I-Flow Corporation (NASDAQ:IFLO) announced today that
the Company has partnered with the University of Minnesota (U of MN)
to conduct an animal study to evaluate the promise of antimicrobial
benefits of ON-Q(R). This will replace a previous study launched in
June in partnership with Tulane University Health Sciences Center,
which was halted abruptly, due to the effects of Hurricane Katrina,
before results could be collected. The new study at the U of MN
mirrors the design of the one at Tulane, and will involve one of the
original investigators, Dr. Bruce Dunn, to maintain continuity.
This is an important research milestone for I-Flow as positive study results could expand the use of ON-Q beyond today's labeling of significantly reducing pain and narcotics intake after surgery. Validation of the therapy's possible antimicrobial properties may extend ON-Q beyond the pain relief market into a much larger surgical site care market, more broadly redefining post-surgical recovery.
As previously stated by I-Flow, the decision to proceed with the upcoming study was based in part on the antimicrobial benefits that were seen in the patients' outcomes in more than 50 ON-Q clinical studies. Although the studies were not designed to evaluate infection rates, the Company observed that the infection rates in those patients who received ON-Q were well below the expected percentage based on the national Centers for Disease Control (CDC) average. The decision was also based on:
-- An extensive literature search that revealed 16 published in vitro studies demonstrating the antimicrobial properties of local anesthetics
-- Findings from a study conducted at Washington University in St. Louis (published in 2004) in which the lead investigator suggested that significant increases in oxygen at the surgical site when ON-Q is used may lead to faster healing and reduced infections
"We're thankful that we are able to re-start this study given the significance that the results could have on the future of ON-Q and its potential role in overall surgical site care," said Donald M. Earhart, I-Flow's Chairman, President and Chief Executive Officer. "If our additional in vivo research confirms the antimicrobial benefits of bathing a surgical site with a local anesthetic, healthcare professionals and facilities may be able to look to ON-Q as a prophylactic measure to reduce surgical site infections. Reducing surgical site infections could have significant impact on overall healthcare costs. Considering the importance of this area of research, we are also actively exploring other ways that ON-Q can deliver antimicrobial benefits."
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 more 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 pediatrics, chronic pain, wound healing and reduced infection risk. 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.
This is an important research milestone for I-Flow as positive study results could expand the use of ON-Q beyond today's labeling of significantly reducing pain and narcotics intake after surgery. Validation of the therapy's possible antimicrobial properties may extend ON-Q beyond the pain relief market into a much larger surgical site care market, more broadly redefining post-surgical recovery.
As previously stated by I-Flow, the decision to proceed with the upcoming study was based in part on the antimicrobial benefits that were seen in the patients' outcomes in more than 50 ON-Q clinical studies. Although the studies were not designed to evaluate infection rates, the Company observed that the infection rates in those patients who received ON-Q were well below the expected percentage based on the national Centers for Disease Control (CDC) average. The decision was also based on:
-- An extensive literature search that revealed 16 published in vitro studies demonstrating the antimicrobial properties of local anesthetics
-- Findings from a study conducted at Washington University in St. Louis (published in 2004) in which the lead investigator suggested that significant increases in oxygen at the surgical site when ON-Q is used may lead to faster healing and reduced infections
"We're thankful that we are able to re-start this study given the significance that the results could have on the future of ON-Q and its potential role in overall surgical site care," said Donald M. Earhart, I-Flow's Chairman, President and Chief Executive Officer. "If our additional in vivo research confirms the antimicrobial benefits of bathing a surgical site with a local anesthetic, healthcare professionals and facilities may be able to look to ON-Q as a prophylactic measure to reduce surgical site infections. Reducing surgical site infections could have significant impact on overall healthcare costs. Considering the importance of this area of research, we are also actively exploring other ways that ON-Q can deliver antimicrobial benefits."
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 more 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 pediatrics, chronic pain, wound healing and reduced infection risk. 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.