Major investment aims to secure clearance for innovative lesion treatment
A PIONEERING microwave health tech firm is undertaking clinical trials on a global scale which could give millions fighting with stubborn skin lesions across the globe access to effective treatment.
Stirling-based Emblation has invested $1 million to conduct clinical trials in the US and Germany, which if successful could see its innovative Swift® device gain widespread use in the treatment of Actinic Keratoses (AK), a common condition which in some cases can develop into skin cancer.
The Swift® technology is already favoured by more than 3,000 global practitioners and has been used in an estimated 300,000 skin lesion treatments, but the technology is currently only allowed to be marketed for general dermatology use.
Dr Matt Kidd, Director of Research and Development at Emblation, said: “Actinic Keratoses is a common condition which affects millions of people globally and unfortunately in some cases can lead to more sinister outcomes.
“Our Swift® method of dealing with this condition is non-invasive, has little to no side effects, and unlike other solutions, is non-ablative.
“The outcome of this clinical trial will be an important step forward in establishing Swift® as a safe, easily accessible route to dealing with AK and securing peace of mind for those afflicted by these irritating lesions.
“The American and European health care sectors are key to our future growth and we will continue to work with the regulatory authorities to provide the research and evidence which will secure the necessary clearance for the wider use of Swift®.”
Sixty people across the US and Germany with AK lesions will be recruited to receive the Swift® treatment and monitored two months after the first of two treatments, with follow up checks at four months, six months and 12 months.
AK will typically develop on areas of the body often exposed to the sun, such as the face, hands, arms, ears and scalp, are usually up to 2cm in size and can feel dry, rough, scaly or itchy. The most common methods of treating AK include cryotherapy (freezing), photo dynamic therapy (light) or medicated creams and gels.
Matt continued: “An initial clinical trial carried out in Dundee saw excellent results in the treatment of AK in 11 patients.
“We are confident that these clinical trials will wield similar, successful results using our patented Swift system to target this troublesome lesion.”
Australians are most susceptible to developing AK with an estimated prevalence among 37-55% of adults aged over 40, compared to approximately 10.2% of females and 26.5% of males in the US, and in the UK 15% in males and 6% in females.
A 2013 study found dermatologists in Germany documented an annual 1.7 million cases of AK and the condition accounted for 8.3% of the hundred most frequently treated dermatological outpatient diagnoses.
The portable Swift® device allows clinicians to deliver a controlled dose of microwave energy into skin lesions, stimulating an immune response, but which does not affect surrounding tissue. It has been a major success with podiatrists and dermatologists in more than 20 countries world-wide because of its effectiveness, particularly in the treatment of verrucae.
The US part of the clinical trial will be supervised by Miami based dermatologic laser expert, Dr Jill Waibel, while Germany-based Professor Thomas Dirschka will oversee the programme as lead investigator.
Swift was launched in 2016 and quickly made an impression with clinicians. The firm’s growth was boosted in 2021, when it was backed by London-based specialist healthcare investors at Apposite Capital.
As well as making possible the new clinical trial, that cash injection has also fuelled Emblation’s rapid growth across Europe, the US and the Middle East. In December 2022 the firm announced the acquisition of a specialist US distributor in a seven-figure deal.
The firm was founded by Gary Beale and Eamon McErlean, who met during post-graduate studies at Heriot Watt university. The pair went on to launch Swift in 2016, as a radical new treatment in the podiatry sector.
To find out more about Emblation, call 01259 236132 or visit https://emblation.com/