- AVITA Medical’s (AVH) skin re-pigmentation device gains tick of approval from the USA’s Food and Drug Administration (FDA) to treat patients with vitiligo
- RECELL is an FDA-approved device which transfers skin cells from pigmented skin to stable de-pigmented areas, offering a safe and effective treatment
- The technology was first approved for treating thermal burn wounds and full thickness skin defects, before being tested on patients with vitiligo
- AVITA Medical CEO Jim Corbett says this is a “breakthrough” treatment
- Shares are down 3.41 per cent, trading at $4.82 at 3:40 pm AEST
AVITA Medical’s (AVH) skin re-pigmentation device to treat patients with vitiligo has secured premarket approval from the USA’s Food and Drug Administration (FDA).
RECELL for repigmentation of stable depigmented vitiligo lesions is the first FDA-approved device to offer a one-time treatment at the point of care. The device transfers skin cells from pigmented skin to stable de-pigmented skin areas, offering a safe and effective treatment.
The technology was originally approved for treating thermal burn wounds and full thickness skin defects, before being tested on patients with vitiligo.
Vitilligo is disease which results in the loss of colour or pigmentation in patches of skin, affecting two per cent of the population globally. The condition can lead to people having low-self esteem and an impaired quality of life.
“This is a breakthrough approval for AVITA Medical, significantly expanding the clinical applications for RECELL, and demonstrates our continued commitment to patient care,” AVITA Medical CEO Jim Corbett said.
RECELL has already been approved by international regulatory authorities such as the Therapeutic Goods association in Australia and the CE mark of approval in Europe.
AVITA was down 3.41 per cent, trading at $4.82 at 3:40 pm AEST.