May 2025

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 (press release available here). Newsroom

CUTISS is making steady progress in the clinical development of denovoSkin™, its personalized, bio-engineered skin graft, as part of the ongoing Phase 3 clinical trial for the treatment of severe burns. The first enrolled patients have now been successfully grafted with denovoSkin™ at clinical sites in the Netherlands and Spain, with additional recruitment underway in France and Italy. There are eight sites involved in this confirmatory study in the EU. In parallel, the trial has also been approved in Switzerland by Swissmedic, with preparations in place to begin patient recruitment. We thank the clinical teams, surgeons, patients, collaborators, and stakeholders whose work and dedication is driving this important progress. Newsroom