FDA Clears Thin, Transparent Wound Dressing Material

Microlyte Ag dressing applied to a wound on a pig (Imbed Biosciences)

5 August 2016. The Food and Drug Administration cleared a new type of thin, transparent wound dressing for marketing in the U.S. as a medical device. The material approved by FDA called Microlyte Ag is made by Imbed Biosciences, a spin-off enterprise from University of Wisconsin in Madison.

Microlyte Ag is made with silver nanoparticles laminated into a thin, transparent film similar to plastic wrap for food that can cling to irregular wound surfaces. While silver is well known as an antimicrobial agent, it can be toxic to skin cells in high loads. The Imbed Biosciences technology makes it possible to sharply reduce the quantity of silver, while maintaining its effectiveness against bacteria.

Company CEO and co-founder Ankit Agarwal says in a university and company statement, “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.” The company says Microlyte Ag was shown effective even against stubborn hospital acquired bacteria, such as methicillin-resistant Staphylococcus aureus, or MRSA, and vancomycin-resistant enterococcus.

Microlyte, says Imbed Biosciences, is breathable as well as ultrathin, allowing oxygen in and gases out. Because the film has a hydrogel layer, it can adhere to uneven surfaces, allowing the material to apply the antimicrobial silver compound in places that would be missed by conventional dressings. As a result, it can deliver effective quantities of silver to the wounds, even in low concentrations in the dressing.

In addition, Microlyte Ag is biodegradable, and the company says tests with animals show it wears off over time, reducing the need for painful dressing changes. “Reducing or eliminating dressing changes reduces the pain that the patient experiences,” says Michael Schurr, a surgeon in Asheville, North Carolina and company co-founder. “It also reduces costs in supplies and reduces the burden to the health care system that supplies visiting nurses to do the dressing changes.”

Agarwal and Schurr started Imbed Biosciences in nearby Fitchburg with four other founders, including Nicholas Abbott, professor of chemical and biological engineering at Wisconsin. Agarwal was a postdoctoral research fellow in Abbott’s lab when he started the company.

FDA’s action clears Imbed to market Microlyte Ag as a class 2 medical device — those with moderate levels of risk — to treat diabetic ulcers, venous ulcers, burns, bedsores and other difficult wounds, which the company estimates at $2 billion. The company plans at first to license Microlyte Ag through hospital suppliers, but is also discussing commercial-scale production.

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