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Home > Press > I-Flow Corporation Receives 510(k) Clearance From FDA for Oxygenated Topical Dressing

Abstract:
Company to Now Start Clinical Studies on First of Its Kind Oxygen Enriched Topical Dressing for Wound Care

I-Flow Corporation Receives 510(k) Clearance From FDA for Oxygenated Topical Dressing

LAKE FOREST, CA | Posted on September 25th, 2008

I-Flow Corporation (NASDAQ: IFLO), through its wholly-owned subsidiary AcryMed Inc., announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) on its oxygen enriched topical hydrophilic closed cell foam wound dressing. Receiving the 510(k) enables I-Flow to start on the path to clinical studies on the dressing in keeping with a plan to make the product commercially available in the second half of 2009. This homogenous oxygenated dressing will likely be the first used for topical oxygen enrichment specifically at the site of tissue damage which may improve healing.

I-Flow's oxygen enriched topical dressing was developed to be intuitive and straightforward for health care professionals treating wounds. Oxygen is a required nutrient for wound healing. This oxygen enriched dressing is intended to supply this nutrient as well as manage wound moisture in difficult to heal wounds. The product is composed of a proprietary material that is treated chemically to generate and capture the oxygen. Supplemental oxygen, delivered by hyperbaric chambers, has been shown to accelerate wound healing for burns and chronic wounds. The I-Flow dressing is indicated for topical application to burns and acute and chronic wounds and may be ideal for many patients that may benefit from supplemental oxygen but that do not have access to hyperbaric oxygen or where that treatment may be contraindicated. Patents for the product have been issued in the U.S. and Europe and others are pending.

"We are excited about this new product, which we believe will drive a paradigm shift toward the use of oxygen enrichment for wound care," said Donald M. Earhart, I-Flow's chairman and chief executive officer. "I-Flow is already a leader in improving surgical outcomes and this topical wound care dressing brings us a step closer to evolving into an acute care company. We believe that this product, like our ON-Q® Pain Relief System, which treats a local area with therapy versus treating the body systemically, will provide significant patient benefits and improve outcomes."

About AcryMed

AcryMed is a pioneering leader at the forefront of innovations in the fields of infection control and wound healing. The company's SilvaSorb® products for advanced wound care and SilvaGard® nanoparticle surface treatment for medical devices are among the breakthrough technologies that have distinguished AcryMed as an industry leader. A wholly-owned subsidiary of I-Flow Corporation, AcryMed maintains on-site GMP/ISO certified manufacturing and lab facilities at its Beaverton, Oregon headquarters. For more information on AcryMed visit www.AcryMed.com.

####

About I-Flow Corporation
I-Flow Corporation (www.IFLO.com) is improving surgical outcomes by designing, developing and marketing technically-advanced, low-cost drug delivery systems and innovative surgical products for post-surgical pain relief and surgical site care.

“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 press 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-K, 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: physician acceptance of infusion-based therapeutic regimens; implementation of the Company’s direct sales strategy; successful integration of the Company’s recent acquisition of AcryMed Incorporated and further development and commercialization of AcryMed’s technologies; 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 Medicare’s and the 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, acceptance and safety; 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; potential non-cash purchase accounting adjustments associated with the AcryMed acquisition; and reliance on the success of the home health care industry. All forward-looking statements, whether made in this press release or elsewhere, should be considered in context with the various disclosures made by the Company about its business.

For more information, please click here

Contacts:
I-Flow Corporation
Orlando Rodrigues
Vice President, Marketing
(949) 206-2619

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