ADDISON, Texas, Sept. 30 /PRNewswire-FirstCall/ -- ULURU Inc. (Amex: ULU) today announced that it has filed a 510k application with the United States Food and Drug Administration (FDA) for Altrazeal(TM) Silver.
Preclinical studies conducted to support the filing have shown that superior healing rates in numerous porcine wound models have been achieved relative to competitive silver dressings. Additionally, in toxicology and in vitro bacteria inhibition studies Altrazeal(TM) Silver has performed favorably relative to competitive silver dressings. This data should favorably position Altrazeal(TM) Silver in the market, providing benefits to both the patient and the health care provider.
The use of silver in wound care is increasing rapidly in the management of infected wounds and wounds at risk for infection. Silver has been used extensively as a broad-spectrum antimicrobial particularly in the treatment of chronic wounds and to manage burn infections. Wounds exhibiting increased bacterial burden have reduced healing responses when compared to wounds containing fewer bacteria.
Commenting on the 510k filing, Kerry P. Gray, President and CEO of ULURU Inc. stated, "This is an important milestone in the development of our wound care franchise. In certain wound types silver-containing products are used extensively by physicians. We have responded to a market need by developing Altrazael(TM) Silver as our sales organization has received consistent feedback from wound care practitioners that a silver containing Altrazeal(TM) is one of the products that would improve wound treatment. We expect to launch Altazeal(TM) Silver in the first quarter 2009."
In addition to being a superior wound dressing Altrazeal(TM), which
incorporates our Nanoflex(TM) technology, is also a controlled drug
delivery technology enabling active wound healing agents to be delivered to
the wound bed over periods of up to 30 days. Altrazeal(TM) Silver is the
first in a s
|SOURCE ULURU Inc.|
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