Avita enrols first patients for leg ulcer trial

Avita Medical (ASX:AVH) has enrolled the first three patients for a clinical trial of ReCell Spray on Skin in leg ulcers.

The European RESTORE study is expected to involve 65 patients with venous leg ulcers (VLUs). The randomised, controlled trial will be conducted across up to five sites.

Patients will receive either ReCell or standard-of-care treatment, and will be followed for at least 12 weeks post-treatment.

An earlier trial of ReCell in around 50 VLU patients has achieved some positive preliminary results.

Avita Medical CEO William Dolphin said the company believes VLUs could represent a large and growing market opportunity. Lower-limb ulcers affect nearly 1.5% of the population in OECD countries, and VLUs account for at least 75% of leg ulcers.

“Chronic wounds, of which VLUs are the most common, are a major burden to patients, healthcare professionals and healthcare systems globally [and] represent a large and growing market throughout the world,” he said.

ReCell Spray on Skin has TGA approval in Australia and CE Mark approval in Europe. It is used in burns, plastic, reconstructive and cosmetic procedures.

The product is not yet approved in the US, but in September last year, Avita Medical was awarded an extra US$800,000 ($895,000) from the US Department of Defense and Armed Forces Institute for Regenerative Medicine (AFIRM) to support its phase III FDA trial in burn injuries.

Avita Medical shares were trading 3.7% lower at $0.13 as of around 1 pm on Friday.