Emblation Collaborates with Esteemed American Dermatologists for Groundbreaking Clinical Trial

Scottish health-tech innovator, Emblation, is embarking on a comprehensive clinical trial that has the potential to revolutionize the prospects of its microwave treatments in the United States. Emblation’s Swift® device is already in use by over 1,000 clinicians across the country, but the new trials aim to secure expanded clearance from the Food and Drug Administration (FDA), the US government regulatory body.

Three distinguished dermatologists will oversee the recruitment of 110 patients from research centers in three US cities. Each participant will receive monthly treatments for up to four months, if necessary, with the progress and results meticulously evaluated by expert assessors.

Significantly, the pivotal trial, which costs $2 million, will directly compare Swift®’s wart and verrucae treatment with cryotherapy, one of the most widely utilized approaches for persistent skin lesions. The study will assess the efficacy and safety of both treatments, providing crucial insights.

Dr. Matt Kidd, Director of Research and Development at Emblation, emphasized the commercial significance of the American healthcare system and the stringent regulations it entails. He explained that the clinical trial represents the culmination of years of research and development efforts to target the US market. The trial’s findings are expected to transform the marketing landscape for Swift® treatments.

Microwave treatment offers distinct advantages due to its precision, repeatability, and non-invasive impact on surrounding tissues. Presently, Swift® holds a general indication of use in dermatology in the US but cannot be marketed specifically for wart and verrucae treatment.

Dr. Kidd expressed his optimism, stating, “This is a major milestone for us, and it has been a long process to get to this stage, made possible by the significant investment that Emblation attracted. We hope the results will allow us to change how our device is labeled and demonstrate the clear advantages of Swift® treatments over cryotherapy.”

The recruitment of patients for the research is being led by three globally renowned dermatologists in Chicago, Miami, and Nashville. Dr. Ashish Bhatia in Chicago is recognized for his surgical expertise, including reconstructive surgery and scar revision. Dr. Jill Waibel in Miami is a leading expert in dermatologic laser surgery, while Dr. Michael Gold in Nashville is highly sought-after for his knowledge of lasers and energy-based devices in dermatology.

Once all 110 patients have completed the three-month study period, the results will be collated and independently assessed, leading to an initial report on the efficacy and safety of the treatments. This report will be submitted to the FDA, which oversees the safety of drugs and medical devices in the US. After the full 12-month study, a final report will provide a definitive evaluation of Swift®’s effectiveness in treating warts and verrucae and preventing reoccurrence, comparing it to cryotherapy.

Emblation’s clinical trial team anticipates that the final findings will be published in mid to late 2024, marking a significant milestone for the company. Founded by Gary Beale and Eamon McErlean, who met during post-graduate studies at Heriot-Watt University in Edinburgh, Emblation launched Swift® in 2016 as an innovative treatment in the podiatry and dermatology sectors.

The company experienced accelerated growth in 2021 when it secured backing from specialist healthcare investors at Apposite Capital in London. This investment not only facilitated the current clinical trial but also fueled Emblation’s rapid expansion across Europe, the US, and the Middle East. In December 2022, the company announced the acquisition of a specialized US distributor in a seven-figure deal. As of that time, over 400 Swift® devices had been deployed in the US, with over 1,000 practitioners trained in its usage and more than 50,000 treatments administered for skin lesions. Globally, Swift® has been utilized in over 300,000 treatments.

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