Positive Phase 2 trial interim analysis on safety and efficacy for denovoSkin™ in pediatric burn patients

CUTISS has completed an interim analysis in its Phase 2 clinical trial evaluating the safety and efficacy of denovoSkin™ in children with severe burns, with positive results.

The randomized, controlled trial enrolled 12 pediatric patients, comparing denovoSkin™ to the current standard of care (autografting) using an intra-patient control design.

The results from the interim analysis confirm a favorable safety profile and show positive signals of efficacy, supporting the continued development of denovoSkin™ for use in pediatric burn care.

Children with extensive burns are particularly vulnerable to complications related to scarring, such as impaired growth and mobility, and visible disfigurement. The findings of this study, together with the results obtained in several pediatric compassionate burn patients, represent an important step in pediatric skin surgery, aiming to offer a personalized, donor site-sparing solution that also addresses the lifelong impact of scarring on quality of life.

The 1 year analysis of the trial will follow; the trial has a total of 3 years of follow-up. In parallel, CUTISS is advancing denovoSkin™ in a Phase 3 clinical trial for adolescents and adults with severe burns in the E.U. and Switzerland, as detailed in our news on 6 May 2025.