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I-Flow Corporation (IFLO) Receives FDA Clearance for Stabilized Antimicrobial Wound Gel


3/12/2009 7:57:10 AM

LAKE FOREST, Calif.--(BUSINESS WIRE)--I-Flow Corporation (NASDAQ:IFLO - News), through its wholly-owned subsidiary AcryMed Inc., announced today that it received 510(k) clearance on February 26, 2009 from the Food and Drug Administration (FDA) for its stabilized antimicrobial wound gel. The product, as yet unnamed, has been FDA cleared for both over-the-counter and prescription-only marketing and distribution.

The new stabilized antimicrobial wound gel contains antimicrobial silver in an amorphous gel. AcryMed pioneered the introduction of silver antimicrobial gels for controlling bioburden in wounds. This new product uses the same proprietary silver stabilization chemistry as its highly successful SilvaSorb® Gel, but is even more potent and durable. It was tested in vitro against a current market-leading prescription antimicrobial wound product and was found to be more active with minimal adverse tissue reactions.

“Our new stabilized silver antimicrobial wound gel is yet another unique and unrivaled product that we are proud to add to our growing portfolio of infection-reducing products,” said Donald M. Earhart, I-Flow's chairman and chief executive officer. “I-Flow is already a leader in improving clinical and economic outcomes when treating pain following surgery and continues to develop innovative products that improve patient outcomes.”

While distribution for the gel has not been finally determined, AcryMed’s typical sales strategy is to out-license their technologies to established distribution and marketing partners.

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 ISO certified manufacturing and lab facilities at its Beaverton, Oregon headquarters. For more information on AcryMed visit www.AcryMed.com.

About I-Flow

I-Flow Corporation (NASDAQ:IFLO - News) is improving clinical and economic outcomes following surgery by designing, developing and marketing technically-advanced, low-cost drug delivery systems and innovative products for post-surgical pain relief and surgical site care. For more information on I-Flow Corporation visit www.iflo.com.

"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.

Contact:

I-Flow Corporation Orlando Rodrigues, Vice President, Marketing, 949-206-2619 orlandorodrigues@iflo.com

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