 that belonged to a control group.

According to the ON-Q study principal investigator and co-author, Steven D. Wexner, MD, FACS, FRCS, these research results are potentially significant due to the growing physician interest and patient demand for better post-surgical pain relief. "The cascade of physiological damage triggered by post-operative pain can interfere with the patient's well-being, comfort and recovery. Additionally, the recovery can be slowed down by narcotics which have unwanted side effects like nausea and vomiting."

Patients in the study who received an ON-Q delivering a local anesthetic got effective pain relief and used significantly less narcotics, experienced an earlier return of bowel function and ambulated (were able to get up and move around) sooner than patients in the control group. It was also stated that after a medical record review 30 days after their surgeries, only a 2.9 percent infection rate was reported in these patients -- which is considerably less than the 7.3 percent rate published by the Centers of Disease Control on surgical wound site infection for patients undergoing colorectal procedures.

The ON-Q study was designed with adequate power to show "statistical significance" in several areas such as narcotic reduction and pain scores. With ON-Q benefits being dramatic and easily identified, the number of patients needed to prove statistical significance with the precision to provide reliable answers was therefore very small.

"Overall, the use of ON-Q can decrease the amount of oral or intravenous analgesia (pain medication) required during the post-operative period. This can translate into lower analgesia requirements systemically with their potential adverse effects, including prolonged post-operative ileus," remarked Dr. Wexner.

"As the leader in our field, I-Flow has a responsibility and a commitment to the millions of patients undergoing surgery who deserve better post-surgical pain relief," noted Donald M. Earhart, I-Flow's Chairman, President and Chief Executive Officer. "We are proud to be included in the research endeavors of a premier medical facility like the Cleveland Clinic Florida and published in the highly respected Journal of the American College of Surgeons. I'm especially excited to see the excellent outcomes, reduced narcotic use and low infection rate," he added.

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 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 tiny, specially designed tube (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 50 studies on the use of ON-Q have been completed and published and more are underway to demonstrate the benefits of ON-Q in additional areas such as reduced infection risk, combination therapies (e.g., a local anesthetic and antibiotic mix, a combination of a local anesthetic and an anti-inflammatory), pediatrics, chronic pain and wound healing. 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 drug delivery systems that are redefining the standard of care by providing life enhancing, cost-effective solutions for pain relief.

"Safe Harbor" Statement

Certain disclosures made 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, such as comments that express the Company's opinions about trends and factors that may impact future operating results. Disclosures that use words such as the Company "believes,""anticipates," or "expects" or use similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ from those expected, and readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to republish revised forward-looking statements to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures made by the Company in this release, which seek to advise interested parties of the risks, and other factors that affect the Company's business, as well as in the Company's periodic reports on Forms 10-K, 10-Q and 8-K filed with the Securities and Exchange Commission. The risks affecting the Company's business include, among others: implementation of our direct sales strategy; dependence on our suppliers and distributors; reliance on the success of the home health care industry; our continuing compliance with applicable laws and regulations, such as the Food, Drug and Cosmetic Act, and the FDA's concurrence with our management's subjective judgment on compliance issues; the reimbursement system currently in place and future changes to that system; competition in the industry; economic and political conditions in foreign countries; currency exchange rates; inadequacy of booked reserves; technological changes; and product availability and acceptance. 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.

www.clevelandclinic.org/florida

http://www.journalacs.org

Source: Business Wire

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