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

he patient with the 27 year old wound who previously reported continuous pain of 9-10 (0-10 scale) experienced immediate pain reduction to 2);
  • Patients increased compliance to the recommended treatment plan and these stagnated wounds healed; and
  • All patients reduced oral pain medication.

  • In addition, a group of second degree burn patients also reported a dramatic drop in pain upon application of Altrazeal® to their wounds. Prior to treatment with Altrazeal®, average pain scores were 8.2 (0-10 scale).  After application of Altrazeal®, pain was reduced to an average of 1.7 and during the treatment period the pain average was 0.4.

    Commenting on the 510(k) application, Kerry P. Gray, President and CEO of ULURU Inc., stated, "Altrazeal® is a scientifically engineered wound treatment product designed to fill a critical unmet clinical need in chronic wound care.  The Company believes that the substantial clinical data we have generated on wound healing and pain management justifies this unique label claim designation. No other wound treatment has demonstrated this major clinical advantage.  Patient compliance and improved patient comfort are critical components in the treatment of chronic wounds. Achieving this amended label claim will be a significant competitive advantage and further differentiate Altrazeal® from other wound products."

    The filing of this application is an integral part of the Company's ongoing product line extension strategy to provide a value added portfolio of products to assist wound care professionals to improve clinical outcomes, as well as provide patients with compliance and comfort benefits.

    Mr. Gray added, "In the near term we intend to file additional 510(k) applications and further product line extensions.  Also, we intend to initiate an additional randomized clinical study to prove healing benefits associated with Altrazeal® that could enable us
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    SOURCE ULURU Inc.
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