It is anticipated that a 510(k) application will be filed with the FDA in approximately 90 days. Assuming no extended delays in FDA review, approval of Altrazeal® exSALT™ could occur as early as the third quarter of 2011. The antimicrobial segment of the North American advanced wound care market is projected to grow in the next 5 years to be in excess of $750 million with annual growth rates above 15%.
Commenting on the Agreement, Kerry P. Gray, President and CEO of ULURU Inc., stated, "Combining these two leading technologies offers the potential for a dominant product in the antimicrobial dressing market. The superior antimicrobial activity at a significantly lower silver concentration is an outstanding product benefit. As we assessed our silver product strategy, given the favorable product profile of Altrazeal® exSALT™, it became obvious that this was our best course of action compared with pursuing our prior silver product application. This revised strategy also addresses questions previously raised by the FDA."
About ULURU Inc.:ULURU Inc. is a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products to provide patients and consumers improved clinical outcomes through controlled delivery utilizing its innovative Nanoflex™ Aggregate technology and OraDisc™ transmucosal delivery system. For further information about ULURU Inc., please visit our website at www.uluruinc.com. For further information
|SOURCE ULURU Inc.|
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