Specialty pharmaceutical firm Uluru has announced the company's launch plan for Altrazeal and the commercial availability of the product commencing the week of May 19, 2008.
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Altrazeal is claimed to be the first wound care dressing to be developed from our nanoparticle aggregate technology. It is an easy to apply and remove powder hydrogel that in the presence of body fluids rapidly converts to a gel material which fills and seals the wound, promoting an optimal moist healing environment and reduces the need for multiple dressing changes.
The company’s focus is to add two products to the wound care franchise in 2009. The first product under development is an antimicrobial dressing containing silver. The necessary toxicology studies for submission of a 510k regulatory application are nearing completion and production scale-up for blending the product has commenced. The company expects to file a 510k application with the FDA in the third quarter of 2008, with the product launch being planned for first quarter 2009.
Renaat Van Den Hooff, executive vice president-operations of Uluru, said: “We believe that by rapidly establishing key opinion leader support we can quickly build a solid foundation from which we plan to penetrate the burn market.”
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