Scottish health technology specialist Emblation is recruiting more than 100 patients in the US for a $2 million trial to prove prove the effectiveness of its microwave technology in the treatment of verrucas and warts.
The company's Swift device is already being used by more than 1,000 clinicians across the US in the treatment of general skin lesions. The new trials should see it achieve extended clearance from the US government’s Food and Drug Administration (FDA).
Known as pivotal trial, the study will compare Swift’s effectiveness in treating warts and verrucae with that of cryotherapy, one of the most widely-used treatments for persistent skin lesions. Matt Kidd, director of research and development at Stirling-based Emblation, said microwave treatment has the advantage of being more accurately trageted so as not to affect surrounding tissue.
“No healthcare system in the world is as commercially important than that in America, which is why it is so heavily regulated," he said.
“This clinical trial is the culmination of years of research and development of our products to target this market. Once the findings are complete, it should transform the way we can market Swift treatments.”
Three dermatologists will recruit a total of 110 patients at research centres in Chicago, Miami and Nashville. Each subject will receive treatment once a month for up to four months, with progress and results blindly reviewed by expert assessors.
The results will be submitted to the FDA, with the final findings expected to be published by the middle to the end of next year.
The company was founded by Gary Beale and Eamon McErlean, who met during post-graduate studies at Heriot Watt University. Swift was launched to the podiatry market in 2016.
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Emblation has financial backing from London-based specialist healthcare investors at Apposite Capital.
Mr Kidd added: “This is a major milestone for us and it has been a long process to get to this stage, ultimately made possible by the fact that Emblation attracted significant investment.
“It is now our very clear hope that the results will allow us to change how our device is labelled, while also demonstrating that Swift® treatments offer clear advantages over cryotherapy.”
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