The news: Regenerative medicine business Avita Medical announced that its RECELL GO therapy, used in healing skin burns and wounds, has received key regulatory approval that would enable commercialisation of the product in Europe.
The context: On Monday, Avita Medical told the exchange that its RECELL GO product had received the CE mark under the European Union Medical Device Regulation. This enables the product to be commercialised in Europe and other markets that use the CE mark, like Switzerland and Turkey.
RECELL GO is used by medical professionals to prepare a sample of the patient’s skin cells that can then be “applied to promote healing in burns and traumatic or surgical wounds”. The product builds on the existing RECELL System, which is already in use in Europe.
RECELL GO will initially be commercialised in select European countries including Germany, Italy and the UK, through burn centres and clinical partners.