Company to Now Start Clinical Studies on First of Its Kind Oxygen
Enriched Topical Dressing for Wound Care
LAKE FOREST, Calif.--(BUSINESS WIRE)--Sept. 24, 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(R) 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(R) products for advanced wound care and SilvaGard(R)
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
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. 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
SOURCE: I-Flow Corporation
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