Avita Medical has initiated an European clinical study of its ReCell Spray-On Skin device, designed for treating venous leg ulcers.
Designed for use in burns, plastic, reconstructive and cosmetic procedures, the device uses the company’s patented and proprietary tissue-culture, collection and application technology.
The control, multicenter and randomized study, which is expected to begin in the first quarter of 2013, will enroll up to 80 patients from the UK, Germany, France and Denmark centers.
In previous preliminary open-label studies conducted at four European centers, ReCell treated 80 patients, aged 70 years, with venous leg ulcers and diabetic foot ulcers that were 21 cm2 in size and 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 results achieved in the treatment of chronic ulcers with ReCell 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 added.
"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."
The company said ReCell, which is an investigational device, is not available for sale in the US.