ULURU Inc. today announced filing a 510k application with the U.S. Food and Drug Administration (FDA) for Altrazeal(TM) Silver.

Preclinical studies prior to the filing show Altrazeal(TM) Silver to have superior healing properties over other silver dressings. Silver is being increasingly used in wound care due to its broad spectrum antimicrobial properties, particularly in the treatment of burns and chronic wounds. With Altrazeal(TM) Silver healing duration in numerous chronic, acute and traumatic wounds is significantly shorter than previously experienced.

Altrazeal(TM) incorporates the company’s Nanoflex(TM) controlled drug delivery technology, which facilitates active wound healing agent delivery to the wound bed over periods of up to 30 days. Nanoflex(TM) is based on hydrogel nanoparticles which aggregate to form a biomaterial of varying strength and elasticity. Altrazeal(TM) Silver is the first in a series of planned line extensions designed to improve the treatment of both acute and chronic wounds. The company has plans to develop additional Altrazeal(TM) products which incorporate active compounds for the treatment of the various phases of wound healing, infection, inflammation, debridement, maturation and closure.

ULURU is a specialty pharmaceutical company focused on the development of a range of wound management, plastic surgery and oral care products which provide patients and consumers improved clinical outcomes through controlled delivery utilizing its transmucosal delivery system, OraDisc(TM), and Nanoflex(TM) Aggregate technology.

Altazeal(TM) Silver is to be launched in the first quarter 2009.

Source: ULURU Inc.