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ULURU Inc. Announces the Filing of a 510(k) Application to Expand Altrazeal®'s Label Claim
Date:3/16/2011

ADDISON, Texas, March 16, 2011 /PRNewswire/ -- ULURUInc. (NYSE Amex: ULU) announced today that it has filed an abbreviated 510(k) application with the U.S. Food and Drug Administration to expand Altrazeal®'s label claim to include the management and mitigation of pain.

The principal data supporting this 510(k) application is a randomized clinical study comparing Altrazeal® to Acquacel® Ag in skin graft donor sites. This amended label claim is also supported by clinical experience using Altrazeal® in various wound types including venous leg ulcers, second degree burns, geriatric wounds and numerous less common wound types.

In the randomized clinical study Altrazeal® when compared to Acquacel® Ag, a market leading product, used as the standard of care for skin graft donor sites at a number of major burn treatment centers, showed the following results:

  • At all 3 time points evaluated Altrazeal® demonstrated a statistically significant reduction in pain (P<0.0001) [Statistical significance is (P<0.05)]; and
  • Patients also reported a statistically significant improvement in comfort (P<0.001).

  • Significant pain reduction has also been reported when Altrazeal® has been used to treat venous leg ulcers.  Wound pain is a significant issue for venous leg ulcer patients with 80% of patients experiencing pain which can lead to poor patient compliance, fatigue, sleep disturbances and depression.

    In a group of patients treated with Altrazeal®, who had experienced venous leg ulcers for 3 – 27 years where all patients reported pain as an inhibiting factor with adherence to recommended compression treatment and the wounds had not decreased in size for several months:

  • All patients reported improvement in pain levels within 15 minutes of application (t
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  • SOURCE ULURU Inc.
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