ULURU Inc, Addison, Texas, has filed a 510k application with the US Food and Drug Administration 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. In addition, in toxicology and in vitro bacteria inhibition studies, Altrazeal Silver has performed favorably relative to competitive silver dressings, according to the manufacturer. Altrazeal incorporates the manufacturer's Nanoflex Technology and 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.
Initial clinical data on Altrazeal were presented recently at the Clinical Symposium on Advances in Skin & Wound Care in Las Vegas, Nevada.
Arobella Medical, LLC, Minneapolis, Minnesota, a leader in advanced ultrasonic wound care devices, has been issued a US patent that covers technology used in the next generation of the company's Qoustic Wound Therapy System. The system offers a safe, cost-effective alternative to painful sharps debridement and other surgical modalities, according to the manufacturer. Light guidance contact produces a dual delivery of low-frequency ultrasound energy directly on the wound bed. This process gently, debrides the wound and provides stable cavitation to remove dead or diseased tissue, harmful bacteria, and biofilm.