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I-Flow Corporation Announces That a Human Study is Underway in Colorectal Surgery to Evaluate Antimicrobial Benefits of ON-Q(R)

Posted on: Tuesday, 26 September 2006, 09:01 CDT

I-Flow Corporation (NASDAQ:IFLO) announced today the beginning of a

human study in colorectal surgery to evaluate the antimicrobial benefits

of the ON-Q®

PainBuster System, its market-leading post-surgical pain relief brand.

The study, which will include utilization of the ON-Q SilverSoaker®

Antimicrobial Catheter, will assess the rate of surgical site infections

in colorectal patients who get ON-Q therapy versus those who do not and

will be conducted at a number of locations across the United States. Two

of the initial sites will be in Atlanta and Omaha. The multi-center

trial is expected to include more than 1,000 patients and take more than

a year to complete.

Currently, ON-Q is cleared by the FDA to significantly reduce pain

better than narcotics and to significantly reduce narcotics intake after

surgery. The pump delivers a non-narcotic local anesthetic (numbing

medicine) automatically to an incision site. ON-Q was used successfully

in hundreds of thousands of surgeries in 2005 in the United States to

relieve post-surgical pain.

I-Flow is proceeding with this human study based on findings from a

recently-completed animal study and on a meta-analysis of past ON-Q

clinical study results that highlights reduced rates of surgical

infections versus expected incidences. A total of 48 studies

encompassing 3,011 patients were included in the analysis. The data,

which was recently presented at the International Conference on Surgical

Infections in Stockholm, Sweden, showed a significant benefit for

continuous wound catheters, such as ON-Q, in lowering the risk of

surgical site infection. Both quantitative and qualitative systematic

review identified the benefit, and the data was confirmed in a

sub-analysis by therapeutic area or specialty.

"Past data has shown that local anesthetics

exhibit an antimicrobial benefit in-vitro and in-vivo,"

said Stephen M. Cohen, MD, a study investigator of Atlanta Colon and

Rectal Surgery in Georgia. "Since ON-Q is used

at the surgical site to deliver local anesthetic, we are expecting this

study to show that ON-Q can reduce the incidence of surgical site

infections."

"It isn't often that

we're able to participate in a study that has

this sort of potential, to truly expand the therapeutic scope of an

already successful product," added Alan G.

Thorson, MD, Clinical Associate Professor of Surgery and Program

Director of Colon and Rectal Surgery at Creighton University in Omaha,

Nebraska. "We have benefited from the

positive outcomes that ON-Q delivers for our patients in relieving their

pain after surgery, so now we're enthusiastic

about exploring the potential antimicrobial benefits of the therapy."

According to the Center for Disease Control's

(CDC's) National Nosocomial Infections

Surveillance (NNIS) system, over 8% of colorectal surgery patients and

an average of 2% of all surgery patients may develop surgical site

infections, often increasing the length of stay in the hospital by an

average of seven or more days and costing the healthcare system hundreds

of millions of dollars each year.

"This is an exciting time for ON-Q, as we

begin to research the therapy's potential

benefits in reducing the incidence of surgical site infections,"

said Don M. Earhart, P-resident and CEO of I-Flow Corporation. "ON-Q

is already redefining recovery for post-surgical patients across the

country by providing superior pain relief so they get back to normal

faster. This study is the next step in identifying a significant new

market opportunity for an already successful technology."

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 presented

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: physician acceptance of infusion-based

therapeutic regimens; 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.

Source: Business Wire

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