ADDISON, Texas, Sept. 30, ULURU, Inc. (Amex: ULU) today announced that it has filed a 510k application with the United States Food and Drug Administration (FDA) for ALTRAZEAL 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 Silver has performed favorably relative to competitive silver dressings. This data should favorably position ALTRAZEAL 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 ALTRAZEAL Silver as our sales organization has received consistent feedback from wound care practitioners that a silver containing ALTRAZEAL is one of the products that would improve wound treatment. We expect to launch ALTRAZEAL Silver in the first quarter 2009."
In addition to being a superior wound dressing ALTRAZEAL, 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 Silver is the first in a series of planned line extensions designed to improve the treatment of both acute and chronic wounds. The company strategy is to develop additional ALTRAZEAL products incorporating active compounds for the treatment of the various phases of wound healing, infection, inflammation, debridement, maturation and closure. By implementing this strategy we believe that we will be delivering the products necessary to significantly improve wound healing.
Gray continued, "Our objective is to transform wound healing from "dressing a wound" to "treating a wound" by providing a range of products for the various phases of wound healing. The initial clinical data on ALTRAZEAL which will be presented at an upcoming wound conference in Las Vegas at the end of October is very exciting. Time to healing in numerous chronic, acute and traumatic wounds is significantly shorter than physicians have previously experienced. We believe that we can further improve wound treatment with our planned introduction of actives in the ALTRAZEAL dressing."
About ULURU Inc.:
ULURU Inc. is an emerging specialty pharmaceutical company focused on the development of a portfolio of wound management, plastic surgery and oral care products to provide patients and consumers improved clinical outcomes through controlled delivery utilizing its innovative transmucosal delivery system and Nanoflex™ Aggregate technology. For further information about ULURU Inc., please visit our website at http://www.uluruinc.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including but not limited to statements made relating to the response to the product from physicians and nurses, the importance of use of the product for burn victims, the ability to use the product for chronic wounds, the perception of the product as a transformational innovation in the wound care market, our plan to add two products to our wound care franchise in 2009, and a product launch in the first quarter of 2009. These statements are subject to numerous risks and uncertainties, including but not limited to the risk factors detailed in the Company's Annual Report on Form 10-KSB for the year ended December 31, 2007, Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 and other reports filed by us with the Securities and Exchange Commission.
Kerry P. Gray, President & CEO
Terry K. Wallberg, Vice President & CFO