Bacteria-Killing Wound Dressing Gets FDA Clearance
Mon, 08/08/2016 – by University of Wisconsin-Madison
Imbed Biosciences received clearance from the Food and Drug Administration to market its patented wound dressing for human use. The Microlyte Ag is a sheet as thin as Saran Wrap and can conform to the bumps and crevices of a wound, said company CEO Ankit Agarwal.
The dressing is now cleared by the FDA as a class II medical device, for prescription and over-the-counter use.
Like many dressings now used to treat burns and other persistent wounds, Microlyte Ag contains silver to kill bacteria — but in much smaller quantities.
“Silver is an excellent antimicrobial agent,” Agarwal said. “It is active against a broad range of bacteria and yeast. But the large silver loads found in conventional silver dressings can be toxic to skin cells. Our dressing uses as little as 1 percent as much silver as the competition, and yet the tests we submitted to the FDA showed that Microlyte kills more than 99.99 percent of bacteria that it contacts.”