Regenerative medicine company Avita Medical has commenced a clinical study in Europe to evaluate the potential of its ReCell Spray-On Skin device in treating venous leg ulcers.
The device, which utilises the company’s patented and proprietary tissue-culture, collection and application technology, is designed for use in burns, plastic, reconstructive and cosmetic procedures.
The control, multicentre and randomised study, which is expected to begin in the first quarter of 2013, will enrol up to 80 patients from the UK, Germany, France and Denmark centres.
In previously conducted preliminary open-label studies on ReCell at four European centres, the trials treated 80 patients with venous leg ulcers and diabetic foot ulcers.
Patients had an average age of 70 years and 21cm² wounds, which remained open for approximately 13 months.
Following a single treatment with ReCell, over 70% of patients showed complete healing of the wound within 7-12 weeks, while pain was reduced within 72 hours.
Avita Medical CEO Dr William Dolphin said the early study results are promising.
"These are hard-to-heal ulcers that pose an enormous burden on healthcare systems and seriously impact on patient’s quality of life," Dolphin said.
"ReCell is approved for use in Europe, Australia and other markets with over 4500 procedures conducted to date, mainly for burns.
"Improved leg ulcer treatment will provide tremendous relief for ulcer patients, potentially deliver significant cost savings to financially stressed healthcare systems and may open additional very large markets for ReCell."
In developed countries, lower limb ulcers including venous leg ulcers and diabetic foot ulcers are considered a major healthcare problem due to their prevalence, high cost of treatment and significant impact on patient quality of life, according to the company.
ReCell is an investigational device and is not available for sale in the US.