Imbed Biosciences, a Fitchburg startup whose technology, with tiny silver particles, is used to heal wounds, can start selling its product for use on humans.
The U.S. Food and Drug Administration has cleared Imbed’s Microlyte Ag for prescription and over-the-counter use.
“We are very excited about it,” said Ankit Agarwal, co-founder and CEO, in an interview.
The technology is based on research Agarwal got involved with as a post-doctoral research scientist at the UW-Madison in 2008.
His five co-founders include Jonathan McAnulty, chair of the Department of Surgical Sciences at the UW-Madison School of Veterinary Medicine and former UW surgeon Dr. Michael Schurr.
The wound dressing is a hydrogel sheet that can be cut to the size of a wound. “It looks like Saran Wrap but you can rinse it off,” Agarwal said.
The small amounts of silver work to kill bacteria — less silver than other treatments, he said. And while commonly used ointments have to be applied to wounds several times a day, Microlyte Ag can stay on for several days, covered by a skin graft or artificial skin.
Agarwal said the product has not been tested on humans but it has been shown effective in animal tests.
“We certainly have no reason to think that this will be different with humans,” McAnulty said, in a news release.
He added in the release, “The principles are the same and a lot of the problems are the same.”
McAnulty said wounds that resisted months of conventional treatment started to have “very dramatic closure” in dogs and cats treated at the UW Veterinary School.
The treatment can be used for chronic skin ulcers, pressure sores and first- and second-degree burns, Agarwal said.
Formed in 2010, Imbed, at 5520 Nobel Drive, has six full-time and four part-time employees. The company has received $3 million so far, from investors and government funding.
The FDA clearance of Microlyte for use as a medical device will mark the start of another effort to raise money, about $4 million to $5 million, Agarwal said, so the company can scale up manufacturing. He said he is hoping to work out an agreement with a major medical products company to market the wound treatment.
Agarwal said he thinks Microlyte could be a blockbuster. “Yes, that’s what we believe in,” he said.
“It is a niche product. There is no other product which is ultra-thin and has silver but has no toxicity,” he said.
Microlyte will compete in the $2 billion market sector of advanced wound dressings.
‘It is a niche product. There is no other product which is ultra-thin and has silver but has no toxicity.’ Ankit Agarwal
co-founder and CEO