Avita gets ID exemption for vitiligo deviceMarch 6, 2020
Avita Medical announced that the US FDA has approved the company’s Investigational Device Exemption (IDE) application to conduct a feasibility study evaluating the safety and effectiveness of the Recell Autologous Cell Harvesting Device for repigmentation of depigmented lesions associated with stable vitiligo.
The randomized controlled study’s primary effectiveness measure is the percent area of repigmented skin 24 weeks after treatment, as evaluated by a clinician blinded to the treatment assignment. Additional effectiveness data collected over the course of the 24-week study will include degree of repigmentation achieved and patient rating of repigmentation.
Avita Medical will collaborate with a leading medical centre to conduct a pilot study with 10 patients who have vitiligo lesions that have been stable
for at least one year. Areas of the vitiligo lesion will be randomly treated with slightly varying cell suspensions prepared using Recell to confirm response rates and optimal suspension parameters.