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| Press Release May 17, 2004 | |
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LAKE FOREST, Calif.--(BUSINESS WIRE)--May 17, 2004-- Interim Data of Over 200 Patients Featured by World-Renowned Urologist in Conjunction with American Urological Association Meeting I-Flow Corporation (NASDAQ: IFLO) today collaborated with a world-renowned urologist to preview interim data on the use of ON-Q(R) PainBuster(R) following radical prostatectomy surgery performed with a robotic minimally invasive technique. The data was featured by Dr. Vipul Patel, Director of Minimally Invasive Surgery at the Urology Centers of Alabama last week in conjunction with the American Urological Association meeting in San Francisco. The study was conducted at St. Vincent's Hospital in Birmingham, Ala. and the Urology Centers of Alabama using a robotic minimally invasive surgical procedure followed by ON-Q PainBuster for post-surgical pain relief and the interim details reported were superior to the results achieved with traditional open prostatectomy. Dr. Patel's results with more than 200 patients treated in this manner were:
-- Average blood loss was minimal
-- Most patients took no narcotics (narcotics are today's
standard of care) for pain relief following surgery
-- Most patients were out of the hospital quicker, many in less
than 24 hours, and the majority were back to independent
activities of daily living faster, within 7-10 days.
"The treatment for prostate cancer is an area of much debate. Historically, the most common treatment for organ-confined prostate cancer has been open radical prostatectomy. However, the procedure is often associated with significant morbidity such as blood loss, pain and an extended recovery period. Due to these limitations urologists have searched for other, less morbid alternatives. Robotic radical prostatectomy is one such option providing prostate removal with decreased morbidity and side effects," said Dr. Patel. "This research, which was conducted over the course of two years, combines the most recent breakthroughs in surgical technique and pain relief to help these patients get over their surgery, over their cancer, and back to normal faster. The results we saw are compelling and it is truly amazing to see patients back on their feet, walking around, and rehabilitating so quickly after surgery." Prostate cancer is the most common type of cancer (excluding skin cancer) among American men. The American Cancer Society estimates that there will be about 230,000 new cases of prostate cancer in the United States in 2004 and about 30,000 men will die of this disease this year. Radical prostatectomy, surgery to remove the entire prostate gland, is a common therapy, however it has historically been a painful and invasive surgery involving a long recovery time. This is due in large part to the standard of care for post-surgical pain relief, narcotics, which are associated with side effects including nausea, drowsiness and constipation, difficulty breathing and potential addiction. With ON-Q, local anesthetic is delivered directly to the incision site, reducing the amount of narcotics patients must take to relieve their pain. Dr. Patel is one of the only surgeons in the world who has combined a robotic minimally invasive surgical procedure and ON-Q PainBuster to provide a less invasive, non-narcotic option for patients. "This interim data is extremely encouraging, specifically because so many patients were able to have their pain relieved with no narcotics following a notably painful procedure. We believe that it is now clear that when ON-Q is used with robotic radical prostatectomy that an optimal recovery can be achieved," said Donald M. Earhart, president and CEO of I-Flow Corporation. "Dr. Patel's data confirms that prostate cancer surgery patients can have a pain-free and narcotic-free recovery without some of the fear that normally accompanies this surgery." Now it is possible for prostate cancer patients to enjoy the survival benefits of prostate cancer removal without significant blood loss or pain and with a reduced recovery period. About ON-Q PainBuster The ON-Q PainBuster 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 through a tiny, specially-designed tube (catheter) directly into the surgical site. The proprietary ON-Q Soaker(TM) Catheter is designed to provide more even distribution of local anesthetic over a wider area, as compared to other catheters, because of its patented wicking capabilities. ON-Q PainBuster delivers narcotic-free pain relief for many surgeries, including: cesarean section, hysterectomy, knee replacement, mastectomy, cardio-vascular/thoracic, foot and ankle and many cosmetic procedures. ON-Q PainBuster helps patients avoid the side effects of narcotics so they can get back to their normal lives faster. Currently, 30 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 pediatrics and wound healing. For more information about ON-Q, visit www.AskYourSurgeon.com or call 800-448-3569. 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. 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 Cosmetics 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 such 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.
CONTACT: Schwartz Communications
Wendy Williams/Brian Bogie, 781-684-0770
iflo@schwartz-pr.com
or
I-Flow Corporation
Orlando Rodrigues, 949-206-2619
orlandorodrigues@iflo.com
SOURCE: I-Flow Corporation
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