This article was published on healthandcare.scot 

An innovative Scottish health technology company is set to conduct a clinical trial of its microwave device to assess its effectiveness compared to cryotherapy for treating persistent skin lesions.

Scottish company Emblation has secured over £1.5m ($2m) to conduct its clinical trial and will begin the in-depth study later this year, with the team recognising the trial as a “major milestone”.

Emblation’s medical device, called Swift® is already being used to treat skin lesions and has shown promise as a less invasive, targeted treatment for cervical cancers.

Now, the Stirling-based company is set to begin a clinical trial which it says could ‘transform’ its role in providing microwave treatments in the United States.

This ‘pivotal’ clinical trial will see the Swift® compared to the current go-to treatment for warts and verrucae – cryotherapy – in the safety and effectiveness of treating persistent skin legions.

Transforming treatment

Dr Matt Kidd, Director of Research and Development at Emblation, says this trial represents the culmination of years of work:

“No healthcare system in the world is as commercially important than that in America, which is why it is so heavily regulated.

“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.”

A total of 110 patients will be recruited by dermatologists across research centres in three US cities, with each patient to receive treatment once a month for up to four months while progress is monitored.

The trial will also be randomised, with half of the patients assigned Swift® microwave treatment and the other half assigned cryotherapy, which involves freezing a wart or verrucae.

The progress and results will be blindly reviewed by expert assessors to better understand the effectiveness of the medical device.

Once all 110 patients have reached the three-month mark following treatment, the results of the study will be collated and independently assessed – with an initial report expected in 2024.

This report will detail the efficacy and safety of the treatments and will be submitted to the US Food and Drug Administration (FDA), which oversees the safety of all drugs and medical devices in the US.

A ‘definitive picture’ of treatment

By using microwaves, the team explains its medical device can achieve accurate and repeatable treatment outcomes without affecting surrounding tissues.

In a process known as microwave hypothermia, the Swift® medical probe delivers ‘precise tissue disruption’ using a directed flow of microwave energy at specific cells.

While Emblation’s Swift® device has been adopted by over 1,000 clinicians across the US, results from this new clinical trial could see it achieve extended FDA clearance and reach patients with warts or verrucae.

In May this year, Glasgow researchers utilised the Swift® probe to target cancerous and precancerous cells and the lead researcher, Professor Graham told healthandcare.scot that it provided mild and highly localised treatment.

Dr Kidd says this new clinical trial will allow the team to expand their work from research:

“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.”

Extending its FDA clearance for Swift® from its current “general indication of use” in dermatology would allow Emblation to share its specific treatment benefits for warts and verrucae more widely.

The team hope to present initial findings mid-2024.