CUTISS completes patient recruitment in Phase 2 pediatric burns trial

CUTISS has completed patient recruitment in its Phase 2 clinical trial evaluating the safety and efficacy of denovoSkin™ in children with severe burns.

This randomized, controlled trial compares denovoSkin™ to the current standard of care, autografting, using an intra-patient control design. It is one of three Phase 2 trials designed to assess denovoSkin™ – a personalized, bioengineered skin graft – across different patient populations and indications.

denovoSkin™ has also been used to treat children on a compassionate use basis where existing therapies are not sufficient or suitable.

Severe burns in children are associated with lifelong consequences, including scarring and restricted growth. By generating clinical evidence in pediatric patients, this study supports the broader development of denovoSkin™ as a skin tissue therapy designed to reduce donor site burden and improve long-term scar outcomes.

With recruitment now completed, the study moves into follow-up and data analysis. Results will contribute to the broader clinical development program of denovoSkin™, currently in Phase 3 for adolescents and adults.

In February 2025, CUTISS announced positive long-term efficacy and safety readout in the Phase 2 clinical trials of denovoSkin™ in reconstructive surgery as well as in burns treatment